Clinical Digest: A Comprehensive Review of Recent Abbvie Clinical Trials
This compilation provides an overview of Abbvie‘s recent clinical trial activity, encompassing up to 200 of their latest trials. Alongside these trials are potentially related publications, patents, and grant funding, which may include work from Abbvie or other entities exploring similar therapeutic areas. This resource aims to offer researchers, clinicians, investors, and the broader public insights into Abbvie’s current research and development pipeline. By presenting clinical trial details alongside related intellectual property and financial backing (regardless of origin), this compilation facilitates a broader understanding of Abbvie’s strategic focus and how it potentially compares to direct and indirect competitors in these therapeutic spaces. This information can be valuable for identifying emerging trends in drug development, assessing the commercial potential of specific research programs, and understanding the broader landscape of scientific contributions related to Abbvie’s clinical trials. (Last updated on: 2025-05-20)
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TABLE 1: Clinical Digest: A Comprehensive Review of Recent Abbvie Clinical Trials
| Clinical Trial | Contact(s) | Updated | |
|---|---|---|---|
| 1 | EpcoReal: A Multi-country, Prospective Observational Study of Epcoritamab in NHL Comprising Two Patient Cohorts (3L+ (D)LBCL and 3L+ FL) PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: Diffuse large B-cell lymphoma (DLBCL) is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections) and the most common type of non-Hodgkin lymphoma. Follicular Lymphoma (FL) is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the real-world effectiveness of subcutaneous epcoritamab in adult participants with advanced DLBCL and FL. Epcoritamab is an investigational drug being developed for treating participants with DLBCL and FL. Approximately 700 participants will be enrolled in approximately 80 sites across 12-20 countries globally. Participants will receive epcoritamab as prescribed by their physician in accordance with local country label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice. |
ABBVIE | 2025-05-16 |
| 2 | A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing The Safety and Efficacy of Upadacitinib to Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Topical therapies applied over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in pediatric participants with moderate to severe AD who are candidates for systemic therapy. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for treating AD patients aged 12 or older. Participants will receive upadacitinib (given as daily dose) or dupilumab (given at label indicated dose every 2 or 4 weeks). Participants will be stratified depending on disease severity, age and response to previous treatment. There is 1 in 5 chance for participants to receive dupilumab during the randomized cohort. Approximately 675 participants aged 2 to less than 12 years of age will be enrolled in this study at approximately 150 sites worldwide. The study population (As defined by participants age or prior treatment) to be enrolled in the study is dependent on local regulatory requirement and/or agreement. Participants will receive upadacitinib oral tablets once daily (or oral solution twice a day) for 160 weeks, … |
ABBVIE | 2025-05-16 |
| 3 | An Open-Label Extension of Studies M15-736 and M20-339 to Evaluate The Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects With Advanced Parkinson’s Disease PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Parkinson’s disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated. ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given as an infusion under the skin for the treatment of Parkinson’s Disease. Adult participants with advanced PD and who have completed M15-736 or M20-339 study will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 60 sites in the United States and Australia. Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of ABBV-951 for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical and remote telephone assessments, blood tests, checking for … |
ABBVIE | 2025-05-16 |
| 4 | A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate The Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants. |
ABBVIE | 2025-05-16 |
| 5 | A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine The Safety, Tolerability, Pharmacokinetics and RP2D of Livmoniplimab (ABBV-151) As A Single Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Locally Advanced or Metastatic Solid Tumors PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: The study will determine the recommended Phase 2 dose (RP2D) of livmoniplimab (ABBV-151) administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of livmoniplimab alone and in combination with budigalimab. The study will consist of 2 parts: dose escalation and dose expansion. |
ABBVIE | 2025-05-16 |
| 6 | A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With T(11;14)-Positive Relapsed or Refractory Multiple Myeloma PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone. |
ABBVIE | 2025-05-16 |
| 7 | An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate The Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Budigalimab in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) inhibitor (budigalimab) to adult participants to treat NSCLC. ABBV-400 and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of ABBV-400 in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 4 treatment groups. Two groups will receive budigalimab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive budigalimab, pemetrexed, and investigator’s choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed. One group will receive the standard of care (SOC) pembrolizumab, pemetrexed, and investigator’s choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 172 adult participants with NSCLC will be enrolled in … |
ABBVIE | 2025-05-16 |
| 8 | A Phase 3 Multicenter 24-Week Open-Label Study to Evaluate The Safety, Tolerability, and Efficacy of Atogepant When Added to OnabotulinumtoxinA (BOTOX) for The Preventive Treatment of Chronic Migraine PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Migraine is characterized by attacks of throbbing, moderate or severe headache, often associated with nausea, vomiting, and/or sensitivity to light and/or sound. The study will assess safety and tolerability of atogepant when added to BOTOX, as well as prospectively evaluate the efficacy of add-on atogepant for migraine prevention. Adverse events and change in disease activity will be monitored. Atogepant is an investigational drug being developed to prevent chronic migraine. Approximately 75 adult participants will be enrolled at approximately 30 sites in the United States. All participants will receive atogepant oral tablet once a day (QD) during the 24-week treatment period, in addition to their standard of care Botox. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. |
ABBVIE | 2025-05-16 |
| 9 | A Phase 2 Multicenter Platform Trial of Targeted Immunomodulator Therapies for Moderate to Severe Atopic Dermatitis PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. The purpose of this study is to evaluate the clinical efficacy and safety of single therapies and/or combination therapies for moderate to severe AD through multiple substudies. This study will consist of multiple sub-studies, Sub-Study 1 will have a randomized, placebo controlled period 1 followed by a lutikizumab treatment period 2 enrolling 80 participants at a 1 to 1 ratio. In Sub-Study 1, participants will receive subcutaneous (SC) injections of lutikizumab or matching placebo every other week for 16 weeks followed by an additional 32 weeks of subcutaneous (SC) injections of lutikizumab every other week for a total of 52 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and biomarker collections. |
ABBVIE | 2025-05-16 |
| 10 | A Phase 2 Dose Finding Study Evaluating The Safety and Efficacy of Linaclotide in Pediatric Subjects 6 Months to Less Than 2 Years of Age With Functional Constipation (FC) PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC. Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 3 groups, which occur consecutively. Each group receives a different dosage of linaclotide. In Part 2 of the study, participants will be randomly assigned to receive either linaclotide or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Up to 30 and at least 18 pediatric participants 6 months to less than 2 years of age with FC will be enrolled in the study at approximately 36 sites worldwide. Participants will receive oral solution of linaclotide prepared from capsule by parent/guardian once daily for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to … |
ABBVIE | 2025-05-16 |
| 11 | A Phase 1b, Open-Label Study of Eftozanermin Alfa (ABBV-621) in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Related Papers Related Patents Related Grants Related Experts Highlight: Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to determine recommended Phase 2 dose and change in disease symptoms of eftozanermin alfa in combination with bortezomib and dexamethasone to assess how efficient the treatment is in adult participants with relapsed/refractory (R/R) MM. Eftozanermin alfa (ABBV-621) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. Participants in one arm will receive different doses of eftozanermin alfa in combination with bortezomib and dexamethasone to determine phase 2 dose (RP2D). Participants in the other arm will receive eftozanermin alfa at RP2D in combination with bortezomib and dexamethasone. Around 40 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 20 sites across the world. Participants will receive eftozanermin alfa as an infusion into the vein in combination with bortezomib as an infusion into the vein or an injection under the … |
ABBVIE | 2025-05-16 |
| 12 | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate The Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in The Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17) PF:5 Related Papers Related Patents Related Grants Related Experts Highlight: Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants – PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment. For qualifying migraine … |
ABBVIE | 2025-05-15 |
| 13 | A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for The Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: Crohn’s disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD. The medicines assessed in this study are risankizumab, ABBV-382 and lutikizumab. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 500 participants will be enrolled in the study at approximately 300 sites worldwide. Risankizumab and ABBV-382 are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. Each group includes a 12-week induction period, a 12-week maintenance period, and an optional long-term extension period where medication will be given after the maintenance period. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend … |
ABBVIE | 2025-05-15 |
| 14 | A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate The Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects With Moderately to Severely Active Crohn’s Disease PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Crohn’s disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants. Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally. Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period … |
ABBVIE | 2025-05-15 |
| 15 | A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated C-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how safe telisotuzumab vedotin is in adult participants with NSCLC. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 70 to 80 sites worldwide. Participants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing … |
ABBVIE | 2025-05-15 |
| 16 | A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Multiple myeloma (MM) is a cancer of the blood’s plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants … |
ABBVIE | 2025-05-15 |
| 17 | Observational Retrospective CoHort Study on Practical ExperienceS of Treatment With Foslevodopa/foScaRbidopa in Advanced Parkinson’s Disease PF:6 Related Papers Related Patents Related Grants Related Experts Highlight: Main objective of this study is to describe the evolution of infusion settings (base, high and low infusion rates) of foslevodopa/foscarbidopa subcutaneous infusion (LDp/CDp) at different timepoints in the treatment of advanced Parkinson’s disease (aPD) as captured in ONE-CRM. |
ABBVIE | 2025-05-14 |
| 18 | SELECT-SLE: A Phase 3 Program to Evaluate The Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE PF:5 Related Papers Related Patents Related Grants Related Experts Highlight: Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is double-blinded, which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 4 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib. Study 4 is a 104-week continued extension if participation is likely to provide a benefit to their SLE. Approximately 500 participants diagnosed with SLE will be enrolled in each of … |
ABBVIE | 2025-05-14 |
| 19 | A Randomized, Phase 2/3 Study to Evaluate The Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: Non-Squamous Non-Small Cell Lung Cancer (NSCLC) remains a leading cause of cancer mortality worldwide, with poor survival prospects for metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab plus chemotherapy versus pembrolizumab plus chemotherapy in participants with untreated metastatic non-squamous non-small cell lung cancer. Livmoniplimab is an investigational drug being developed for the treatment of NSCLC. There are 2 stages to this study. In Stage 1, there are 4 treatment arms. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug) + chemotherapy, budigalimab +chemotherapy, or pembrolizumab +chemotherapy. In Stage 2, there are 2 treatments arms. Participants will either receive livmoniplimab (optimized dose) in combination with budigalimab +chemotherapy or placebo in combination with pembrolizumab +chemotherapy. Chemotherapy consists of IV Infused pemetrexed + IV infused cisplatin or IV infused or injected carboplatin. Approximately 840 adult participants will be enrolled in the study across 200 sites worldwide. Stage 1: In cohort 1, participants will receive intravenously (IV) infused livmoniplimab (dose A)+ IV infused budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + IV Infused pemetrexed. In cohort 2, participants will … |
ABBVIE | 2025-05-14 |
| 20 | A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate The Safety and Efficacy of Atogepant for The Preventive Treatment of Episodic Migraine in Pediatric Subjects 6-17 Years of Age PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17. Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or … |
ABBVIE | 2025-05-14 |
| 21 | A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Urothelial carcinoma (UC) is the ninth most common cancer type worldwide. While the treatment of front-line metastatic urothelial carcinoma (mUC) has improved, there remains a high unmet need for effective therapies for participants who have recurrent disease and disease that has progressed after frontline treatment. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab. Livmoniplimab is an investigational drug being developed for the treatment of mUC. There are 3 treatment arms in this study and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at one of 2 different doses) in combination with budigalimab (another investigational drug), or either docetaxel, paclitaxel, or gemcitabine (based on investigator’s choice). Approximately 150 adult participants will be enrolled in the study across 56 sites worldwide. In arm 1, participants will receive intravenously (IV) infused livmoniplimab (dose A) in combination with IV infused budigalimab. In arm 2, participants will receive IV infused livmoniplimab (dose B) in combination with IV infused budigalimab. In arm 3 (control), participants will receive the investigator’s choice: IV infused or injected docetaxel; IV infused or injected paclitaxel; or IV infused gemcitabine. The estimated duration of … |
ABBVIE | 2025-05-14 |
| 22 | A Randomized, Single-blind, Placebo-controlled, Phase 1 Study to Evaluate The Safety and Pharmacokinetics of Single Doses of ABBV-382 in Healthy Adult Chinese Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: The main objectives of this study are to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single subcutaneous (SC) and intravenous (IV) doses of ABBV-382 in healthy adult Chinese volunteers. |
ABBVIE | 2025-05-14 |
| 23 | A Phase 1 Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-453 in Adult Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries. The purpose of this study is to assess how well ABBV-453 works adult participants with relapsed/refractory (R/R) untreated CLL/small lymphocytic lymphoma (SLL). Adverse events, pharmacokinetics, and change in disease activity will be assessed. ABBV-453 is an investigational drug for the treatment of CLL and SLL. There are 2 parts to this study. In part A participants will be placed 1 of 5 cohorts with a specific target dose for each cohort and receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the appropriate target dose is achieved. In part B participants will be placed in 2 cohorts and receive up to the maximum dose in part A, with cohort 2.1 including a debulking period (obinutuzumab) as in part A. Approximately 80 adult participants with previously R/R CLL/SLL will be enrolled in the study in approximately 40 sites across the world. Participants in part A will placed into 1 of 5 cohorts with a specific target dose for each cohort and will receive intravenous (IV) obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the appropriate target dose is achieved. … |
ABBVIE | 2025-05-14 |
| 24 | A Prospective, Multicenter, Open-Label, Non-Randomized, Controlled Pivotal Study to Evaluate The Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix in Implant-Based Two Stage Prepectoral Breast Reconstruction Post-Mastectomy PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy. |
ABBVIE | 2025-05-13 |
| 25 | A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated C-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 300 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked … |
ABBVIE | 2025-05-13 |
| 26 | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose Study to Evaluate The Efficacy, Safety, and Tolerability of ABBV-932 As An Adjunct to Antidepressant Therapies in The Treatment of Subjects With Generalized Anxiety Disorder Who Have Had An Inadequate Response to Antidepressant Therapies PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess how safe and effective ABBV-932 is when added to the antidepressant therapies in adult participants with GAD who have had an inadequate response ADTs. ABBV-932 is an investigational drug being developed for the adjunctive treatment of GAD. Participants will be randomly assigned to receive ABBV-932 or Placebo in addition to their currently prescribed ADTs. There is 1 in 3 chance of participants assigned to Placebo. Approximately 315 adult participants with GAD and inadequate response to ADTs will be enrolled in approximately 50 sites in the United States and Puerto Rico. Participants will receive oral capsules of ABBV-932 or matching placebo in addition to their prescribed ADT for 6 weeks and then will be followed for an additional 4 week follow-up period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing … |
ABBVIE | 2025-05-13 |
| 27 | A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV 324 in Adults With Hepatocellular Cancer or Squamous Cell Non-Small Cell Lung Cancer PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: HCC is a common cancer worldwide and a leading cause of cancer-related death. Lung cancer is the most frequently diagnosed cancer in the world, and the leading cause of cancer deaths. The purpose of this study is to assess adverse events and change in disease activity when ABBV-324 is given to adult participants to treat hepatocellular cancer (HCC) or squamous-cell non-small cell lung cancer (LUSC). ABBV-324 is an investigational drug being developed for the treatment of HCC and LUSC. Study doctors put the participants in groups called arms. Each arm receives ABBV-324 alone (monotherapy) or a comparator drug, lenvatinib followed by a safety follow-up period. Approximately 232 HCC or LUSC will be enrolled in the study in approximately 45 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of ABBV-324 until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will receive ABBV-324, or a comparator of oral lenvatinib. The study will run for a duration of approximately 6.5 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at … |
ABBVIE | 2025-05-13 |
| 28 | A Prospective, Multicenter Clinical Study to Evaluate The Safety and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Subjects With Glaucoma PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab interno (inside the eye) and ab externo (outside the eye) approach. Adverse events and intraocular pressure will be assessed. XEN63 is an investigational device for the treatment of intraocular pressure (IOP) in patients with glaucoma when both medical and conventional surgical treatments have failed (for US approval) and when medical treatments have failed (for outside US \[OUS\] approval). Participants will be placed in one of two groups called study arms. One group will receive the XEN63 gel stent ab interno (inside the eye) and the other group will receive the XEN63 gel stent ab externo (outside the eye). Approximately 130 participants aged 45 years or older with glaucoma will be enrolled in this study at approximately 32 sites in select countries in North America and Europe. Participants will receive XEN63 implanted using either the ab interno approach or the ab externo approach on Day 1 and will be followed for 12 months. Participants will attend regular visits during the study at a hospital or clinic. The … |
ABBVIE | 2025-05-13 |
| 29 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Efficacy, Safety, and Tolerability of Ubrogepant for The Preventive Treatment of Menstrual Migraine With An Open-Label Extension PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed. Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 450 adult female participants with menstrual migraine will be enrolled in approximately 100 sites in the United States and Puerto Rico. Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per … |
ABBVIE | 2025-05-13 |
| 30 | A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for The Treatment of Adult Subjects With Active Psoriatic Arthritis PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Psoriatic arthritis (PsA) is a type of arthritis that happens when the body’s immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies, for the treatment of active psoriatic arthritis and to assess the changes in disease symptoms. The therapies being assessed in this sub-study are risankizumab and lutikizumab. Participants will be randomized in a 1:1:1 ratio to one of the three treatment arms: lutikizumab monotherapy, risankizumab monotherapy or a combination therapy of lutikizumab and risankizumab. Around 120 participants will be enrolled in the study at approximately 40 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. |
ABBVIE | 2025-05-13 |
| 31 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With An Open-Label Extension to Evaluate The Efficacy, Safety, and Tolerability of Atogepant for The Preventive Treatment of Menstrual Migraine PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often throbbing or pulsating. The headache is often accompanied by sensitivity to light, sensitivity to sound, nausea, or other symptoms. Menstrual migraine (MM) attacks are migraine attacks that occur in individuals before or during their menstrual period. The main goals of the study are to evaluate the efficacy (how well the medicine works), safety, and tolerability (the degree to which any adverse symptoms can be handled by the patients during the study) of atogepant, compared to placebo (looks like the study treatment but has no medicine in it), for the prevention of MM. Atogepant is an investigational drug being developed for the preventive treatment of menstrual migraine. Participants are randomly assigned to one of the 2 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 2 chance for the participant to receive placebo. Approximately 430 adult female participants with menstrual migraine will be enrolled in approximately 85 sites across the world. Participants will receive oral atogepant or matching placebo for 3 menstrual cycles during the double-blind period. During the open-label treatment period, participants will … |
ABBVIE | 2025-05-13 |
| 32 | A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate The Safety and Efficacy of Atogepant for The Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Migraine is a disease that most often causes moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age. Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world. Participants will receive oral tablets of atogepant or placebo once daily for … |
ABBVIE | 2025-05-13 |
| 33 | A Phase 1 First-In-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-291 in Non-Hodgkin’s Lymphoma PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Non-Hodgkin’s lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-291 in adult participants in relapsed or refractory (R/R) NHL, including but not limited to diffuse large b-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL). Adverse events will be assessed. ABBV-291 is an investigational drug being developed for the treatment of NHL. This study will include a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-291 and a dose expansion/optimization phase to determine the change in disease activity in participants with R/R NHL. Approximately 165 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide In the dose escalation phase of the study participants will receive escalating Intravenously (IV) infused doses of ABBV-291, until the MAD/MTD is determined. In the dose expansion/optimization phase of the study participants receive IV infused ABBV-291, as part of the approximately 74 month study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will … |
ABBVIE | 2025-05-13 |
| 34 | A Prospective, Post-marketing, Non-interventional Study of RISankizumab Evaluating Real-world Clinical Effectiveness in Crohn’s Disease (APPRISE) PF:5 Related Papers Related Patents Related Grants Related Experts Highlight: Crohn’s disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective risankizumab is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed. Risankizumab is a drug approved for the treatment of CD. All study participants will receive risankizumab as prescribed by their study doctor in accordance with approved local label. Approximately 1000 participants will be enrolled worldwide. Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 36 months. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care. |
ABBVIE | 2025-05-09 |
| 35 | A 6-Week, Double-Blind, Placebo-Controlled Study Evaluating The Efficacy and Safety of Cariprazine in The Acute Exacerbation of Schizophrenia, With An Additional 18-Week Blinded Extension Period PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess how safe and effective cariprazine is in treating adult participants with schizophrenia in Japan and Taiwan. Adverse events and change in disease activity will be assessed. Cariprazine (VRAYLAR) is an approved drug for the treatment of schizophrenia in the United States. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Approximately 402 adult participants, 18-65 years of age with schizophrenia will be enrolled in approximately 75 sites across Taiwan and Japan. Participants will receive oral capsules of cariprazine or placebo for 6 weeks. Upon completion of 6-week treatment period, participants will be eligible to receive oral capsules of cariprazine for additional 18 weeks. The safety follow up period will follow after for an additional 8 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of … |
ABBVIE | 2025-05-09 |
| 36 | A ProspeCtive ObseRvatioNal Study of Atogepant Effectiveness in Routine Clinical Practice PF:5 Related Papers Related Patents Related Grants Related Experts Highlight: Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will evaluate the effectiveness of atogepant in treating adult participants with migraine in a real-world setting. Atogepant is an approved drug for preventive treatment of migraine in adults. Approximately 1000 adult participants who are prescribed atogepant by their doctors will be enrolled in this study across the world. Participants will receive atogepant oral tablets as prescribed per standard clinical practice and will be followed for 2 years. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice. |
ABBVIE | 2025-05-08 |
| 37 | A Phase 3b/4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluate The Efficacy and Safety of Upadacitinib for The Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis and Inadequate Response to Dupilumab (SWITCH-UP) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD. Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab Dose A. Based on the participants response to upadacitinib Dose A, they may have their dose increased to upadacitinib Dose B after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 300 adult participants ages 18 to 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 94 … |
ABBVIE | 2025-05-08 |
| 38 | A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate The Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa PF:5 Related Papers Related Patents Related Grants Related Experts Highlight: Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with moderate to severe HS . Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms. In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period … |
ABBVIE | 2025-05-07 |
| 39 | A Phase 1 Study With AGN-151586 and OnabotulinumtoxinA in Subjects for Treatment of Glabellar Lines (GL) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: The objective of this Phase 1 study is to assess the safety and efficacy of single treatment of AGN-151586 and of OnabotulinumtoxinA in the glabellar complex of participants with moderate to severe glabellar lines (GL). |
ABBVIE | 2025-05-07 |
| 40 | A Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Safety and Efficacy Study of Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation (FC) With A 24-week Open-label Treatment Extension PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC. Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients, ages 2 to 5, who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. All participants in Part 2 will receive linaclotide. Approximately 116 participants aged 2 to 5 years with FC will be enrolled in this study at around 45 sites worldwide. Participants will receive daily doses of oral Linaclotide capsules or matching placebo for 12 weeks in Part 1 of the study. In Part 2, the open label long-term safety extension, participants with FC who completed study intervention in Part 1 of Study M21-572 or the Phase 2 Study LIN-MD-67 will receive … |
ABBVIE | 2025-05-07 |
| 41 | A Randomized Phase 2 Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Patients With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: The purpose of this study is to evaluate the incidence rate and severity of prespecified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer \[PSOC\] or platinum-resistant ovarian cancer \[PROC\]) with high folate receptor alpha (FRα) expression. |
ABBVIE | 2025-05-07 |
| 42 | A Phase 3, Multi-Center Study to Evaluate The Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Crohn's Disease PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Crohn’s Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to \< 18 years old who have had intolerance or inadequate response to other therapies. Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and CD and is being developed for the treatment of CD in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based induction regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 110 ... |
ABBVIE | 2025-05-07 |
| 43 | A Phase 1 Study With ABBV-CLS-484 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: The study will assess the safety, PK, PD, and preliminary efficacy of ABBVCLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a or a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). The trial aims to establish a safe, tolerable, and efficacious dose of ABBVCLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy). Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors. Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid tumors. Part 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting or with a VEGFR … |
ABBVIE | 2025-05-06 |
| 44 | An Extension Study of Venetoclax for Subjects Who Have Completed A Prior Venetoclax Clinical Trial PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: The purpose of this extension study is to provide venetoclax and obtain long-term safety data for subjects who continue to tolerate and derive benefit from receiving venetoclax in ongoing studies. |
ABBVIE | 2025-05-06 |
| 45 | Evaluation of Function And Satisfaction of UbrogepanT-treated Migraine Patients in Canada (FAST): Prospective, Observational, Real-world Study PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will evaluate function and satisfaction with oral ubrogepant in treating adult participants after multiple migraine attacks. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Approximately 167 participants will be enrolled in approximately 10-15 sites across Canada. Participants will receive ubrogepant as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 12 weeks. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice. |
ABBVIE | 2025-05-06 |
| 46 | BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults. |
ABBVIE | 2025-05-06 |
| 47 | Effectiveness of Upadacitinib in Patients With Axial Spondyloarthritis Suffering From Typical Disease Activity and Pain in A Real-World Setting PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain that might be difficult to distinguish from other causes of chronic back pain. Many participants report persistent pain, including back pain, which impacts disease activity and and impairs quality of life while evoking typical disease burden such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. This study will assess the real-world effectiveness of upadacitinib on early and sustained disease control, and the association between pain and clinical/patient-reported outcomes in axSpA participants. Upadacitinib is being developed for the treatment of axSpA. Approximately 352 adult participants with active axSpA will be enrolled in Germany. Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. The overall duration of the study is approximately 52 weeks. There may be a higher burden for participants in this study compared to usual standard of care due to study procedures. Participants will attend regular visits per routine clinical … |
ABBVIE | 2025-05-06 |
| 48 | A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate The Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous (SC) administration with on-body Injector in Healthy Adult Participants. |
ABBVIE | 2025-05-06 |
| 49 | A Phase 3, Prospective, Open-Label, Multicenter Study to Evaluate The Safety, Efficacy and Pharmacokinetics of Paricalcitol Oral Solution for The Treatment of Secondary Hyperparathyroidism in Pediatric Subjects Ages 0 to 9 Years With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal Dialysis (PD) or Hemodialysis (HD). The 24-week study is divided into two 12-week dosing periods (Dosing Period 1 followed by Dosing Period 2). |
ABBVIE | 2025-05-06 |
| 50 | A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Arm Study to Assess The Safety and Efficacy of A Single Treatment of BOTOX, Followed By An Optional Open-Label Treatment With BOTOX, in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic and debilitating urological complex of disorders characterized by symptoms of bladder pain or discomfort, mostly upon bladder filling, and often accompanied by lower urinary tract symptoms (LUTS). This study will assess how safe and effective BOTOX (onabotulinumtoxinA) is in treating IC/BPS. Adverse events and change in disease symptoms will be evaluated. BOTOX (onabotulinumtoxinA) is an investigational drug being developed for the treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Study doctors randomly assign the participants to 1 of 2 groups, called treatment arms, to receive BOTOX or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 80 female participants, aged 18 to 75 years, with a diagnosis of IC/BPS will be enrolled in approximately 40 sites in the United States and Canada. Participants will receive BOTOX or placebo injected into the bladder on Day 1 and will be followed for at least 12 weeks in treatment 1. Eligible participants may request additional dose of BOTOX between Weeks 12 and 24, and will be followed for 12 weeks in treatment period 2. There may be higher treatment burden for participants in this trial compared to their standard … |
ABBVIE | 2025-05-06 |
| 51 | A Phase 3b Study to Evaluate The Safety and Efficacy of Elagolix in Combination With Combined Oral Contraceptives in Premenopausal Women With Documented Endometriosis and Associated Moderate to Severe Pain PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain. Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico. Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18. There will be higher … |
ABBVIE | 2025-05-02 |
| 52 | A Prospective, Multi-center, Open-label Study to Evaluate Subject Satisfaction and Natural Outcomes Following Administration of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects With Upper Facial Lines (Glabellar Lines, Lateral Canthal Lines, and Forehead Lines) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Facial lines that develop from repeated facial expression, such as glabellar lines (GL), lateral canthal lines (LCL), and forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate participant satisfaction and natural outcomes following the administration of BOTOX Cosmetic in adult participants with upper facial lines (GL, LCL, and FHL). This is an open-label study in which all participants will receive active study treatment. Around 100 adult participants with an assessment of moderate to severe GL, LCL, and FHL, will be enrolled at approximately 10 sites in the United States and Canada. Participants will receive BOTOX Cosmetic as intramuscular injections to the glabellar lines, lateral canthal lines, and forehead lines at Day 1. Participants will attend regular visits during the study. The effect of the treatment will be checked by medical assessments for side effects and questionnaires will be completed during regular study visits. |
ABBVIE | 2025-05-02 |
| 53 | A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Crohn’s Disease and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, And/or Biologic Therapy PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Crohn’s disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn’s Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active … |
ABBVIE | 2025-05-02 |
| 54 | Multi-Country Prospective Real-World Study to Validate The CLCI Instrument (DermCLCI-p) in Patients With Moderate-to-Severe Chronic Plaque Psoriasis (IMMagine) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: The IMMagine study aims to validate the newly developed CLCI instrument (DermCLCI-p) in moderate to severe psoriasis (PsO) patients, who will be started on Risankizumb (RZB) treatment and will be enrolled into the validation study up to 28 weeks. The treatment decision for RZB must be made independent of this study enrollment. |
ABBVIE | 2025-05-02 |
| 55 | A Phase 2 Open-Label Study of The Efficacy of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: This is a Phase 2, open-label, multicenter study, evaluating the efficacy of venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) either in presence of 17p deletion (Cohort 1) or those who have failed a B-receptor signaling pathway inhibitor (BCRI) therapy and who have also failed, or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status (Cohort 2). |
ABBVIE | 2025-05-02 |
| 56 | A Phase 1, Randomized, Placebo-controlled Trial to Evaluate The Safety, Tolerability, and Pharmacokinetics of Emraclidine Following Multiple Oral Doses in Healthy Elderly Participants (Part A) and to Evaluate The Safety and Tolerability of Emraclidine in Participants With Dementia Due to Alzheimer’s Disease (Part B) PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: The primary purpose of the study is to evaluate the safety and tolerability of emraclidine administered orally to healthy elderly participants in Part A (multiple ascending doses) and participants with dementia due to Alzheimer’s disease (AD) in Part B. |
ABBVIE | 2025-05-02 |
| 57 | A Post-marketing Observational Study for ABBV-951 in Patients Diagnosed With Advanced Parkinson’s Disease (aPD) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Parkinson’s disease (PD) is a neurological condition, which affects the brain. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to assess how safe and effective ABBV-951 is in treating participants with Parkinson’s disease in real world setting. ABBV-951 is an approved drug being developed for the treatment of PD in Japan. Approximately 250 adult participants over 15 years with a diagnosis of PD who are prescribed ABBV-951 by their physicians will be enrolled in this study across Japan. Participants will receive ABBV-951 as prescribed their physician and followed for 52 weeks. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care. |
ABBVIE | 2025-05-01 |
| 58 | A Multi-Center, Open-Label Study of The Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Ulcerative Colitis Who Completed The Study M11-290 PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis. |
ABBVIE | 2025-05-01 |
| 59 | Mass Balance Study of [14C] ABBV-932 Following Single Oral Dose Administration in Healthy Male Volunteers Related Papers Related Patents Related Grants Related Experts Highlight: The main objective of this study is to assess the safety and tolerability of ABBV-932 in healthy adult male participants. |
ABBVIE | 2025-05-01 |
| 60 | Botulinum A Toxin (OnabotulinumtoxinA) Use in Mexican Pediatric Population With Spasticity Associated With Cerebral Palsy: Phase IV, Observational, Non-Interventional, Prospective, Multicenter Study PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. Upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. This study will assess how effective OnabotulinumtoxinA is in treating pediatric participants with Spasticity. Change in disease activity will be evaluated. OnabotulinumtoxinA is approved drug for treatment of Spasticity. Approximately 106 pediatric participants aged 2-17 years with spasticity associated with cerebral palsy will be enrolled in approximately 10 sites across Mexico. Participants will receive OnabotulinumtoxinA as prescribed by their physician in accordance to local label and followed for 12 months. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits to a hospital or clinic in their routine practice. |
ABBVIE | 2025-04-30 |
| 61 | Non-interventional Prospective Descriptive Study to Assess The Impact on Patient´s Well-being of Fixed-time Duration (FTD) and Continuous Oral Regimens for Newly Diagnosed and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) in Routine Clinical Practice in Spain PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Chronic lymphocytic leukemia (CLL) is the most common leukemia in the Western world. Since in most cases CLL remains an incurable disease, the goals of therapy are to improve quality of life and to prolong survival. This study will evaluate the participant’s related outcomes and experience of CLL in adult participants who are treated in the Spain. Study participants will receive oral treatments for CLL as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed various treatments will be enrolled. Around 132 participants will be enrolled in the study in sites in Spain. Participants will receive oral treatments for CLL according to the approved local label. The overall study duration will be 18 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice. |
ABBVIE | 2025-04-30 |
| 62 | A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, And/or Biologic Therapy PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective Upadacitinib is in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 44-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 260 week open-label extension (OLE) of Period 1. Approximately 110 pediatric participants with moderate to severely active UC will be enrolled at up to 100 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each … |
ABBVIE | 2025-04-29 |
| 63 | Multicenter, Evaluator-blinded, Randomized, Controlled Study of The Safety and Effectiveness of JUVÉDERM® VOLITE™ XC Injectable Gel for Improvement in Neck Appearance PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: The cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The neck is a frequently mentioned area by patients complaining about its crepey texture and deep lines. VOLITE XC is a crosslinked HA gel implant formulated with lidocaine that was developed to provide a safe, minimally invasive method of treating fine lines and improving skin quality. The purpose of this study is to assess adverse events and effectiveness of VOLITE XC in adults seeking improvement in neck appearance. VOLITE XC is an investigational product being developed for the improvement of horizontal neck lines. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in 3 chance that participants will be assigned to the control group. Around 212 adult participants with transverse neck lines will be enrolled in the study at approximately 20 sites. Participants in the treatment group will receive VOLITE XC at Day 1 and followed for up to 14 Months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of VOLITE XC during the follow-up duration period. The control group received … |
ABBVIE | 2025-04-29 |
| 64 | Real World Clinical and Patient-Reported Outcomes of Patients With Moderate-to-Severe Rheumatoid Arthritis Initiating Upadacitinib in The United Kingdom: A Prospective, Observational Cohort Study PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. RA can reduce the ability to perform everyday tasks. This study will assess the clinical and patient-reported outcomes with upadacitinib in adult participants with moderate-to-severe RA in a real-world setting. Upadacitinib is an approved drug for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate. Adult participants with moderate-to-severe RA will be enrolled. Around 150 participants will be enrolled in the study in multiple sites in the United Kingdom. Participants will receive upadacitinib per their physician’s usual prescription. Individual data will be collected for 6 months. No additional study-related tests will be conducted during the routine physician visits. Only data which are routinely collected during a regular visit will be utilized for this study. |
ABBVIE | 2025-04-29 |
| 65 | An Open-Label Phase 1b Study Evaluating The Safety and Efficacy of Etentamig (ABBV-383) in AL Amyloidosis PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Immunoglobulin light chain (AL) amyloidosis is the most common form of systemic amyloidosis. AL amyloidosis has many root causes and is characterized by the overproduction of AL that are secreted by clonal bone marrow plasma cells. This is a study to determine adverse events and change in disease activity in adult participants with AL amyloidosis treated with ABBV-383. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of AL amyloidosis. This study in broken into 2 parts (dose escalation and safety expansion) with 5 arms. During dose escalation (arms 1-3) participants will receive 1 of 3 doses of ABBV-383 to determine the part 2 doses. After completion of the dose escalation portion of the study, the safety expansion (part 2) portion of the study will begin. Two arms (arm 4-5) will begin and participants will receive 1 of 2 doses as determined during the dose escalation portion (part 1). Around 76 adult participants with relapsed/refractory AL amyloidosis will be enrolled at approximately 20 sites across the world. Participants will receive Etentamig (ABBV-383) as an infusion into the vein for up to approximately 2 year study duration. There may be higher treatment burden for participants in this trial compared … |
ABBVIE | 2025-04-29 |
| 66 | A Prospective, Open-Label, Phase IIb/III Study to Evaluate The Risk of TLS and Optimization of The Initiation of Venetoclax in Combination With Obinutuzumab or Acalabrutinib With Different Ramp- Up Periods in Previously Untreated Subjects With CLL PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 120 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide. Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months. There may be higher treatment burden for participants … |
ABBVIE | 2025-04-25 |
| 67 | Open-label, Randomized, Assessor-blinded, Efficacy, Safety, Tolerability, and Pharmacokinetics Study of Subcutaneous Risankizumab With An Adalimumab Reference Arm in Children With Active Juvenile Psoriatic Arthritis PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Psoriatic arthritis (PsA) is a type of arthritis that happens when the body’s immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient’s 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms. Risankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide. Participants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be … |
ABBVIE | 2025-04-25 |
| 68 | A Multicenter, Open-Label, Phase 2 Study to Evaluate The Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events and change in disease activity will be assessed. Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study in approximately 60 sites worldwide. Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. … |
ABBVIE | 2025-04-25 |
| 69 | Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination With Ruxolitinib Versus Best Available Therapy in Subjects With Relapsed/Refractory Myelofibrosis (TRANSFORM-2), Incorporating Extension Arm C – Continued Access for Navitoclax to Roll Over Subjects From Studies M10-166, M16-109, M16-191, and M19-753 PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, compared to best available therapy, for adult participants with MF. Navitoclax is an investigational drug (not yet approved) being developed for the treatment of MF. Participants in this study will be randomly selected (like picking numbers out of a hat) to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to pick which treatment arm a participants enters. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best available therapy (BAT) for MF. In Arm C, participants will receive navitoclax. Adult participants with a diagnosis of MF that came back or did not get better after earlier treatment will be enrolled. Approximately 330 participants will be enrolled in approximately 322 sites across the world. In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth ruxolitinib tablet twice daily. In Arm B, participants will … |
ABBVIE | 2025-04-24 |
| 70 | A Phase 1/2 Study to Evaluate The Safety and Efficacy of AGN-193408 SR in Participants With Open-Angle Glaucoma or Ocular Hypertension PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-groups (Cohort 2) and (Cohort 3) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension |
ABBVIE | 2025-04-24 |
| 71 | A Study to Assess The Effect of Food on ABBV-101 Pharmacokinetics When Administered As An Oral ABBV-101 Tablet Formulation in Healthy Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: This study will assess the effect of food (high fat) on oral ABBV-101 and how ABBV-101 moves through the body in healthy adult participants |
ABBVIE | 2025-04-23 |
| 72 | Prospective Observational Study Of Upadacitinib in Ulcerative Colitis in China PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Ulcerative colitis (UC) is a chronic, relapsing, and incurable inflammatory disease of the large intestine. The hallmark clinical symptoms include bloody diarrhea associated with rectal urgency and tenesmus.. This study will assess how effective upadacitinib is in treating UC within a Chinese population. Upadacitinib is an approved drug for treating UC. Approximately 80 adult participants, who have been prescribed upadacitinib for UC by their physician in accordance with local label, will be enrolled in China. Upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. Participants in the study will be followed for up to 1 year. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and only data which are routinely collected during a regular visit will be utilized for this study. |
ABBVIE | 2025-04-23 |
| 73 | Comparison of Persistence of UPadacitinib Vs. TNF-inhibitoRs In A German Real-world SettING PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: This study will compare the retention rates for UPA vs. TNFi treatment in adult participants with moderate to severe active RA per local label and according to local standard of care This is a mono-country, prospective, multi-center observational study in patients with moderate to severe active RA receiving UPA or TNFi therapy. Around 678 participants will be enrolled in approximately 80 sites in Germany. Study recruitment will last approximately 24 months, and the study participation time will be up to 24 months, for a total study duration of approximately 48 months. |
ABBVIE | 2025-04-22 |
| 74 | A Phase 2b Double-Blind, Placebo-Controlled, Adaptive, Dose-Escalation Study to Evaluate The Safety and Efficacy of OnabotulinumtoxinA for The Achievement of Primary Fascial Closure Without The Use of Component Separation Technique, in Subjects Undergoing Open Abdominal Ventral Hernia Repair PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Ventral hernias form when there is a loss of integrity of the abdominal wall muscles. Abdominal hernias can expand and can cause severe pain as the abdominal wall weakens. The purpose of this study is to evaluate the safety and efficacy of a range of onabotulinumtoxinA (BOTOX) doses to achieve primary fascial closure (PFC) without use of component separation technique (CST) in ventral hernia surgical repair. BOTOX is an investigational drug being developed for the treatment of ventral hernias. In this dose escalation study, participants will be placed in 1 of 3 cohorts. Cohort 1 will be randomized to receive placebo or 1 of 2 BOTOX doses, after which time Cohort 2 will be randomized to receive placebo or 1 of 3 BOTOX doses. Participants in Cohort 3 will be randomized to receive placebo or 1 of 3 BOTOX doses. Adult participants undergoing open abdominal ventral hernia repair will be enrolled. Around 200 participants will be enrolled in the study at approximately 20 sites in the United States. Participants will receive a single intramuscular injection of BOTOX Dose A, BOTOX Dose B, BOTOX Dose C, or placebo. There may be higher treatment burden for participants in this trial compared to … |
ABBVIE | 2025-04-22 |
| 75 | Venetoclax Real-World Observational Study on Effectiveness and Treatment Management in Patients With Newly Diagnosed AML Who Are Ineligible for Intensive Chemotherapy in Italy PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well venetoclax in combination with azacitidine works to treat AML in newly diagnosed adult participants who are ineligible for intensive chemotherapy in Italy. Venetoclax in combination with azacitidine is approved in Italy to treat Acute myeloid leukemia (AML) in newly diagnosed adults who are ineligible for intensive chemotherapy. All study participants will receive venetoclax in combination with azacitidine as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML will be enrolled. Around 150 participants will be enrolled in the study at approximately 20-25 sites in Italy. Participants will receive venetoclax tablets to be taken by mouth in combination with azacitidine given by subcutaneous (SC) injection according to the approved local label. The duration of the study is approximately 18 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 18 months. |
ABBVIE | 2025-04-22 |
| 76 | A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B). |
ABBVIE | 2025-04-22 |
| 77 | A Phase 4 Study of Venetoclax in Combination With Azacitidine in Newly Diagnosed Subjects With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy in China PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for participants who are unable to undergo intensive chemotherapy, the current standard of care. This study is to evaluate how safe the combination of azacitidine and venetoclax is and how effective the combination of azacitidine and venetoclax is in adult participants with acute myeloid leukemia (AML), in China. Adverse events and change in disease state will be assessed. The combination of azacitidine and venetoclax is being evaluated in the treatment of acute myeloid leukemia (AML). Participants will receive azacitidine with increasing doses of venetoclax. Adult participants with a diagnosis of AML will be enrolled. Around 40 participants will be enrolled in the study in approximately 30 sites in China. At cycle 1 during ramp-up period, participants will receive venetoclax oral tablets once daily in increasing doses until the study dose is achieved on day 3. Then ventoclax oral tablets will continue once daily thereafter. Azacitidine will be given by subcutaneous injection (SC) for 7 days beginning on Day 1 of each 28-day cycle. There may be higher treatment burden for participants in this trial compared to their standard of … |
ABBVIE | 2025-04-22 |
| 78 | A Phase 3b/4 Randomized, Double-blind, Dose-Flexibility Study of Upadacitinib in Adult Subjects With Moderate to Severe Atopic Dermatitis (Flex-Up) PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study evaluates the dosing flexibility of upadacitinib in adult participants with moderate to severe AD. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for the treatment of moderate to severe/active immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and AD. The study is comprised of a 35-day Screening Period, a 12-week double-blind period and a 12-week single-blind period. During the double-blind period, participants are placed in 1 of 2 groups, called treatment arms and will be randomized in a 1:1 ratio to receive upadacitinib. At 12 weeks during the single blind period, participants will be blinded to the upadacitinib dose based on their EASI response and reassigned to in 1 of 6 arms. Non-responders will be placed in the Non-responder arm on or after Week 16 and will receive upadacitinib. After the last study visit, there is a 30-day follow-up visit. Approximately 600 adult participants … |
ABBVIE | 2025-04-20 |
| 79 | A Multi-country, Prospective, Post-marketing Study of UPadacitinib Evaluating Speed of Onset and Durability of Effectiveness for Patients With Moderate to Severe Crohn’s Disease for 3 Years in Real-world Clinical Practice (UPlift) PF:5 Related Papers Related Patents Related Grants Related Experts Highlight: Crohn’s disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Speed of onset and durability of effectiveness will be assessed. Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1200 participants will be enrolled in approximately 230 sites across the world. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care. |
ABBVIE | 2025-04-18 |
| 80 | A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy. |
ABBVIE | 2025-04-18 |
| 81 | Non-Interventional, Prospective Observational Cohort Study to Investigate The Effectiveness and Sustained Disease Control of An Upadacitinib Therapy in Moderate to Severe Atopic Dermatitis Patients Over Two Years PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study will assess the real-world effectiveness of upadacitinib on early and sustained response along adolescent and adult participants with AD. This study also aims to understand upadacitinib utilization patterns in real-world clinical practice. Upadacitinib (RINVOQ) is approved in the EU for the treatment of moderate to severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy. Approximately 772 adolescent and adult participants with AD will be enrolled at up to 200 sites in Germany. Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. The overall duration of the study is approximately 2 years. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires. |
ABBVIE | 2025-04-18 |
| 82 | A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy. |
ABBVIE | 2025-04-18 |
| 83 | Cariprazine Real-world Use in Bipolar I Disorder: Effectiveness, Functioning, Quality of Life, and Tolerability PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Bipolar I disorder (BP-I) is a common, chronic, and disabling mental illness with significant morbidity and mortality defined by episodes of mania and depression (or symptoms of both at once, known as mixed features). This prospective, observational study will examine effectiveness, functioning and quality of life outcomes in adult patients with BP-I experiencing a major depressive episode (with or without mixed features) requiring treatment and initiating treatment with cariprazine. It will examine outcomes of cariprazine treatment in a real-world setting in patients with BP-I commonly seen in clinical practices. Cariprazine (Vraylar) is a medication indicated in the United States and Canada to treat adult patients experiencing manic, mixed or depressive episodes associated with BP-I. This study plans to enroll approximately 170 adult patients with BP-I from the United States and Canada. Cariprazine should be prescribed by the physician under the usual and customary practice of physician prescription. The decision to initiate treatment with cariprazine should be made prior to, and independently from, the patient’s decision to participate in the study. Participants will receive cariprazine as prescribed by their physician. Observational data will be collected during visits which should align to routine standard of care for a duration of up to … |
ABBVIE | 2025-04-18 |
| 84 | A Prospective, Real-World Study EvalUating The EffectiveNess and Safety of RISankizumab in PatiEnts With Ulcerative Colitis (SUNRISE-UC) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess the change in disease activity of risankizumab treatment in adult participants with moderate to severe UC in real-world clinical practice. Risankizumab is an approved drug for treating participants with ulcerative colitis. Approximately 200 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately multiple sites across Germany and Austria. Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 52 weeks. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice. |
ABBVIE | 2025-04-18 |
| 85 | Prospective Multi-country, Real-world, Multi-arm Study of Treatment PErsistence With RISankizumab in Psoriatic Arthritis (PERIS) PF:5 Related Papers Related Patents Related Grants Related Experts Highlight: Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. This study aims to describe the long term usage and effectiveness with risankizumab (RZB) relative to other advanced therapeutic options for the management of PsA in daily clinical practice. Risankizumab is an approved drug for the treatment of psoriatic arthritis. The study will not be conducted in the United States, however it will be conducted in approximately 15 countries and include at least 900 and up to 1200 participants with a 2 to1 ratio of participant allocation between participants receiving risankizumab and participants receiving other advanced therapeutic agents. The therapy is prescribed in the usual manner in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. All study visits will occur during routine clinical practice and participants will be followed for 24 months. There is expected to be no additional burden for participants in this study. |
ABBVIE | 2025-04-17 |
| 86 | A Post-marketing Non-interventional Study for Upadacitinib in Patients With Moderately to Severely Active Crohn’s Disease (CD) in Japan PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Crohn’s disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed. Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 240 participants will be enrolled in Japan. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 64 weeks. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care. |
ABBVIE | 2025-04-17 |
| 87 | First-in-Human Study to Evaluate The Safety, Pharmacokinetics, and Preliminary Efficacy of The BTK Degrader, ABBV-101, in Participants With B-cell Malignancies PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Non-Hodgkin’s lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed or refractory (R/R) non-Hodgkin’s lymphomas: third line or later of treatment (3L) + chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large b-cell lymphoma (DLBCL), non-germinal center B cell (GCB) DLBCL, mantle cell lymphoma (MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), or transformed indolent NHL. Adverse events will be assessed. ABBV-101 is an investigational drug being developed for the treatment of NHL. This study will include a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-101 and a dose expansion phase to determine the change in disease activity in participants with CLL or non-GCB DLBCL. Approximately 244 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating oral doses of ABBV-101, until the MAD/MTD is determined, as part of the approximately 88 month study duration. In the dose expansion phase … |
ABBVIE | 2025-04-16 |
| 88 | A Multicenter, Randomized Study to Evaluate The Safety and Efficacy of Lutikizumab for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). The purpose of this study is to assess how safe and effective lutikizumab is in adult participants with moderate to severe UC and how lutikizumab compares to adalimumab in the treatment of UC. Adverse events and changes in disease activity will be assessed. Lutikizumab is an investigational product being developed for the treatment of moderate to severe UC. Participants are placed in groups called treatment arms. Each group receives a different treatment. In the Induction Period, participants will be randomized into 1 of 3 arms receiving lutikizumab Dose 1, lutikizumab Dose 2, or adalimumab. In the Maintenance Period, participants who responded to lutikizumab will be randomized into 1 of 2 arms of lutikizumab maintenance and participants who responded to adalimumab will continue to receive adalimumab. All participants who did not achieve clinical response per modified Mayo Score at the end of the Induction period will receive open label lutikizumab. Around 200 adult participants with UC will be enrolled at approximately 280 sites worldwide. During the 12 week Induction Period, participants will be randomized to receive … |
ABBVIE | 2025-04-16 |
| 89 | A Phase 1, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGN151 (Anti-FRα Antibody-drug Conjugate) in Adult Patients With Recurrent Gynaecological Cancers PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: IIMGN151-1001 is a Phase 1, first in human, open-label dose-escalation, optimization, and expansion study designed to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of IMGN151 in adult participants with recurrent endometrial cancer; recurrent, high-grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers; or recurrent cervical cancers. All participants will be, in the opinion of the investigator, appropriate for nonplatinum single-agent therapy for their next line of therapy. |
ABBVIE | 2025-04-15 |
| 90 | A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy. ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are parts to this study. Participants will receive ABBV-969 as a single agent at different doses. Approximately 140 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-969 will be intravenously infused in escalating doses as a monotherapy. In part 2, multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. The estimated duration of the study is up to 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans. |
ABBVIE | 2025-04-15 |
| 91 | A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell responsible for fighting infections. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy. ABBV-525 is an investigational drug being developed for the treatment of B-Cell Malignancies. Study doctors put the participants in groups called treatment arms. Participants will receive ABBV-525 at different doses. Approximately 100 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), participants will receive escalating oral doses of ABBV-525. In part 2 (dose optimization), participants will receive one of two oral doses of ABBV-525, until the recommended phase 2 dose (RP2D) is determined. In part 3 (dose expansion), participants will receive the RP2D oral dose of ABBV-525. The estimated duration of the study is up to 64 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans. |
ABBVIE | 2025-04-15 |
| 92 | An Open-Label Positron Emission Tomography (PET) Study to Evaluate The Dopamine D2 and D3 Receptor Occupancy in The Brain After Multiple Doses of ABBV-932 PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: The main objective of this study is to evaluate the dopamine D2 and D3 receptor occupancy in the brain as measured by PET with radiotracer \[11C\]-(+)-PHNO up to 14 days of once-daily oral doses of ABBV-932 in healthy subjects. ABBV-932 is a dopamine D3 receptor-preferring D3/D2 receptor partial agonist. Approximately 12 adult healthy volunteers will be enrolled in the United Kingdom. Participants will receive ABBV-932 oral capsules once daily for 2 weeks and followed for 60 days. Participants will be confined for approximately 15 days. Participants will receive 3 \[11C\]-(+)-PHNO PET scans during the study. Adverse Events and blood tests will be performed. |
ABBVIE | 2025-04-15 |
| 93 | A Multicenter, Phase 1b, Open-label Study of ABBV-383 Administered Subcutaneously in Subjects With Relapsed or Refractory Multiple Myeloma PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Multiple myeloma (MM) is a cancer of the blood’s plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety and pharmacokinetics of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R MM. This study is broken into 3 Arms: Arm A with 2 parts and Arm B as an expansion. Participants will receive ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusion in Arm A and SC injections of ABBV-383 in Arm B. Around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 25 sites across the world In Arm A participants will receive one of two doses of ABBV-383 as an SC injection and (IV) infusions, during the 151 week study duration. In Arm B, participants will receive the selected dose from Arm A as SC injections, during the 151 week study duration. There may be higher … |
ABBVIE | 2025-04-15 |
| 94 | A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Subcutaneous Doses of ABBV-701 in Healthy Adult Western and Asian Subjects PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: The main objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous (SC) ABBV-701 in healthy adult western and Asian participants. |
ABBVIE | 2025-04-15 |
| 95 | Post-marketing Surveillance Study to Evaluate The Safety and Effectiveness of Atogepant for The Prevention of Migraine in Korean Adult Patients PF:6 Related Papers Related Patents Related Grants Related Experts Highlight: Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The study will assess the safety and effectiveness of atogepant for the preventive treatment of migraine in Korean adult patients with chronic migraine or episodic migraine under routine clinical practice. Atogepant is an approved drug for preventive treatment of migraine in adults. Approximately 3000 adult participants who are prescribed atogepant by their doctors will be enrolled in this study in Korea. Participants will receive atogepant oral tablets as prescribed by their physician. Participants will be followed for up to week 12. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice. |
ABBVIE | 2025-04-10 |
| 96 | Randomized, Double-blind, Placebo-Controlled, Multiple-Attack Study With An Open-Label Extension to Evaluate The Efficacy, Safety, Tolerability, and The Consistency of Effect of Atogepant for The Acute Treatment of Migraine (ECLIPSE) PF:5 Related Papers Related Patents Related Grants Related Experts Highlight: A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and well-tolerated in treating migraine attacks quickly. Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world. All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will … |
ABBVIE | 2025-04-10 |
| 97 | AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With C-Met Over-Expressed Refractory Metastatic Colorectal Cancer PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events disease activity when comparing intravenously (IV) infused ABBV-400 to trifluridine and tipiracil (LONSURF) oral tablets plus IV infused bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer (mCRC). ABBV-400 is an investigational drug being developed for the treatment of CRC. Participants are put into treatment arms as part of 2 stages. Each treatment arm in stage 1 receives a different dose of ABBV-400. Each treatment arm in stage 2 receives the optimal dose of ABBV-400 or LONSURF plus bevacizumab. Up to approximately 460 adult participants with c-Met over-expressed (OE) refractory mCRC, will be enrolled in the study in approximately 160 sites in 15-20 countries. In stage 1, participants will receive intravenously (IV) infused ABBV-400 dose A or B. In stage 2, participants will receive the optimal dose of IV infused ABBV-400 or the standard of care (SOC), LONSURF oral tablets plus IV infused bevacizumab. The total study duration will be approximately 4 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will … |
ABBVIE | 2025-04-10 |
| 98 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate The Safety and Efficacy of Eluxadoline in Pediatric Participants (Age 6 to 17 Years) With Irritable Bowel Syndrome With Diarrhea (IBS-D) PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the pharmacokinetics of eluxadoline in pediatric participants with IBS-D, and to evaluate the safety and tolerability of eluxadoline in pediatric participants with IBS-D. Enrollment of 12-17 years old age group is closed, enrollment of the 6-11 years old age group will continue. |
ABBVIE | 2025-04-10 |
| 99 | A Phase 2/3 Multicenter, Double Blinded, Randomized, Dose-conversion, Active Control Study Examining The Efficacy and Safety of Armour Thyroid Compared to Synthetic T4 for The Treatment of Adults With Primary Hypothyroidism PF:6 Related Papers Related Patents Related Grants Related Experts Highlight: This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone \[TSH\]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy. |
ABBVIE | 2025-04-09 |
| 100 | A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy PF:5 Related Papers Related Patents Related Grants Related Experts Highlight: Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This study will assess how safe and effective upadacitinib is in treating adult and adolescent participants with moderate to severe HS who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy. Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for ulcerative colitis, atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of HS. This study is double-blinded, meaning that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo. This study is comprised of 3 periods. In Period 1, participants are randomized into 2 groups called treatment arms where each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In Period 2, participants are placed into 6 different groups depending on their placement and results in Period 1. Period 3 is the long-term extension period where participants will continue treatment from Period 2. Approximately 1328 adult and adolescent … |
ABBVIE | 2025-04-09 |
| 101 | REal-world Utilization and Treatment Target ACHievement With Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis in China PF:5 Related Papers Related Patents Related Grants Related Experts Highlight: Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Upadacitinib is an approved drug for treating AD. Approximately 1000 adolescents and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in up to 40 sites in China. Participants will receive oral upadacitinib tablets as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 12 months. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice. |
ABBVIE | 2025-04-09 |
| 102 | A Phase 3b/4 Randomized, Double-Blind, Double Dummy, Active Comparator-Controlled Study, Comparing The Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis on A Stable Background of MTX and Who Had An Inadequate Response or Intolerance to A Single TNF Inhibitor (SELECT- SWITCH) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world. Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in … |
ABBVIE | 2025-04-09 |
| 103 | A First In Human Multicenter, Open-Label Study to Determine The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), or R/R CLL. Adverse events will be assessed. ABBV-319 is an investigational drug being developed for the treatment of R/R DLBCL, R/R FL, or R/R CLL. This study will include a dose escalation phase to determine the doses of ABBV-319 that will be used in the next phase and a dose expansion phase to determine the change in disease activity in participants with R/R DLBCL, R/R FL, and R/R CLL. Approximately 154 adult participants with R/R B cell lymphomas including R/R DLBCL, R/R FL, and R/R CLL will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating intravenously infused doses of ABBV-319 in 21-day cycles, until the Phase 2 dose … |
ABBVIE | 2025-04-09 |
| 104 | A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of The Efficacy and Safety of Cariprazine in Pediatric Subjects (10 to 17 Years of Age) in The Treatment of Depressive Episodes Associated With Bipolar I Disorder PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population. Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide. Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient … |
ABBVIE | 2025-04-09 |
| 105 | A Two-year Non-interventional, Real-world, Observational Study to Assess Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Patients With Diabetic Macular Edema in China PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: The dexamethasone intravitreal implant (OZURDEX) delivers dexamethasone gradually to the retina over time. It is an approved drug for the treatment of diabetic macular edema (DME). This study will assess the long-term safety and effectiveness of OZURDEX in adult participants with DME in the routine clinical setting in China. Approximately 110 participants who are prescribed OZURDEX by their physicians will be enrolled in multiple medical institutions in China where OZURDEX is used for DME in routine clinical practice. Participants will be followed for 24 months after the first administration of OZURDEX according to the routine clinical practice of the prescribing centers. A subsequent 30-day follow-up after the last dose will be performed to obtain information on any new or ongoing safety events and concomitant medications. No additional burden for participants in this trial is expected. |
ABBVIE | 2025-04-09 |
| 106 | US HARMONY in DIVERSITY: A Prospective, Open-label Study to Evaluate Subject Satisfaction With The Overall Face and Neck Appearance After Combined Treatment PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: A study to evaluate overall participant satisfaction of face and neck appearance after treatment with onabotulinumtoxinA, JUVÉDERM® products, KYBELLA, CoolSculpting Elite, and select SkinMedica products in a diverse population. |
ABBVIE | 2025-04-09 |
| 107 | Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone As Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab (GLORIOSA) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of mirvetuximab Soravtansine as maintenance therapy in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression. |
JENNIFER SCALICI; | 2025-04-08 |
| 108 | German Real-World Evidence Study on The Effectiveness of Foslevodopa/Foscarbidopa at Initial Stages of Advanced Parkinson’s Disease: Motor Symptoms, Quality of Life, Psychosocial Functioning and Work Ability PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Parkinson’s disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how effective foscarbidopa/ foslevodopa is in treating German adult participants at initial stages of advanced Parkinson’s disease under routine clinical practice. Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson’s Disease. Approximately 125 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 20 sites in Germany. Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 12 months. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice. |
ABBVIE | 2025-04-08 |
| 109 | A Phase 1, Two Part, Randomized, Single and Multiple Dose Crossover Study to Assess The Relative Bioavailability Between Tavapadon Clinical and Commercial Tablets PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: This study will assess the relative bioavailability of two different Oral formulations of tavapadon in healthy adult participants. |
ABBVIE | 2025-04-08 |
| 110 | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate The Efficacy, Safety, and Tolerability of Tavapadon As Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: The purpose of this study is to assess the effect of tavapadon on the change from baseline in total daily hours of on time without troublesome dyskinesia in L-Dopa-treated participants with Parkinson’s Disease (PD) who are experiencing motor fluctuations. |
ABBVIE | 2025-04-04 |
| 111 | An 8-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Phase 3 Study of The Efficacy and Safety of Cariprazine in The Treatment of Pediatric Subjects (5 to 17 Years of Age) With Autism Spectrum Disorder PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Autism spectrum disorder (ASD) consists of deficits in social, communication, and cognitive development, repetitive and stereotypic behaviors. Many ASD patients show notably high levels of irritability, including verbal and physical aggression, self injury, and/or property destruction. Autistic infants tend to avoid eye contact and show little interest in others. This study will assess how safe and effective cariprazine is in treating pediatric participants (5 to 17 years of age) with ASD. Adverse events and change in disease activity will be assessed. Cariprazine is an investigational drug being developed for the treatment of irritability due to ASD. This study is double-blinded means that neither the participants nor the study doctors will know who will be given cariprazine and who will be given placebo (does not contain treatment drug). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 152 participants diagnosed with ASD will be enrolled in approximately 40 sites globally. Participants will receive oral capsules or oral solution of cariprazine or placebo once daily for 8-weeks and will undergo a 4-week safety follow-up period. There … |
ABBVIE | 2025-04-04 |
| 112 | A 57-Week, Multicenter, Active-treatment, Open-label Extension Trial of CVL-865 As Adjunctive Therapy in Adults With Drug-Resistant Focal Onset Seizures PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: The purpose of this study is to assess the long-term safety and tolerability of CVL-865 as adjunctive therapy in participants with focal onset seizures. |
ABBVIE | 2025-04-04 |
| 113 | A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Evaluate The Efficacy, Safety, and Tolerability of Two Fixed Doses (15 Mg and 30 Mg QD) of CVL-231 (Emraclidine) in Participants With Schizophrenia Experiencing An Acute Exacerbation of Psychosis PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 6-week trial to evaluate the efficacy, safety, and tolerability of 2 fixed doses of CVL-231 (Emraclidine) (15 mg QD and 30 mg QD) in male and female participants who have schizophrenia and are experiencing an acute exacerbation of psychosis. |
ABBVIE | 2025-04-04 |
| 114 | A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Evaluate The Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: The purpose of this trial is to measure the efficacy, safety, and tolerability of darigabat (25 milligrams \[mg\] twice daily \[BID\]) compared with placebo in participants with panic disorder. |
ABBVIE | 2025-04-04 |
| 115 | A Phase 1 Open-label Trial to Evaluate The Pharmacokinetics and Safety Following A Single Dose of Emraclidine in Adult Participants With Mild, Moderate, and Severe Renal Impairment Compared With Adult Participants With Normal Renal Function PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: The primary purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe renal impairment relative to matched participants with normal renal function. |
ABBVIE | 2025-04-04 |
| 116 | A Phase 1, Open-label Trial to Evaluate The Pharmacokinetics and Safety Following A Single Dose of Emraclidine in Adult Participants With Mild, Moderate, and Severe Hepatic Impairment Compared With Adult Participants With Normal Hepatic Function PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: The primary purpose of this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe hepatic impairment relative to matched participants with normal hepatic function. |
ABBVIE | 2025-04-04 |
| 117 | Expanded Access to Telisotuzumab Adizutecan Related Papers Related Patents Related Grants Related Experts Highlight: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to telisotuzumab adizutecan prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient’s medical history and program eligibility criteria. |
ABBVIE | 2025-04-04 |
| 118 | Expanded Access to ABBV-787 Related Papers Related Patents Related Grants Related Experts Highlight: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-787 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient’s medical history and program eligibility criteria. |
ABBVIE | 2025-04-04 |
| 119 | Expanded Access to Fosigotifator Related Papers Related Patents Related Grants Related Experts Highlight: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Fosigotifator prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient’s medical history and program eligibility criteria. |
ABBVIE | 2025-04-04 |
| 120 | Expanded Access to Elezanumab Related Papers Related Patents Related Grants Related Experts Highlight: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Elezanumab prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient’s medical history and program eligibility criteria. |
ABBVIE | 2025-04-04 |
| 121 | Expanded Access to Venetoclax Related Papers Related Patents Related Grants Related Experts Highlight: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Venetoclax prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient’s medical history and program eligibility criteria. |
ABBVIE | 2025-04-04 |
| 122 | Expanded Access to Telisotuzumab Vedotin Related Papers Related Patents Related Grants Related Experts Highlight: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Telisotuzumab vedotin prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient’s medical history and program eligibility criteria. |
ABBVIE | 2025-04-04 |
| 123 | Expanded Access to Upadacitinib Related Papers Related Patents Related Grants Related Experts Highlight: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient’s medical history and program eligibility criteria. |
ABBVIE | 2025-04-04 |
| 124 | Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Axial Spondylarthritis (UPSTAND) PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain (IBP) that might be difficult to distinguish from other causes of chronic back pain (CBP). Many participants report persistent pain, including back pain, which impacts disease activity and quality of life including creating burdens such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. This study will assess the real-world effectiveness of upadacitinib on early and sustained pain control, and the association between pain and clinical/patient-reported outcomes in axSpA participants. Upadacitinib is being developed for the treatment of axSpA. Approximately 650 adult participants with active-axSpA will be enrolled across approximately 19 countries in Europe, North America, South America, and Asia-Pacific. Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. Participants will be followed for 12 months. There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical … |
ABBVIE | 2025-04-03 |
| 125 | A Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate The Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-552 in Participants With Mild Alzheimer’s Disease PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Alzheimer’s disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. This study will assess how safe and effective ABBV-552 is in treating symptoms of early AD. Adverse events, change in disease activity, how ABBV-552 moves through body of participants and the body response to ABBV-552 will be assessed. ABBV-552 is an investigational drug being developed for the treatment of Alzheimer’s disease (AD). Study doctors put the participants in 1 of 4 groups (3 active dose groups and a placebo group), called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Approximately 240 participants aged 50-90 years with mild AD will be enrolled in approximately 60 sites across the world. Participants will receive oral ABBV-552 or placebo capsules once daily for 12 weeks and followed for 30 days after the last dose of study drug. There may be higher … |
ABBVIE | 2025-04-03 |
| 126 | A 52-week, Phase 2, Open-label Trial to Evaluate The Long-term Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: The primary purpose of this study is to assess the long-term safety and tolerability of oral emraclidine in adult participants with schizophrenia. |
ABBVIE | 2025-04-02 |
| 127 | A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: The purpose of this study is to determine whether CVL-871 is safe and tolerable in patients with Dementia-Related Apathy and if CVL-871 shows changes in clinical measurements of apathy. |
ABBVIE | 2025-04-02 |
| 128 | Effectiveness and Safety of Elagolix Treatment in Moderate to Severe Endometriosis-associated Pain in Routine Clinical Practice in Israel- ENDORSE Study PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Endometriosis is an abnormal, estrogen-dependent growth of endometrial tissue outside the uterus that frequently results in dysmenorrhea and pelvic pain and often causes infertility. Endometriosis is a significant burden on the quality of life of women. This study will assess the tolerability and how effective elagolix is in changing the disease symptoms in adult female participants with endometriosis. Elagolix is an approved drug for treatment of endometriosis. Adult female participants with a diagnosis of endometriosis, who are prescribed elagolix by their physicians, in accordance with local clinical practice and label will be observed for up to 24 months. Around 80 female participants will be enrolled in the study in Israel. Participants will receive Elagolix as prescribed by their physicians. There may be a higher burden for participants in this study compared to standard of care. Patients report outcomes, in the form of questionnaires will be collected up to 24 months prospectively to assess the impact of elagolix on quality of life. |
ABBVIE | 2025-04-01 |
| 129 | Post-Marketing Surveillance to Evaluate The Safety and Effectiveness of Risankizumab (Skyrizi) in Adult Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis Patients PF:6 Related Papers Related Patents Related Grants Related Experts Highlight: Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis or psoriatic arthritis and to assess change in disease symptoms. Risankizumab is an approved drug for the treatment of psoriasis and psoriatic arthritis. Around 3000 adult participants with a moderate to severe plaque psoriasis or psoriatic arthritis who had been prescribed risankizumab by their doctor will be enrolled in this study in multiple sites across Korea. The sample size for this study is a requirement by local authorities. Participants will receive risankizumab prefilled syringe for injection for 52 weeks as prescribed by their physician. There is expected to be no additional burden for participants in this study. All study visits will occur during routine clinical practice and participants will be followed for 52 weeks. |
ABBVIE | 2025-03-30 |
| 130 | A Multicenter, Evaluator and Subject-blinded, Randomized, Comparator-controlled, Parallel-design Study to Evaluate The Safety and Effectiveness of NOA VOLUME Compared to JUVÉDERM® VOLUMA® XC for Improvement of Mid-face Volume PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Facial fullness is often regarded as a characteristic feature of a youthful face. Chronic reduction of collagen, elastin, and glycosaminoglycans contribute to the facial volume loss that characterizes the aging face. Volume restoration by replacing or augmenting soft tissue is critical to successful facial rejuvenation. NOA VOLUME is a crosslinked Hyaluronic Acid (HA) gel implant formulated with lidocaine that was developed to provide a safe, minimally invasive method of improving mid-face volume deficit. The purpose of this study is to assess safety and effectiveness of NOA VOLUME in adult participants seeking improvement of mid-face volume compared to JUVÉDERM VOLUMA XC (VOLUMA XC). NOA VOLUME is an investigational device being developed for the improvement of mid-face volume. There will be 2 cohorts in this study. In Cohort 1, participants will receive either NOA VOLUME or VOLUMA XC with a fixed follow-up period. In Cohort 2, participants will receive either NOA VOLUME or VOLUMA XC with a variable follow-up period. Around 231 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 15 sites in the United States. Participants will receive either NOA VOLUME or VOLUMA XC as subcutaneous and/or supraperiosteal plane injections in the cheek on … |
ABBVIE | 2025-03-28 |
| 131 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Safety and Efficacy of Upadacitinib in Subjects With Giant Cell Arteritis: SELECT-GCA PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of Period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1. Safety and efficacy data through 06 February 2024 are included in the interim analysis, which was conducted after all participants completed the Week 52 visit or discontinued from the study. |
ABBVIE | 2025-03-27 |
| 132 | A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate The Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan With Moderate to Severe Atopic Dermatitis PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Pediatric atopic dermatitis (AD), also known as childhood eczema, is a skin condition that may cause a rash and itching due to inflammation of the skin. The purpose of this study is to assess the change in disease activity (Efficacy) and to assess the safety of upadacitinib in combination with topical corticosteroids (TCS) in pediatric participants 2 to 11 years of age in Japan with moderate to severe AD who are candidates for systemic therapy. Upadacitinib is approved for the treatment of moderate to severe AD in adults and adolescents 12 years of age and older in many countries, including Japan. This study comprises a 35-day screening period; a 12-week, randomized, double-blind treatment period where there will be a 1 in 2 chance that a participant is assigned placebo. This will be followed by an open-label upadacitinib treatment period up to Week 52. Around 98 participants will be enrolled in the study at approximately 35 sites in Japan. Participants will receive upadacitinib oral tablets, or matching placebo, once daily (or an adult equivalent oral solution dose twice a day) for up to 52 weeks. There may be higher treatment burden for participants in this trial compared to their standard of … |
ABBVIE | 2025-03-27 |
| 133 | 58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: The purpose of this study is to evaluate the safety and efficacy of long-term administration of flexible doses of tavapadon in participants with Parkinson’s Disease. |
ABBVIE | 2025-03-26 |
| 134 | Effectiveness ANd Use of FosleVOdopa-foscarbidopa in Advanced Parkinson Disease in Real Life Setting PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Parkinson’s disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how effective foscarbidopa/ foslevodopa is in treating French adult participants with advanced Parkinson disease under routine clinical practice. Foslevodopa/foscarbidopa is an approved drug outside of US for the treatment of Parkinson’s Disease. Approximately 200 adult participants who are prescribed foslevodopa/foscarbidopa by their doctors will be enrolled across approximately 30 sites in France. Participants will receive foscarbidopa/ foslevodopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 12 months. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice. |
ABBVIE | 2025-03-26 |
| 135 | A Multi-country, Post Marketing Observational Study of DME Patients With Suboptimal Response to Anti-VEGF Who Are Initiated With Dexamethasone Intravitreal Implant (DEX-I) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: The dexamethasone 700 μg intravitreal implant (DEX-I) delivers dexamethasone gradually to the retina over time. It is an approved drug for the treatment of DME. This study will assess adult participants with diabetic macular edema (DME) and suboptimal response to anti-vascular endothelial growth factor therapy that are treated with DEX-I in the routine clinical setting. Approximately 327 participants who are prescribed DEX-I by their physicians will be enrolled at approximately 40 sites in approximately 10 countries globally. Participants will be followed for 18 months post-DEX-I implantation according to the routine clinical practice of the prescribing centers. Only one eye per participant will be evaluated in the study. No additional burden for participants in this trial is expected. |
ABBVIE | 2025-03-26 |
| 136 | Early TherapeUtic RespOnse and Predictivity of Long-term Effectiveness of Upadacitinib in Ulcerative Colitis (EUROPE) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will assess how effective upadacitinib is in treating UC. Upadacitinib (RINVOQ) is an approved drug for treating UC. Approximately 400 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in Germany, Austria and Switzerland. Upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. Participants in the study will be followed for up to 2 years. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and only data which are routinely collected during a regular visit will be utilized for this study. |
ABBVIE | 2025-03-25 |
| 137 | A Phase 2, Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Folinic Acid, and Bevacizumab in Previously Treated Subjects With Unresectable Metastatic Colorectal Cancer PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Folinic Acid, and Bevacizumab to adult participants to treat unresctable metastatic colorectal cancer. ABBV-400 is an investigational drug being developed for the treatment of unresectable metastatic colorectal cancer. Fluorouracil, folinic acid, and bevacizumab is an drug approved for the treatment of unresectable metastatic colorectal cancer. Study doctors put the participants in groups called treatment arms. Each treatment arm receives a different dose of ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab (FFB) in escalating doses on two different schedules (safety lead in), followed by low or high doses of ABBV-400 in combination with FFB or fluorouracil, folinic acid, irinotecan, and bevacizumab (standard of care \[SOC\]) \[dose optimization\] on its own. Approximately 206 adult participants with unresectable metastatic colorectal cancer will be enrolled in the study in 65 sites worldwide. In the safety lead in, participants will receive escalating intravenous (IV) ABBV-400 in combination with IV FFB on two different schedules. During the dose optimization participants will receive IV ABBV-400 in … |
ABBVIE | 2025-03-25 |
| 138 | A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-706 As Monotherapy and in Combination With Budigalimab (ABBV-181), Carboplatin, or Cisplatin in Adult Subjects With Advanced Solid Tumors PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin. ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 350 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade CNS tumors, and high-grade NECs. In part 2, multiple doses will be selected from Part 1 and SCLC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. In Part 3a, participants with SCLC or NECs will receive ABBV-706 in combination with budigalimab intravenously every 3 weeks. … |
ABBVIE | 2025-03-25 |
| 139 | An Open-label, Multi-center, Post-marketing, Observational Study to Assess The Effectiveness and Safety of Adalimumab (Humira®) in Pediatric Patients With Polyarticular Juvenile Idiopathic Arthritis (pJIA) in China PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease affecting children, characterized by chronic synovitis with systemic multi-organ damage. Polyarticular juvenile idiopathic arthritis (pJIA) is a subtype of JIA defined as disease involving more than five joints in the first 6 months of disease. This study will assess how safe and effective adalimumab (Humira®) is in treating pediatric participants with pJIA in China real-world setting. Adalimumab is an approved drug for the treatment of pJIA. Approximately 50 participants age 2 to 17 who are prescribed adalimumab for the treatment of pJIA in routine clinical practice will be enrolled at multiple sites in China. Participants will receive adalimumab per their physician’s usual prescription. Individual data will be collected for 52 weeks. No additional study-related tests will be conducted during the routine physician visits. Only data which are routinely collected during a regular visit will be utilized for this study. |
ABBVIE | 2025-03-24 |
| 140 | A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Metastatic Colorectal Cancer PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab … |
ABBVIE | 2025-03-21 |
| 141 | A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax Co-Administered With Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: The primary objective of this study is to evaluate if venetoclax when co administered with low-dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment-naïve patients with acute myeloid leukemia (AML). |
ABBVIE | 2025-03-21 |
| 142 | A Phase 4, Open-Label, Milk-Only Lactation Study to Assess Concentration of Risankizumab in Breast Milk of Lactating Women With Inflammatory Bowel Disease Who Are Receiving Risankizumab Therapeutically PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Inflammatory bowel disease (IBD) is a chronic inflammatory disease that requires lifelong treatment. This study will asses the concentrations of risankizumab in the breast milk of lactating women with IBD Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and Crohn’s Disease. This is an open-label milk-only study lactation study to evaluate the presence of risankizumab in the milk of lactating women. Approximately 10 adult lactating women with IBD will be enrolled from approximately 3 sites in Israel and or the United States. Participants will receive risakizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study. The study duration is approximately 7 months. Participants will attend regular visits during the study at a hospital or clinic. The participants will also be completing questionnaires and will have medical assessments, checking for side effects. |
ABBVIE | 2025-03-21 |
| 143 | A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with docetaxel/osimertinib in participants with solid tumors (NSCLC). Adverse events and change in disease activity will be assessed. ABBV-637 is an investigational drug being developed for the treatment of solid tumors. Study consists of 3 parts – monotherapy dose escalation (Part 1), combination dose escalation and expansion (Parts 2a and 2b) with docetaxel and combination dose escalation and expansion (Parts 3a and 3b) with osimertinib. Approximately 109 adult participants with relapsed/refractory (R/R) solid tumors will be enrolled in approximately 30 sites across the world. In Part 1, participants with solid tumors will receive intravenous (IV) ABBV-637 in 28-day cycles. In Part 2a and 2b, participants will receive IV ABBV-637 in combination with IV docetaxel in 28-day cycles. In Part 3a and 3b, participants will receive intravenous (IV) ABBV-637 in combination with daily oral tablets of … |
ABBVIE | 2025-03-20 |
| 144 | A Phase 2/3, Randomized Study to Evaluate The Dose Optimization, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab in Subjects With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Treatment PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab. Livmoniplimab is an investigational drug being developed for the treatment of HCC. There are 2 stages to this study. In Stage 1, there are 3 treatment arms and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug), atezolizumab in combination with bevacizumab, or tremelimumab in combination with durvalumab. In Stage 2, there are 2 treatments arms and participants will be randomized in a 1:1 ratio. Participants will either receive livmoniplimab (optimized dose) in combination with budigalimab or tremelimumab in combination with durvalumab. Approximately 660 adult participants will be enrolled in the study across 185 sites worldwide. Stage 1: In arm 1, participants will receive intravenously (IV) infused livmoniplimab (Dose 1) in combination with IV infused budigalimab, every 3 weeks. In arm 2, participants will receive IV infused livmoniplimab (Dose 2) in combination with IV infused budigalimab, … |
ABBVIE | 2025-03-19 |
| 145 | A Phase 2, Randomized, Controlled, Dose-escalation Study to Evaluate The Efficacy, Safety, and Tolerability of RGX-314 Gene Therapy Delivered Via A Single Suprachoroidal Space (SCS) Injections in Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME)(ALTITUDE) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: ABBV-RGX-314 is being developed as a novel, potential one-time gene therapy treatment for the treatment of Diabetic Retinopathy (DR) with and without Center-Involved Diabetic Macular Edema (CI-DME). DR is a chronic and progressive complication of diabetes mellitus. It is a sight-threatening disease characterized in the early stages by neuronal and vascular dysfunction in the retina, and later by neovascularization that leads to further deterioration of functional vision. Despite the availability of current treatments, diabetic retinopathy remains the leading cause of vision loss in working-age adults, those between the ages of 20 and 74. Existing treatment with anti-VEGF agents, although shown to be effective, are limited by short therapeutic half-lives, which then require frequent intravitreal injections over the patient’s lifetime, resulting in increased risk of associated adverse events and significant treatment burden. Due to the burden of treatment, patients often do not closely adhere to treatment regimens and experience sub-optimal outcomes and a decline in vision. |
PHOENIX SITE PI; | 2025-03-19 |
| 146 | A Phase 3, Multicenter, Randomized, Placebo-Controlled Study of AGN-151586 for The Treatment of Moderate to Severe Glabellar Lines PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 compared to placebo in adult participants. AGN-151586 is an investigational product being developed for the treatment of GL. In the first period, participants are randomly assigned to receive AGN-151586 or placebo. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In the second period, all participants who meet retreatment criteria will receive open-label AGN-151586. Around 160 participants will be enrolled in the study at approximately 14 sites in China, Taiwan, and Japan. Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Eligible participants may then receive AGN-151586 injections on Day 43 and will be followed for up to 6 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care due to multiple study visits. Participants will attend regular visits during the study at a hospital or clinic. The effect of … |
ABBVIE | 2025-03-19 |
| 147 | Multicenter, Evaluator-blinded, Randomized, Controlled Study of The Safety and Effectiveness of JUVÉDERM® VOLITE™ for Correction of Neck Lines in Chinese Adults PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: The cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The neck is a frequently mentioned area by participants complaining about its crepey texture and deep lines. JUVÉDERM® VOLITE™ is a crosslinked Hyaluronic Acid (HA) gel implant formulated with lidocaine that was developed to provide a safe, minimally invasive method of treating fine lines and improving skin quality. The purpose of this study is to assess adverse events and effectiveness of VOLITE in Chinese adults seeking correction of transverse neck lines. VOLITE is an investigational product being developed for correction of transverse neck lines. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in 3 chance that participants will be assigned to the control group. Around 159 adult participants with transverse neck lines will be enrolled in the study at approximately 8 sites in China. Participants in the treatment group will receive the initial injection of VOLITE at Visit 1 and followed for up to 13 months. Participants may have the opportunity to receive optional touch-up treatment of VOLITE during the follow-up duration period. Participants in … |
ABBVIE | 2025-03-18 |
| 148 | A Phase 2 Randomized Study to Evaluate The Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Leucovorin, and Budigalimab As First-Line Treatment in Subjects With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (AndroMETa-GEA-977) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Leucovorin, and a programmed cell death receptor 1 (PD1) inhibitor (Budigalimab) (AFLB) to adult participants to treat locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEA). ABBV-400 and Budigalimab are investigational drugs being developed for the treatment of mGEA. Fluorouracil and Leucovorin are drugs approved for the treatment of mGEA. This study will be divided into two stages, with the first stage treating participants with increasing doses of ABBV-400 within the AFLB regimen until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into groups called treatment arms where one group will receive fluorouracil, leucovorin, and oxaliplatin (FOLFOX). A further two treatment groups will receive AFLB, but with two optimized doses of ABBV-400 to allow for the best dose to be studied in the future. Approximately 180 adult participants with mGEA will be enrolled in the study in 51 sites worldwide. In the dose escalation stage participants will be treated with increasing … |
ABBVIE | 2025-03-18 |
| 149 | A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With An Active Treatment Extension to Evaluate The Efficacy, Safety, and Tolerability of Oral Atogepant for The Prevention of Migraine in Japanese Subjects With Episodic Migraine PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed. Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 50 sites across Japan. Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose A, … |
ABBVIE | 2025-03-17 |
| 150 | A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects With Axial Spondyloarthritis Followed By A Remission-Withdrawal Period PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently. The main objectives of this protocol are: * To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adults with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2). * To assess the safety and tolerability of upadacitinib in adults with active axSpA including bDMARD-IR AS (Study 1) and nr-axSpA (Study 2). * To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and nr-axSpA who have completed the Double-Blind Period (Study 2). * To evaluate the maintenance of disease control after withdrawal of upadacitinib. |
ABBVIE | 2025-03-17 |
| 151 | A Global Real-World Evidence Study on The Long-term Effectiveness of ABBV-951 in Advanced Parkinson´s Disease in Routine Clinical Practice (ROSSINI: Real-world Outcomes With ContinuouS Subcutaneous Levodopa INfusIon) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Parkinson’s disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to evaluate how effective ABBV-951 is in treating adult participants with advanced PD in real world setting. ABBV-951 (foslevodopa/foscarbidopa) is an approved drug for the treatment of Parkinson’s Disease. The main ROSSINI study will have approximately 450 adult participants with PD (300 participants new to ABBV-951, up to 150 participants transitioning from open-label extension study) will be enrolled across approximately 60 sites. Decision to treat with ABBV-951 (or continue the treatment in Cohort B) will be made by the doctor prior to any decision to approach the participant to participate in this study. There will be a sub-study that will enroll 40 naïve participants who initiated Foslevodopa/Foscarbidopa treatment for the first time (Cohort A of the ROSSINI parent study only) from 6 to 15 centers in the United States, Germany and Spain. All participants will receive subcutaneous infusion of ABBV-951 for approximately 3 years. Participants will attend regular clinic visits during the course of the … |
ABBVIE | 2025-03-17 |
| 152 | A Multiple Dose Escalation Study to Evaluate The Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Subjects, Subjects With Generalized Anxiety Disorder (GAD) and Subjects With Bipolar Disorder PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: The purpose of this study is to assess the pharmacokinetics, safety, and tolerability following multiple ascending oral doses of ABBV-932 or placebo in healthy adult participants, participants with Generalized Anxiety Disorder (GAD), and participants with bipolar disorder (BPD). |
ABBVIE | 2025-03-17 |
| 153 | A Randomized, Double-blind, Placebo-controlled, Phase 1a Study to Evaluate The Safety and Pharmacokinetics of Single Ascending Doses of ABBV-141 in Healthy Adult Western and Asian Subjects PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in healthy adult Western and Asian participants. |
ABBVIE | 2025-03-15 |
| 154 | A Prospective, Multicenter Clinical Study to Evaluate The Safety and Effectiveness of Ab Externo Implantation of Glaucoma Gel Stent PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab externo approach. Adverse events and intraocular pressure will be assessed. XEN45 is an approved device for the treatment of glaucoma implanted using the ab interno approach (inside the eye). XEN45 implanted using the ab externo approach (outside the eye) is being studied in this study. Approximately 65 participants aged 45 years or older with open-angle glaucoma will be enrolled in this study at approximately 22 sites in the United States. All participants will receive XEN45 implanted using the ab externo approach on Day 1 and will be followed for 12 months. Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations. |
ABBVIE | 2025-03-13 |
| 155 | A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Subjects With Myelofibrosis (REFINE) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of navitoclax alone or when added to ruxolitinib in participants with myelofibrosis. Safety and efficacy data through 16 January 2023 are included in the interim analysis. |
ABBVIE | 2025-03-12 |
| 156 | A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single Ascending Dose Trial to Assess The Safety, Tolerability and Pharmacokinetic Effects of ALIA-1758 in Healthy Participants PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: This is a Phase 1, first in human (FIH), double-blind, placebo-controlled, single ascending dose (SAD) trial to assess the safety, tolerability, and pharmacokinetics (PK) of intravenously (IV) or subcutaneously (SC) injected ALIA-1758 in healthy male and female participants. |
ABBVIE | 2025-03-12 |
| 157 | Assessment of The Relative Bioavailability of ABBV-932 Formulations in Healthy Adult Subjects PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: This study will assess the relative bioavailability and effect of food on pharmacokinetics of ABBV-932 oral administration in healthy adult participants. |
ABBVIE | 2025-03-11 |
| 158 | A Phase 1 Open-Label Study to Evaluate The Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called cohorts. Each cohort receives ABBV-400 alone (monotherapy) followed by a safety follow-up period. Approximately 260 adult participants with hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), esophageal squamous cell carcinoma (ESCC), triple negative breast cancer (TNBC), hormone receptor+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (hormone receptor-positive \[HR+\]/HER2-breast cancer \[BC\]), head and neck squamous-cell-carcinoma (HNSCC), Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer, or advanced solid tumors, will be enrolled in the study in approximately 54 sites worldwide. In the each cohorts, participants with the following advanced solid tumor indications: HCC, PDAC, BTC, ESCC, TNBC, HR+/HER2-BC, HNSCC, and PROC/primary peritoneal/fallopian tube cancer will receive intravenous (IV) ABBV-400 monotherapy for up to 2 years during and up to the treatment period with an additional safety follow-up period of … |
ABBVIE | 2025-03-10 |
| 159 | A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-787 in Adult Subjects With Acute Myeloid Leukemia (AML) PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Acute myeloid leukemia (AML) is the second most common type of leukemia diagnosed in adults and children, but most cases occur in adults. This study is to evaluate how safe ABBV-787 is and how it moves within the body in adult participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). Adverse events and maximum tolerated dose (MTD) of ABBV-787 will be assessed. ABBV-787 is an investigational drug being developed for the treatment of AML. Participants will receive ABBV-787 in escalating doses until the maximum tolerated dose (MTD) is determined. Approximately 60 adult participants with a diagnosis of AML will be enrolled worldwide. Participants will receive intravenous (IV) infusions of ABBV-787 during the approximately 3 year duration a participant is followed. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects. |
ABBVIE | 2025-03-06 |
| 160 | A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for The Treatment of Upper Limb Essential Tremor PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Upper limb essential tremor (UL ET) is a movement disorder characterized by postural and/or kinetic tremor. It can cause difficulty with everyday tasks such as writing, pouring, and eating, and patients also experience associated social embarrassment. This study will assess how safe and effective BOTOX is in treating UL ET. Adverse events and change in disease activity will be evaluated. BOTOX is an investigational drug being developed for the treatment of UL ET. Participants are randomly assigned to 1 of the 4 groups, called treatment arms. Each group receives different treatment. There is 1 in 2 chance that participants will be assigned to placebo. Around 174 participants, aged 18 to 80 years with UL ET will be enrolled in approximately 40 sites in North America. Participants will receive BOTOX or placebo injections in Cycle 1 and Cycle 2. In Cycle 3, participants will receive unilateral or bilateral BOTOX injections. Each cycle is 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side … |
ABBVIE | 2025-03-05 |
| 161 | Understanding Local TReatment Patterns and Outcomes With UpAdacitinib in IBD Patients in Belgium PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Crohn’s disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. This study will assess the (long-term) effectiveness and safety of upadacitinib in real-world clinical practice in adult participants with moderate to severe ulcerative colitis (UC) and crohn’s disease (CD). Upadacitinib is an approved drug for treating ulcerative colitis (UC) and Crohn’s disease (CD). Approximately 280 participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 8 sites across Belgium. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice |
ABBVIE | 2025-03-05 |
| 162 | An Open-label Study Evaluating The Safety and Effectiveness of Intradermal Injections of ELAPR002f Injectable Gel in The Improvement of Multiple Attributes of Skin Quality in Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Elastin is a protein found in the dermis of the skin that is gradually lost with aging which impacts skin tissue and leads to reduced structural integrity, hydration, and elasticity of the skin, resulting in loose skin and the formation of folds and wrinkles. Loose skin, folds, and wrinkles can be treated by injecting biocompatible structures to fill the the affected area and improve elasticity/hydration upon implantation. The purpose of this study is to evaluate the safety and effectiveness of ELAPR002f injectable gel in adult participants for the improvement of skin quality in adults. ELAPR002f injectable gel is an investigational device being developed for the improvement of facial skin quality attributes such as fine lines, elasticity, and hydration. Approximately 30 participants 30 to 60 years of age seeking improvement of skin quality will be enrolled. Participants will receive 3 treatment sessions, 1 month apart, of ELAPR002f injectable gel to each cheek and behind 1 ear (for histological assessment) and will be followed up for up to 4 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect … |
ABBVIE | 2025-03-05 |
| 163 | A Phase 1b Study to Evaluate The Safety and Pharmacokinetics of Livmoniplimab in Combination With Budigalimab in Chinese Subjects With Locally Advanced or Metastatic Child-Pugh A Hepatocellular Carcinoma Who Have Progressed After A First-Line Regimen That Includes An Immune Checkpoint Inhibitor PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic disease. The purpose of this study is to assess adverse events and how livmoniplimab in combination with budigalimab moves through the body in adult Chinese participants with Locally Advanced or metastatic Child-Pugh A Hepatocellular Carcinoma (HCC). Livmoniplimab is an investigational drug being developed for the treatment of HCC. There are 2 stages to this study. Stage 1 is a safety run-in. There are 2 treatment arms in stage 1 and participants will receive escalating doses of Livmoniplimab in combination with budigalimab (fixed dose). Stage 2 is dose expansion. There are 2 treatment arms in stage 2 and participants will receive Livmoniplimab in combination with budigalimab in multiple doses. Approximately 20 adult participants will be enrolled in the study across 15 sites in China. In part 1 (dose escalation), participants will be intravenously infused with escalating doses of livmoniplimab in combination with budigalimab every 3 weeks. In part 2 (dose expansion), participants will be intravenously infused with livmoniplimab in combination with budigalimab in multiple doses every 3 weeks. The estimated duration of the … |
ABBVIE | 2025-03-04 |
| 164 | Special Drug Use – Results Survey Of Evaluating Safety And Effectiveness Of RINVOQ In Patients With Rheumatoid Arthritis PF:5 Related Papers Related Patents Related Grants Related Experts Highlight: Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. RA can reduce the ability to perform everyday tasks. The purpose of this study is to observe the incidence of serious infections, regardless of their relationship to RINVOQ, in Japanese daily practice. RINVOQ is an approved drug for the treatment of adults with moderately to severely active RA. This study evaluates medical records from institutions participating in the study to identify any adverse events (untoward medical occurrence), and reasons for discontinuation of RINVOQ in participants taking the study drug. A target of 1000 Japanese participants’ data will be observed for 3 years. Participants will receive RINVOQ per their physicians’ usual prescription. Individual data will be collected for three years. No additional study-related tests will be conducted during routine clinic visits. Only data which are routinely collected during clinic visits will be utilized for this study. |
ABBVIE | 2025-03-03 |
| 165 | Prospective Real World Study Of Upadacitinib in Ulcerative Colitis (PROFUNDUS) PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed. Upadacitinib is a drug approved for the treatment of Ulcerative colitis (UC). All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1000 adult participants will be enrolled worldwide. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice. |
ABBVIE | 2025-02-28 |
| 166 | A Post-marketing Observational Study for Venetoclax in Patients Diagnosed With Acute Myeloid Leukemia in Japan PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections) and is the most common acute leukemia in adults. This study will assess how safe and effective oral venetoclax is in participants with AML. Adverse events and change in disease activity will be monitored under routine clinical practice. Venetoclax is an approved drug to treat Acute Myeloid Leukemia (AML). Around 400 participants of any age who are treated with oral venetoclax tablets for AML in accordance with the approved label will be enrolled in the study across Japan. Participants will be followed up to 52 weeks following the first dose of oral venetoclax tablets. There is expected to be no additional burden for participants in this study. Data will be collected by information provided by participating physicians based on routine medical records. |
ABBVIE | 2025-02-28 |
| 167 | Real-world Effectiveness and Use of UPaDAcitinib in Patients With ModeraTE-to-severe Atopic Dermatitis PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. This study will assess how effective upadacitinib is in treating AD. Upadacitinib is an approved drug for treating AD. Approximately 300 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in France. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice. |
ABBVIE | 2025-02-27 |
| 168 | A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, An Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination with osimertinib, erlotinib, and nivolumab in participants with advanced solid tumors likely to express c-Met. Enrollment is closed for the monotherapy arms, Arm A, and Arm D. |
ABBVIE | 2025-02-26 |
| 169 | A Phase 4 Multicenter, Randomized, Double-Blind Study of Risankizumab for The Treatment of Adult Subjects With Moderate to Severe Genital Psoriasis or Moderate to Severe Scalp Psoriasis PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is in adult participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Adverse events and change in disease signs and symptoms will be monitored. Risankizumab (Skyrizi) is a drug being studied for the treatment of moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Approximately 200 participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis will be enrolled across approximately 45 sites globally. The study will be broken up into 2 sub-studies by disease location, participants with moderate to severe genital psoriasis (Study G) and moderate to severe scalp psoriasis (Study S). In both sub-studies participants will receive subcutaneous (SC) injections of risankizumab during the 52 week treatment period, or SC injections of placebo risankizumab during the 16 week treatment period followed by SC injections of risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period. There may be higher treatment burden for participants in this trial compared to their standard of care. … |
ABBVIE | 2025-02-26 |
| 170 | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate The Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3. |
ABBVIE | 2025-02-24 |
| 171 | A Phase 1b/2 Study of IMGN632 As Monotherapy or Combination With Venetoclax And/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: This is an open-label, multicenter, Phase 1b/2 study to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax in participants with relapsed and frontline CD123-positive AML. |
ABBVIE | 2025-02-24 |
| 172 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts body’s normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis. Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 190 sites worldwide. Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue untill the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug. There may be a higher treatment burden for participants … |
ABBVIE | 2025-02-21 |
| 173 | A Multicenter, Randomized Open-Label Study to Assess The Efficacy, Safety, and Pharmacokinetics of Upadacitinib With A Tocilizumab Reference Arm in Subjects From 1 Year to Less Than 18 Years Old With Active Systemic Juvenile Idiopathic Arthritis PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis that affects children. The term idiopathic means of unknown origin. It is a chronic (long-lasting) disease that causes swelling, warmth, and pain of one or more small joints. Systemic JIA ia a rare and serious form of JIA. Systemic means it may affect not only the joints but other parts of the body, including the liver, lungs and heart. sJIA is more severe and can be more challenging to diagnose and treat than other types of juvenile idiopathic arthritis. It is a lifelong disease for many patients and can continue into adulthood. This study will assess how safe and effective upadacitinib is in treating pediatric and adolescent participants aged 1 to \< 18 with systemic juvenile idiopathic arthritis (sJIA) and will include a tocilizumab treatment arm for reference. Adverse events and change in the disease activity will be assessed. Upadacitinib is an investigational drug being developed for the treatment of sJIA. Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive upadacitinib or tocilizumab reference. In cohort 2, participants will receive upadacitinib. Approximately 90 participants with sJIA will be enrolled in approximately 45 sites worldwide. ... |
ABBVIE | 2025-02-21 |
| 174 | A Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 As Monotherapy and in Combination With Bevacizumab in Adult Subjects With Advanced Solid Tumors PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose and combination with bevacizumab. Approximately 500 adult participants with NSCLC, gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) and colorectal cancer (CRC) or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 85-95 sites in the Dose Expansion phase worldwide. Dose escalation arms, participants will receive intravenous (IV) escalating doses of ABBV-400 monotherapy. Dose expansion arms, participants in the following advanced solid tumor indications: non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) \[Part 2i\] or mutated EGFR-expression (mutEGFR NSCLC) \[Part 2ii\], squamous NSCLC \[Part … |
ABBVIE | 2025-02-20 |
| 175 | Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Fixed-dose Study to Evaluate The Efficacy, Safety, and Tolerability of ABBV-932 in Subjects With Depressive Episodes Associated With Bipolar I or II Disorder PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. This study will assess how safe and effective ABBV-932 is in treating participants with bipolar I or II disorder. ABBV-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Study doctors put participants in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 adult participants with bipolar I or II disorder will be enrolled in approximately 40 sites worldwide. Participants will receive oral capsules of ABBV-932 or matching placebo once daily for 6 weeks. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. |
ABBVIE | 2025-02-20 |
| 176 | A Phase 1 Study Evaluating The Safety of ABT-263 in Combination With Rituximab in Subjects With CD20-positive Lymphoid Malignancies PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with rituximab in participants with CD20-positive lymphoproliferative disorders. The extension portion of the study will allow active participants to continue to receive ABT-263 for up to 14 years after the last participant transitions with quarterly study evaluations. |
ABBVIE | 2025-02-20 |
| 177 | A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without The PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P. |
ABBVIE | 2025-02-19 |
| 178 | A First-in-Human Single Ascending Dose, Mass Balance, and Food Effect Study to Evaluate The Safety, Tolerability, and Pharmacokinetics of ABBV-1088 in Healthy Adult Subjects PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: This study will assess the single dose safety, tolerability and pharmacokinetic properties of ABBV-1088 in healthy adult participants |
ABBVIE | 2025-02-19 |
| 179 | A Phase 1, Open-label Study to Assess PK Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab. |
ABBVIE | 2025-02-18 |
| 180 | A Randomized, Double-Blind, Phase 3 Study Evaluating The Safety and Efficacy of Venetoclax in Combination With Azacitidine in Patients Newly Diagnosed With Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS) PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person’s bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS. Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms – In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide. Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or … |
ABBVIE | 2025-02-14 |
| 181 | A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing The Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects With Moderate to Severe Atopic Dermatitis (Level-Up) PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed. Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment Period 1 and a 16-week treatment Period 2. Participants are randomly assigned to 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab in Period 1. There is a 30-day or 12-week follow-up visit for those on upadacitinib or dupilumab respectively, who will not enter Period 2. In Period 2, participants will receive upadacitinib Dose A or Dose B for 16 weeks, followed by a 30-day follow-up visit. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at … |
ABBVIE | 2025-02-14 |
| 182 | A Phase 1 Open-Label Study Evaluating The Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Myeloproliferative Neoplasm Subjects PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: There are 5 parts to this study for which the primary objectives are to evaluate safety, tolerability, and pharmacokinetics (PK) of navitoclax when administered alone (Part 1) or when administered in combination with ruxolitinib (Part 2). In Part 2, participants must have been receiving a stable dose of ruxolitinib therapy for at least 12 weeks prior to study enrollment. In Part 3, all eligible participants will receive navitoclax, with the primary objective being to evaluate potential navitoclax effect on QTc prolongation. In Part 4, effect of navitoclax is evaluated on the PK, safety, and tolerability of a single dose of celecoxib. In Part 5, all eligible participants will receive ruxolitinib twice daily and navitoclax once daily for drug-drug interaction (DDI) assessment, followed by continued administration of navitoclax in combination with ruxolitinib. |
ABBVIE | 2025-02-14 |
| 183 | A Multicenter, Evaluator-blinded, Randomized, Delayed Treatment Control Group Study of The Safety and Effectiveness of HAC 20L for The Correction of Moderate to Severe Nasolabial Folds PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Nasolabial folds (NLF) are the two skin folds that run from each side of the nose to the corners of the mouth. Prominent NLFs distort the contour of the midface, giving a fatigued and aged appearance. Soft tissue fillers can be used to reduce the depth of NLFs and restore a more youthful appearance. The purpose of this study is to evaluate how safe and effective HAC 20L is in the correction of moderate to severe NLF in adult participants. HAC 20L is an investigational drug being developed for the treatment of NLF. There are 2 cohorts in this study. In each cohort participants are assigned to either the treatment group or no-treatment control group. There is a 1 in 3 chance that participants will be assigned to the no-treatment control group. Around 75 adult participants with moderate to severe NLF will be enrolled in the study at approximately 20 sites worldwide. Participants in the treatment group will receive an injection of HAC 20L to the NLF on Day 1 in Cohort 1 and Cohort 2 with the option of re-treatment after completion of Month 12 visit. The control group will receive no treatment but will be offered an optional … |
ABBVIE | 2025-02-11 |
| 184 | Multicenter, Evaluator-Blinded, Randomized, No-Treatment Controlled Study of The Effectiveness and Safety of JUVÉDERM® VOLITE™ Injectable Gel for The Improvement in Skin Quality PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Facial fine lines and wrinkles are caused by skin thinning, loss of moisture, and loss of elasticity due to factors such as age, ultraviolet (UV) radiation, and environmental exposures. Today, many injectable fillers are used to treat facial aging and correct skin defects. In this study, adverse effects and effectiveness of JUVÉDERM® VOLITE™ will be assessed in the treatment of fine lines and improving skin quality. VOLITE is an investigational device being developed for improving skin quality. In this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to the no-treatment control group. Adult participants seeking improvement of skin quality, especially hydration and radiance, in the treatment area will be enrolled. Around 135 participants will be enrolled in the study at approximately 6 sites in China. Participants in the treatment group will receive the initial injection of VOLITE; the control group will receive no treatment, but will have the opportunity to receive VOLITE after 2 months. Participants will be followed up for 12 months. There may be higher treatment burden for participants in this trial compared to their standard … |
ABBVIE | 2025-02-06 |
| 185 | A Long-term, Multi-center, Longitudinal Post-marketing, Observational Study to Assess Long Term Safety and Effectiveness of HUMIRA® (Adalimumab) in Children With Moderately to Severely Active Polyarticular or Polyarticular-course Juvenile Idiopathic Arthritis (JIA) – STRIVE PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: This is a global registry, to evaluate the long-term safety of Humira® in patients with moderate to severe polyarticular Juvenile Idiopathic Arthritis (JIA), that are treated as recommended in the Humira® product label. Patients treated with MTX will be considered a reference group. Patients will be followed in both the Humira® and Methotrexate (MTX) arms for 10 years from the enrollment date into one of the treatment arms. |
ABBVIE | 2025-02-04 |
| 186 | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate The Safety and Efficacy of OnabotulinumtoxinA Purified Neurotoxin Complex for The Treatment of Moderate to Severe Forehead Lines in Japan PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to assess adverse events and effectiveness of onabotulinumtoxinA in Japanese adults with moderate to severe FHL. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Participants are randomly assigned to receive onabotulinumtoxinA or placebo. There is a 1 in 5 chance that a participant will receive placebo. Around 150 adult participants with moderate to severe FHL will be enrolled in the study in approximately 15 sites in Japan. In Period 1, participants will receive intramuscular injections on Day 1. In Period 2, participants will receive up to 3 additional treatment cycles. Participants will be followed for up to 12 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at the study site. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires. |
ABBVIE | 2025-02-03 |
| 187 | An Extension Trial to Evaluate The Long-term Safety and Efficacy of Bimatoprost SR in Patients With Open Angle Glaucoma or Ocular Hypertension PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study. |
ABBVIE | 2025-01-01 |
| 188 | An Open-label Study to Evaluate The Pharmacokinetics, Safety, and Tolerability of Icalcaprant in Healthy Adult Japanese and Han Chinese Subjects PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: This study will assess the pharmacokinetics, safety, and tolerability of icalcaprant administered orally in healthy adult Japanese and Han Chinese participants. |
ABBVIE | 2025-01-01 |
| 189 | A Phase 1 Open-label Study to Evaluate The Effect of Itraconazole on The Pharmacokinetics of Icalcaprant in Healthy Adult Subjects PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: This study is to assess the change of itraconazole, a strong CYP3A inhibitor, on the pharmacokinetics, safety, and tolerability of a single dose of icalcaprant in healthy participants. |
ABBVIE | 2025-01-01 |
| 190 | Prospective Observational Cohort Study of Patients With Moderate to Severe Chronic Plaque Psoriasis in Taiwan PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Psoriasis (PsO) is a chronic, disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques and is associated with high burden of illness that results in a negative impact on long-term health outcomes including quality of life (QoL). The main objective of this study is to characterize the durability of response of risankizumab compared to other biologics measured by the Psoriasis Area and Severity Index (PASI) 90 response in adult participants with moderate to severe chronic plaque psoriasis who are either new or have used a biological treatment in the past. Risankizumab is a drug approved for the treatment of moderate-to-severe plaque psoriasis. Participants who are prescribed risankizumab or other comparator drugs in the real world setting are enrolled in this study. Data from a total of approximately 240 participants; 160 using risankizumab and 80 using other biologics will be evaluated across Taiwan. Participants will receive subcutaneous risankizumab injection or or other biologic as prescribed by their physician. Data from these participants will be collected for approximately 2 years. There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The … |
ABBVIE | 2024-12-31 |
| 191 | A Study to Evaluate Effectiveness of Upadacitinib in Moderate to Severe AD With Prurigo Nodularis in The Real World in Japan PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Around one-third of patients with AD have had at least 1 incidence of prurigo nodularis (PN), which is characterized by intense, persistent itchy skin and sometimes pain with burning. In this study, the effectiveness of upadacitinib (UPA) will be assessed in participants with prurigo-type AD in a real world (RW) setting in Japan. UPA is an approved drug for the treatment of AD. Adults and adolescents who have been diagnosed with prurigo-type AD and prescribed UPA according to the label and practice in Japan will be enrolled in this observational study. The doctor’s decision to prescribe UPA will be made prior to and independently of study participation. Approximately 200 participants will be enrolled in the study at 10 sites in Japan. Participants will receive extended-release oral tablets of UPA once-daily for 48 weeks. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. |
ABBVIE | 2024-12-31 |
| 192 | The Frequency of UMRD in Japanese Patients With CLL After 24 Months of Treatment With Venetoclax±Rituximab in The 2L+ in The Real-World Setting PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Most cases of Chronic lymphocytic leukemia (CLL) remain an incurable disease with the goal of therapy being to improve quality of life and to prolong survival. This study will evaluate the participant’s related outcomes and experience of CLL in adult participants who are treated in the Japan. Study participants will receive oral treatments of Venetoclax±Rituximab for CLL as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed various treatments Venetoclax±Rituximab will be enrolled. Around 89 participants will be enrolled in the study in sites in Japan. Participants will receive oral venetoclax tablets ± intravenously (IV) infused rituximab treatments for CLL according to the approved local label. The overall study duration will be 27 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice. |
ABBVIE | 2024-12-31 |
| 193 | International Real-World Study of MET Overexpression in Patients With Non-Small Cell Lung Cancer PF:4 Related Papers Related Patents Related Grants Related Experts Highlight: Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 80%-85% of lung cancers cases of which 60% are non-squamous (NSQ). This study will evaluate the prevalence of mesenchymal epithelial transition (MET) overexpression (OE) in adult participants with advanced or metastatic NSQ NSCLC. Archived tissue biopsies will be tested for MET OE and data from approximately 500 participants will be collected. No participants will be enrolled in this study. Participants’ charts will be reviewed. No drug will be administered as a part of this study. The duration of the study will be approximately 15 months. There is no additional burden for participants in this trial. |
ABBVIE | 2024-12-30 |
| 194 | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-916 in Subjects With Early Alzheimer’s Disease PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Alzheimer’s disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. This study will assess how safe and effective ABBV-916 is in treating early AD. Adverse events, change in disease activity, and how ABBV-916 moves through body of participants will be assessed. ABBV-916 is an investigational drug being developed for the treatment of early AD. This study is conducted in 2 stages. Stage A is a multiple ascending dose study. There is a 1 in 4 chance that participants are assigned to receive placebo. Stage B is a proof-of-concept study. In Stage B, there is a 1 in 5 chance that participants will be assigned to receive placebo. The first 6 months of this study are double-blind, which means that neither the trial participant nor the study doctors know which treatments will be given. This will be followed by a 2-year extension period in which all participants will receive ABBV-916. Approximately 195 … |
ABBVIE | 2024-12-30 |
| 195 | A Phase 3, Multi-center, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate The Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for The Treatment of Moderate to Severe Forehead Lines in China PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Facial lines (such as glabellar lines [GL], lateral canthal lines [LCL], and forehead lines [FHL]) are perhaps the most visible signs of aging. Hyperfunctional facial lines that develop from repeated facial expression may be treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to assess adverse events and effectiveness of BOTOX in Chinese adults with moderate to severe FHL. Participants are placed in 1 of 2 groups, called treatment arms. Around 140 adult participants with moderate to severe FHL will be enrolled in the study. Participants in the treatment group will receive intramuscular injections on Day 1 and followed for up to 180 Days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at the study site. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires. |
ABBVIE | 2024-12-07 |
| 196 | REAL-world Patient CharacterISTICs, Treatment Pattern, Clinical Outcomes, and Healthcare Resource Utilization in Chinese Patients Receiving Upadacitinib for Atopic Dermatitis: A Retrospective Chart Review Study PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Atopic Dermatitis (AD) is a common, chronic, and flaring systemic inflammatory skin disorder characterized by intensely pruritic and distressing skin eruptions. This study will assess treatment patterns, treatment outcomes, healthcare resource utilization in Chinese participants receiving Upadacitinib for Atopic Dermatitis (AD) undergoing chart review. |
ABBVIE | 2024-11-10 |
| 197 | A Multicenter, Open-label, Single-arm Study to Demonstrate The Efficacy and Safety of The Human Anti-TNF Monoclonal Antibody Adalimumab in Chinese Subjects Requiring High Dose Corticosteroids for Active Non-Infectious Intermediate-, Posterior-, or Pan-uveitis PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: Non-infectious intermediate-, posterior- and pan-uveitis (NIIPPU) are sight threatening diseases with a high patient burden and negative impact on quality of life. Corticosteroids remain the mainstay of first-line treatment for NIIPPU in China despite serious side effects associated with long-term and high-dose corticosteroid use. Adalimumab is used to treat NIIPPU in adults who have had inadequate response to corticosteroids, or who need corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. The purpose of this study is to assess adverse events and effectiveness of adalimumab in Chinese participants requiring high dose corticosteroids with NIIPPU. Adalimumab is a conditionally approved drug in China used to treat participants with NIIPPU. All participants will receive the same treatment. Approximately 87 adult participants will be enrolled at approximately 15 sites in China. Participants will receive one subcutaneous loading dose of adalimumab at baseline followed a week later by a lower dose of adalimumab every other week for up to 30 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking … |
ABBVIE | 2024-11-10 |
| 198 | Multicenter, Evaluator-blind, Randomized, No-treatment Controlled Study to Evaluate The Safety and Effectiveness of JUVÉDERM® VOLITE™ for Correction of Perioral Lines in Chinese Population PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Facial fine lines and wrinkles are caused by skin thinning, loss of moisture, and loss of elasticity due to factors such as age, ultraviolet (UV) radiation, and environmental exposures. Today, many injectable fillers are used to treat facial aging and correct skin defects. In this study, adverse effects and effectiveness of JUVÉDERM® VOLITE™ will be assessed in correcting perioral lines (around the mouth). VOLITE is an investigational device being developed for the correction of perioral lines. In this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to the no-treatment control group. Adult participants seeking improvement of lines, hydration, and skin smoothness in perioral area will be enrolled. Around 198 participants will be enrolled in the study at approximately 12 sites in China. Participants in the treatment group will receive the initial injection of VOLITE; the control group will receive no treatment, but will have the opportunity to receive VOLITE after 2 months. Participants will be followed up for 12 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants … |
ABBVIE | 2024-10-20 |
| 199 | A Phase 1 Study in Healthy Adult Subjects to Evaluate The Pharmacokinetics, Immunogenicity, Safety, and Tolerability of A Ravagalimab Subcutaneous Formulation in A Pre-Filled Syringe PF:2 Related Papers Related Patents Related Grants Related Experts Highlight: The objective of this study is to assess the pharmacokinetics, immunogenicity, safety, and tolerability, of subcutaneous formulation of ravagalimab in a pre-filled syringe in healthy adult participants. |
ABBVIE | 2024-10-09 |
| 200 | Canadian Real-life Post-marketing Observational Study Assessing The Effectiveness of Upadacitinib for Treating Rheumatoid Arthritis (CLOSEUP) PF:3 Related Papers Related Patents Related Grants Related Experts Highlight: Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study will assess how effective Upadacitinib is in changing the disease symptoms in Canadian participants with RA. Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult Canadian participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 390 participants will be enrolled this study, in multiple sites within Canada. Participants will receive Upadacitinib as prescribed by the physician and will be followed for approximately 24 months. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit. |
ABBVIE | 2024-09-30 |