
Search Clinical Trials
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PAIRS: Friend-Based AISA Intervention
State University of New York at Buffalo
Sexual Violence
College Drinking
Behavioral Changes
This Phase 2 trial will to examine the efficacy of a brief dyad-based motivational
interview (PAIRS MI) delivered to friend dyads with an active treatment-as-usual
condition, and a 1-year follow-up. expand
This Phase 2 trial will to examine the efficacy of a brief dyad-based motivational interview (PAIRS MI) delivered to friend dyads with an active treatment-as-usual condition, and a 1-year follow-up. Type: Interventional Start Date: May 2026 |
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[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
Blue Earth Diagnostics
Colorectal Cancer
Epithelial Ovarian Cancer
Gastric Cancer
Invasive Lobular Breast Carcinoma
Pancreatic Ductal Adenocarcinoma
This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the
safety, radiation dosimetry, and preliminary diagnostic performance of [18F]FPyQCP in
detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma
(PDAC), invasive lobular breast can1 expand
This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of [18F]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC). Type: Interventional Start Date: Feb 2026 |
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A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non1
Novartis Pharmaceuticals
Non-segmental Vitiligo
The main purpose of this multicenter, randomized, double-blind, placebo-controlled Phase
2b study is to investigate the safety and efficacy of GIA632 in participants with NSV and
to identify the optimal dose to be promoted into the confirmatory Phase 3 program. expand
The main purpose of this multicenter, randomized, double-blind, placebo-controlled Phase 2b study is to investigate the safety and efficacy of GIA632 in participants with NSV and to identify the optimal dose to be promoted into the confirmatory Phase 3 program. Type: Interventional Start Date: Mar 2026 |
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Virtual Reality for Caregiver Assembly, Relief, Empowerment, and Support (VR-CARES)
Rendever, Inc.
Direct Care Workers
Dementia Caregiver
In-Home Care
Caregiver Social Support
Peer Support
The VR-CARES project is an innovative, collaborative effort that invites dementia care
professionals into the design process of a virtual reality platform seeking to mitigate
their work-related burden and social isolation by cultivating a virtual community of
support. The co-created, caregiver-spec1 expand
The VR-CARES project is an innovative, collaborative effort that invites dementia care professionals into the design process of a virtual reality platform seeking to mitigate their work-related burden and social isolation by cultivating a virtual community of support. The co-created, caregiver-specific VR platform will serve as a safe, communal space where caregivers can remotely connect with their peers, share fun experiences together, access support, learn self-care and build resilience within a supportive virtual network to enhance their social and mental health and job satisfaction. Central to VR-CARES in the principle of user-led innovation, ensuring that the technology not only serves but is informed and successfully adopted by the very individuals it intends to benefit, an important standard for empathetic and inclusive technology in healthcare. Type: Interventional Start Date: Mar 2026 |
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A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve a1
AstraZeneca
Systemic Lupus Erythematosus
The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS
remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as
add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at
enrolment.
Patients will be naïve to an1 expand
The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at enrolment. Patients will be naïve to any prior conventional immunosuppressant including prior biologic therapy at enrolment. The study will also employ a tapering protocol for a systematic approach to GC tapering, seeking to understand better the proportion of patients in remission who can successfully withdraw chronic GC completely. Type: Interventional Start Date: Apr 2026 |
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INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythem1
Ono Pharmaceutical Co., Ltd.
Polycythemia Vera
The purpose of this study is to evaluate the efficacy and safety of sapablursen when
added on to current standard of care (SOC) for Polycythemia Vera (PV) therapy. The study
will be conducted in three sequential parts (Part 1a blinded treatment, Part 1b
open-label treatment, & Part 2 long-term exte1 expand
The purpose of this study is to evaluate the efficacy and safety of sapablursen when added on to current standard of care (SOC) for Polycythemia Vera (PV) therapy. The study will be conducted in three sequential parts (Part 1a blinded treatment, Part 1b open-label treatment, & Part 2 long-term extension). Participants may receive treatment for up to 156 weeks. Type: Interventional Start Date: May 2026 |
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Amygdala Insula Retraining in the Management of Perimenopause Symptoms
Chronic Conditions Research Fund
Perimenopause
Menopausal Complaints
The goal of this study is to evaluate a neuroplasticity-based mind-body intervention,
Amygdala and Insula Retraining (AIR), compared to a wait-list control in individuals
experiencing perimenopausal symptoms.
Our research questions include:
Does AIR reduce overall perimenopausal symptom burden co1 expand
The goal of this study is to evaluate a neuroplasticity-based mind-body intervention, Amygdala and Insula Retraining (AIR), compared to a wait-list control in individuals experiencing perimenopausal symptoms. Our research questions include: Does AIR reduce overall perimenopausal symptom burden compared to a wait-list control? Does AIR improve sleep disturbance, vasomotor symptom interference, fatigue, mood, anxiety, and quality of life in perimenopausal individuals? Are symptom changes associated with improvements in autonomic regulation and sleep parameters, as reflected by exploratory wearable measures including heart rate variability? Type: Interventional Start Date: Jul 2026 |
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Healthy Volunteers Enteral Nutrition Study (HEN)
James Lewis
Enteral Nutrition's Effect on the Gut
This research study is being conducted to determine the effects of enteral nutrition on
healthy people. Enteral nutrition for the purpose of this study refers to the use of a
specially developed formula taken by mouth that provides all essential nutrition either
in the absence of food or to supplem1 expand
This research study is being conducted to determine the effects of enteral nutrition on healthy people. Enteral nutrition for the purpose of this study refers to the use of a specially developed formula taken by mouth that provides all essential nutrition either in the absence of food or to supplement the intake of foods. Enteral nutrition can be used for many reasons, such as to gain or lose weight, to treat food allergies, or to reduce inflammation in certain intestinal diseases. We would like to understand the effects of enteral nutrition in the absence of intestinal inflammation. Type: Interventional Start Date: Jun 2026 |
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A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 i1
Genentech, Inc.
Diabetic Macular Edema
The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD),
and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME,
administered by intravitreal (IVT) injection as monotherapy and co-administered with
faricimab. expand
The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab. Type: Interventional Start Date: Apr 2026 |
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Vestibular Innovation in Pain 2
Icahn School of Medicine at Mount Sinai
Fibromyalgia
Nociplastic Pain
Fibromyalgia is the most common centralized pain disorder, affecting up to 3% of the
population. Current treatments are incompletely effective, often poorly tolerated, and
costly: there remains an urgent need for novel, effective, and well-tolerated therapy.
Preliminary data suggests that vestibulo1 expand
Fibromyalgia is the most common centralized pain disorder, affecting up to 3% of the population. Current treatments are incompletely effective, often poorly tolerated, and costly: there remains an urgent need for novel, effective, and well-tolerated therapy. Preliminary data suggests that vestibulocortical stimulation (VCS), or irrigating the external ear canal with temperate water, could rapidly improve pain and quality of life in this cohort. The VIPR trial will assess the efficacy of a single session of VCS - a safe & cost-effective bedside technique using a plastic syringe and temperate water - relative to sham in treating pain & improving quality of life using validated patient-reported outcomes. Type: Interventional Start Date: Mar 2026 |
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Preliminary Effectiveness of Enhanced Text Message + Incentives
University of Kansas Medical Center
Smoking Cessation
Pregnancy
This study is a preliminary evaluation of a smoking cessation intervention designed for
pregnant women that combines text message support and financial incentives.
The aims of this study are to determine the preliminary feasibility and acceptability of
text message + incentives (intervention) vs.1 expand
This study is a preliminary evaluation of a smoking cessation intervention designed for pregnant women that combines text message support and financial incentives. The aims of this study are to determine the preliminary feasibility and acceptability of text message + incentives (intervention) vs. text message only (control). Type: Interventional Start Date: Apr 2026 |
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A Study of GEN1106 in Participants With Solid Tumors
Genmab
Solid Tumors
Urothelial Carcinoma
The purpose of this trial is to learn about the safety and effectiveness of GEN1106 when
it is used for the treatment of participants with certain types of cancer.
The trial has multiple parts. The first part of the trial tests different doses of
GEN1106 to find out if it is safe and determine wha1 expand
The purpose of this trial is to learn about the safety and effectiveness of GEN1106 when it is used for the treatment of participants with certain types of cancer. The trial has multiple parts. The first part of the trial tests different doses of GEN1106 to find out if it is safe and determine what are the best doses to use. The second and third parts continues to test the safety of and how well GEN1106 works in additional participants with a specific cancer type and at doses chosen based on results from the first part of the trial. For each participant, the trial will last approximately 17 months but will vary for each person. This includes up to 21 days for screening prior to receiving trial treatment, approximately 5 months of treatment (the duration of treatment may vary for each participant), and approximately 11 months of follow up after trial treatment ends (the duration of follow up may vary for each participant). Participation in the trial will require visits to the site, with more frequent visits during the first 6 weeks of treatment and then less frequent visits afterwards. At site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, computed tomography [CT] scans) to monitor whether the treatment is safe and effective. All participants will receive active drug; no one will be given placebo. Type: Interventional Start Date: Apr 2026 |
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LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
Eli Lilly and Company
Ulcerative Colitis (UC)
Ulcerative Colitis, Active Moderate
Ulcerative Colitis, Active Severe
The main purpose of this study is to evaluate the safety and effectiveness of LY4268989
when compared to placebo in adult participants with moderately to severely active
ulcerative colitis (UC). The study drug will be administered orally.
The study will last up to approximately 108 weeks, excludin1 expand
The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally. The study will last up to approximately 108 weeks, excluding screening. Type: Interventional Start Date: Mar 2026 |
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A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies
Mirati Therapeutics Inc.
Solid Tumors
This is an open-label, solid tumor, continuation, rollover trial which enrolls
participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849,
BMS-986503) either as monotherapy or in combination with other cancer therapies in
patients with non-small cell lung cancer (NSCLC), colorec1 expand
This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors. Type: Interventional Start Date: May 2026 |
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Trial of Spiritual Care Interventions for Patients With Cancer
Weill Medical College of Cornell University
Advanced Cancer
This study aims to determine the effects of 2 spiritual care interventions. Spiritual
wellness and healthcare service utilization will be measured from a sample of advanced
cancer patients recruited from outpatient settings. expand
This study aims to determine the effects of 2 spiritual care interventions. Spiritual wellness and healthcare service utilization will be measured from a sample of advanced cancer patients recruited from outpatient settings. Type: Interventional Start Date: Mar 2026 |
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A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tu1
MediLink Therapeutics (Suzhou) Co., Ltd.
Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma
This is a phase Ib/II, multicenter, open-label study of YL201 combined with atezolizumab.
The study will include 2 parts. Part 1 of the study is a dose escalation in participants
with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in
combination with fixed dose of at1 expand
This is a phase Ib/II, multicenter, open-label study of YL201 combined with atezolizumab. The study will include 2 parts. Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in combination with fixed dose of atezolizumab. The planned dose levels of YL201 are 1.2 mg/kg, 1.6 mg/kg and 2.0 mg/kg. Part 2 consists of a dose optimization stage followed by a dose expansion stage. During the dose optimization stage, participants will be randomized 1:1:1 to receive either YL201 at 1.2 mg/kg,1.6 mg/kg or 2.0 mg/kg Q3W in combination with fixed dose of atezolizumab. The decision to initiate the dose expansion stage in Part 2 and choose one or two of the YL201 dose level(s) will be based on the review of safety, PK, and efficacy from the dose optimization stage. Treatment will continue until disease progression, unacceptable toxicity, or withdraw of consent. Type: Interventional Start Date: Mar 2026 |
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Respiratory Muscle Training to Improve Cerebrovascular and Immune Function
Florida State University
Obesity
Cerebrovascular Function
Immune Cells Activity
Millions of adults in America have too much body fat, resulting in obesity. Obesity is
detrimental to health and causes disease. Obesity reduces brain health, which causes the
brain to function less effectively. Additionally, a lack of exercise contributes to
poorer brain health. Most individuals f1 expand
Millions of adults in America have too much body fat, resulting in obesity. Obesity is detrimental to health and causes disease. Obesity reduces brain health, which causes the brain to function less effectively. Additionally, a lack of exercise contributes to poorer brain health. Most individuals feel they do not have time to exercise. There is a need for a quicker type of training that improves brain health. Newly developed breathing exercises could be a time-efficient, cost-effective, and home-based practice to increase brain health. This practice acts as weightlifting for breathing muscles. These new breathing exercises have already been shown to increase heart health. Heart health is linked to brain health; if an intervention helps the heart, it is likely to also help the brain. It is currently unknown if breathing training can improve brain health in younger adults with obesity. The investigators will utilize the same 8-week program shown to improve heart health. Testing will be conducted before and after the breathing training. The first part of the study will determine if breathing exercises help brain health. Obesity also causes inflammation. This is measured via blood but affects the entire body. It is thought to cause some of the negative outcomes of obesity. By lowering inflammation, it is likely to improve overall health. Breathing exercises may reduce inflammation, but more research is required. The second part of this study will determine whether breathing exercises help reduce inflammation. This study will determine if brain health can be improved in adults with obesity. This could help 40% of American adults with obesity to live longer and healthier lives. Type: Interventional Start Date: Jan 2026 |
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TOUCH® CMC 1 New Enrollment US Study
Keri Medical SA
Osteoarthritis Thumb
Thumb Carpometacarpal Joint Osteoarthritis
The purpose of this study is to meet a PMA (P240020) condition of approval of the TOUCH®
CMC 1 Prosthesis to evaluate the effectiveness and safety of the prosthesis in the United
States (US) population. The device performance in newly enrolled US patients implanted by
US surgeons will be compared t1 expand
The purpose of this study is to meet a PMA (P240020) condition of approval of the TOUCH® CMC 1 Prosthesis to evaluate the effectiveness and safety of the prosthesis in the United States (US) population. The device performance in newly enrolled US patients implanted by US surgeons will be compared to device performance observed within the outside the US (OUS) premarket cohort. Type: Observational Start Date: Mar 2026 |
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Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastati1
OHSU Knight Cancer Institute
Advanced Biliary Tract Carcinoma
Advanced Head and Neck Squamous Cell Carcinoma
Advanced Hepatocellular Carcinoma
Advanced Lung Non-Small Cell Carcinoma
Advanced Malignant Solid Neoplasm
This phase IV trial is evaluating whether morning versus afternoon administration of
standard of care immunotherapy impacts its effectiveness in treating patients with solid
tumors that may have spread from where it first started to nearby tissue, lymph nodes, or
distant parts of the body (advanced1 expand
This phase IV trial is evaluating whether morning versus afternoon administration of standard of care immunotherapy impacts its effectiveness in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Circadian rhythm refers to the internal biological clock in which various processes in the body, including immune cell activity, are controlled by the time of day. Exactly how this works is not fully understood, and the researchers want to see if circadian rhythm control of the immune system can influence response to immunotherapy based on whether it is given in the morning (before 11:00 am) or afternoon (12:00pm). The time of day that immunotherapy is given (morning versus afternoon) may impact the effectiveness in treating patients with advanced or metastatic solid tumors. Type: Interventional Start Date: Jun 2026 |
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Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
Revolution Medicines, Inc.
Advanced Solid Tumors
Metastatic Solid Tumors
Non-small Cell Lung Cancer (NSCLC)
NSCLC
Colorectal Cancer (CRC)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK),
and preliminary antitumor activity of RAS(ON) inhibitors in combination with ivonescimab
in adults with advanced or metastatic solid tumors with a RAS mutation. expand
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RAS(ON) inhibitors in combination with ivonescimab in adults with advanced or metastatic solid tumors with a RAS mutation. Type: Interventional Start Date: Jan 2026 |
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Functional Ovarian Reserve in Sickle Cell Disease
St. Jude Children's Research Hospital
Sickle Cell Disease
This study aims to look at AMH levels in female children with SCD as they go through
puberty to see if they are at the same level as other children without SCD at the same
age and/or pubertal stage and will also look at how treatment exposures and pain crises
affect the AMH levels in children with1 expand
This study aims to look at AMH levels in female children with SCD as they go through puberty to see if they are at the same level as other children without SCD at the same age and/or pubertal stage and will also look at how treatment exposures and pain crises affect the AMH levels in children with SCD. Primary Objective: - To evaluate whether AMH levels are lower in pre-teens and adolescent females with SCD when compared with healthy female controls (siblings, relatives, non-relatives of similar race/ethnicity) at the same age and pubertal stage. Secondary Objectives: - To evaluate whether AMH has a similar trajectory in female pre-teens and adolescents with SCD when compared with the general population and controls. - To describe pubertal timing, menstrual history, and markers of functional ovarian reserve (FOR), as well as prevalence of premature ovarian insufficiency (POI) as determined by medical history and laboratory markers in pre-teens and adolescents with SCD in comparison with their female controls. - To correlate AMH levels with FSH and estradiol levels, normal pubertal timing, and menstrual history in children and adolescents with SCD. - To correlate the severity of SCD (number of vaso-occlusive events) with pubertal timing, presence of normal vs abnormal menstruation, and laboratory markers of FOR, in pre-teens and adolescents with SCD. - To correlate the use of SCD modifying treatment modalities with pubertal timing, menstrual pattern, and laboratory markers of FOR in pre-teens and adolescents with SCD. Type: Observational Start Date: Jun 2026 |
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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone1
National Cancer Institute (NCI)
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Estrogen Receptor-Positive Breast Carcinoma
HER2-Negative Breast Carcinoma
This phase III trial compares standard of care hormone therapy plus ribociclib to
chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients
with high anatomic stage breast cancer with low risk of the cancer returning (low risk
recurrence). Ribociclib may stop the growth1 expand
This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk. Type: Interventional Start Date: Feb 2027 |
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Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-s1
National Cancer Institute (NCI)
Lung Non-Small Cell Carcinoma
This phase III trial compares the effect of atezolizumab (or atezolizumab and recombinant
human hyaluronidase) to standard observation for preventing cancer return after surgery
(recurrence) in patients who have undergone a complete surgical removal (resection) of
stage I non-small cell lung cancer1 expand
This phase III trial compares the effect of atezolizumab (or atezolizumab and recombinant human hyaluronidase) to standard observation for preventing cancer return after surgery (recurrence) in patients who have undergone a complete surgical removal (resection) of stage I non-small cell lung cancer (NSCLC). Patients who have undergone resection for lung cancer are typically followed by observation or active surveillance, which involves closely watching a patient's condition but not giving treatment unless there are changes in test results. During active surveillance, patients are given certain exams and tests done on a regular schedule. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Atezolizumab and recombinant human hyaluronidase is a formulation of atezolizumab combined with an enzyme called hyaluronidase, which helps increase tissue absorption of the drug. Giving atezolizumab or atezolizumab and recombinant human hyaluronidase after resection may be effective for preventing NSCLC recurrence, and may be a better approach to treating patients with stage I NSCLC than the usual observation approach. Type: Interventional Start Date: Mar 2027 |
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A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokineti1
Amgen
Uncontrolled Gout
The primary objective of this trial is to evaluate the effect of pegloticase 18 mg
subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg
intravenously (IV) every two weeks with MTX on the response rate during Month 6, as
measured by the sustained normalization of serum1 expand
The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to < 6 mg/dL for at least 80% of the time during Month 6. Type: Interventional Start Date: Feb 2026 |
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A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosi1
Ipsen
Primary Sclerosing Cholangitis
The purpose of this study is to find out how well and safely elafibranor works compared
to placebo in adult participants with Primary sclerosing cholangitis (PSC). PSC is a rare
disease that causes inflammation and scarring of the bile ducts in the liver. Over time,
this can lead to liver damage an1 expand
The purpose of this study is to find out how well and safely elafibranor works compared to placebo in adult participants with Primary sclerosing cholangitis (PSC). PSC is a rare disease that causes inflammation and scarring of the bile ducts in the liver. Over time, this can lead to liver damage and serious health problems, including the need for a liver transplant and death. In this study, about 350 participants with large duct PSC will take part. Participants will be randomized to receive either elafibranor 120 mg once daily or a placebo (a tablet with no active medicine). The study includes a screening period, an treatment period, and a post-treatment safety follow-up. During the study, participants will undergo routine clinical assessments, laboratory testing, imaging evaluations, and complete patient-reassessments to evaluate liver disease progression, symptoms, quality of life and safety. Following the end of treatment, participants will complete a safety follow-up period at approximately four weeks. Participants may withdraw from the study at any time. Each participant may be in the study for several years, as the treatment period will continue until the study reaches enough health events among participants, which is expected to take about 5 years. Type: Interventional Start Date: May 2026 |