Actively Recruiting
A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis
Led by Ipsen · Updated on 2026-05-28
350
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well and safely elafibranor works compared to a placebo in adults with Primary Sclerosing Cholangitis (PSC), a rare liver disease that causes inflammation and scarring of the bile ducts. The study aims to understand the effects of elafibranor in slowing liver damage and reducing serious health risks such as the need for a liver transplant or death. This is a Phase III, randomized, double-blind, placebo-controlled trial sponsored by Ipsen. Participants will be randomly assigned to receive either elafibranor 120 mg once daily or a placebo tablet once daily. The study includes a screening period, a treatment period expected to last up to about 5 years until enough health events occur, and a post-treatment safety follow-up of approximately four weeks. Both treatments are given orally as tablets. During the study, participants will have routine clinical assessments including lab tests, imaging, and patient-reported symptom evaluations to monitor liver disease progression, symptoms like itching and fatigue, quality of life, and safety. Researchers will measure event-free survival from baseline until the end of treatment, and monitor adverse events, physical exams, vital signs, ECG readings, and laboratory parameters. Participants may withdraw at any time and may be involved for several years depending on study progress.
CONDITIONS
Brief Title
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults participants aged 18 years or older
- Confirmed diagnosis of primary sclerosing cholangitis based on standard clinical, biochemical, and imaging criteria
- Compensated liver disease at screening
- Stable background therapy, where applicable prior to study entry
- Women of childbearing potential must use a highly effective method of birth control during the entire study
- Ability to provide written informed consent and comply with study procedures
You will not qualify if you...
- History or presence of other concomitant chronic liver disease
- History of hepatic decompensation or liver transplantation
- Participants with cirrhosis classified as Child-Pugh B or C
- Recent biliary intervention or presence of bile duct stent
- History of bacterial cholangitis or recent antibiotic use for cholangitis
- Current or suspected cholangiocarcinoma or hepatocellular carcinoma
- Known malignancy within the last 5 years except certain local skin or cervical cancers
- Medical conditions causing non-hepatic increases in alkaline phosphatase
- Recent use of prohibited medications including certain fibrates, corticosteroids, and hepatotoxic drugs
- Participation in other investigational drug or device studies within 30 days
- Previous exposure to elafibranor
- Abnormal ECG with prolonged QT interval
- Significant renal disease
- Pregnancy or lactation
- Excessive regular alcohol intake or recent substance abuse
- Sensitivity or allergy to study interventions
- Mental instability or incompetence
- Positive HIV test at screening
- Medical conditions reducing life expectancy to less than 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants take 1 tablet of elafibranor 120 mg or placebo orally once daily while being monitored for safety and efficacy.
Regular visits throughout treatment duration
Trial Site Locations
Total: 2 locations
1
Arizona Liver Health
Chandler, Arizona, United States, 85224
Actively Recruiting
2
American Research Corporation at The Texas Liver Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
I
Ipsen Clinical Study Enquiries
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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