Actively Recruiting
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
Led by Ipsen · Updated on 2026-05-06
350
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 throughout the 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, including prior liver transplantation or MELD 3.0 score ≥12 due to liver impairment
- Evidence of complications of cirrhosis
- Cirrhosis classified as Child-Pugh B or C
- Biliary intervention within 60 days before screening or presence of percutaneous drain or bile duct stent
- History of bacterial cholangitis or recent antibiotic use for cholangitis prophylaxis within 60 days before screening
- History or suspicion of cholangiocarcinoma or hepatocellular carcinoma
- Known malignancy or history of malignancy within last 5 years except treated basal cell carcinoma or in-situ carcinoma of uterine cervix
- Medical conditions causing non-hepatic increases in ALP (e.g., Paget's disease)
- Use of prohibited medications including norucholic acid, fibrates, seladelpar, glitazones, cyclosporine, mycophenolate, pentoxifylline, or chronic systemic corticosteroids (except stable IBD management) within 3 months before baseline
- Participation in investigational drug or device study within 30 days or five half-lives prior to screening
- Previous exposure to elafibranor
- ECG with QTcF >450 msec in males or >470 msec in females without bundle branch block
- Significant kidney disease
- Known pregnancy, positive pregnancy test, or lactation
- Excessive alcohol intake above recommended limits
- History of alcohol or substance abuse within 1 year prior to screening
- Sensitivity or allergy to study interventions or components
- Mental instability or incompetence
- Positive HIV test at screening
- Medical conditions likely to reduce life expectancy to less than 2 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
American Research Corporation at The Texas Liver Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
I
Ipsen Clinical Study Enquiries
CONTACT
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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