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Elafibranor for Primary Sclerosing Cholangitis

This study is looking at how well and safely a medicine called elafibranor works for adults with Primary Sclerosing Cholangitis (PSC). PSC is a rare liver disease that causes inflammation and scarring of the bile ducts. The study aims to see if elafibranor can help prevent serious problems like liver damage or the need for a liver transplant, compared to a placebo (a tablet with no active medicine). About 350 adults with PSC will join this study. You may be eligible if you are between 18 and 75 years old, have a confirmed PSC diagnosis, and stable liver disease.

Study design
This study will involve about 350 participants who will be randomly assigned to receive either elafibranor or a placebo. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
The study includes a screening period, a treatment period where you will take a tablet once daily, and a safety follow-up after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Event-Free Survival from the start of treatment until the end of treatment, which is estimated to be up to 5 years.

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NCT07387549

A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis

Recruiting
PHASE3Ages 18–75InterventionalTreatment
Ipsen
~350 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:ElafibranorPlacebo

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event-Free Survival
Measured over From baseline until the end of treatment (estimated up to 5 years)

Conditions

Primary Sclerosing Cholangitis

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Primary Sclerosing Cholangitis

Where it's being run

6 sites across 5 states
Texas2
Arizona1
Colorado1
Tennessee1
Washington1

Study leadership

  • Ipsen Medical Director · STUDY_DIRECTOR · Ipsen

Who to contact

Ipsen Clinical Study Enquiries
[email protected]
see email
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 have to apply during the entire duration of the study a highly effective method of birth control
Ability to provide written informed consent and comply with study procedures.

Exclusion

Participants with cirrhosis who are also classified as Child-Pugh B or C based on the Child Pugh score.
History of biliary intervention within 60 days prior to the screening period, and/or presence of percutaneous drain or bile duct stent at SV.
History of bacterial cholangitis, and/or participant on antibiotics for prophylaxis of recurrent cholangitis within 60 days prior to the SV.
History or any current suspicion of cholangiocarcinoma or hepatocellular carcinoma
Known malignancy or history of malignancy within the last 5 years, with the exception of local, successfully treated basal cell carcinoma or in-situ carcinoma of the uterine cervix.
Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).
Administration of the following medications are prohibited as specified below:
Participants who are currently participating in, plan to participate in, or have participated in an investigational drug or medical device study containing active substance within 30 days or five half-lives, whichever is longer, prior to the SV. - Participants with previous exposure to elafibranor.
Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) \>450 msec in males or QTcF \>470 msec in females for participants without bundle branch block.
Significant renal disease,
For female participants: known pregnancy, or has a positive serum pregnancy test, or lactating.
Regular alcohol intake in excess of the recommended limit of 2 standard drinks per day for men or 1 standard drink per day for women
History of alcohol abuse, or other substance abuse within 1 year prior to SV.
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that contraindicates participation in the study.
Mental instability or incompetence
Participant has or is known to have tested positive for human immunodeficiency virus (HIV) type 1 or 2 at SV.
Medical conditions that may diminish life expectancy to \<2 years.

What this trial measures

  • Event-Free SurvivalFrom baseline until the end of treatment (estimated up to 5 years)

    Event-free survival is defined as the time from randomisation to either adjudicated disease progression or death, whichever occurs first.