Recruiting
Phase 3

Elafibranor

Sponsor:

Ipsen

Code:

NCT07387549

Conditions

Primary Sclerosing Cholangitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Elafibranor

Placebo

Study Details

Brief summary:

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

Primary Sclerosing Cholangitis

Study ID

NCT07387549

Start date

May 14, 2026

Status verified date

Aug, 2026

Completion date

May 31, 2031

Anticipated

Primary completion date

Apr 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

\- History or presence of other concomitant chronic liver disease

\- History of hepatic decompensation, including: i) History of liver transplantation, current MELD 3.0 score ≥12 due to hepatic impairment.

ii) Evidence of complications of cirrhosis

  • 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:

i) 3 months prior to baseline: norucholic acid, fibrates, seladelpar and glitazones.

ii) 3 months prior to baseline: cyclosporine, mycophenolate, pentoxifylline, and chronic systemic corticosteroids (except as part of management of IBD at an ongoing stable dose); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin).

  • 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.

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Elafibranor 120 mg

Participants will take 1 tablet of elafibranor 120 mg orally once daily

placebo comparator: Placebo

Participants will take 1 placebo tablet orally once daily

Interventions

Elafibranor

Round and orange film coated tablet of 120 mg

Placebo

Round and orange film coated tablet of placebo

Primary outcome measure

  • Event-Free Survival [ Time Frame: From baseline until the end of treatment (estimated up to 5 years) ]

Central Contacts and Locations

Central contacts

Ipsen Clinical Study Enquiries

see emailclinical.trials@ipsen.com

Locations

Arizona Liver Health

Recruiting

Chandler, Arizona, United States, 85224

Southern California Research Center

Recruiting

Coronado, California, United States, 92118

Peak Gastroenterology Associates

Recruiting

Colorado Springs, Colorado, United States, 80920

South Denver Gastroenterology,P.C.

Recruiting

Englewood, Colorado, United States, 80113

Rocky Mountain Gastroenterology (RMG)

Recruiting

Littleton, Colorado, United States, 90046

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Mercy Medical Center, Inc

Recruiting

Baltimore, Maryland, United States, 21202

University Gastroenterology

Recruiting

Providence, Rhode Island, United States, 02904

Medical University of South Carolina (MUSC)

Recruiting

Charleston, South Carolina, United States, 29425

Gastrointestinal Associates of Northeast Tennessee

Recruiting

Johnson City, Tennessee, United States, 37604

Liver Associates of Texas, P.A.

Recruiting

Houston, Texas, United States, 77030

American Research Corporation at The Texas Liver Institute

Recruiting

San Antonio, Texas, United States, 78215

Velocity Clinical Research, Seattle

Recruiting

Seattle, Washington, United States, 98105

More Information

Sponsor

Ipsen

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ipsen on 2026-08-31.