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

NCT07387549 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CLIN-60190-4752026-525242-29-00
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Event-Free Survival

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

  From baseline until the end of treatment (estimated up to 5 years)

Secondary Outcomes (9)

• Percentage of participants with ALP level within the pre-defined level

  From baseline to Week 48

• Change from baseline in severity of a patient-reported cholestatic symptom: Pruritus

  From baseline to Week 24

• Change from baseline in severity of a patient-reported cholestatic symptom: Fatigue

  From baseline to Week 48

• Percentage of participants experiencing treatment-emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs)

  From baseline until the end of treatment (estimated up to 5 years)

• Percentage of participants developing clinically significant changes in physical examination findings

  From baseline until the end of treatment (estimated up to 5 years)

Study Arms (2)

Elafibranor 120 mg

EXPERIMENTAL

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

Drug: Elafibranor

Placebo

PLACEBO COMPARATOR

Participants will take 1 placebo tablet orally once daily

Other: Placebo

Interventions

Placebo OTHER

Round and orange film coated tablet of placebo

Placebo

Elafibranor DRUG

Round and orange film coated tablet of 120 mg

Also known as: IPN60190

Elafibranor 120 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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,

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

American Research Corporation at The Texas Liver Institute

San Antonio, Texas, 78215, United States

RECRUITING

MeSH Terms

Conditions

Cholangitis, Sclerosing

Interventions

2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Central Study Contacts

Ipsen Clinical Study Enquiries

CONTACT

see email; clinical.trials@ipsen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2031
• Study Completion (Estimated): May 31, 2031
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
• Access Criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Locations

US (1)