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

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Ipsen
Study ID
NCT07387549
Phase
PHASE3
Status
Recruiting
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Conditions

  • Primary Sclerosing Cholangitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Elafibranor — DRUG
    Round and orange film coated tablet of 120 mg
  • Placebo — OTHER
    Round and orange film coated tablet of placebo

Study Details

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.

Key Dates

Start date
May 14, 2026
Status verified
May 2026
Primary completion
Apr 30, 2031
Completion
May 31, 2031

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Arizona Liver HealthChandlerArizona85224-
American Research Corporation at The Texas Liver InstituteSan AntonioTexas78215-

Find similar trials in Chandler, AZ

By research site
Arizona Liver Health· Chandler, AZAmerican Research Corporation at The Texas Liver Institute· San Antonio, TX

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