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MinorTrial sites expanded: 13 → 231 locationsEligibility criteria expanded, about 23 words · Secondary endpoints: details revised at 1 of 9 entriesShow 2 more changesShow less
Eligibility criteria expanded, about 23 words
Secondary endpoints: details revised at 1 of 9 entries
MinorTrial sites expanded: 6 → 13 locationsv9
MinorStudy sites: 4 to 6v8
MinorStudy sites: 2 to 4v7
MinorStudy sites: 1 to 2Start date changed from estimate of Apr 30, 2026 to May 14, 2026v6Show 1 more changeShow less
Start date changed from estimate of Apr 30, 2026 to May 14, 2026
NotableRecruitment openedStudy sites: 0 to 1v5Show 1 more changeShow less
Study sites: 0 to 1
MinorRe-verified, no change to tracked fieldsv4
MinorStart date: Apr 14, 2026 to Apr 30, 2026v3
MinorRe-verified, no change to tracked fieldsv2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.