A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.

About the trial

Sponsor

Ipsen

Tested

Elafibranor 80 mg (drug), Elafibranor 120 mg (drug), Placebo Matched to Elafibranor 80 mg (drug), Placebo Matched to Elafibranor 120 mg (drug)

Dates

Started 2022-12-29; completion 2031-09-23

Results posted

Not yet

This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC) during the double-blind period, an initial 96 week open-label extension (OLE) period, and an optional open-label extension long-term (OLE-LT) period beyond OLE Week 96. PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial will be to study the safety and side effects of the study drug, including long-term s…

From ClinicalTrials.gov, last updated 2026-10-23. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Ipsen Bioscience Inc. reported $357,800 in research payments for this study in 2025 (184 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.