A Phase II Multicenter Double-Blind Randomised Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC)

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A Phase II Multicenter Double-Blind Randomised Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC)

Brief description of study

The sponsor is conducting this phase II study to evaluate the safety and tolerability of 2 doses of elafibranor in participants with PSC, and its potential effect on the change in serum alkaline phosphatase (ALP) and other hepatic markers of PSC during 12 weeks of treatment in the double-blind period (DBP) compared to placebo. This will be followed by a 96-week open-label extension (OLE) period to assess long-term safety and maintenance of effects of elafibranor.

Clinical Study Identifier: s23-00115

ClinicalTrials.gov Identifier: NCT05627362

Principal Investigator: Ira M. Jacobson.

Other Investigator: Monique Julia Carasso.

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