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

Recruiting Phase 3 Interventional Study
Primary Sclerosing Cholangitis
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
350 (estimated)
Sponsor
Ipsen · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 …
Contacts

Ipsen Clinical Study Enquiries

see email

clinical.trials@ipsen.com

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