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Clinical Trial Active — Not Recruiting Phase II NCT05627362

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

A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis. — Active Not Recruiting • Phase II • Gastroenterology • NCT05627362.

📅 01 Oct 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase II
NCT ID
NCT05627362
Start
2022-12-29
Completion
2031-09-23
ClinicaliQ Trial Snapshot
  • A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis. — Active Not Recruiting • Phase II • Gastroenterology • NCT05627362.
  • A trial testing whether a drug called elafibranor can safely treat primary sclerosing cholangitis, a rare liver disease.

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What This Trial Is Studying

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…

Full Trial Details
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Eligibility criteria, protocol, and results when available
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