A Study to Assess how Well and Safely Elafibranor Works in Adult Participants with Primary Sclerosing Cholangitis
Brief description of study
This phase III, multicenter, randomized, double-blind, placebo-controlled study aims to further evaluate the efficacy and safety of elafibranor 120 mg/day in adult participants with primary sclerosing cholangitis (PSC). The primary objective is to evaluate the efficacy of daily oral administration of elafibranor 120 mg compared to placebo based on time to first occurrence of clinical outcome events in adult participants with PSC. The study consists of three periods: an up-to 10-week screening period; an event-driven treatment period; and a 4-week safety follow-up after the last dose of study intervention.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: 99 years or below
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Gender: All
TBD
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