NCT05627362

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

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).

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC). 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. The trial will also study the study drug's effects on blood tests and other tests related to PSC disease activity.

Conditions

• Primary Sclerosing Cholangitis

Interventions

Type	Name	Description
DRUG	Elafibranor 80 mg	Oral Tablet
DRUG	Elafibranor 120 mg	Oral Tablet
DRUG	Placebo Matched to Elafibranor 80 mg	Oral Tablet
DRUG	Placebo Matched to Elafibranor 120 mg	Oral Tablet

Timeline

• Start date: 2022-12-29
• Primary completion: 2026-08-28
• Completion: 2026-08-28
• First posted: 2022-11-25
• Last updated: 2026-04-01

Locations

62 sites across 7 countries: United States, Canada, Germany, Italy, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study