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

NCT05627362 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-04-30

No results posted yet for this study

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

DRUG

Placebo Matched to Elafibranor 120 mg

Oral Tablet

DRUG

Elafibranor 80 mg

Oral Tablet

DRUG

Elafibranor 120 mg

Oral Tablet

DRUG

Placebo Matched to Elafibranor 80 mg

Oral Tablet

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical, Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-29
Primary Completion
2026-08-28
Completion
2026-08-28
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05627362 on ClinicalTrials.gov