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NCT07387549 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
A Phase 3 study, sponsored by Ipsen.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
NCT07387549 is a Phase 3 study that is actively recruiting participants, run by Ipsen. The registered enrollment target is 350 participants.
The verdict
NCT07387549, a Phase 3 study, is actively recruiting participants, sponsored by Ipsen.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
Study Summary
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 350 participants with large duct PSC will take part. Participants will be randomized to receive either elafibranor 120 mg once daily or a placebo (a tablet with no active medicine). The study includes a screening period, an treatment period, and a post-treatment safety follow-up. During the study, participants will undergo routine clinical assessments, laboratory testing, imaging evaluations, and complete patient-reassessments to evaluate liver disease progression, symptoms, quality of life and safety. Following the end of treatment, participants will complete a safety follow-up period at approximately four weeks. Participants may withdraw from the study at any time. Each participant may be in the study for several years, as the treatment period will continue until the study reaches enough health events among participants, which is expected to take about 5 years.
Interventions
- OTHER Placebo
- DRUG Elafibranor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2026-05-14 |
| Est. Completion | 2031-05-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07387549
The ClinicalTrials.gov registry entry for NCT07387549 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07387549 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07387549 about?
NCT07387549 is a clinical study titled "A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis". 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...
What is the current status of trial NCT07387549?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2026-05-14. Estimated completion is 2031-05-31.
What interventions are being tested in trial NCT07387549?
The interventions under investigation include: Placebo (OTHER), Elafibranor (DRUG).
Who is sponsoring clinical trial NCT07387549?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
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