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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: Recruiting Phase 3 study, sponsored by Ipsen.
NCT07387549 is a Phase 3 study that is actively recruiting participants, run by Ipsen. The registered enrollment target is 350 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Event-free survival is defined as the time from randomisation to either adjudicated disease progression or death, whichever occurs first.
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 |
What NCT07387549 shows while recruiting
NCT07387549 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07387549 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07387549's enrollment target sits among peer trials
350 1034th of 2000 higher than 956 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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