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NCT05627362 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
A Phase 2 study of Primary Sclerosing Cholangitis, sponsored by Ipsen.
- Active
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 20
- Study locations
NCT05627362: Active Phase 2 study of Primary Sclerosing Cholangitis, sponsored by Ipsen.
NCT05627362 is a Phase 2 study of Primary Sclerosing Cholangitis that is active but no longer recruiting, run by Ipsen. The registered enrollment target is 68 participants, below the 550-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05627362, a Phase 2 study of Primary Sclerosing Cholangitis, is active but no longer recruiting, sponsored by Ipsen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AESIs are AEs that may not be serious but are of special importance to a particular drug or class of drugs.
Conditions Studied
Interventions
- DRUG Elafibranor 80 mg
- DRUG Elafibranor 120 mg
- DRUG Placebo Matched to Elafibranor 80 mg
- DRUG Placebo Matched to Elafibranor 120 mg
Study Locations (20)
California
- Om Research LLC - Lancaster
- Cedars-Sinai Medical Center - Los Angeles
- University of California, Davis - Sacramento
- Sutter Health Van Ness Campus Medical Office Building - San Francisco
Colorado
- Peak Gastroenterology Associates - Colorado Springs
- South Denver Gastroenterology,P.C. - Englewood
- Rocky Mountain Gastroenterology (RMG) - Littleton
Florida
- Schiff Center for Liver Diseases - University of Miami - Miami
- Covenant Research - Sarasota
Connecticut
- Yale University School Of Medicine - Yale Center For Clinical Investigation - New Haven
Georgia
- Piedmont Hospital - Piedmont Transplant Institute - Atlanta
Louisiana
- Tandem Clinical Research GI - Marrero
Maryland
- Mercy Medical Center - Baltimore
Massachusetts
- Beth Israel Deaconess Medical Center, Liver Research Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2022-12-29 |
| Est. Completion | 2026-08-28 |
| Phase | Phase 2 |
What the registry record for NCT05627362 still lists
NCT05627362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 550-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Primary Sclerosing Cholangitis appearing as the primary indexed condition, and to 4 interventions - of which Elafibranor 80 mg is the first listed.
NCT05627362 names 20 study sites across 14 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT05627362 about?
NCT05627362 is a clinical study titled "A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.". 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...
What is the current status of trial NCT05627362?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2022-12-29. Estimated completion is 2026-08-28.
What conditions does trial NCT05627362 study?
This clinical trial studies the following conditions: Primary Sclerosing Cholangitis.
What interventions are being tested in trial NCT05627362?
The interventions under investigation include: Elafibranor 80 mg (DRUG), Elafibranor 120 mg (DRUG), Placebo Matched to Elafibranor 80 mg (DRUG), Placebo Matched to Elafibranor 120 mg (DRUG).
Who is sponsoring clinical trial NCT05627362?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05627362 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Sclerosing Cholangitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05627362's enrollment target sits among peer trials
68 13th of 23 higher than 11 of 23 other Primary Sclerosing Cholangitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Sclerosing Cholangitis 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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-
A Study of NGM282 in Patients With Primary Sclerosing Cholangitis
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