A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
Public ClinicalTrials.gov record NCT05627362. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC) during the double-blind period, an initial 96 week open-label extension (OLE) period, and an optional open-label extension long-term (OLE-LT) period beyond OLE Week 96. 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, including long-term safety during the open-label extension periods. The trial will also study the study drug's effects on blood tests and other tests related to PSC disease activity.
Study identification
- NCT ID
- NCT05627362
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 68 participants
Conditions and interventions
Conditions
Interventions
- Elafibranor 80 mg Drug
- Elafibranor 120 mg Drug
- Placebo Matched to Elafibranor 80 mg Drug
- Placebo Matched to Elafibranor 120 mg Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 28, 2022
- Primary completion
- Sep 22, 2031
- Completion
- Sep 22, 2031
- Last update posted
- Aug 30, 2026
2022 – 2031
United States locations
- U.S. sites
- 30
- U.S. states
- 20
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Om Research LLC | Lancaster | California | 93534 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| University of California, Davis | Sacramento | California | 95817 | — |
| Sutter Health Van Ness Campus Medical Office Building | San Francisco | California | 94109 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | — |
| South Denver Gastroenterology,P.C. | Englewood | Colorado | 80113 | — |
| Rocky Mountain Gastroenterology (RMG) | Littleton | Colorado | 80120 | — |
| Yale University School Of Medicine - Yale Center For Clinical Investigation | New Haven | Connecticut | 06510 | — |
| Schiff Center for Liver Diseases - University of Miami | Miami | Florida | 33136 | — |
| Covenant Research | Sarasota | Florida | 34240 | — |
| Piedmont Hospital - Piedmont Transplant Institute | Atlanta | Georgia | 30309 | — |
| Tandem Clinical Research GI | Marrero | Louisiana | 70072 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Beth Israel Deaconess Medical Center, Liver Research Center | Boston | Massachusetts | 02215 | — |
| Huron Gastroenterology Associates - Center for Digestive Care | Ypsilanti | Michigan | 48197 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Southwest Gastroenterology Associates, PC (SWGA) | Albuquerque | New Mexico | 87109-4342 | — |
| New York University Langone Health | New York | New York | 06510 | — |
| Gastro Health Research | Cincinnati | Ohio | 45219 | — |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19017 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Gastro One | Cordova | Tennessee | 38018 | — |
| University Of Texas Southwestern Medical Center At Dallas | Dallas | Texas | 75235 | — |
| American Research Corporation at The Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22093 | — |
| Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond | Richmond | Virginia | 23226 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| Liver Institute Northwest | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 32 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05627362, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 30, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05627362 live on ClinicalTrials.gov.