A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
Condition(s) studied
Investigational drug(s) / intervention(s)
Elafibranor: Round and orange film coated tablet of 120 mg
Placebo: Round and orange film coated tablet of placebo
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.
Eligibility
Primary outcome measure(s)
- Event-Free Survival — From baseline until the end of treatment (estimated up to 5 years)
Event-free survival is defined as the time from randomisation to either adjudicated disease progression or death, whichever occurs first.
Trial sites (231)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Liver Health | Chandler | Arizona | Recruiting |
| Mayo Clinic in Arizona | Phoenix | Arizona | Not Yet Recruiting |
| Southern California Research Center | Coronado | California | Recruiting |
| University of California San Diego | La Jolla | California | Not Yet Recruiting |
| Keck Medicine of USC - USC Healthcare Center 1 | Los Angeles | California | Not Yet Recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | Not Yet Recruiting |
| California Liver Research Institute | Pasadena | California | Not Yet Recruiting |
| Stanford University | Redwood City | California | Not Yet Recruiting |
| University of California Davis Medical Center | Sacramento | California | Not Yet Recruiting |
| Sutter Health Van Ness Campus Medical Office Building | San Francisco | California | Not Yet Recruiting |
| University of California, San Francisco Medical Center | San Francisco | California | Not Yet Recruiting |
| University of Colorado Hospital Anschutz Outpatient Pavilion | Aurora | Colorado | Not Yet Recruiting |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | Recruiting |
| South Denver Gastroenterology,P.C. | Englewood | Colorado | Recruiting |
| Rocky Mountain Gastroenterology (RMG) | Littleton | Colorado | Recruiting |
| Yale Medical Group - Yale Digestive Diseases -Temple Medical Center Location | New Haven | Connecticut | Not Yet Recruiting |
| MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH) | Washington D.C. | District of Columbia | Not Yet Recruiting |
| University of Miami - Schiff Center for Liver Diseases | Miami | Florida | Not Yet Recruiting |
| Piedmont Hospital - Piedmont Transplant Institute | Atlanta | Georgia | Not Yet Recruiting |
| Northwestern Medicine | Chicago | Illinois | Not Yet Recruiting |
| Rush University Medical Center | Chicago | Illinois | Not Yet Recruiting |
| The University of Chicago Medicine | Chicago | Illinois | Not Yet Recruiting |
| Indiana University School of Medicine | Indianapolis | Indiana | Recruiting |
| Gastroenterology Health Partners, PLLC (Southern Indiana Location) | New Albany | Indiana | Not Yet Recruiting |
| Deaconess GI Specialty Center | Newburgh | Indiana | Not Yet Recruiting |
| The University of Iowa Hospitals & Clinics | Iowa City | Iowa | Not Yet Recruiting |
| University Of Louisville School Of Medicine | Louisville | Kentucky | Not Yet Recruiting |
| Mercy Medical Center, Inc | Baltimore | Maryland | Recruiting |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | Not Yet Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Not Yet Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | Not Yet Recruiting |
| University of Michigan | Ann Arbor | Michigan | Not Yet Recruiting |
| Henry Ford Health System | Detroit | Michigan | Not Yet Recruiting |
| Mayo Clinic Cancer Center (MCCC) - Rochester | Rochester | Minnesota | Not Yet Recruiting |
| Saint Louis University | St Louis | Missouri | Not Yet Recruiting |
| University of Nebraska Medical Center | Omaha | Nebraska | Not Yet Recruiting |
| NYU Langone Gastroenterology and Hepatology Associates | New York | New York | Not Yet Recruiting |
| Weill Medical College Of Cornell University | New York | New York | Not Yet Recruiting |
| Mount Sinai Medical Center | New York | New York | Not Yet Recruiting |
| University of Rochester Medical Center | Rochester | New York | Not Yet Recruiting |
+ 191 more sites — see the full list on the official registry below.
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07387549 on ClinicalTrials.gov ↗ ← All trials in Australia