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A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
Sponsor: Ipsen
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.
Official title: A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2026-05-14
Completion Date
2031-05-31
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Elafibranor
Round and orange film coated tablet of 120 mg
Placebo
Round and orange film coated tablet of placebo
Locations (231)
Arizona Liver Health
Chandler, Arizona, United States
Mayo Clinic in Arizona
Phoenix, Arizona, United States
Southern California Research Center
Coronado, California, United States
University of California San Diego
La Jolla, California, United States
Keck Medicine of USC - USC Healthcare Center 1
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
California Liver Research Institute
Pasadena, California, United States
Stanford University
Redwood City, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Sutter Health Van Ness Campus Medical Office Building
San Francisco, California, United States
University of California, San Francisco Medical Center
San Francisco, California, United States
University of Colorado Hospital Anschutz Outpatient Pavilion
Aurora, Colorado, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
South Denver Gastroenterology,P.C.
Englewood, Colorado, United States
Rocky Mountain Gastroenterology (RMG)
Littleton, Colorado, United States
Yale Medical Group - Yale Digestive Diseases -Temple Medical Center Location
New Haven, Connecticut, United States
MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
Washington D.C., District of Columbia, United States
University of Miami - Schiff Center for Liver Diseases
Miami, Florida, United States
Piedmont Hospital - Piedmont Transplant Institute
Atlanta, Georgia, United States
Northwestern Medicine
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
The University of Chicago Medicine
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Gastroenterology Health Partners, PLLC (Southern Indiana Location)
New Albany, Indiana, United States
Deaconess GI Specialty Center
Newburgh, Indiana, United States
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University Of Louisville School Of Medicine
Louisville, Kentucky, United States
Mercy Medical Center, Inc
Baltimore, Maryland, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
NYU Langone Gastroenterology and Hepatology Associates
New York, New York, United States
Weill Medical College Of Cornell University
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Digestive Health Partners, PA
Asheville, North Carolina, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Carolinas Medical Center -Center for Liver Disease and Transplant-Kidney Transplant Centre
Charlotte, North Carolina, United States
Duke University Health System
Durham, North Carolina, United States
Dayton Gastroenterology- Englewood
Beavercreek, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Penn State Milton S.Hershey Medical Center - Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital - Jefferson Digestive Disease Institute (JDDI)
Philadelphia, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Rapid City Medical Center
Rapid City, South Dakota, United States
Gastro One
Cordova, Tennessee, United States
Gastrointestinal Associates of Northeast Tennessee
Johnson City, Tennessee, United States
Methodist Health Systems Clinical Research Institute
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Liver Associates of Texas, P.A.
Houston, Texas, United States
American Research Corporation at The Texas Liver Institute
San Antonio, Texas, United States
Starhope Liver Center, PA - Starhope Clinical Research, LLC
San Antonio, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Northwest Gastroenterology Associates
Bellevue, Washington, United States
Velocity Clinical Research, Seattle
Seattle, Washington, United States
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, United States
GEDYT (Gastroenterologia Diagnostica y Terapeutica)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital El Cruce
San Juan Bautista, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., Argentina
STAT Research S.A.
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Universitario Austral
Pilar, Pcia de Buenos Aires, Argentina
Hospital Provincial del Centenario
Santa Fe, Santa Fe Province, Argentina
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, Australia
Central Adelaide Local Health Network - Royal Adelaide Hospital
Adelaide, South Australia, Australia
Lyell McEwin Hospital
Adelaide, South Australia, Australia
Austin Hospital
Heidelberg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital (SCGH)
Nedlands, Western Australia, Australia
Northern Hospital Epping
Epping, Australia
St Vincent's Hospital
Fitzroy, Australia
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III
Vienna, State of Vienna, Austria
Medizinische Universitaetsklinik Graz
Graz, Styria, Austria
Medical University Innsbruck
Innsbruck, Tyrol, Austria
University Hospital St. Poelten
Sankt Pölten, Austria
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
Brussels, Anderlecht, Belgium
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
UZ Gent
Ghent, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Hospital Universitario Cassiano Antonio de Moraes
Vitória, Espírito Santo, Brazil
Hospital Universitario Cassiano
Vitória, Espírito Santo, Brazil
Instituto D'Or de Pesquisa e Ensino - Hospital Aliança
Salvador, Estado de Bahia, Brazil
Hospital das Clínicas da Universidade Federal de Goias - HC-UFG
Goiânia, Goiás, Brazil
Nucleo de Pesquisa Clinica NUPEC
Belo Horizonte, Minas Gerais, Brazil