A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
Start Date
5/14/2026
Completion Date
5/31/2031
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 Criteria
Age Range: 18 years to 75 years
Interventions
Elafibranor
Placebo
Conditions
Locations
Arizona Liver Health
Chandler, Arizona 85224
United States
Mayo Clinic in Arizona
Phoenix, Arizona 85054
United States
Southern California Research Center
Coronado, California 92118
United States
University of California San Diego
La Jolla, California 92037-0897
United States
Keck Medicine of USC - USC Healthcare Center 1
Los Angeles, California 90033
United States
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
California Liver Research Institute
Pasadena, California 91105
United States
Stanford University
Redwood City, California 94063
United States
University of California Davis Medical Center
Sacramento, California 95817
United States
Sutter Health Van Ness Campus Medical Office Building
San Francisco, California 94109
United States
University of California, San Francisco Medical Center
San Francisco, California 94143
United States
University of Colorado Hospital Anschutz Outpatient Pavilion
Aurora, Colorado 80045
United States
Peak Gastroenterology Associates
Colorado Springs, Colorado 80920
United States
South Denver Gastroenterology,P.C.
Englewood, Colorado 80113
United States
Rocky Mountain Gastroenterology (RMG)
Littleton, Colorado 90046
United States
Yale Medical Group - Yale Digestive Diseases -Temple Medical Center Location
New Haven, Connecticut 06510-2738
United States
MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
Washington D.C., District of Columbia 20007
United States
University of Miami - Schiff Center for Liver Diseases
Miami, Florida 33136
United States
Piedmont Hospital - Piedmont Transplant Institute
Atlanta, Georgia 30309
United States
Northwestern Medicine
Chicago, Illinois 60611
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
The University of Chicago Medicine
Chicago, Illinois 60637
United States
Indiana University School of Medicine
Indianapolis, Indiana 46202
United States
Gastroenterology Health Partners, PLLC (Southern Indiana Location)
New Albany, Indiana 47150
United States
Deaconess GI Specialty Center
Newburgh, Indiana 47630
United States
The University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United States
University Of Louisville School Of Medicine
Louisville, Kentucky 40202
United States
Mercy Medical Center, Inc
Baltimore, Maryland 21202
United States
Johns Hopkins University School of Medicine
Baltimore, Maryland 21287
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Henry Ford Health System
Detroit, Michigan 48202
United States
Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota 55905
United States
Saint Louis University
St Louis, Missouri 63104-1015
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
NYU Langone Gastroenterology and Hepatology Associates
New York, New York 10016
United States
Weill Medical College Of Cornell University
New York, New York 10021
United States
Mount Sinai Medical Center
New York, New York 10029
United States
University of Rochester Medical Center
Rochester, New York 14642
United States
Digestive Health Partners, PA
Asheville, North Carolina 28803
United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599-7584
United States
Carolinas Medical Center -Center for Liver Disease and Transplant-Kidney Transplant Centre
Charlotte, North Carolina 28204
United States
Duke University Health System
Durham, North Carolina 27710
United States
Dayton Gastroenterology- Englewood
Beavercreek, Ohio 45440
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195-0001
United States
Penn State Milton S.Hershey Medical Center - Penn State Hershey Cancer Institute
Hershey, Pennsylvania 17033
United States
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
United States
Thomas Jefferson University Hospital - Jefferson Digestive Disease Institute (JDDI)
Philadelphia, Pennsylvania 19107-5244
United States
University Gastroenterology
Providence, Rhode Island 02904
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425
United States
Rapid City Medical Center
Rapid City, South Dakota 57701
United States
Gastro One
Cordova, Tennessee 38018
United States
Gastrointestinal Associates of Northeast Tennessee
Johnson City, Tennessee 37604
United States
Methodist Health Systems Clinical Research Institute
Dallas, Texas 75203
United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390-9045
United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas 77030
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
Liver Associates of Texas, P.A.
Houston, Texas 77030
United States
American Research Corporation at The Texas Liver Institute
San Antonio, Texas 78215
United States
Starhope Liver Center, PA - Starhope Clinical Research, LLC
San Antonio, Texas 78251
United States
Intermountain Medical Center
Murray, Utah 84107
United States
University of Virginia Medical Center
Charlottesville, Virginia 22903
United States
Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia 23226
United States
Virginia Commonwealth University Medical Center
Richmond, Virginia 23298-0341
United States
Northwest Gastroenterology Associates
Bellevue, Washington 98004
United States
Velocity Clinical Research, Seattle
Seattle, Washington 98105
United States
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin 53792
United States
GEDYT (Gastroenterologia Diagnostica y Terapeutica)
Ciudad Autonoma de Buenos Aires, Buenos Aires
Argentina
Hospital El Cruce
San Juan Bautista, Buenos Aires 1888
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D. 1181
Argentina
STAT Research S.A.
Buenos Aires, Buenos Aires F.D. C1023AAB
Argentina
Hospital Universitario Austral
Pilar, Pcia de Buenos Aires B16290DT
Argentina
Hospital Provincial del Centenario
Santa Fe, Santa Fe Province S2002KDS
Argentina
Royal North Shore Hospital
Saint Leonards, New South Wales 2065
Australia
Westmead Hospital
Westmead, New South Wales 2145
Australia
Sunshine Coast University Hospital
Birtinya, Queensland 4575
Australia
Mater Hospital Brisbane
South Brisbane, Queensland v
Australia
Central Adelaide Local Health Network - Royal Adelaide Hospital
Adelaide, South Australia 5000
Australia
Lyell McEwin Hospital
Adelaide, South Australia 5112
Australia
Austin Hospital
Heidelberg, Victoria 3084
Australia
The Alfred Hospital
Melbourne, Victoria 3004
Australia
Sir Charles Gairdner Hospital (SCGH)
Nedlands, Western Australia 6009
Australia
Northern Hospital Epping
Epping, 3076
Australia
St Vincent's Hospital
Fitzroy, 3065
Australia
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III
Vienna, State of Vienna 1090
Austria
Medizinische Universitaetsklinik Graz
Graz, Styria 8036
Austria
Medical University Innsbruck
Innsbruck, Tyrol 6020
Austria
University Hospital St. Poelten
Sankt Pölten, 3100
Austria
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
Brussels, Anderlecht 1070
Belgium
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital 1200
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Belgium
UZ Gent
Ghent, 9000
Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000
Belgium
Hospital Universitario Cassiano Antonio de Moraes
Vitória, Espírito Santo 29040-091
Brazil
Hospital Universitario Cassiano
Vitória, Espírito Santo 29040-091
Brazil
Instituto D'Or de Pesquisa e Ensino - Hospital Aliança
Salvador, Estado de Bahia 41920-900
Brazil
Hospital das Clínicas da Universidade Federal de Goias - HC-UFG
Goiânia, Goiás 74605
Brazil
Nucleo de Pesquisa Clinica NUPEC
Belo Horizonte, Minas Gerais 30140-062
Brazil
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
Rio de Janeiro, Rio de Janeiro 21941-617
Brazil
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul 90035-903
Brazil
Universidade Estadual Paulista Julio De Mesquita Filho (UNESP) Hospital das Clinicas Faculdade de Medicina de Botucatu (HCFMB)
Botucatu, SaoPaulo 18618970
Brazil
Hospital de Base - Centro Integrado de Pesquisa ( CIP )
São José do Rio Preto, São Paulo 15090-000
Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo 05403-000
Brazil
Instituto de Gestao Estrategica de Saude do Distrito Federal
Brasília, 70335 900
Brazil
Instituto Americas
Rio de Janeiro, 22793-334
Brazil
University of Calgary
Calgary, Alberta T2N 4Z6
Canada
University Of Alberta Hospital-Zeidler Ledcor Centre
Edmonton, Alberta T6G 2X8
Canada
(G.I.R.I) GI Research Institute Foundation
Vancouver, British Columbia V6Z 2K5
Canada
Shared Health Inc. Health Sciences Centre
Winnipeg, Manitoba R3E 3P4
Canada
Queen Elizabeth II (QEII) Health Sciences Centre -Dalhousie University-Victoria General
Halifax, New Brunswick B3H2Y9
Canada
Brampton Civic Hospital (BCH) - Osler Hepatitis Centre
Brampton, Ontario L6R 3J7
Canada
London Health Sciences Centre (LHSC) - University Hospital
London, Ontario N6A 5A5
Canada
Dr Gauthier,MD,Office Of
North Bay, Ontario P1B 2H3
Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario K1H 8L6
Canada
University Health Network (UHN) - Toronto General Hospital (TGH) - Liver Transplant Clinic
Toronto, Ontario M5G 2C4
Canada
Toronto Liver Centre
Toronto, Ontario M6H 3M1
Canada
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
Montreal, Quebec H2X 0A9
Canada
Beijing Ditan Hospital
Beijing, Beijing Municipality 100015
China
Peking Union Medical College Hospital
Beijing, Beijing Municipality 100032
China
Peking University Peoples Hospital (PKUPH)
Beijing, Beijing Municipality 100044
China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality 100050
China
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong 510060
China
Henan Provincial People's Hospital
Zhengzhou, Henan 450003
China
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi 330000
China
The First Hospital of Jilin University
Changchun, Jilin 130021
China
Qilu Hospital of Shandong University
Jinan, Shandong 250012
China
Renji hospital shanghai jiao tong university school of medicine
Shanghai, Shanghai Municipality 200001
China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality 300052
China
Research Site s.r.o.
Pilsen, 301 00
Czechia
Institute for Clinical and Experimental Medicine - IKEM
Prague, 14021
Czechia
ISCARE IVF Klinika Centrum
Prague, 190 00
Czechia
Copenhagen University Hospital-Rigshospitalet University Hospital
Copenhagen, Capital Region 2100
Denmark
Aarhus Universitets hospital
Aarhus, 8200
Denmark
Turun Yliopistollinen Keskussairaala (TYKS) - Main Hospital
Turku, 20521
Finland
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, 59000
France
Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
Lyon, 69004
France
Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
Montpellier, 34295
France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
Nantes, 44093
France
Hopitaux Universitaires Est Parisien - Hopital Saint-Antoine
Paris, 75012
France
Hopitaux Universitaires Pitie Salpetriere Charles Foix
Paris, 75013
France
Clinique Pasteur
Toulouse, 31076
France
Centre Hepato-Biliaire Hospital Paul Brousse (AP-HP)
Villejuif, 94800
France
DRK Kliniken Berlin Mitte
Berlin, 13359
Germany
Universitatsklinikum Carl Gustav Carus an der Technischen Universitat Dresden
Dresden, 1307
Germany
Medizinische Hochschule Hannover, Hannover Medical School
Hanover, 30625
Germany
Universitatsklinikum Heidelberg
Heidelberg, 69120
Germany
Universitaetsklinikum Leipzig
Leipzig, 4103
Germany
Otto-von-Guericke-Universitaet Magdeburg - Universitaetsklinikum Magdeburg A.Oe.R - Universitaetshautklinik
Magdeburg, 39120
Germany
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
Mainz, 55131
Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076
Germany
St. Josefs-Hospital Wiesbaden Gmbh
Wiesbaden, 65189
Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97080
Germany
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino
Genova, 16132
Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, 41124
Italy
Ospedale San Gerardo
Monza, 20900
Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
Italy
Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
Padova, 35128
Italy
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Roma, 168
Italy
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
Rozzano, 20089
Italy
ASUFC
Udine, 33100
Italy
Chiba University Hospital
Chiba, Chiba 260-8677
Japan
Hiroshima University Hospital
Hiroshima, Hiroshima 734-8551
Japan
Teikyo University Hospital
Itabashi-ku, Itabashi-ku 173-8606
Japan
Yokohama City University Medical Center
Yokohama, Kanagawa 232-0024
Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki 856-8562
Japan
Nara Medical University Hospital
Kashihara, Nara 634-8522
Japan
Niigata University Medical & Dental Hospital
Niigata, Niigata 951-8520
Japan
The University of Osaka Hospital
Suita, Osaka 565-0871
Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo 113-8431
Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo 113-8655
Japan
Keio University Hospital
Tokyo, 160-8582
Japan
Radboud University Medical Center
Nijmegen, Gelderland 6525 GA
Netherlands
Amsterdam University Medical Center (Amsterdam UMC), Vrije University Medical Center (VUMC)
Amsterdam, 1081 HV
Netherlands
University Medical Center Groningen
Groningen, 9713 GZ
Netherlands
Leiden University Medical Center (Leids Universitair Medisch Centrum (LUMC))
Leiden, 2333 ZA
Netherlands
Erasmus University Medical Center
Rotterdam, 3015 GD
Netherlands
Universitair Medisch Centrum Utrecht (UMC Utrecht)
Utrecht, 3584 CX
Netherlands
Akershus Universitetssykehus HF
Lorenskog, Akershus 1478
Norway
Haraldsplass Diakonale Sykehus
Bergen, 5009
Norway
Oslo University Hospital
Oslo, 372
Norway
Medrise sp. z o.o
Lublin, 20-582
Poland
ID Clinic
Mysłowice, 41-400
Poland
Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501
Poland
Unidade Local De Saude De Sao Jose E.P.E.
Lisbon, Lisbon District 1150-199
Portugal
Hospital da Luz Lisboa
Lisbon, Lisbon District 1500-650
Portugal
Unidade Local de Saude de Santo Antonio
Porto, Porto District 4050-011
Portugal
Centro Hospitalar E Universitario de Coimbra EPE
Coimbra, 3000-075
Portugal
Hospital Santa Maria
Lisbon, 1649-035
Portugal
CUF Porto Hospital
Porto, 4100-180
Portugal
Spitalul Judetean de Urgenta Satu Mare
Satu Mare, Jud Satu-Mare
Romania
Spitalul Clinic De Urgenta Prof. Dr. Octavian Fodor
Cluj-Napoca, Jud. Cluj 400132
Romania
Spital Clinic Dr I Cantacuzino
Bucharest, 20475
Romania
Institutul Clinic Fundeni
Bucharest, 22328
Romania
Gastromedica Srl
Iași, 700111
Romania
Asan Medical Center (AMC)
Seoul, Seoul 5505
South Korea
Pusan National University Hospital (PNUH)
Busan, 49241
South Korea
Samsung Medical Center
Seoul, Seoul
South Korea
Seoul National University Hospital
Seoul, Seoul
South Korea
Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques (IMIM) (Hospital del Mar Research Institute)
Barcelona, 8003
Spain
Vall de Hebron University Hospital
Barcelona, 8035
Spain
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, 8036
Spain
Hospital Universitario Reina Sofia
Córdoba, 14004
Spain
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, 28007
Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital De Montecelo
Pontevedra, 36071
Spain
Instituto De Investigacion Marques De Valdecilla (IDIVAL)
Santander, 39008
Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, 46026
Spain
Hospital Universitario Miguel Servet de Zaragoza
Zaragoza, 50009
Spain
Mag-Tarm Mottagningen-Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45
Sweden
Orebro University Hospital
Örebro, 702 21
Sweden
Karolinska Universitetssjukhuset
Stockholm, 141 86
Sweden
Akademiska Sjukhuset - Uppsala University Hospital
Uppsala, 751 85
Sweden
University Hospital Basel
Basel, 4031
Switzerland
Universitaetsspital Bern - Inselspital
Bern, 3010
Switzerland
Ospedale Civico
Lugano, 6900
Switzerland
Universitatsspital Zurich
Zurich, 8091
Switzerland
Frimley Park Hospital - Frimley Health NHS Foundation Trust
Frimley, Camberley GU16 7UJ
United Kingdom
The Royal Free Hospital - Royal Free London NHS Foundation Trust
London, Greater London NW3 2QG
United Kingdom
King's College Hospital
London, Greater London SE5 9RS
United Kingdom
Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk NR4 7UY
United Kingdom
John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire OX3 9DU
United Kingdom
Hull University Teaching Hospitals NHS Trust - Castle Hill Hospital - Queen's Centre for Oncology and Haematology
Cottingham, Yorkshire and the Humber HU16 5JQ
United Kingdom
Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
Aberdeen, AB25 2ZD
United Kingdom
Queen Elizabeth Hospital
Birmingham, B15 2TT
United Kingdom
NHS Greater Glasgow and Clyde (NHSGGC), The Queen Elizabeth University Hospital (QEUH)
Glasgow, G4 0SF
United Kingdom
The Royal London Hospital - Barts Health NHS Trust
London, E1 1FR
United Kingdom
Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
United Kingdom