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RECRUITING
NCT07387549
PHASE3

A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis

Sponsor: Ipsen

View on ClinicalTrials.gov

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

2026-10-01

Healthy Volunteers

No

Interventions

DRUG

Elafibranor

Round and orange film coated tablet of 120 mg

OTHER

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

Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)

Rio de Janeiro, Rio de Janeiro, Brazil

Hospital de Clinicas de Porto Alegre (HCPA)

Porto Alegre, Rio Grande do Sul, Brazil

Universidade Estadual Paulista Julio De Mesquita Filho (UNESP) Hospital das Clinicas Faculdade de Medicina de Botucatu (HCFMB)

Botucatu, SaoPaulo, Brazil

Hospital de Base - Centro Integrado de Pesquisa ( CIP )

São José do Rio Preto, São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Instituto de Gestao Estrategica de Saude do Distrito Federal

Brasília, Brazil

Instituto Americas

Rio de Janeiro, Brazil

University of Calgary

Calgary, Alberta, Canada

University Of Alberta Hospital-Zeidler Ledcor Centre

Edmonton, Alberta, Canada

(G.I.R.I) GI Research Institute Foundation

Vancouver, British Columbia, Canada

Shared Health Inc. Health Sciences Centre

Winnipeg, Manitoba, Canada

Queen Elizabeth II (QEII) Health Sciences Centre -Dalhousie University-Victoria General

Halifax, New Brunswick, Canada

Brampton Civic Hospital (BCH) - Osler Hepatitis Centre

Brampton, Ontario, Canada

London Health Sciences Centre (LHSC) - University Hospital

London, Ontario, Canada

Dr Gauthier,MD,Office Of

North Bay, Ontario, Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

University Health Network (UHN) - Toronto General Hospital (TGH) - Liver Transplant Clinic

Toronto, Ontario, Canada

Toronto Liver Centre

Toronto, Ontario, Canada

Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)

Montreal, Quebec, Canada

Beijing Ditan Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Peking University Peoples Hospital (PKUPH)

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Guangzhou Eighth People's Hospital

Guangzhou, Guangdong, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The Second Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Renji hospital shanghai jiao tong university school of medicine

Shanghai, Shanghai Municipality, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Research Site s.r.o.

Pilsen, Czechia

Institute for Clinical and Experimental Medicine - IKEM

Prague, Czechia

ISCARE IVF Klinika Centrum

Prague, Czechia

Copenhagen University Hospital-Rigshospitalet University Hospital

Copenhagen, Capital Region, Denmark

Aarhus Universitets hospital

Aarhus, Denmark

Turun Yliopistollinen Keskussairaala (TYKS) - Main Hospital

Turku, Finland

Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

Lille, France

Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse

Lyon, France

Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi

Montpellier, France

Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu

Nantes, France

Hopitaux Universitaires Est Parisien - Hopital Saint-Antoine

Paris, France

Hopitaux Universitaires Pitie Salpetriere Charles Foix

Paris, France

Clinique Pasteur

Toulouse, France

Centre Hepato-Biliaire Hospital Paul Brousse (AP-HP)

Villejuif, France

DRK Kliniken Berlin Mitte

Berlin, Germany

Universitatsklinikum Carl Gustav Carus an der Technischen Universitat Dresden

Dresden, Germany

Medizinische Hochschule Hannover, Hannover Medical School

Hanover, Germany

Universitatsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

Otto-von-Guericke-Universitaet Magdeburg - Universitaetsklinikum Magdeburg A.Oe.R - Universitaetshautklinik

Magdeburg, Germany

Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz

Mainz, Germany

Universitaetsklinikum Tuebingen

Tübingen, Germany

St. Josefs-Hospital Wiesbaden Gmbh

Wiesbaden, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino

Genova, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Azienda Ospedaliero-Universitaria Policlinico di Modena

Modena, Italy

Ospedale San Gerardo

Monza, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, Italy

Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia

Padova, Italy

A. Gemelli University Hospital, Catholic University of the Sacred Heart

Roma, Italy

IRCCS Istituto clinico humanitas - Humanitas Mirasole spa

Rozzano, Italy

ASUFC

Udine, Italy

Chiba University Hospital

Chiba, Chiba, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Teikyo University Hospital

Itabashi-ku, Itabashi-ku, Japan

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

National Hospital Organization Nagasaki Medical Center

Ōmura, Nagasaki, Japan

Nara Medical University Hospital

Kashihara, Nara, Japan

Niigata University Medical & Dental Hospital

Niigata, Niigata, Japan

The University of Osaka Hospital

Suita, Osaka, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

Keio University Hospital

Tokyo, Japan

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Amsterdam University Medical Center (Amsterdam UMC), Vrije University Medical Center (VUMC)

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Leiden University Medical Center (Leids Universitair Medisch Centrum (LUMC))

Leiden, Netherlands

Erasmus University Medical Center

Rotterdam, Netherlands

Universitair Medisch Centrum Utrecht (UMC Utrecht)

Utrecht, Netherlands

Akershus Universitetssykehus HF

Lorenskog, Akershus, Norway

Haraldsplass Diakonale Sykehus

Bergen, Norway

Oslo University Hospital

Oslo, Norway

Medrise sp. z o.o

Lublin, Poland

ID Clinic

Mysłowice, Poland

Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Poland

Unidade Local De Saude De Sao Jose E.P.E.

Lisbon, Lisbon District, Portugal

Hospital da Luz Lisboa

Lisbon, Lisbon District, Portugal

Unidade Local de Saude de Santo Antonio

Porto, Porto District, Portugal

Centro Hospitalar E Universitario de Coimbra EPE

Coimbra, Portugal

Hospital Santa Maria

Lisbon, Portugal

CUF Porto Hospital

Porto, 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, Romania

Spital Clinic Dr I Cantacuzino

Bucharest, Romania

Institutul Clinic Fundeni

Bucharest, Romania

Gastromedica Srl

Iași, Romania

Asan Medical Center (AMC)

Seoul, Seoul, South Korea

Pusan National University Hospital (PNUH)

Busan, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques (IMIM) (Hospital del Mar Research Institute)

Barcelona, Spain

Vall de Hebron University Hospital

Barcelona, Spain

Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Hospital General Universitario Gregorio Maranon (HGUGM)

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital De Montecelo

Pontevedra, Spain

Instituto De Investigacion Marques De Valdecilla (IDIVAL)

Santander, Spain

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

Valencia, Spain

Hospital Universitario Miguel Servet de Zaragoza

Zaragoza, Spain

Mag-Tarm Mottagningen-Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Orebro University Hospital

Örebro, Sweden

Karolinska Universitetssjukhuset

Stockholm, Sweden

Akademiska Sjukhuset - Uppsala University Hospital

Uppsala, Sweden

University Hospital Basel

Basel, Switzerland

Universitaetsspital Bern - Inselspital

Bern, Switzerland

Ospedale Civico

Lugano, Switzerland

Universitatsspital Zurich

Zurich, Switzerland

Frimley Park Hospital - Frimley Health NHS Foundation Trust

Frimley, Camberley, United Kingdom

The Royal Free Hospital - Royal Free London NHS Foundation Trust

London, Greater London, United Kingdom

King's College Hospital

London, Greater London, United Kingdom

Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, United Kingdom

John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, United Kingdom

Hull University Teaching Hospitals NHS Trust - Castle Hill Hospital - Queen's Centre for Oncology and Haematology

Cottingham, Yorkshire and the Humber, United Kingdom

Aberdeen Royal Infirmary NHS Grampian Grampian Health Board

Aberdeen, United Kingdom

Queen Elizabeth Hospital

Birmingham, United Kingdom

NHS Greater Glasgow and Clyde (NHSGGC), The Queen Elizabeth University Hospital (QEUH)

Glasgow, United Kingdom

The Royal London Hospital - Barts Health NHS Trust

London, United Kingdom

Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom