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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Ipsen • ClinicalTrials.gov ID: NCT07387549

Registry updated: 2026-10-01
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Description

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.

Interventions

  • Elafibranor (Drug)
    Round and orange film coated tablet of 120 mg
  • Placebo (Other)
    Round and orange film coated tablet of placebo

Eligibility criteria

Inclusion Criteria: * Adults participants aged 18 years or older * Confirmed diagnosis of primary sclerosing cholangitis based on standard clinical, biochemical, and imaging criteria * Compensated liver disease at screening * Stable background therapy, where applicable prior to study entry * Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control * Ability to provide written informed consent and comply with study procedures. Exclusion Criteria: \- History or presence of other concomitant chronic liver disease \- History of hepatic decompensation, including: i) History of liver transplantation, current MELD 3.0 score ≥12 due to hepatic impairment. ii) Evidence of complications of cirrhosis * Participants with cirrhosis who are also classified as Child-Pugh B or C based on the Child Pugh score. * History of biliary intervention within 60 days prior to the screening period, and/or presence of percutaneous drain or bile duct stent at SV. * History of bacterial cholangitis, and/or participant on antibiotics for prophylaxis of recurrent cholangitis within 60 days prior to the SV. * History or any current suspicion of cholangiocarcinoma or hepatocellular carcinoma * Known malignancy or history of malignancy within the last 5 years, with the exception of local, successfully treated basal cell carcinoma or in-situ carcinoma of the uterine cervix. * Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease). * Administration of the following medications are prohibited as specified below: i) 3 months prior to baseline: norucholic acid, fibrates, seladelpar and glitazones. ii) 3 months prior to baseline: cyclosporine, mycophenolate, pentoxifylline, and chronic systemic corticosteroids (except as part of management of IBD at an ongoing stable dose); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin). * Participants who are currently participating in, plan to participate in, or have participated in an investigational drug or medical device study containing active substance within 30 days or five half-lives, whichever is longer, prior to the SV. - Participants with previous exposure to elafibranor. * Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) \>450 msec in males or QTcF \>470 msec in females for participants without bundle branch block. * Significant renal disease, * For female participants: known pregnancy, or has a positive serum pregnancy test, or lactating. * Regular alcohol intake in excess of the recommended limit of 2 standard drinks per day for men or 1 standard drink per day for women * History of alcohol abuse, or other substance abuse within 1 year prior to SV. * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that contraindicates participation in the study. * Mental instability or incompetence * Participant has or is known to have tested positive for human immunodeficiency virus (HIV) type 1 or 2 at SV. * Medical conditions that may diminish life expectancy to \<2 years.

Conditions

Primary Sclerosing Cholangitis

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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