Primary Sclerosing CholangitisPhase 3ELASCOPENCT07387549
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
A Phase 3 study testing Elafibranor in people with Primary Sclerosing Cholangitis, run by Ipsen at 231 sites in 25 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- Elafibranor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 231 sitesin 25 countries
- Study dates
- 14 May 2026to 31 May 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
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- 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:
- 3 months prior to baseline: norucholic acid, fibrates, seladelpar and glitazones.
- 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.
Trial locations and contacts
231 sites in 25 countries. Contact the study team or a site near you to ask about taking part.
231 sites in 25 countries
United States69 sites, 69 recruiting
- Not yet recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Not yet recruiting
Digestive Health Partners, PA
Asheville, North Carolina, 28803
- Not yet recruiting
Piedmont Hospital - Piedmont Transplant Institute
Atlanta, Georgia, 30309
- Not yet recruiting
University of Colorado Hospital Anschutz Outpatient Pavilion
Aurora, Colorado, 80045
- Recruiting
Mercy Medical Center, Inc
Baltimore, Maryland, 21202
- Not yet recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
- Not yet recruiting
Dayton Gastroenterology- Englewood
Beavercreek, Ohio, 45440
- Not yet recruiting
Northwest Gastroenterology Associates
Bellevue, Washington, 98004
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Not yet recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
Arizona Liver Health
Chandler, Arizona, 85224
- Not yet recruiting
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7584
- Recruiting
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
- Not yet recruiting
Carolinas Medical Center -Center for Liver Disease and Transplant-Kidney Transplant Centre
Charlotte, North Carolina, 28204
- Recruiting
University of Virginia Medical Center
Charlottesville, Virginia, 22903
- Not yet recruiting
Northwestern Medicine
Chicago, Illinois, 60611
- Not yet recruiting
Rush University Medical Center
Chicago, Illinois, 60612
- Not yet recruiting
The University of Chicago Medicine
Chicago, Illinois, 60637
- Not yet recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Not yet recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195-0001
- Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80920
- Recruiting
Gastro One
Cordova, Tennessee, 38018
- Recruiting
Southern California Research Center
Coronado, California, 92118
- Recruiting
Methodist Health Systems Clinical Research Institute
Dallas, Texas, 75203
- Not yet recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9045
- Not yet recruiting
Henry Ford Health System
Detroit, Michigan, 48202
- Not yet recruiting
Duke University Health System
Durham, North Carolina, 27710
- Recruiting
South Denver Gastroenterology,P.C.
Englewood, Colorado, 80113
- Not yet recruiting
Penn State Milton S.Hershey Medical Center - Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033
- Not yet recruiting
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, 77030
- Not yet recruiting
Houston Methodist Hospital
Houston, Texas, 77030
- Recruiting
Liver Associates of Texas, P.A.
Houston, Texas, 77030
- Recruiting
Indiana University School of Medicine
Indianapolis, Indiana, 46202
- Recruiting
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
- Recruiting
Gastrointestinal Associates of Northeast Tennessee
Johnson City, Tennessee, 37604
- Not yet recruiting
University of California San Diego
La Jolla, California, 92037-0897
- Recruiting
Rocky Mountain Gastroenterology (RMG)
Littleton, Colorado, 90046
- Not yet recruiting
Keck Medicine of USC - USC Healthcare Center 1
Los Angeles, California, 90033
- Not yet recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
- Not yet recruiting
University Of Louisville School Of Medicine
Louisville, Kentucky, 40202
- Not yet recruiting
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, 53792
- Recruiting
University of Miami - Schiff Center for Liver Diseases
Miami, Florida, 33136
- Not yet recruiting
Intermountain Medical Center
Murray, Utah, 84107
- Not yet recruiting
Gastroenterology Health Partners, PLLC (Southern Indiana Location)
New Albany, Indiana, 47150
- Not yet recruiting
Yale Medical Group - Yale Digestive Diseases -Temple Medical Center Location
New Haven, Connecticut, 06510-2738
- Not yet recruiting
NYU Langone Gastroenterology and Hepatology Associates
New York, New York, 10016
- Not yet recruiting
Weill Medical College Of Cornell University
New York, New York, 10021
- Not yet recruiting
Mount Sinai Medical Center
New York, New York, 10029
- Not yet recruiting
Deaconess GI Specialty Center
Newburgh, Indiana, 47630
- Not yet recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Recruiting
California Liver Research Institute
Pasadena, California, 91105
- Not yet recruiting
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
- Not yet recruiting
Thomas Jefferson University Hospital - Jefferson Digestive Disease Institute (JDDI)
Philadelphia, Pennsylvania, 19107-5244
- Not yet recruiting
Mayo Clinic in Arizona
Phoenix, Arizona, 85054
- Recruiting
University Gastroenterology
Providence, Rhode Island, 02904
- Not yet recruiting
Rapid City Medical Center
Rapid City, South Dakota, 57701
- Not yet recruiting
Stanford University
Redwood City, California, 94063
- Not yet recruiting
Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23226
- Not yet recruiting
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298-0341
- Not yet recruiting
Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota, 55905
- Not yet recruiting
University of Rochester Medical Center
Rochester, New York, 14642
- Not yet recruiting
University of California Davis Medical Center
Sacramento, California, 95817
- Recruiting
American Research Corporation at The Texas Liver Institute
San Antonio, Texas, 78215
- Recruiting
Starhope Liver Center, PA - Starhope Clinical Research, LLC
San Antonio, Texas, 78251
- Not yet recruiting
Sutter Health Van Ness Campus Medical Office Building
San Francisco, California, 94109
- Recruiting
University of California, San Francisco Medical Center
San Francisco, California, 94143
- Recruiting
Velocity Clinical Research, Seattle
Seattle, Washington, 98105
- Not yet recruiting
Saint Louis University
St Louis, Missouri, 63104-1015
- Not yet recruiting
MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
Washington D.C., District of Columbia, 20007
Brazil12 sites, 12 recruiting
- Not yet recruiting
Nucleo de Pesquisa Clinica NUPEC
Belo Horizonte, Minas Gerais, 30140-062
- Not yet recruiting
Universidade Estadual Paulista Julio De Mesquita Filho (UNESP) Hospital das Clinicas Faculdade de Medicina de Botucatu (HCFMB)
Botucatu, SaoPaulo, 18618970
- Not yet recruiting
Instituto de Gestao Estrategica de Saude do Distrito Federal
Brasília, 70335 900
- Not yet recruiting
Hospital das Clínicas da Universidade Federal de Goias - HC-UFG
Goiânia, Goiás, 74605
- Not yet recruiting
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-903
- Not yet recruiting
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
Rio de Janeiro, Rio de Janeiro, 21941-617
- Not yet recruiting
Instituto Americas
Rio de Janeiro, 22793-334
- Not yet recruiting
Instituto D'Or de Pesquisa e Ensino - Hospital Aliança
Salvador, Estado de Bahia, 41920-900
- Not yet recruiting
Hospital de Base - Centro Integrado de Pesquisa ( CIP )
São José do Rio Preto, São Paulo, 15090-000
- Not yet recruiting
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-000
- Not yet recruiting
Hospital Universitario Cassiano Antonio de Moraes
Vitória, Espírito Santo, 29040-091
- Not yet recruiting
Hospital Universitario Cassiano
Vitória, Espírito Santo, 29040-091
Canada12 sites, 12 recruiting
- Not yet recruiting
Brampton Civic Hospital (BCH) - Osler Hepatitis Centre
Brampton, Ontario, L6R 3J7
- Not yet recruiting
University of Calgary
Calgary, Alberta, T2N 4Z6
- Not yet recruiting
University Of Alberta Hospital-Zeidler Ledcor Centre
Edmonton, Alberta, T6G 2X8
- Not yet recruiting
Queen Elizabeth II (QEII) Health Sciences Centre -Dalhousie University-Victoria General
Halifax, New Brunswick, B3H2Y9
- Not yet recruiting
London Health Sciences Centre (LHSC) - University Hospital
London, Ontario, N6A 5A5
- Not yet recruiting
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
Montreal, Quebec, H2X 0A9
- Not yet recruiting
Dr Gauthier,MD,Office Of
North Bay, Ontario, P1B 2H3
- Not yet recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
- Not yet recruiting
University Health Network (UHN) - Toronto General Hospital (TGH) - Liver Transplant Clinic
Toronto, Ontario, M5G 2C4
- Not yet recruiting
Toronto Liver Centre
Toronto, Ontario, M6H 3M1
- Not yet recruiting
(G.I.R.I) GI Research Institute Foundation
Vancouver, British Columbia, V6Z 2K5
- Not yet recruiting
Shared Health Inc. Health Sciences Centre
Winnipeg, Manitoba, R3E 3P4
Australia11 sites, 11 recruiting
- Not yet recruiting
Central Adelaide Local Health Network - Royal Adelaide Hospital
Adelaide, South Australia, 5000
- Not yet recruiting
Lyell McEwin Hospital
Adelaide, South Australia, 5112
- Not yet recruiting
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
- Not yet recruiting
Northern Hospital Epping
Epping, 3076
- Recruiting
St Vincent's Hospital
Fitzroy, 3065
- Not yet recruiting
Austin Hospital
Heidelberg, Victoria, 3084
- Not yet recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
- Not yet recruiting
Sir Charles Gairdner Hospital (SCGH)
Nedlands, Western Australia, 6009
- Not yet recruiting
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
- Not yet recruiting
Mater Hospital Brisbane
South Brisbane, Queensland, v
- Not yet recruiting
Westmead Hospital
Westmead, New South Wales, 2145
China11 sites, 11 recruiting
- Not yet recruiting
Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
- Not yet recruiting
Peking University Peoples Hospital (PKUPH)
Beijing, Beijing Municipality, 100044
- Not yet recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
- Not yet recruiting
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, 510060
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
- Not yet recruiting
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, 330000
- Recruiting
Renji hospital shanghai jiao tong university school of medicine
Shanghai, Shanghai Municipality, 200001
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Japan11 sites, 11 recruiting
- Not yet recruiting
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
- Not yet recruiting
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8655
- Not yet recruiting
Chiba University Hospital
Chiba, Chiba, 260-8677
- Not yet recruiting
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
- Not yet recruiting
Teikyo University Hospital
Itabashi-ku, Itabashi-ku, 173-8606
- Not yet recruiting
Nara Medical University Hospital
Kashihara, Nara, 634-8522
- Not yet recruiting
Niigata University Medical & Dental Hospital
Niigata, Niigata, 951-8520
- Not yet recruiting
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, 856-8562
- Not yet recruiting
The University of Osaka Hospital
Suita, Osaka, 565-0871
- Not yet recruiting
Keio University Hospital
Tokyo, 160-8582
- Not yet recruiting
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024
Spain11 sites, 11 recruiting
- Not yet recruiting
Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques (IMIM) (Hospital del Mar Research Institute)
Barcelona, 8003
- Not yet recruiting
Vall de Hebron University Hospital
Barcelona, 8035
- Recruiting
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, 8036
- Not yet recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
- Not yet recruiting
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, 28007
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
- Not yet recruiting
Hospital Universitario La Paz
Madrid, 28046
- Not yet recruiting
Hospital De Montecelo
Pontevedra, 36071
- Not yet recruiting
Instituto De Investigacion Marques De Valdecilla (IDIVAL)
Santander, 39008
- Recruiting
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, 46026
- Not yet recruiting
Hospital Universitario Miguel Servet de Zaragoza
Zaragoza, 50009
United Kingdom11 sites, 11 recruiting
- Not yet recruiting
Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
Aberdeen, AB25 2ZD
- Not yet recruiting
Queen Elizabeth Hospital
Birmingham, B15 2TT
- Not yet recruiting
Hull University Teaching Hospitals NHS Trust - Castle Hill Hospital - Queen's Centre for Oncology and Haematology
Cottingham, Yorkshire and the Humber, HU16 5JQ
- Not yet recruiting
Frimley Park Hospital - Frimley Health NHS Foundation Trust
Frimley, Camberley, GU16 7UJ
- Not yet recruiting
NHS Greater Glasgow and Clyde (NHSGGC), The Queen Elizabeth University Hospital (QEUH)
Glasgow, G4 0SF
- Not yet recruiting
The Royal Free Hospital - Royal Free London NHS Foundation Trust
London, Greater London, NW3 2QG
- Not yet recruiting
King's College Hospital
London, Greater London, SE5 9RS
- Not yet recruiting
The Royal London Hospital - Barts Health NHS Trust
London, E1 1FR
- Not yet recruiting
Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
- Not yet recruiting
Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
- Not yet recruiting
John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 9DU
Germany10 sites, 10 recruiting
- Not yet recruiting
DRK Kliniken Berlin Mitte
Berlin, 13359
- Not yet recruiting
Universitatsklinikum Carl Gustav Carus an der Technischen Universitat Dresden
Dresden, 1307
- Not yet recruiting
Medizinische Hochschule Hannover, Hannover Medical School
Hanover, 30625
- Not yet recruiting
Universitatsklinikum Heidelberg
Heidelberg, 69120
- Not yet recruiting
Universitaetsklinikum Leipzig
Leipzig, 4103
- Not yet recruiting
Otto-von-Guericke-Universitaet Magdeburg - Universitaetsklinikum Magdeburg A.Oe.R - Universitaetshautklinik
Magdeburg, 39120
- Not yet recruiting
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
Mainz, 55131
- Not yet recruiting
Universitaetsklinikum Tuebingen
Tübingen, 72076
- Not yet recruiting
St. Josefs-Hospital Wiesbaden Gmbh
Wiesbaden, 65189
- Not yet recruiting
Universitaetsklinikum Wuerzburg
Würzburg, 97080
Italy9 sites, 9 recruiting
- Not yet recruiting
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino
Genova, 16132
- Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
- Not yet recruiting
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, 41124
- Not yet recruiting
Ospedale San Gerardo
Monza, 20900
- Not yet recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
- Not yet recruiting
Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
Padova, 35128
- Not yet recruiting
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Roma, 168
- Not yet recruiting
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
Rozzano, 20089
- Not yet recruiting
ASUFC
Udine, 33100
France8 sites, 8 recruiting
- Not yet recruiting
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, 59000
- Not yet recruiting
Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
Lyon, 69004
- Not yet recruiting
Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
Montpellier, 34295
- Recruiting
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
Nantes, 44093
- Recruiting
Hopitaux Universitaires Est Parisien - Hopital Saint-Antoine
Paris, 75012
- Not yet recruiting
Hopitaux Universitaires Pitie Salpetriere Charles Foix
Paris, 75013
- Not yet recruiting
Clinique Pasteur
Toulouse, 31076
- Recruiting
Centre Hepato-Biliaire Hospital Paul Brousse (AP-HP)
Villejuif, 94800
Argentina6 sites, 6 recruiting
- Not yet recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., 1181
- Not yet recruiting
STAT Research S.A.
Buenos Aires, Buenos Aires F.D., C1023AAB
- Not yet recruiting
GEDYT (Gastroenterologia Diagnostica y Terapeutica)
Ciudad Autonoma de Buenos Aires, Buenos Aires
- Not yet recruiting
Hospital Universitario Austral
Pilar, Pcia de Buenos Aires, B16290DT
- Not yet recruiting
Hospital El Cruce
San Juan Bautista, Buenos Aires, 1888
- Not yet recruiting
Hospital Provincial del Centenario
Santa Fe, Santa Fe Province, S2002KDS
Netherlands6 sites, 6 recruiting
- Not yet recruiting
Amsterdam University Medical Center (Amsterdam UMC), Vrije University Medical Center (VUMC)
Amsterdam, 1081 HV
- Not yet recruiting
University Medical Center Groningen
Groningen, 9713 GZ
- Not yet recruiting
Leiden University Medical Center (Leids Universitair Medisch Centrum (LUMC))
Leiden, 2333 ZA
- Recruiting
Radboud University Medical Center
Nijmegen, Gelderland, 6525 GA
- Not yet recruiting
Erasmus University Medical Center
Rotterdam, 3015 GD
- Not yet recruiting
Universitair Medisch Centrum Utrecht (UMC Utrecht)
Utrecht, 3584 CX
Portugal6 sites, 6 recruiting
- Not yet recruiting
Centro Hospitalar E Universitario de Coimbra EPE
Coimbra, 3000-075
- Not yet recruiting
Unidade Local De Saude De Sao Jose E.P.E.
Lisbon, Lisbon District, 1150-199
- Not yet recruiting
Hospital da Luz Lisboa
Lisbon, Lisbon District, 1500-650
- Not yet recruiting
Hospital Santa Maria
Lisbon, 1649-035
- Not yet recruiting
Unidade Local de Saude de Santo Antonio
Porto, Porto District, 4050-011
- Not yet recruiting
CUF Porto Hospital
Porto, 4100-180
Belgium5 sites, 5 recruiting
- Recruiting
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
Brussels, Anderlecht, 1070
- Not yet recruiting
Universitair Ziekenhuis Antwerpen
Edegem, 2650
- Recruiting
UZ Gent
Ghent, 9000
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, 3000
- Not yet recruiting
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital, 1200
Romania5 sites, 5 recruiting
- Recruiting
Spital Clinic Dr I Cantacuzino
Bucharest, 20475
- Not yet recruiting
Institutul Clinic Fundeni
Bucharest, 22328
- Recruiting
Spitalul Clinic De Urgenta Prof. Dr. Octavian Fodor
Cluj-Napoca, Jud. Cluj, 400132
- Recruiting
Gastromedica Srl
Iași, 700111
- Recruiting
Spitalul Judetean de Urgenta Satu Mare
Satu Mare, Jud Satu-Mare
Austria4 sites, 4 recruiting
- Not yet recruiting
Medizinische Universitaetsklinik Graz
Graz, Styria, 8036
- Not yet recruiting
Medical University Innsbruck
Innsbruck, Tyrol, 6020
- Not yet recruiting
University Hospital St. Poelten
Sankt Pölten, 3100
- Not yet recruiting
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III
Vienna, State of Vienna, 1090
South Korea4 sites, 4 recruiting
- Not yet recruiting
Pusan National University Hospital (PNUH)
Busan, 49241
- Not yet recruiting
Asan Medical Center (AMC)
Seoul, Seoul, 5505
- Not yet recruiting
Samsung Medical Center
Seoul, Seoul
- Not yet recruiting
Seoul National University Hospital
Seoul, Seoul
Sweden4 sites, 4 recruiting
- Not yet recruiting
Mag-Tarm Mottagningen-Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45
- Not yet recruiting
Orebro University Hospital
Örebro, 702 21
- Not yet recruiting
Karolinska Universitetssjukhuset
Stockholm, 141 86
- Not yet recruiting
Akademiska Sjukhuset - Uppsala University Hospital
Uppsala, 751 85
Switzerland4 sites, 4 recruiting
- Not yet recruiting
University Hospital Basel
Basel, 4031
- Not yet recruiting
Universitaetsspital Bern - Inselspital
Bern, 3010
- Not yet recruiting
Ospedale Civico
Lugano, 6900
- Not yet recruiting
Universitatsspital Zurich
Zurich, 8091
Czechia3 sites, 3 recruiting
- Not yet recruiting
Research Site s.r.o.
Pilsen, 301 00
- Not yet recruiting
Institute for Clinical and Experimental Medicine - IKEM
Prague, 14021
- Recruiting
ISCARE IVF Klinika Centrum
Prague, 190 00
Norway3 sites, 3 recruiting
- Not yet recruiting
Haraldsplass Diakonale Sykehus
Bergen, 5009
- Not yet recruiting
Akershus Universitetssykehus HF
Lorenskog, Akershus, 1478
- Recruiting
Oslo University Hospital
Oslo, 372
Poland3 sites, 3 recruiting
- Not yet recruiting
Medrise sp. z o.o
Lublin, 20-582
- Recruiting
ID Clinic
Mysłowice, 41-400
- Recruiting
Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501
Denmark2 sites, 2 recruiting
- Not yet recruiting
Aarhus Universitets hospital
Aarhus, 8200
- Not yet recruiting
Copenhagen University Hospital-Rigshospitalet University Hospital
Copenhagen, Capital Region, 2100
Finland1 site, 1 recruiting
- Not yet recruiting
Turun Yliopistollinen Keskussairaala (TYKS) - Main Hospital
Turku, 20521
About this study
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
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.
Read more
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.
- Conditions
- Primary Sclerosing Cholangitis
- Being tested
- Elafibranor, Placebo
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElafibranorDrug
Also called IPN60190
Round and orange film coated tablet of 120 mg
PlaceboOther
Round and orange film coated tablet of placebo
| Study group | Role | What they receive |
|---|---|---|
| Elafibranor 120 mg | Experimental | Participants will take 1 tablet of elafibranor 120 mg orally once daily Receives: Drug: Elafibranor |
| Placebo | Placebo comparator | Participants will take 1 placebo tablet orally once daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival
Event-free survival is defined as the time from randomisation to either adjudicated disease progression or death, whichever occurs first.
Measured: From baseline until the end of treatment (estimated up to 5 years)
Secondary outcomes (9)
Percentage of participants with ALP level within the pre-defined level
Difference between elafibranor and placebo in the percentage of participants with alkaline phosphatase (ALP) within the pre-defined level at Week 48.
Measured: From baseline to Week 48
Change from baseline in severity of a patient-reported cholestatic symptom: Pruritus
Symptom will be assessed using a patient-reported outcome scale
Measured: From baseline to Week 24
Change from baseline in severity of a patient-reported cholestatic symptom: Fatigue
Symptom will be assessed using a patient-reported outcome scale
Measured: From baseline to Week 48
Percentage of participants experiencing treatment-emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs)
An Adverse event (AE) is any untoward medical occurrence, temporally associated with the use of study intervention, whether or not related to the study intervention. AESIs are AEs that may not be serious but are of special importance to a particular drug or class of drugs
Measured: From baseline until the end of treatment (estimated up to 5 years)
Percentage of participants developing clinically significant changes in physical examination findings
The clinical significance will be graded by the investigator
Measured: From baseline until the end of treatment (estimated up to 5 years)
Percentage of participants developing clinically significant changes in vital signs
The clinical significance will be graded by the investigator
Measured: From baseline until the end of treatment (estimated up to 5 years)
Percentage of participants developing clinically significant changes in Electrocardiogram (ECG) readings.
The clinical significance will be graded by the investigator
Measured: From baseline until the end of treatment (estimated up to 5 years)
Percentage of participants with clinically significant changes in laboratory parameters (blood chemistry, hematology, coagulation and urinalysis)
The clinical significance will be graded by the investigator
Measured: From baseline until the end of treatment (estimated up to 5 years)
Percentage of participants developing cholangiocarcinoma (CCA), hepatocellular carcinoma (HCC), or colorectal cancer (CRC)
Measured: From baseline until the end of treatment (estimated up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start14 May 2026
- Primary completion30 Apr 2031 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387549
- Sponsor's protocol ID
- CLIN-60190-475
- Other IDs
- 2026-525242-29-00
- Acronym
- ELASCOPE
- Status last verified
- Oct 2026
- First submitted
- 28 Jan 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.