A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
ELASCOPE
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
2 other identifiers
interventional
350
24 countries
220
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2026
Longer than P75 for phase_3
220 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2026
CompletedFirst Posted
Study publicly available on registry
February 4, 2026
CompletedStudy Start
First participant enrolled
May 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2031
October 1, 2026
September 1, 2026
5 years
January 28, 2026
September 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Event-Free Survival
Event-free survival is defined as the time from randomisation to either adjudicated disease progression or death, whichever occurs first.
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
From baseline to Week 48
Change from baseline in severity of a patient-reported cholestatic symptom: Pruritus
From baseline to Week 24
Change from baseline in severity of a patient-reported cholestatic symptom: Fatigue
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)
From baseline until the end of treatment (estimated up to 5 years)
Percentage of participants developing clinically significant changes in physical examination findings
From baseline until the end of treatment (estimated up to 5 years)
- +4 more secondary outcomes
Study Arms (2)
Elafibranor 120 mg
EXPERIMENTALParticipants will take 1 tablet of elafibranor 120 mg orally once daily
Placebo
PLACEBO COMPARATORParticipants will take 1 placebo tablet orally once daily
Interventions
Round and orange film coated tablet of 120 mg
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- 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,
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (231)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2026
First Posted
February 4, 2026
Study Start
May 14, 2026
Primary Completion (Estimated)
April 30, 2031
Study Completion (Estimated)
May 31, 2031
Last Updated
October 1, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
- Access Criteria
- Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
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.