A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis (ELFIDENCE)

April 29, 2026 updated by: Ipsen

A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)

The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver).

PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage.

The liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.

This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant.

The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death).

This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.

Study Overview

Status

Recruiting

Conditions

Primary Biliary Cholangitis (PBC)

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

276

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Ipsen Clinical Study Enquiries
Phone Number: See e mail
Email: clinical.trials@ipsen.com

Study Locations

Argentina
- - Buenos Aires, Argentina
    - Recruiting
    - Hospital Britanico de Buenos Aires
  - Buenos Aires, Argentina
    - Recruiting
    - Hospital Italiano de Buenos Aires
  - Buenos Aires, Argentina
    - Recruiting
    - Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.L
  - Buenos Aires, Argentina
    - Not yet recruiting
    - DIM Centro Medico
  - Córdoba, Argentina
    - Recruiting
    - Centro Médico Colón
  - Mendoza, Argentina
    - Recruiting
    - Hospital Español de Mendoza
  - Pilar, Argentina
    - Recruiting
    - Hospital Universitario Austral
  - San Juan Bautista, Argentina
    - Recruiting
    - Hospital El Cruce
Australia
- - Birtinya, Australia
    - Recruiting
    - Sunshine Coast University Hospital
  - Footscray, Australia
    - Recruiting
    - Footscray Hospital, Western Health
  - Kingswood, Australia
    - Recruiting
    - Nepean Clinical School
  - Melbourne, Australia
    - Recruiting
    - Monash University - Monash Health -Monash Medical Centre
  - Sydney, Australia
    - Recruiting
    - St George Hospital
  - Westmead, Australia
    - Recruiting
    - Westmead Hospital
Belgium
- - Edegem, Belgium
    - Recruiting
    - Universitair Ziekenhuis Antwerpen
  - Genk, Belgium
    - Recruiting
    - Ziekenhuis Oost-Limburg
  - Ghent, Belgium
    - Recruiting
    - Gent University Hospital
  - Roeselare, Belgium
    - Recruiting
    - Algemeen Ziekenhuis Delta
Brazil
- - Belo Horizonte, Brazil
    - Recruiting
    - NUPEC Cardio
  - Goiânia, Brazil
    - Recruiting
    - Universidade Federal de Goias
  - Porto Alegre, Brazil
    - Recruiting
    - Hospital de Clinicas de Porto Alegre (HCPA)
  - Salvador, Brazil
    - Recruiting
    - Instituto D'Or de Pesquisa e Ensino - Hospital Aliança
  - São Paulo, Brazil
    - Recruiting
    - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  - São Paulo, Brazil
    - Recruiting
    - Hospital de Base - Centro Integrado de Pesquisa ( CIP )
  - São Paulo, Brazil
    - Recruiting
    - Universidade Estadual Paulista Julio De Mesquita Filho (UNESP) Hospital das Clinicas Faculdade de Medicina de Botucatu (HCFMB)
Bulgaria
- - Sofia, Bulgaria
    - Recruiting
    - Diagnostic-Consultative Center Aleksandrovska EOOD
  - Sofia, Bulgaria
    - Recruiting
    - Tokuda Hospital, Dept. of Internal Medicine
  - Sofia, Bulgaria
    - Recruiting
    - University Hospital City Clinic Cancer Center
Canada
- - Edmonton, Canada
    - Recruiting
    - University of Alberta - Faculty of Medicine & Dentistry - The Centre of Excellence for Gastrointestinal Inflammation and Immunity Research (CEGIIR)
  - Toronto, Canada
    - Recruiting
    - University Health Network (UHN) - Toronto General Hospital (TGH) - Toronto General Research Institute (TGRI)
Chile
- - Las Condes, Chile
    - Recruiting
    - Universidad De Los Andes
  - Santiago, Chile
    - Recruiting
    - Enroll SpA
  - Santiago, Chile
    - Recruiting
    - Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)
  - Santiago, Chile
    - Recruiting
    - Hospital Clinico de la Pontificia Universidad Catolica de Chile
  - Santiago, Chile
    - Recruiting
    - University of Chile Clinical Hospital (Hospital Clinico de la Universidad de Chile)
  - Viña del Mar, Chile
    - Recruiting
    - Centro Medico Cedid - Centro de Diagnostico Digestivo
Czechia
- - Hradec Králové, Czechia
    - Recruiting
    - Hepato-Gastroenterologie HK, s.r.o.
  - Liberec, Czechia
    - Not yet recruiting
    - Krajska Nemocnice Liberec
  - Ostrava, Czechia
    - Recruiting
    - Artroscan
  - Pilsen, Czechia
    - Recruiting
    - Research Site s.r.o.
  - Prague, Czechia
    - Recruiting
    - Institute for Clinical and Experimental Medicine - IKEM
Denmark
- - Copenhagen, Denmark
    - Recruiting
    - Bispebjerg Hospital
France
- - Créteil, France, 94000
    - Recruiting
    - Hospital Henri Mondor
  - Lille, France
    - Recruiting
    - Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
  - Lyon, France
    - Recruiting
    - Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
  - Marseille, France
    - Withdrawn
    - Hopital Saint Joseph - Marseille
  - Nice, France
    - Recruiting
    - CHU de Nice, Hopital de l'Archet
  - Paris, France, 75013
    - Recruiting
    - Hopital Pitie-Salpetriere - APHP
  - Poitiers, France
    - Recruiting
    - CHU Poitiers
  - Toulouse, France
    - Recruiting
    - Clinique Pasteur
  - Villejuif, France
    - Recruiting
    - Hopital Paul-Brousse - APHP
Greece
- - Athens, Greece
    - Recruiting
    - General Hospital of Athens Laiko
  - Athens, Greece
    - Recruiting
    - General Oncological Hospital of Kifisia Oi Agioi Anargyroi
  - Athens, Greece
    - Recruiting
    - Agios Savvas Regional Cancer Hospital
  - Thessaloniki, Greece
    - Recruiting
    - GeneIppokratio General Hospital of Thessaloniki
Hungary
- - Budapest, Hungary
    - Recruiting
    - Central Hospital of Northern Pest - Military Hospital
  - Debrecen, Hungary
    - Recruiting
    - Kenezy County Hospital
  - Szeged, Hungary
    - Recruiting
    - Szegedi Tudomanyegyetem AOK, I. sz Belgyogyaszati Klinika
Israel
- - Beersheba, Israel
    - Suspended
    - Institute of Gastroenterology and Liver Diseases - Soroka University Medical Center
  - Haifa, Israel
    - Suspended
    - Rambam Health Care Campus (RHCC)
  - Jerusalem, Israel
    - Suspended
    - Hadassah University Hospital (HUH) - Ein-Kerem
  - Jerusalem, Israel
    - Suspended
    - Shaare Zedek Medical Center
  - Nahariya, Israel
    - Suspended
    - Galilee Medical Center, ZIV Medical Center
  - Nahariya, Israel
    - Suspended
    - Galilee Medical Center
  - Petah Tikva, Israel
    - Suspended
    - Rabin Medical Center - Beilinson Hospital - Liver Institute
Italy
- - Modena, Italy
    - Recruiting
    - Azienda Ospedaliero Universitaria Modena
  - Monza, Italy
    - Recruiting
    - Ospedale San Gerardo
  - Naples, Italy
    - Recruiting
    - Azienda Ospedaliero Universitaria Federico II di Napoli
  - Padova, Italy
    - Recruiting
    - Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
  - Palermo, Italy
    - Recruiting
    - Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
  - Pavia, Italy
    - Withdrawn
    - Fondazione I.R.C.C.S. Policlinico San Matteo
  - Pisa, Italy
    - Not yet recruiting
    - Azienda Ospedaliero Universitaria Pisana
  - San Giovanni Rotondo, Italy
    - Recruiting
    - Ospedale Casa Sollievo della Sofferenza
Lithuania
- - Kaunas, Lithuania
    - Recruiting
    - Hospital of Lithuanian University of Health Sciences Kaunas
  - Vilnius, Lithuania
    - Recruiting
    - Vilnius University Hospital Santaros Klinikos
Malaysia
- - Johor Bahru, Malaysia
    - Recruiting
    - Hospital Sultanah Aminah
  - Kota Kinabalu, Malaysia
    - Recruiting
    - Hospital Queen Elizabeth II
  - Kuala Lumpur, Malaysia
    - Recruiting
    - University of Malaya Medical Centre
Mexico
- - Guadalajara, Mexico
    - Recruiting
    - Centro de Investigacion Clinica y Medicina Traslacional
  - Jalisco, Mexico
    - Not yet recruiting
    - Centro de Investigacion Medico Biologica y Terapia Avanzada
  - Mexico City, Mexico
    - Recruiting
    - Centro de Investigacion y Gastroenterologia SC
  - Monterrey, Mexico
    - Recruiting
    - Hospital Angeles Valle Oriente
  - Yucatán, Mexico
    - Recruiting
    - Medical Care & Research
New Zealand
- - Christchurch, New Zealand
    - Recruiting
    - Canterbury District Health Board
  - Hamilton, New Zealand
    - Recruiting
    - Waikato Hospital
Poland
- - Elblag, Poland
    - Recruiting
    - NZOZ Twoje Zdrowie EL Sp. z o.o.
  - Katowice, Poland
    - Recruiting
    - Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
  - Krakow, Poland
    - Recruiting
    - Krakowskie Centrum Medyczne Sp.z.o.o - FutureMeds
  - Krakow, Poland
    - Withdrawn
    - Szpital Uniwersytecki w Krakowie
  - Lublin, Poland
    - Recruiting
    - Medrise Sp. z o.o.
  - Małogoskie, Poland
    - Not yet recruiting
    - Krakowskie Centrum Medyczne Sp.z.o.o. - FutureMeds
  - Rzeszów, Poland
    - Recruiting
    - Centrum Medyczne Medyk Sp. z o.o. Sp. K.
  - Sosnowiec, Poland
    - Withdrawn
    - Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) - Poliklinika Doktora Bessera
  - Warsaw, Poland
    - Recruiting
    - FutureMeds Warszawa Centrum
  - Wroclaw, Poland
    - Recruiting
    - FutureMeds sp. z o. o
  - Wroclaw, Poland
    - Recruiting
    - Nzoz Centrum BadanKlinicznych
  - Wroclaw, Poland
    - Recruiting
    - PlanetMed Sp. z o.o.
Portugal
- - Funchal, Portugal, 9004-514
    - Recruiting
    - Hospital Dr. Nelio Mendonca
  - Vila Real, Portugal, 5000-508
    - Recruiting
    - Unidade Local de Saúde de Trás-os-Montes e Alto Douro, E. P. E
Romania
- - Bucharest, Romania
    - Recruiting
    - Centrul Pentru Studiul Metabolismului
  - Bucharest, Romania
    - Recruiting
    - Sana S.R.L
  - Bucharest, Romania
    - Recruiting
    - Spital Clinic Dr I Cantacuzino
  - Cluj-Napoca, Romania
    - Recruiting
    - Cluj County Clinical Emergency Hospital
  - Iași, Romania, 700111
    - Recruiting
    - Gastromedica Srl
Slovakia
- - Bratislava, Slovakia
    - Recruiting
    - Gastroenterological Centre Thalion
  - Košice, Slovakia
    - Not yet recruiting
    - Univerzitna Nemocnica L. Pasteura Kosice
  - Nitra, Slovakia
    - Not yet recruiting
    - Fakultna nemocnica Nitra
South Korea
- - Busan, South Korea
    - Recruiting
    - Pusan National University Hospital (Pnuh)
  - Daegu, South Korea
    - Recruiting
    - Keimyung University Dongsan Hospital
  - Daejeon, South Korea
    - Recruiting
    - The Catholic University of Korea Daejeon St.Mary's Hospital
  - Goyang-si, South Korea
    - Recruiting
    - Inje University Ilsan Paik Hospital
  - Gyeonggi-do, South Korea
    - Recruiting
    - Korea University Ansan Hospital
  - Incheon, South Korea
    - Recruiting
    - Inha University Hospital
  - Junggu, South Korea
    - Recruiting
    - Kyungpook National University Hospital (KNUH)
  - Seongnam-si, South Korea
    - Recruiting
    - CHA Bundang Medical Center, CHA University
  - Seoul, South Korea
    - Recruiting
    - Chung-Ang University Hospital
  - Seoul, South Korea
    - Recruiting
    - Samsung Medical Center
  - Seoul, South Korea
    - Recruiting
    - Seoul National University Hospital
  - Seoul, South Korea
    - Recruiting
    - Korea University Guro Hospital
  - Seoul, South Korea
    - Withdrawn
    - Hallym University Kangnam Sacred Heart Hospital
  - Seoul, South Korea
    - Recruiting
    - Seoul National University Bundang Hospital (SNUBH)
  - Seoul, South Korea
    - Recruiting
    - Severance Hospital, Yonsei University Health System
  - Seoul, South Korea
    - Recruiting
    - The Catholic University of Korea, Eunpyeong St. Mary's Hospital
  - Seoul, South Korea
    - Recruiting
    - The Catholic University of Korea, Seoul ST. Mary's Hospital
  - Seoul, South Korea
    - Recruiting
    - Hanyang University Seoul Hospital
  - Uijeongbu-si, South Korea
    - Recruiting
    - The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Spain
- - Barcelona, Spain
    - Recruiting
    - Hospital Universitario Vall d'Hebron
  - Barcelona, Spain
    - Recruiting
    - Hospital Clinic i Provincial de Barcelona
  - Madrid, Spain
    - Not yet recruiting
    - Hospital Universitario La Paz
  - Madrid, Spain
    - Recruiting
    - Hospital General Universitario Gregorio Maranon (HGUGM)
  - Madrid, Spain
    - Recruiting
    - Clinica Universidad Navarra-Sede Madrid
  - Majadahonda, Spain
    - Recruiting
    - Hospital Universitario Puerta de Hierro de Majadahonda
  - Málaga, Spain
    - Recruiting
    - Hospital Universitario Virgen de la Victoria
  - Pontevedra, Spain
    - Withdrawn
    - Hospital De Montecelo
  - Sabadell, Spain
    - Recruiting
    - Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli
  - Seville, Spain
    - Recruiting
    - Hospital Universitario Virgen del Rocío
  - Valencia, Spain, 46026
    - Recruiting
    - Hospital Universitario y Politecnico La Fe
  - Valladolid, Spain
    - Active, not recruiting
    - Hospital Universitario Rio Hortega
  - Zaragoza, Spain
    - Recruiting
    - Hospital Universitario Miguel Servet
Thailand
- - Chiang Mai, Thailand
    - Recruiting
    - Chiang Mai University
United States
- Arizona
  - Tucson, Arizona, United States, 85641
    - Recruiting
    - Arizona Liver Health
- Arkansas
  - Little Rock, Arkansas, United States, 55130
    - Terminated
    - Arkansas Diagnostic Center, PA
- California
  - Coronado, California, United States, 92118
    - Recruiting
    - Southern California Research Center
  - Los Angeles, California, United States, 90048
    - Recruiting
    - Cedars-Sinai Medical Center
  - Los Angeles, California, United States, 90067
    - Recruiting
    - GastroIntestinal BioSciences
  - Los Angeles, California, United States, 90404
    - Withdrawn
    - University of California Los Angeles
  - Sacramento, California, United States, 95817
    - Recruiting
    - University of California Davis Medical Center
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - University of Colorado
  - Colorado Springs, Colorado, United States, 80829
    - Recruiting
    - Peak Gastroenterology Associates
  - Englewood, Colorado, United States, 80113
    - Recruiting
    - South Denver Gastroenterology, P.C.
  - Littleton, Colorado, United States, 80120
    - Recruiting
    - Rocky Mountain Gastroenterology
- Florida
  - Miami, Florida, United States, 33136
    - Recruiting
    - University Of Miami School Of Medicine, Center For Liver Diseases
  - Pembroke Pines, Florida, United States, 12105
    - Recruiting
    - Bolanos Clinical Research
  - Tampa, Florida, United States, 33614
    - Recruiting
    - International Center for Research
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Not yet recruiting
    - University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic
- Louisiana
  - Shreveport, Louisiana, United States, 71103
    - Recruiting
    - Louisiana Research Center, LLC
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - University of Michigan Health System
  - Ypsilanti, Michigan, United States, 48197
    - Active, not recruiting
    - Huron Gastroenterology Associates - Center for Digestive Care
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - Active, not recruiting
    - Southwest Gastroenterology Associates, PC (SWGA)
- New York
  - New York, New York, United States, 10016
    - Recruiting
    - NYU Langone Gastroenterology and Hepatology Associates
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15213
    - Recruiting
    - University of Pittsburgh
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina
- Tennessee
  - Cordova, Tennessee, United States, 38138
    - Recruiting
    - Gastroenterology Center Of The Midsouth
- Texas
  - Arlington, Texas, United States, 22201
    - Recruiting
    - Texas Clinical Research Institute
  - Austin, Texas, United States, 78757
    - Recruiting
    - American Research Corporation
  - Dallas, Texas, United States, 75390
    - Recruiting
    - University of Texas Southwestern Medical Center at Dallas
  - Dallas, Texas, United States, 75203
    - Recruiting
    - Methodist Transplant Physicians
  - Dallas, Texas, United States, 75203
    - Recruiting
    - Liver Center of Texas
  - Dallas, Texas, United States, 60612
    - Withdrawn
    - Rush University Medical Center - University Cardiovascular Surgeons
  - Fort Worth, Texas, United States, 76104
    - Withdrawn
    - Baylor Scott & White All Saints Medical Center - Forth Worth
  - Houston, Texas, United States, 77030
    - Recruiting
    - Liver Associates of Texas
  - Houston, Texas, United States, 77584
    - Recruiting
    - Houston Methodist Cancer Center
  - Katy, Texas, United States, 77904
    - Withdrawn
    - Gastro health & Nutrition
  - San Antonio, Texas, United States, 78015
    - Recruiting
    - American Research Corporation at the Texas Liver Institute
  - Waco, Texas, United States, 76710
    - Recruiting
    - Impact Research Tx
- Virginia
  - Charlottesville, Virginia, United States, 22903
    - Recruiting
    - University of Virginia Medical Center
  - Richmond, Virginia, United States, 23298
    - Not yet recruiting
    - Virginia Commonwealth University Medical Center - West Hospital
  - Richmond, Virginia, United States, 23226
    - Recruiting
    - Bon Secours St. Mary's Hospital of Richmond, Inc
- Washington
  - Columbia, Washington, United States, 20007
    - Withdrawn
    - Medstar Georgetown Transplant Institute University Hospital (MGUH)
  - Seattle, Washington, United States, 98105
    - Recruiting
    - Velocity Clinical Research at Liver Institute Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria :

Male or female participants must be ≥18 years of age at the time of signing the informed consent.
Participants with a definite or probable diagnosis of primary biliary cholangitis (PBC)
Participants with cirrhosis at SV1. • Participants must be Child Pugh A or Child Pugh B.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria :

History or presence of other concomitant liver disease including but not limited to:
- i) Primary sclerosing cholangitis (PSC).
- ii) Autoimmune hepatitis (AIH) by simplified Diagnostic Criteria of the International Autoimmune Hepatitis Group (IAIHG) ≥6, or if treated for an overlap of PBC with AIH, or if there is clinical suspicion and evidence of overlap AIH features, that cannot be explained alone by insufficient response to UDCA.
- iii) Positive hepatitis B surface antigen (HBsAg). Participants with negative HBsAg and positive hepatitis B core antibody (HBcAb) may be eligible if hepatitis B virus deoxyribonucleic acid (HBV DNA) is negative.
- iv) Hepatitis C virus (HCV) infection defined by positive anti-HCV antibody and positive HCV ribonucleic acid (RNA) (Note: Participants with positive anti-HCV antibody due to previously treated HCV infection, may be enrolled if a confirmatory HCV RNA is undetectable and sustained viral response has been documented).
- v) Alcohol-associated liver disease (ALD).
- vi) Nonalcoholic steatohepatitis (NASH).
- vii) Other chronic liver diseases, such as alpha-1 antitrypsin deficiency.
History or presence of clinically significant hepatic decompensation, including:
- i) History of liver transplantation, current placement on a liver transplant list, current model for end-stage liver disease including (MELD) 3.0 score >12 due to hepatic impairment.
- ii) Evidence of complications of cirrhosis, including hepatic decompensation or evidence of significant portal hypertension complications including presence of uncontrolled ascites; history of variceal bleeding or related interventions (e.g. variceal banding, or transjugular intrahepatic portosystemic shunt placement); presence of hepatic encephalopathy Grade 2 or higher per West-Haven criteria; history or presence of spontaneous bacterial peritonitis. Note: participants with low-risk varices (Grade I) without history of bleeding or other treatment may be eligible to enrol.
- iii) Hepatorenal syndrome (HRS) (type I or II ). • vi) Hospitalisation for liver-related complication within 12 weeks prior to SV1.
Known history of human immunodeficiency virus (HIV) infection or having a positive confirmatory test for HIV type 1 or 2.
Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).
Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematologic, gastrointestinal, neurological, or psychiatric disease as evaluated by the investigator; other clinically significant conditions that are not well controlled.
Non-hepatic medical conditions that may diminish life expectancy to <2 years, including known cancers.
History of hepatocellular carcinoma.
Alpha-fetoprotein (AFP) >20 ng/mL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) imaging suggesting presence of 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.
Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below: • i) 3 months prior to screening period: fibrates, seladelpar, glitazones, obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (parenteral and oral chronic administration only); 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 study or medical device study containing active substance within 30 days or 5 half-lives, whichever is longer, prior to the screening period.
i) If the previous study was for an experimental therapy being studied for potential benefit in PBC, and the potential therapeutic agent was proven to have no beneficial effect in PBC and there are no safety concerns, the participant may enrol after 30 days or 5 half-lives from the last dose of the therapeutic agent, whichever is longer.ii) For therapeutic agents being studied for potential benefit in PBC for which it is still unclear if there may be a potential benefit, participants may enrol after 6 months from the last dose of the therapeutic agent.
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. For participants with bundle branch block or other intraventricular conduction delay, a longer QTcF >480 msec would be exclusionary.
Total bilirubin (TB) >5x ULN
Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5x ULN at SV1
Creatinine phosphokinase (CPK) >2x ULN.
Platelet count <50,000/μL
International normalised ratio (INR) >1.8 in the absence of anticoagulant therapy.
Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2 per the Modification of Diet in Renal Disease (MDRD)-6 Study formula at SV1.
Significant renal disease, including nephritic syndrome, chronic kidney disease (CKD) (defined as participants with evidence of significantly impaired kidney function or underlying kidney injury).
For female participants: known current pregnancy, or has a positive serum pregnancy test, or is breastfeeding.
Participants unwilling or unable to be abstinent from alcohol during the study.
History of alcohol abuse, or other substance abuse within 1 year prior to SV1.
Known hypersensitivity to elafibranor or to any of the excipients of the investigational product(s).
Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
Any other condition that, in the opinion of the investigator, would interfere with study participation or completion, or would put the participant at risk, including a potential participant assessed as being at high risk of noncompliance with the study.
Alkaline phosphatase (ALP) ≥10x ULN.
Albumin <2.8 g/dL due to impaired hepatic function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elafibranor 80 mg Participants will take 1 tablet of elafibranor 80 mg per day orally before breakfast with a glass of water at approximately the same time each morning.	Drug: Elafibranor Duration: up to an estimated 42-month (3.5-year) double-blind treatment period during which elafibranor 80 mg tablet will be administered once daily
Placebo Comparator: Placebo Participants will take 1 placebo tablet per day orally (matching the 80 mg elafibranor sized tablet) before breakfast with a glass of water at approximately the same time each morning.	Other: Matched 80 mg placebo Duration: up to an estimated 42-month (3.5-year) double-blind treatment period during which matching placebo tablet will be administered once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free survival Time Frame: From baseline until 4 weeks after the end of treatment (maximum duration of 3.5 years)	Event-free survival is defined as the time from randomisation to either adjudicated disease progression or death, whichever occurs first.	From baseline until 4 weeks after the end of treatment (maximum duration of 3.5 years)

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Investigators

Study Director: Ipsen Medical Director, Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2023

Primary Completion (Estimated)

May 31, 2029

Study Completion (Estimated)

May 31, 2029

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CLIN-60190-454
2023-505251-43-00 (Ctis: Ipsen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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/).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Primary Biliary Cholangitis (PBC)

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