Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06016842

PHASE3

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

Sponsor: Ipsen

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

276

Start Date

2023-08-31

Completion Date

2029-05-31

Last Updated

2026-04-01

Healthy Volunteers

Conditions

Primary Biliary Cholangitis (PBC)

Interventions

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

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

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.

Locations (177)

Arizona Liver Health

Tucson, Arizona, United States

Arkansas Diagnostic Center, PA

Little Rock, Arkansas, United States

Southern California Research Center

Coronado, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

GastroIntestinal BioSciences

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

University of California Davis Medical Center

Sacramento, California, United States

University of Colorado

Aurora, Colorado, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

South Denver Gastroenterology, P.C.

Englewood, Colorado, United States

Rocky Mountain Gastroenterology

Littleton, Colorado, United States

University Of Miami School Of Medicine, Center For Liver Diseases

Miami, Florida, United States

Bolanos Clinical Research

Pembroke Pines, Florida, United States

International Center for Research

Tampa, Florida, United States

University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic

Kansas City, Kansas, United States

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Huron Gastroenterology Associates - Center for Digestive Care

Ypsilanti, Michigan, United States

Southwest Gastroenterology Associates, PC (SWGA)

Albuquerque, New Mexico, United States

NYU Langone Gastroenterology and Hepatology Associates

New York, New York, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Gastroenterology Center of the Midsouth

Cordova, Tennessee, United States

Texas Clinical Research Institute

Arlington, Texas, United States

American Research Corporation

Austin, Texas, United States

Rush University Medical Center - University Cardiovascular Surgeons

Dallas, Texas, United States

Liver Center of Texas

Dallas, Texas, United States

Methodist Transplant Physicians

Dallas, Texas, United States

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Baylor Scott & White All Saints Medical Center - Forth Worth

Fort Worth, Texas, United States

Liver Associates of Texas

Houston, Texas, United States

Houston Methodist Cancer Center

Houston, Texas, United States

Gastro health & Nutrition

Katy, Texas, United States

American Research Corporation at The Texas Liver Institute

San Antonio, Texas, United States

Impact Research Tx

Waco, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Bon Secours St. Mary's Hospital of Richmond, Inc

Richmond, Virginia, United States

Virginia Commonwealth University Medical Center - West Hospital

Richmond, Virginia, United States

Medstar Georgetown Transplant Institute University Hospital (MGUH)

Columbia, Washington, United States

Velocity Clinical Research at Liver Institute Northwest

Seattle, Washington, United States

DIM Centro Medico

Buenos Aires, Argentina

Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.L

Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Centro Medico Colon

Córdoba, Argentina

Hospital Espanol de Mendoza

Mendoza, Argentina

Hospital Universitario Austral

Pilar, Argentina

Hospital El Cruce

San Juan Bautista, Argentina

Sunshine Coast University Hospital

Birtinya, Australia

Footscray Hospital, Western Health

Footscray, Australia

Nepean Clinical School

Kingswood, Australia

Monash University - Monash Health -Monash Medical Centre

Melbourne, Australia

St George Hospital

Sydney, Australia

Westmead Hospital

Westmead, Australia

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

Gent University Hospital

Ghent, Belgium

Algemeen Ziekenhuis Delta

Roeselare, Belgium

NUPEC Cardio

Belo Horizonte, Brazil

Universidade Federal de Goias

Goiânia, Brazil

Hospital de Clinicas de Porto Alegre (HCPA)

Porto Alegre, Brazil

Instituto D'Or de Pesquisa e Ensino - Hospital Aliança

Salvador, Brazil

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

São Paulo, Brazil

Hospital de Base - Centro Integrado de Pesquisa ( CIP )

São Paulo, Brazil

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

São Paulo, Brazil

Diagnostic-Consultative Center Aleksandrovska EOOD

Sofia, Bulgaria

Tokuda Hospital, Dept. of Internal Medicine

Sofia, Bulgaria

University Hospital City Clinic Cancer Center

Sofia, Bulgaria

University of Alberta - Faculty of Medicine & Dentistry - The Centre of Excellence for Gastrointestinal Inflammation and Immunity Research (CEGIIR)

Edmonton, Canada

University Health Network (UHN) - Toronto General Hospital (TGH) - Toronto General Research Institute (TGRI)

Toronto, Canada

Universidad De Los Andes

Las Condes, Chile

Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)

Santiago, Chile

Enroll SpA

Santiago, Chile

Hospital Clinico de la Pontificia Universidad Catolica de Chile

Santiago, Chile

University of Chile Clinical Hospital (Hospital Clinico de la Universidad de Chile)

Santiago, Chile

Centro Medico Cedid - Centro de Diagnostico Digestivo

Viña del Mar, Chile

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, Czechia

Krajska Nemocnice Liberec

Liberec, Czechia

Artroscan

Ostrava, Czechia

Research Site s.r.o.

Pilsen, Czechia

Institute for Clinical and Experimental Medicine - IKEM

Prague, Czechia

Bispebjerg Hospital

Copenhagen, Denmark

Hospital Henri Mondor

Créteil, France

Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

Lille, France

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

Lyon, France

Hopital Saint Joseph - Marseille

Marseille, France

CHU de Nice, Hopital de l'Archet

Nice, France

Hopital Pitie-Salpetriere - APHP

Paris, France

CHU Poitiers

Poitiers, France

Clinique Pasteur

Toulouse, France

Hopital Paul-Brousse - APHP

Villejuif, France

Agios Savvas Regional Cancer Hospital

Athens, Greece

General Hospital of Athens Laiko

Athens, Greece

General Oncological Hospital of Kifisia Oi Agioi Anargyroi

Athens, Greece

GeneIppokratio General Hospital of Thessaloniki

Thessaloniki, Greece

Central Hospital of Northern Pest - Military Hospital

Budapest, Hungary

Kenezy County Hospital

Debrecen, Hungary

Szegedi Tudomanyegyetem AOK, I. sz Belgyogyaszati Klinika

Szeged, Hungary

Institute of Gastroenterology and Liver Diseases - Soroka University Medical Center

Beersheba, Israel

Rambam Health Care Campus (RHCC)

Haifa, Israel

Hadassah University Hospital (HUH) - Ein-Kerem

Jerusalem, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Galilee Medical Center, ZIV Medical Center

Nahariya, Israel

Galilee Medical Center

Nahariya, Israel

Rabin Medical Center - Beilinson Hospital - Liver Institute

Petah Tikva, Israel

Azienda Ospedaliero Universitaria Modena

Modena, Italy

Ospedale San Gerardo

Monza, Italy

Azienda Ospedaliero Universitaria Federico II di Napoli

Naples, Italy

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

Padova, Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Italy

Fondazione I.R.C.C.S. Policlinico San Matteo

Pavia, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Hospital Sultanah Aminah

Johor Bahru, Malaysia

Hospital Queen Elizabeth II

Kota Kinabalu, Malaysia

University of Malaya Medical Centre

Kuala Lumpur, Malaysia

Centro de Investigacion Medico Biologica y Terapia Avanzada

Jalisco, Mexico

Centro de Investigacion y Gastroenterologia SC

Mexico City, Mexico

Medical Care & Research

Yucatán, Mexico

Canterbury District Health Board

Christchurch, New Zealand

Waikato Hospital

Hamilton, New Zealand

NZOZ Twoje Zdrowie EL Sp. z o.o.

Elblag, Poland

Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego

Katowice, Poland

Krakowskie Centrum Medyczne Sp.z.o.o - FutureMeds

Krakow, Poland

Szpital Uniwersytecki w Krakowie

Krakow, Poland

Medrise Sp. z o.o.

Lublin, Poland

Krakowskie Centrum Medyczne Sp.z.o.o. - FutureMeds

Małogoskie, Poland

Centrum Medyczne Medyk Sp. z o.o. Sp. K.

Rzeszów, Poland

Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) - Poliklinika Doktora Bessera

Sosnowiec, Poland

FutureMeds Warszawa Centrum

Warsaw, Poland

FutureMeds sp. z o. o

Wroclaw, Poland

Nzoz Centrum BadanKlinicznych

Wroclaw, Poland

PlanetMed Sp. z o.o.

Wroclaw, Poland

Hospital Dr. Nelio Mendonca

Funchal, Portugal

Unidade Local de Saúde de Trás-os-Montes e Alto Douro, E. P. E

Vila Real, Portugal

Centrul Pentru Studiul Metabolismului

Bucharest, Romania

Sana S.R.L

Bucharest, Romania

Spital Clinic Dr I Cantacuzino

Bucharest, Romania

Cluj County Clinical Emergency Hospital

Cluj-Napoca, Romania

Gastromedica Srl

Iași, Romania

Gastroenterological Centre Thalion

Bratislava, Slovakia

Univerzitna nemocnica L. Pasteura Kosice

Košice, Slovakia

Fakultna nemocnica Nitra

Nitra, Slovakia

Pusan National University Hospital (PNUH)

Busan, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

The Catholic University of Korea Daejeon St.Mary's Hospital

Daejeon, South Korea

Inje University Ilsan Paik Hospital

Goyang-si, South Korea

Korea University Ansan Hospital

Gyeonggi-do, South Korea

Inha University Hospital

Incheon, South Korea

Kyungpook National University Hospital (KNUH)

Junggu, South Korea

CHA Bundang Medical Center, CHA University

Seongnam-si, South Korea

Chung-Ang University Hospital

Seoul, South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, South Korea

Hanyang University Seoul Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Bundang Hospital (SNUBH)

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

The Catholic University of Korea, Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Clinica Universidad Navarra-Sede Madrid

Madrid, Spain

Hospital General Universitario Gregorio Maranon (HGUGM)

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital De Montecelo

Pontevedra, Spain

Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli

Sabadell, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitario y Politecnico La Fe

Valencia, Spain

Hospital Universitario Rio Hortega

Valladolid, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (177)