A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
NCT ID: NCT06383403
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
69 participants
INTERVENTIONAL
2024-07-09
2026-06-26
Brief Summary
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Primary biliary cholangitis is a slowly progressive disease characterised by damage of 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 scarring (cirrhosis). PBC may also be associated with multiple symptoms.
Many patients with PBC may require a 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).
The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease.
There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored.
Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio).
Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver).
They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Elafibranor
Round and orange film coated tablet of 80 mg.
Placebo
Participants will take 1 placebo tablet per day orally before breakfast with a glass of water at approximately the same time each morning.
Placebo
Round and orange film coated tablet of placebo
Interventions
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Elafibranor
Round and orange film coated tablet of 80 mg.
Placebo
Round and orange film coated tablet of placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with a historical diagnosis of PBC as demonstrated by the presence of ≥2 of the following three historical diagnostic criteria:
* i. History of elevated ALP levels for ≥6 months prior to the first screening visit (SV1).
* ii. Positive Antimitochondrial antibody (AMA) titres (≥1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay) or positive PBC-specific antinuclear antibodies.
* iii. Liver biopsy consistent with PBC.
* ALP \>1 × ULN and \<1.67 × ULN.
* Participants taking UDCA should have been on this medication for at least 6 months and at a stable dose for ≥3 months. Participants who are intolerant to UDCA should have taken the last dose of UDCA ≥3 months prior.
* Participants taking medications for management of pruritus must be on a stable dose for ≥3 months.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
\* (a) Male participants must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception. The participant must agree to use contraception during the whole period of the study and for 30 days after the last dose of study intervention.
* Capable of giving signed informed consent
Exclusion Criteria
* Participants with known cirrhosis who have a Child-Pugh B or C score. Participants with cirrhosis with Child-Pugh A score are allowed.
* History of liver transplantation.
* History or presence of clinically significant hepatic decompensation.
* Known history of human immunodeficiency virus (HIV) infection.
* Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).
* Evidence of any other unstable or untreated clinically significant conditions that are not well controlled.
* Medical condition with a life expectancy \<2 years.
* Known malignancy or history of malignancy within the last 2 years, except for successfully treated localised basal cell carcinoma or squamous cell carcinoma of the skin; or in-situ carcinoma of the uterine cervix.
* History of hepatocellular carcinoma.
* Alpha-foetoprotein (AFP) \>20 ng/mL with 4-phase liver computed tomography (CT) or magnetic resonance imaging (MRI) scans suggesting presence of liver cancer.
* Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below:
\* i. Systemic (oral or parenteral) use within 3 months prior to SV1 of: fibrates, seladelpar, glitazones, obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate, or long-term systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs (including α-methyl-dopa, valproic acid, isoniazid or nitrofurantoin)
* Participants with previous exposure to elafibranor.
* 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.
* Total bilirubin (TB) \>2 × ULN. Participants with Gilbert's syndrome are eligible with a TB above 2 × ULN if direct bilirubin is \<30% of TB.
* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>5 × ULN.
* Creatine phosphokinase (CPK) \>2 × ULN.
* Platelet count \<75,000/µL.
* International normalised ratio \>1.3 in the absence of anticoagulant therapy.
* Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m2.
* Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as participants with evidence of significantly impaired kidney function or underlying kidney injury).
Other exclusions
* For female participants: known pregnancy, or has a positive serum pregnancy test, or is breastfeeding.
* 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.
* Known hypersensitivity to the investigational product or to any of the excipients of elafibranor.
* 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.
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Southern California Research Center
Coronado, California, United States
Topgraphy Health, Inc.
Los Angeles, California, United States
University of California, Davis
Sacramento, California, United States
Stanford University Medical Center
Stanford, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Rocky Mountain Gastroenterology
Littleton, Colorado, United States
International Center for Research
Tampa, Florida, United States
Delta Research Partners, LLC
West Monroe, Louisiana, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Huron Gastroenterology Associates - Center for Digestive Care
Ypsilanti, Michigan, United States
South Denver Gastroenterology,P.C.
Englewood, New Jersey, United States
Southwest Gastroenterology Associates, PC (SWGA)
Albuquerque, New Mexico, United States
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York, United States
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina, United States
Coastal Research Institute
Fayetteville, North Carolina, United States
Gastroenterology Center of the Midsouth
Cordova, Tennessee, United States
Methodist Transplant Physicians
Dallas, Texas, United States
American Research Corporation at The Texas Liver Institute
San Antonio, Texas, United States
American Research Corporation
San Antonio, Texas, United States
Velocity Liver Institute NW
Seattle, Washington, United States
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
Artroscan
Ostrava, , Czechia
Research Site s.r.o.
Pilsen, , Czechia
Institute for Clinical and Experimental Medicine - IKEM
Prague, , Czechia
Clinique Pasteur
Toulouse, , France
Universitatsklinikum Heidelberg
Heidelberg, , Germany
Gastroenterologsiche Studiengesellschaft Herne
Hemer, , Germany
EUGASTRO GmbH
Leipzig, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Ospedale Policlinico San Martino - IRCCS
Genova, , Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
Rozzano, , Italy
Krakowskie Centrum Medyczne Sp.z.o.o - FutureMeds
Krakow, , Poland
FutureMeds Warszawa Centrum
Warsaw, , Poland
Cluj County Clinical Emergency Hospital
Cluj-Napoca, , Romania
Gastromedica Srl
Iași, , Romania
Korea University Ansan Hospital
Ansan-si, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Kyungpook National University Hospital (KNUH)
Daegu, , South Korea
Pusan National University Hospital (PNUH)
Pusan, , South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, , South Korea
Seoul National University Bundang Hospital (SNUBH)
Seongnam-si, , South Korea
Samsung Medical Center
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
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, , Spain
Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli
Sabadell, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
Aberdeen, , United Kingdom
Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation
Bradford, , United Kingdom
Frimley Park Hospital - Frimley Health NHS Foundation Trust
Frimley, , United Kingdom
Queen Elizabeth University Hospital - Greater Glasgow Health Board
Glasgow, , United Kingdom
Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust
Hull, , United Kingdom
Ambrose King Centre-Royal London Hospital-Barts Health NHS Trust
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Countries
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Other Identifiers
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2024-510695-20-00
Identifier Type: CTIS
Identifier Source: secondary_id
CLIN-60190-463
Identifier Type: -
Identifier Source: org_study_id
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