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New hope for rare liver disease: drug trial targets bile duct damage

NCT ID NCT05627362

Disease control Sponsor: Ipsen Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 4 times

Summary

This study tests a drug called elafibranor in 68 adults with primary sclerosing cholangitis (PSC), a rare liver disease that damages bile ducts. The main goal is to check the drug's safety and side effects compared to a placebo. Researchers will also look at blood tests to see if the drug helps slow the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

68 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria : The following inclusion criteria apply to entry into the double-blind period and initial open-label extension (OLE) period up to OLE Week 96, unless otherwise specified. * Participants with a diagnosis of Primary sclerosing cholangitis (PSC) as demonstrated by the presence of the following, and in the absence of apparent causes of secondary sclerosing cholangitis: i) Historical evidence of an elevated Alkaline phosphatase (ALP) \> Upper Limit Normal (ULN) since at least 6 months prior to SV1. ii) Cholangiogram (e.g. magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic cholangiography (PTC) with features compatible with large duct PSC. * ALP ≥1.5x ULN during screening (with variability ≤30% based on two values). * Total bilirubin ≤2.0x ULN at Screening Visit 1(SV1) * Participants taking ursodeoxycholic acid (UDCA) at a total daily dose ≤23 mg/kg/day, with a minimum of 6 months of stable treatment prior to screening period and expected to remain on stable dose through the 12-week DBP. Minimum of 3 months off treatment prior to screening period if UDCA was recently discontinued. * For participants with Inflammatory bowel disease (IBD): i) Participants with Crohn's disease must be in remission based on the investigator's clinical assessment and should be on stable treatment prior to randomisation and during screening. ii) Participants with ulcerative colitis must be in remission or have low activity disease as per the judgement of the investigator and should be on stable treatment prior to randomisation and during screening. iii) Current treatment for IBD is permitted, if the participant has been well controlled for ≥3 months prior to the screening period and is anticipated to remain on a stable dose of drugs for IBD treatment, including biologics, immunosuppressants, immunomodulators, or systemic corticosteroids. iv) Participants with IBD should have a colonoscopy performed within one year prior to the screening period showing no evidence of dysplasia or cancer. * Medications for management of pruritus (e.g. cholestyramine, rifampin, naltrexone or sertraline) must be on a stable dose for ≥3 months prior to the screening period. * Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. -A female participant is eligible to participate if she is not pregnant or breastfeeding at screening, is willing not to become pregnant during the study and is willing to follow applicable protocol requirements related to this. - Male participants are eligible to participate if they agree to follow applicable protocol requirements related to contraception. * 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. Inclusion Criteria for Entry into Optional Open-Label Extension Long-Term (OLE-LT) Period Beyond Week 96 For entry into the optional OLE-LT period, participants: * Must have completed the initial OLE period up to OLE Week 96 * Must not have permanently discontinued the study intervention during the initial OLE period * Must, in the opinion of the investigator, benefit from continuing to receive study intervention The eligibility criteria assessed at Screening Visit 1 (SV1) for entry into the double-blind period are not reassessed for entry into the optional OLE-LT period. Contraception requirements applicable during the OLE-LT period: * Male participants: No contraception requirements apply. * Female participants of childbearing potential: Must continue to use a highly effective contraceptive method during study intervention and for at least one month after the last dose. If using a hormonal contraceptive, an additional barrier method or a switch to a highly effective non-hormonal method is required. Exclusion Criteria : * History or presence of other concomitant chronic liver disease including: i) ImmunoglobulinG 4 (IgG4) related sclerosing cholangitis, or IgG4 ≥4x ULN at SV1. ii) Small duct PSC. iii) Documented history of secondary sclerosing cholangitis. iv) Presence of hepatitis B surface antigen (HBsAg) at screening. v) Hepatitis C virus (HCV) infection vi) Primary biliary cholangitis (PBC) or positive anti-mitochondrial antibody. vii) Alcohol-related liver disease. viii) Autoimmune hepatitis (AIH): Simplified Diagnostic Criteria of the IAIHG ≥6. ix) Presence of history of PSC-PBC or PSC-AIH overlap syndrome. x) Non-alcoholic steatohepatitis (NASH). SMD form protocol master data--23- INT / Version 1 Known history of alpha-1 antitrypsin deficiency * Presence of percutaneous drain or bile duct stent at screening or within three months prior to screening. * History of bacterial cholangitis within 60 days prior to the screening period, or participant on antibiotics for prophylaxis of recurrent cholangitis. * History or any current suspicion of cholangiocarcinoma or elevated value of carbohydrate antigen 19-9 (CA19-9) \>129 U/mL at SV1. * Alpha-fetoprotein (AFP) \>20 ng/mL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) suggesting presence of liver cancer. * Participants with cirrhosis who are also classified as Child-Pugh B or C based on the Child-Pugh score. Participants with cirrhosis with Child-Pugh A score are allowed. * History of clinically significant hepatic decompensation as described in the study protocol * Presence or history of hepatocellular carcinoma. * Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease). * Medical conditions that may diminish life expectancy to \<2 years, including known cancers. * Participant has a positive test for human immunodeficiency virus (HIV) type 1 or 2 at SV1, or participant is known to have tested positive for HIV. * Evidence of any other unstable or untreated clinically significant immunological, endocrine, neurological, gastrointestinal, haematologic, psychiatric diseases as evaluated by the investigator; other clinically significant conditions that are not well controlled * 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. * Participants with previous exposure to elafibranor * ALT and/or AST \>5x ULN * Albumin \<3.0 g/dL at SV1. * Platelet count \<100,000/microliter. * International normalised ratio (INR) \>1.3 due to altered hepatic function. * Creatine phosphokinase (CPK) \>2x ULN during screening period. * Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2

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Conditions

The condition(s) this trial relates to.

Cholangitis, Sclerosing primary sclerosing cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary sclerosing cholangitis

Contacts and locations

Locations

  • Aberdeen Royal Infirmary NHS Grampian Grampian Health Board

    Aberdeen, AB25 2ZD, United Kingdom

  • Ambrose King Centre-Royal London Hospital-Barts Health NHS Trust

    London, E1 1BB, United Kingdom

  • American Research Corporation at The Texas Liver Institute

    San Antonio, Texas, 78215, United States

  • Aspen Woods Clinic

    Calgary, T3H 0V5, Canada

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90127, Italy

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

    Padova, 35128, Italy

  • Azienda Ospedaliero Universitaria Modena

    Modena, 41124, Italy

  • Beth Israel Deaconess Medical Center, Liver Research Center

    Boston, Massachusetts, 02215, United States

  • Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond

    Richmond, Virginia, 23226, United States

  • Brampton Civic Hospital (BCH) - Osler Hepatitis Centre

    Brampton, Ontario, L6R 3J7, Canada

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centre de Recherche du Centre Hospitalier de l'Universite de Montreal

    Montreal, H2X 0A9, Canada

  • Centro Hospitalar Universitario Lisboa Norte

    Lisbon, 1345-035, Portugal

  • Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz

    Lisbon, 1349-019, Portugal

  • Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira

    Guimarães, 4800-055, Portugal

  • Charite Campus Virchow

    Berlin, 13353, Germany

  • Covenant Research

    Sarasota, Florida, 34240, United States

  • Frimley Park Hospital - Frimley Health NHS Foundation Trust

    Frimley, GU16 7UJ, United Kingdom

  • G.I Research Institute

    Vancouver, V6Z 2K5, Canada

  • Gastro Health Research

    Cincinnati, Ohio, 45219, United States

  • Gastro One

    Cordova, Tennessee, 38018, United States

  • Glasgow Royal Infirmary - Greater Glasgow Health Board

    Glasgow, G4 0SF, United Kingdom

  • Gruppo Humanitas - Humanitas Research Hospital, Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Hospital De Montecelo

    Pontevedra, 36071, Spain

  • Hospital General Universitario Gregorio Maranon (HGUGM)

    Madrid, 28007, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Puerta de Hierro

    Majadahonda, 28222, Spain

  • Hospital Universitario Rio Hortega

    Valladolid, 47012, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust

    Hull, HU3 2JZ, United Kingdom

  • Huron Gastroenterology Associates - Center for Digestive Care

    Ypsilanti, Michigan, 48197, United States

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt

    Frankfurt, 60590, Germany

  • Liver Institute Northwest

    Seattle, Washington, 98105, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Mercy Medical Center

    Baltimore, Maryland, 21202, United States

  • New York University Langone Health

    New York, New York, 06510, United States

  • Om Research LLC

    Lancaster, California, 93534, United States

  • Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013, Italy

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907, United States

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Piedmont Hospital - Piedmont Transplant Institute

    Atlanta, Georgia, 30309, United States

  • Queen Elizabeth Hospital

    Birmingham, B15 2TT, United Kingdom

  • Rocky Mountain Gastroenterology (RMG)

    Littleton, Colorado, 80120, United States

  • Schiff Center for Liver Diseases - University of Miami

    Miami, Florida, 33136, United States

  • South Denver Gastroenterology,P.C.

    Englewood, Colorado, 80113, United States

  • Southwest Gastroenterology Associates, PC (SWGA)

    Albuquerque, New Mexico, 87109-4342, United States

  • Sutter Health Van Ness Campus Medical Office Building

    San Francisco, California, 94109, United States

  • Tandem Clinical Research GI

    Marrero, Louisiana, 70072, United States

  • The Royal Free Hospital - Royal Free London NHS Foundation Trust

    London, NW3 2QG, United Kingdom

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19017, United States

  • Universitaetsklinikum Heidelberg - Nationales Centrum fuer Tumorerkrankungen

    Heidelberg, 69120, Germany

  • University Hospital Ulm

    Ulm, 89081, Germany

  • University Of Alberta Hospital-Zeidler Ledcor Centre

    Edmonton, Alberta, T6G 2X8, Canada

  • University Of Texas Southwestern Medical Center At Dallas

    Dallas, Texas, 75235, United States

  • University of Calgary

    Calgary, Alberta, T2N 4Z6, Canada

  • University of California, Davis

    Sacramento, California, 95817, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22093, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

  • Yale University School Of Medicine - Yale Center For Clinical Investigation

    New Haven, Connecticut, 06510, United States

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