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Study on the Safety and Effectiveness of Elafibranor for Adults with Primary Sclerosing Cholangitis

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a liver disease called Primary Sclerosing Cholangitis (PSC). PSC is a condition that affects the bile ducts, which are tubes that carry bile from the liver to the gallbladder and small intestine. The study is testing a treatment called elafibranor, which is taken as a film-coated tablet. Elafibranor works by activating certain proteins in the body that may help improve liver function. The study will compare the effects of elafibranor at two different doses, 80 mg and 120 mg, to a placebo, which is a tablet that does not contain any active medication.

The purpose of the study is to evaluate the safety and effectiveness of elafibranor in adults with PSC. Participants will take the medication daily for a period of 12 weeks during the initial phase of the study. After this period, there is an option for participants to continue in a long-term extension phase, where they can receive elafibranor for a longer duration to further assess its safety and tolerability. Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition.

This study aims to provide valuable information about the potential benefits and risks of using elafibranor for treating PSC. By participating, individuals with PSC can contribute to research that may lead to better treatment options for this challenging liver disease. The study is conducted under strict guidelines to ensure the safety and well-being of all participants.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants are randomly assigned to receive either elafibranor or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

    The study involves taking a film-coated tablet orally. The dosage of elafibranor is either 80 mg or 120 mg, taken daily.

  2. Step 2

    Double-blind period (DBP)

    During the first 12 weeks, the focus is on assessing the safety and tolerability of the treatment. Participants will continue taking their assigned tablet daily.

    Regular monitoring includes physical examinations, vital signs, and laboratory tests to check liver and kidney function, among other health indicators.

  3. Step 3

    Evaluation at week 12

    At the end of the 12-week period, participants undergo a comprehensive evaluation to assess changes in their condition, particularly focusing on liver function tests.

    The study measures the relative and absolute changes in specific liver enzymes and other markers to determine the treatment's impact.

  4. Step 4

    Open-label extension period (OLE)

    Participants who continue into the open-label extension will receive elafibranor up to 120 mg daily. This phase is designed to evaluate the long-term safety and effects of the treatment.

    The open-label phase allows all participants to know they are receiving the active medication, not a placebo.

  5. Step 5

    Long-term monitoring

    Throughout the open-label extension, participants will be monitored regularly, with evaluations at weeks 52 and 96 to assess ongoing safety and liver function.

    The study aims to observe any long-term changes in liver enzyme levels and overall health status.

Who can join the trial?

15 criteria

  • Participants must be **male or female** and between **18 to 75 years old** at the time of signing the consent form.
  • Participants must have a diagnosis of **Primary Sclerosing Cholangitis (PSC)**, which is a liver disease. This should be confirmed by:
    • Historical evidence of an elevated **ALP** (a liver enzyme) above normal levels for at least 6 months before the first screening visit.
    • A **cholangiogram** (a type of imaging test) showing features compatible with PSC.
    • During screening, participants must have an **ALP** level that is at least 1.5 times the upper limit of normal (ULN), with specific conditions on the variability of these levels.
    • **Total bilirubin** levels must be no more than 2 times the ULN at the first screening visit. Bilirubin is a substance made by the liver.
    • If taking **UDCA** (a medication for liver disease), participants should have:
      • A total daily dose of no more than 23 mg per kg of body weight per day.
      • Been on a stable treatment for at least 6 months before screening and expected to continue this dose during the 12-week study period.
      • Stopped taking UDCA at least 3 months before screening if it was recently discontinued.
      • For participants with **Inflammatory Bowel Disease (IBD)**:
        • Those with **Crohn's disease** must be in remission, meaning the disease is not active, based on the doctor's assessment and on stable treatment before and during screening.
        • Those with **ulcerative colitis** must be in remission or have low disease activity, as judged by the doctor, and on stable treatment before and during screening.
        • Current treatment for IBD is allowed if the participant has been well-controlled for at least 3 months before screening and is expected to stay on a stable dose of IBD medications.
        • A **colonoscopy** (a test to look inside the colon) must have been done within two years before screening, showing no signs of abnormal cell growth or cancer.
        • Medications for managing **itching** (pruritus) must be on a stable dose for at least 3 months before screening.
        • Participants must use **contraception** according to local regulations for clinical study participants.
        • Participants must be able to give signed **informed consent**, agreeing to follow the study's requirements and restrictions.

Who cannot join the trial?

6 criteria

  • Patients who have a different liver condition other than Primary Sclerosing Cholangitis cannot participate. This is a specific liver disease that affects the bile ducts.
  • Patients who are not adults are excluded. This means only individuals who are 18 years or older can participate.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with certain medical conditions that could interfere with the study results may be excluded.
  • Patients who are unable to follow the study procedures or take the study medication as required will not be able to participate.
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Investigated drugs

Elafibranor is a medication being studied for its potential to treat adults with Primary Sclerosing Cholangitis (PSC). In this clinical trial, researchers are evaluating how safe and tolerable it is for patients to take elafibranor daily. The study includes a double-blind period where neither the participants nor the researchers know who is receiving the medication or a placebo. After this period, there is an open-label extension where all participants receive elafibranor to further assess its long-term safety and effects.

What is already known about the treatment

Elafibranor – Elafibranor is administered orally in tablet form and is currently being studied in clinical trials for its potential use in treating Primary Sclerosing Cholangitis (PSC). It is in the Phase II stage of clinical trials, where its safety and effectiveness are being evaluated. The main therapeutic indication for Elafibranor is to improve liver function in patients with PSC. At the molecular level, Elafibranor works by activating certain proteins in the body that help regulate lipid and glucose metabolism, as well as inflammation. It is classified pharmacologically as a dual PPAR alpha/delta agonist, which means it targets specific receptors involved in metabolic processes.

Investigated diseases

Primary Sclerosing Cholangitis – This is a chronic liver disease characterized by inflammation and scarring of the bile ducts inside and outside the liver. Over time, the scarring can cause the bile ducts to become blocked, leading to a buildup of bile in the liver. This can result in liver damage and eventually lead to liver failure. The disease progresses slowly, and symptoms may not appear until significant liver damage has occurred. Common symptoms include fatigue, itching, and jaundice. The exact cause of primary sclerosing cholangitis is unknown, but it is often associated with inflammatory bowel diseases like ulcerative colitis.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511370-72-00Protocol codeCLIN-60190-453Estimated enrolment68 patientsSponsorIpsen Bioscience Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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