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NotablePrimary endpoints: details revised at 1 of 1 entrySecondary endpoints: details revised at 20 of 43 entries · Site details revised at 1 of 16 sites · Eligibility criteria expanded, about 2 wordsShow 3 more changesShow less
Secondary endpoints: details revised at 20 of 43 entries
Site details revised at 1 of 16 sites
Eligibility criteria expanded, about 2 words
Minor7 versionsRe-verified since Feb 27, 2026, no change to tracked fieldsv15-v21
NotablePrimary completion date: Mar 19, 2026 to Dec 17, 2026Trial status: Recruiting to Active, Not Recruiting · Site details revised at 16 of 16 sitesv14Show 2 more changesShow less
Trial status: Recruiting to Active, Not Recruiting
Site details revised at 16 of 16 sites
Minor8 versionsRe-verified since Apr 30, 2025, no change to tracked fieldsv6-v13
MinorSite details revised at 9 of 16 sitesv5
Show 3 earlier versionsHide 3 earlier versions
MinorSite details revised at 4 of 16 sitesv4
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 16 · Start date changed from estimate of Jan 14, 2025 to Jan 16, 2025v3Show 2 more changesShow less
Study sites: 0 to 16
Start date changed from estimate of Jan 14, 2025 to Jan 16, 2025
NotableStart date: Dec 9, 2024 to Jan 14, 2025v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to find out about the safety and how well the study intervention (elafibranor) works in participants with PBC. The participants in this study will have confirmed PBC with inadequate response or intolerance to UDCA, which is a medication used in the management and treatment of cholestatic liver disease.
PBC 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. In this study all participants will receive a daily dose of elafibranor (the study intervention).
The main aim of this study is to determine if elafibranor reduces alkaline phosphatase (ALP) and total bilirubin levels. High ALP and bilirubin levels in the blood can indicate liver disease.
There will be 4 periods in this study: A screening period (up to 10 weeks) to assess whether the participant can take part. A treatment period (52 weeks) where all eligible participants will receive elafibranor. A variable treatment extension period (2-5 years) from End Of Treatment (EOT) period up to the commercial availability of elafibranor in Japan. A follow-up period (4 weeks) where participants' health will be monitored.
Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a non-invasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (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 approximately 6 years