Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05627362 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
MinorEligibility criteria expanded, about 20 wordsSecondary endpoints: details revised at 3 of 21 entries · Site details revised at 3 of 62 sites · Publications: details revised at 1 of 1 entryShow 3 more changesShow less
Secondary endpoints: details revised at 3 of 21 entries
Site details revised at 3 of 62 sites
Publications: details revised at 1 of 1 entry
Minor2 versionsRe-verified since Jul 31, 2026, no change to tracked fieldsv43-v44
NotablePrimary and study completion pushed from Aug 28, 2026 to Sep 23, 2031Primary endpoint(s) modified · Trial arms changed: 4 → 5 · Eligibility criteria expanded, about 171 words · 1 morev42Show 4 more changesShow less
Minor19 versionsRe-verified since Nov 29, 2024, no change to tracked fieldsv23-v41
NotablePrimary and study completion dates: Dec 16, 2024 to Aug 28, 2026v22
Show 20 earlier versionsHide 20 earlier versions
Minor2 versionsRe-verified since Aug 31, 2024, no change to tracked fieldsv20-v21
MinorTrial status: Recruiting to Active, Not RecruitingEnrollment target: estimated 60 to confirmed 68 · Site details revised at 62 of 62 sitesv19Show 2 more changesShow less
Enrollment target: estimated 60 to confirmed 68
Site details revised at 62 of 62 sites
MinorStart date: Jan 27, 2023 to Dec 29, 2022v18
MinorRe-verified, no change to tracked fieldsv17
MinorSite details revised at 1 of 62 sitesv16
MinorCompletion date: Dec 16, 2025 to Dec 16, 2024Site details revised at 1 of 62 sitesv15Show 1 more changeShow less
Site details revised at 1 of 62 sites
MinorRe-verified, no change to tracked fieldsv14
MinorSite details revised at 13 of 62 sitesv13
MinorRe-verified, no change to tracked fieldsv12
NotablePrimary completion date: Feb 24, 2024 to Dec 16, 2024Completion date: Dec 13, 2025 to Dec 16, 2025 · Site details revised at 3 of 62 sitesv11Show 2 more changesShow less
Completion date: Dec 13, 2025 to Dec 16, 2025
Site details revised at 3 of 62 sites
MinorSite details revised at 1 of 62 sitesv10
MinorStudy sites: 13 to 62v9
Minor2 versionsRe-verified since Jun 16, 2023, no change to tracked fieldsv7-v8
MinorStudy sites: 7 to 13v6
MinorStudy sites: 4 to 7v5
NotableStart date: Jan 27, 2022 to Jan 27, 2023v4
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 4 · Start date changed from estimate of Jan 13, 2023 to Jan 27, 2022v3Show 2 more changesShow less
Study sites: 0 to 4
Start date changed from estimate of Jan 13, 2023 to Jan 27, 2022
NotableStart date: Dec 1, 2022 to Jan 13, 2023v2
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.
This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC) during the double-blind period, an initial 96 week open-label extension (OLE) period, and an optional open-label extension long-term (OLE-LT) period beyond OLE Week 96. PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial will be to study the safety and side effects of the study drug, including long-term safety during the open-label extension periods. The trial will also study the study drug's effects on blood tests and other tests related to PSC disease activity.