A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
← catalyst calendarSponsored by Ipsen (industry) · IPN.PA — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
92actual
Sites
60
Countries
Czechia, France, Germany +7
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-07-09 | actual | When the study began enrolling |
| Primary completion | 2026-06-16 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-16 | actual | The whole study's end, after follow-up |
| First posted | 2024-04-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Primary Biliary Cholangitis
Interventions
- Drug: Elafibranor — also filed as IPN60190
- Other: Placebo
Primary outcome
what the primary-completion date above is the date OFPercentage of participants with normalisation of Alkaline Phosphate (ALP) Levels
measured At Week 52
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