A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
← catalyst calendarNCT06016842 · readout in 1,016 d
Sponsored by Ipsen (industry) · IPN.PA — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
276estimated
Sites
186
Countries
Argentina, Australia, Belgium +23
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 | 2023-08-31 | actual | When the study began enrolling |
| Primary completion | 2029-05-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-05-31 | estimated | The whole study's end, after follow-up |
| First posted | 2023-08-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-03 | 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 (PBC)
Interventions
- Drug: Elafibranor
- Other: Matched 80 mg placebo
Primary outcome
what the primary-completion date above is the date OFEvent-free survival
measured From baseline until 4 weeks after the last dose of study intervention (maximum duration of 3.5 years)
Permalink · IPN.PA's whole pipeline · Catalyst calendar · Every registered study · What changed