A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-525242-29-00

Enrollment

Registered

2026-07-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sclerosing Cholangitis

Brief summary

1. Event-free survival, defined as the time from randomisation to the first occurrence of any of the following adjudicated clinical outcome events: • All-cause mortality • Liver transplantation • Hepatic decompensation, • Portal hypertension syndromes: • Cholangiopathy-related events:

Interventions

DRUGOtherwise identical to the IMP

DRUGelafibranor

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Event-free survival, defined as the time from randomisation to the first occurrence of any of the following adjudicated clinical outcome events: • All-cause mortality • Liver transplantation • Hepatic decompensation, • Portal hypertension syndromes: • Cholangiopathy-related events:	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 24, 2026