At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 45 enrolled
Drug / intervention
Elafibranor 80 mg +2 moredrug
Likely dose
Elafibranor 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg After 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic Acid
In Brief
A Phase 2 clinical trial evaluating Elafibranor 80 mg, Elafibranor 120 mg, and 1 other intervention for Primary Biliary Cholangitis (PBC). Completed, enrolled 45 participants across 24 sites in 5 countries.
Detailed Summary
The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Biliary Cholangitis (PBC)
CountriesFrance, Germany, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartApr 2017
First PostedApr 2017
Primary CompletionOct 2018
TodayJul 2026
First PostedApr 21, 2017
Enrollment StartApr 5, 2017
Primary CompletionOct 31, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.2 years ago
Interventions
Elafibranor 80 mgdrug
Two coated tablets daily for 12 weeks
Elafibranor 120 mgdrug
Two coated tablets daily for 12 weeks
Placebodrug
Two coated tablets daily for 12 weeks