At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 238 enrolled
Drug / intervention
Linerixibat +1 moredrug
Likely dose
Not stated in 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 Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC)
In Brief
A Phase 3 clinical trial evaluating Linerixibat and Placebo for Pruritus. Completed, enrolled 238 participants across 114 sites in 19 countries.
Detailed Summary
This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPruritus
CountriesArgentina, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Greece, Israel, Italy, Japan, Mexico, Poland, Russia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedJul 2021
Enrollment StartAug 2021
Primary CompletionOct 2024
Study CompletionDec 2024
TodayJul 2026
First PostedJul 6, 2021
Enrollment StartAug 27, 2021
Primary CompletionOct 28, 2024
Study CompletionDec 20, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 5.0 years ago
Interventions
Linerixibatdrug
Participants will receive linerixibat.
Placebodrug
Participants will receive placebo.