At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 61 enrolled
Drug / intervention
Part 1: LJN452 +4 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 Multi-part, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Primary Biliary Cholangitis
In Brief
A Phase 2 clinical trial evaluating Part 1: LJN452, Part 1: Placebo, and 3 other interventions for Primary Biliary Cholangitis. Completed, enrolled 61 participants across 28 sites in 6 countries.
Detailed Summary
A multi-part study to assess safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Biliary Cholangitis
CountriesCanada, Germany, Poland, Russia, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartSep 2015
Primary CompletionAug 2018
TodayJul 2026
First PostedAug 6, 2015
Enrollment StartSep 9, 2015
Primary CompletionAug 2, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.9 years ago
Interventions
Part 1: LJN452drug
LJN452 capsules administered once daily for 28 days
Part 1: Placebodrug
Matching placebo capsules administered once daily for 28 days
Part 2: LJN452 Dose level 1drug
LJN452 capsules administered once a day for 12 weeks
Part 2: Placebodrug
Matching placebo to LJN452 administered once a day for 12 weeks
Part 2: LJN452 Dose level 2drug
LJN452