At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 68 enrolled
Drug / intervention
EDP-305 1 mg +2 moredrug
Likely dose
EDP-305 1 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 Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)
In Brief
A Phase 2 clinical trial evaluating EDP-305 1 mg, EDP-305 2.5 mg, and 1 other intervention for Primary Biliary Cholangitis. Completed, enrolled 68 participants across 86 sites in 10 countries.
Detailed Summary
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Biliary Cholangitis
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Netherlands, Spain, United Kingdom, United States
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartDec 2017
First PostedJan 2018
Primary CompletionDec 2019
Study CompletionJan 2020
TodayJul 2026
First PostedJan 9, 2018
Enrollment StartDec 27, 2017
Primary CompletionDec 19, 2019
Study CompletionJan 16, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.5 years ago
Interventions
EDP-305 1 mgdrug
Two tablets daily for 12 weeks
EDP-305 2.5 mgdrug
Two tablets daily for 12 weeks
Placebodrug
Two tablets daily for 12 weeks