At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 66 enrolled
Drug / intervention
LUM001 +2 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 Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi) in Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primary Biliary Cirrhosis
In Brief
A Phase 2 clinical trial evaluating LUM001, Placebo, and 1 other intervention for PBC and Primary Biliary Cirrhosis. Completed, enrolled 66 participants across 24 sites in 3 countries.
Detailed Summary
The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with LUM001 or placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPBC, Primary Biliary Cirrhosis
CountriesCanada, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2013
Enrollment StartAug 2013
Primary CompletionApr 2015
TodayJul 2026
First PostedJul 22, 2013
Enrollment StartAug 1, 2013
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.9 years ago
Interventions
LUM001drug
Placebodrug
Ursodeoxycholic Aciddrug