Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis

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.

Timeline

Start

2013-08

Primary completion

2015-04

Completion

2015-04

Outcome

Missed primary endpoint

registry p = 0.6603; Least squares mean difference -2.28 (95% CI -12.59 to 8.03) NCT01904058 ↗

registry p = 0.4380; Least squares mean difference -3.99 (95% CI -14.20 to 6.23) NCT01904058 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Maralixibat	Small molecule	—	Oral
Background	Ursodeoxycholic Acid	Small molecule	—	Oral

Indications