NCT01904058

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Mirum Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PBC
• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
DRUG	LUM001
DRUG	Placebo
DRUG	Ursodeoxycholic Acid

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2013-07-22
• Last updated: 2019-03-27
• Results posted: 2016-07-06

Locations

24 sites across 3 countries: United States, Canada, United Kingdom