Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and
tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus
placebo on the biochemical markers and pruritus associated with Alagille Syndrome.
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
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.
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)
Active, not recruiting
Lumena Pharmaceuticals, Inc.
The purpose of this extension study is to determine the long-term safety and tolerability of
an investigational treatment (LUM001) in children with ALGS who have completed participation
in the LUM001-302 study.
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