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Last Updated: September 25, 2020

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CLINICAL TRIALS PROFILE FOR LUM001

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Clinical Trials for LUM001

Trial ID Title Status Sponsor Phase Summary
NCT01903460 Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome Completed Shire Phase 2 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.
NCT01904058 Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis Completed Shire Phase 2 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.
NCT02047318 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. Phase 2 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.
NCT02047318 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 Shire Phase 2 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.
NCT02057692 Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome Active, not recruiting Childhood Liver Disease Research and Education Network Phase 2 The study is a randomized, double-blind, placebo-controlled study in children with Alagille Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on pruritus, serum bile acids, liver enzymes, and other biochemical markers in patients with ALGS.
NCT02057692 Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome Active, not recruiting Shire Phase 2 The study is a randomized, double-blind, placebo-controlled study in children with Alagille Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on pruritus, serum bile acids, liver enzymes, and other biochemical markers in patients with ALGS.
NCT02057718 Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis Active, not recruiting Lumena Pharmaceuticals, Inc. Phase 2 This is an open label study in children with Progressive Familial Intrahepatic Cholestasis (PFIC) designed to evaluate the safety and efficacy of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 on the biochemical markers and pruritus associated with PFIC.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for LUM001

Condition Name

Condition Name for
Intervention Trials
Alagille Syndrome 5
Primary Biliary Cirrhosis 2
Progressive Familial Intrahepatic Cholestasis (PFIC) 2
PBC 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Cholestasis 6
Liver Diseases 5
Alagille Syndrome 5
Syndrome 5
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Clinical Trial Locations for LUM001

Trials by Country

Trials by Country for
Location Trials
United States 53
United Kingdom 16
Canada 5
Poland 2
Australia 2
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Trials by US State

Trials by US State for
Location Trials
California 6
Washington 4
Texas 4
Indiana 4
Colorado 4
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Clinical Trial Progress for LUM001

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 1
Phase 2 11
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Active, not recruiting 4
Completed 4
Not yet recruiting 3
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Clinical Trial Sponsors for LUM001

Sponsor Name

Sponsor Name for
Sponsor Trials
Shire 10
Lumena Pharmaceuticals, Inc. 3
Mirum Pharmaceuticals, Inc. 3
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 16
Other 3
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