NCT02061540

Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis

A Pilot, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Primary Sclerosing Cholangitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Mirum Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study is an open-label study in adults with primary sclerosing cholangitis to evaluate the safety, tolerability, and effect of 14-weeks of daily dosing of LUM001.

Conditions

• Primary Sclerosing Cholangitis (PSC)

Interventions

Type	Name	Description
DRUG	LUM001	LUM001 oral dose

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-02-13
• Last updated: 2019-03-29
• Results posted: 2017-04-12

Locations

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