NCT03394924

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis

A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	EDP-305 1 mg	Two tablets daily for 12 weeks
DRUG	EDP-305 2.5 mg	Two tablets daily for 12 weeks
DRUG	Placebo	Two tablets daily for 12 weeks

Timeline

• Start date: 2017-12-27
• Primary completion: 2019-12-19
• Completion: 2020-01-16
• First posted: 2018-01-09
• Last updated: 2021-05-18
• Results posted: 2021-05-18

Locations

86 sites across 10 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study