NCT05050136

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Biliary Cholangitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Mirum Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.

Conditions

• Primary Biliary Cholangitis
• PBC

Interventions

Type	Name	Description
DRUG	Volixibat	Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.
DRUG	Placebo	Capsules matched to study drug without the active pharmaceutical ingredient

Timeline

• Start date: 2021-09-22
• Primary completion: 2027-04-01
• Completion: 2027-07-01
• First posted: 2021-09-20
• Last updated: 2026-04-02

Locations

130 sites across 15 countries: United States, Argentina, Belgium, Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Netherlands, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study