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

Mirum Pharmaceuticals

Status and phase

Enrolling

Phase 2

Conditions

PBC

Primary Biliary Cholangitis

Treatments

Drug: Volixibat

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05050136

VLX-601

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study
Male or female, age ≥18 years at the screening visit
Confirmed diagnosis of PBC in line with the AASLD guidelines
UDCA and anti-pruritic medication use will be allowed if meeting additional criteria
Qualified pruritus associated with PBC as assessed by Adult ItchRO

Exclusion criteria

Pruritus associated with an etiology other than PBC
Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events
Current symptomatic cholelithiasis or inflammatory gallbladder disease
History of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation.
Evidence, history, or suspicion of other liver diseases; PBC patients with AIH are not excluded
History of Liver transplantation