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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Primary Biliary Cholangitis, PBC

In brief

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.

Key facts

Study ID

NCT05050136

Run by

Mirum Pharmaceuticals, Inc.

People needed

260

Starts

2021-09-22

Expected to finish

2027-07-01

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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, anti-pruritic medication and PPAR agonist use will be allowed if meeting additional criteria
• Qualified pruritus associated with PBC as assessed by Adult ItchRO

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic - Main Campus — Cleveland, Ohio, United States (enrolling)
• The Liver Institute at Methodist Dallas Medical Center — Dallas, Texas, United States (enrolling)
• Virtua Center for Liver Disease-Camden — Camden, New Jersey, United States (enrolling)
• Science 37, Inc (Remote-homebased Telemedicine) — Morrisville, North Carolina, United States (enrolling)
• Galen Medical Group, P.C — Tennessee City, Tennessee, United States (enrolling)
• University of California Los Angeles — Los Angeles, California, United States (enrolling)
• CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan — Omaha, Nebraska, United States (enrolling)
• UC Davis — Sacramento, California, United States (enrolling)
• University of Colorado — Aurora, Colorado, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Einstein Healthcare Network - Einstein Medical Center — Philadelphia, Pennsylvania, United States (enrolling)
• Yale University Digestive Diseases — New Haven, Connecticut, United States (enrolling)
• Tampa General Hospital — Tampa, Florida, United States (enrolling)
• Cleveland Clinic Florida — Weston, Florida, United States (enrolling)
• UF Hepatology Research at CTRB — Gainesville, Florida, United States (enrolling)
• Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Loyola University Health System - Loyola Outpatient Center — Maywood, Illinois, United States (enrolling)
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States (enrolling)
• Ochsner Clinic Foundation-Baton Rouge — Baton Rouge, Louisiana, United States (enrolling)
• LSU Health Science Center Shreveport — Shreveport, Louisiana, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Advanced Research Institute, Inc — New Port Richey, Florida, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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