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Clinical Trials in France / NCT05050136
Active, not recruiting Phase 2

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

NCT05050136 · tracked via the Priya Life Science France tracker
Sponsor
Mirum Pharmaceuticals, Inc
Phase
Phase 2
Started
2021-09-22
Last updated
2026-08-25

Condition(s) studied

Primary Biliary CholangitisPBC

Investigational drug(s) / intervention(s)

Volixibat →Placebo

Volixibat: Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.

Placebo: Capsules matched to study drug without the active pharmaceutical ingredient

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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, anti-pruritic medication and PPAR agonist 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

Primary outcome measure(s)

  • Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire — Baseline to week 28
    The Adult ItchRO is an 11-point NRS measurement of itch severity ranging from 0=no itch to 10=worst possible itch.

Trial sites (130)

FacilityCityRegionStatus
Southern California Research Center Coronado California
Cedars Sinai Medical Center Los Angeles California
University of California Los Angeles Los Angeles California
UC Davis Sacramento California
University of Colorado Aurora Colorado
Yale University Digestive Diseases New Haven Connecticut
Covenant Metabolic Specialists Fort Myers Florida
UF Hepatology Research at CTRB Gainesville Florida
UF Health Gastroenterology- Emerson Jacksonville Florida
IHS Health Kissimmee Florida
Schiff Center for Liver Diseases Miami Florida
Advanced Research Institute, Inc New Port Richey Florida
Covenant Research and Clinics, LLC Sarasota Florida
Tampa General Hospital Tampa Florida
Cleveland Clinic Florida Weston Florida
Southeast Clinical Research Center Dalton Georgia
Northwestern University Chicago Illinois
Loyola University Health System - Loyola Outpatient Center Maywood Illinois
University of Iowa Hospitals & Clinics Iowa City Iowa
Ochsner Clinic Foundation-Baton Rouge Baton Rouge Louisiana
LSU Health Science Center Shreveport Shreveport Louisiana
Massachusetts General Hospital Boston Massachusetts
Beth Israel Deaconess Boston Massachusetts
Mayo Clinic Rochester Minnesota
Jackson Liver and GI Specialists Jackson Mississippi
CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan Omaha Nebraska
Virtua Center for Liver Disease-Camden Camden New Jersey
Montefiore Medical Center The Bronx New York
Science 37, Inc (Remote-homebased Telemedicine) Morrisville North Carolina
Cleveland Clinic - Main Campus Cleveland Ohio
Einstein Healthcare Network - Einstein Medical Center Philadelphia Pennsylvania
Methodist Le Bonheur Healthcare Memphis Tennessee
Galen Medical Group, P.C Tennessee City Tennessee
Amel Med LLC Austin Texas
The Liver Institute at Methodist Dallas Medical Center Dallas Texas
Soma Clinical Trials Denison Texas
Baylor College of Medicine Houston Texas
Liver Associates of Texas Houston Texas
Impact Research Waco Texas
University of Utah Health Care Salt Lake City Utah

+ 90 more sites — see the full list on the official registry below.

More Mirum Pharmaceuticals, Inc. trials in France

Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND) Active, not recruiting
Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome or Progressive Familial Intrahepatic Cholestasis in the European Union (LEAP-EU) Recruiting
A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2) Recruiting
Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide Recruiting
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) Active, not recruiting

Other trials for the same condition

LEOPARD Training and Validation Data Collection Study Recruiting
LEOPARD Prospective Validation Cohort 1 Recruiting
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05050136 on ClinicalTrials.gov ↗ ← All trials in France