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Clinical Trials in the UK / NCT04663308
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 Sclerosing Cholangitis (PSC)

NCT04663308 · tracked via the Priya Life Science UK tracker
Sponsor
Mirum Pharmaceuticals, Inc.
Phase
Phase 2
Started
2020-12-18
Last updated
2026-08-26

Condition(s) studied

Primary Sclerosing Cholangitis

Investigational drug(s) / intervention(s)

VolixibatPlacebo

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

Placebo: Capsules matched to study drug minus active substance

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 Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Provide freely signed informed consent and assent (as applicable) and be willing to comply with all study visits and requirements through end of study, including the follow-up period. 2. Subjects aged ≥12 years for eligible regions; otherwise ≥18 years 3. Confirmed diagnosis of large duct or small duct PSC based on American Association for the Study of Liver Disease (AASLD) guidelines. 4. Pruritus associated with PSC as assessed by Adult ItchRO. 5. Ursodeoxycholic acid (UDCA) and anti-pruritic medication use will be allowed if meeting additional criteria. 6. Concomitant Inflammatory Bowel Disease (IBD) is allowed if meeting additional criteria. Exclusion Criteria: 1. Pruritus associated with an etiology other than PSC 2. Evidence or clinical suspicion of decompensated cirrhosis, or a history of decompensation events 3. History of ileostomy or small bowel surgery/resection or other surgeries that may have disrupted the enterohepatic circulation 4. Evidence, history, or suspicion of other liver disease; PSC patients with AIH are not excluded. 5. Bile duct stent or percutaneous bile duct drain placement, or balloon dilatation procedure of a stricture within 12 weeks of Screening 6. Exceeding pre-defined biochemical values for alanine aminotransferase/aspartate aminotransferase (ALT/AST), estimated glomerular filtration rate (eGFR),serum creatinine (sCr), platelet count, international normalized ratio (INR) and total bilirubin 7. History of liver transplantation

Primary outcome measure(s)

Trial sites (103)

FacilityCityRegionStatus
Southern California Research Center Coronado California
Cedars Sinai Medical Center Los Angeles California
University of California, Davis Sacramento California
California Pacific Medical Center Research Institute San Francisco California
University of Colorado - Anschutz Medical Campus Aurora Colorado
MedStar Georgetown University Hospital Washington D.C. District of Columbia
Florida Research Institute Lakewood Rch Florida
University of Miami - Schiff Center for Liver Diseases Miami Florida
Tampa General Hospital Tampa Florida
Beth Israel Deaconess Medical Center Boston Massachusetts
Henry Ford Hospital Detroit Michigan
Mayo Clinic Rochester Minnesota
Southern Therapy and Advanced Research LLC Jackson Mississippi
Northwell Health Manhasset New York
New York University Langone Health New York New York
Weill Cornell Medical College New York New York
Columbia University Medical Center - Presbyterian Hospital and Vanderbilt Clinic New York New York
University of Rochester Medical Center - Strong Memorial Hospital Rochester New York
Duke Health - Duke University Medical Center Durham North Carolina
Science 37, Inc (Remote-homebased Telemedicine) Morrisville North Carolina
Cleveland Clinic Cleveland Ohio
Einstein Healthcare Network - Einstein Medical Center Philadelphia Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Galen Medical Group Hixson Tennessee
Vanderbilt University Medical Center Nashville Tennessee
The Liver Institute At Methodist Dallas Medical Center Dallas Texas
University of Texas Southwestern Medical Center Dallas Texas
Houston Methodist Hospital Houston Texas
Liver Associates of Texas Houston Texas
University of Utah Health Care Salt Lake City Utah
Bon Secours Liver Institution of Hampton Roads Mary Immaculate Hospital Office Newport News Virginia
Richmond Community Hospital LLC Richmond Virginia
University of Washington - Harborview Medical Center Seattle Washington
Liver Institute Northwest Seattle Washington
Hospital Italiano de Buenos Aires Buenos Aires Argentina
Glenny Corp S.A. Ciudad Autónoma Buenos Aires Argentina
Hospital El Cruce San Juan Bautista Argentina
Royal Adelaide Hospital Adelaide Australia
Northern Health Epping Australia
Liverpool Hospital Liverpool Australia

+ 63 more sites — see the full list on the official registry below.

More Mirum Pharmaceuticals, Inc. trials in the UK

Other trials for the same condition

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 NCT04663308 on ClinicalTrials.gov ↗ ← All trials in the UK