RECRUITING

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

Description

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.

Conditions

Primary Sclerosing Cholangitis
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Related Conditions:

Primary Sclerosing Cholangitis

Study Overview

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Study Details

Study overview

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.

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 Sclerosing Cholangitis

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

Condition
Primary Sclerosing Cholangitis
Intervention / Treatment

-

Contacts and Locations

Coronado

Southern California Research Center, Coronado, California, United States, 92118

Culver City

Science 37, Inc (Remote-homebased Telemedicine), Culver City, California, United States, 90230

Los Angeles

Cedars Sinai Medical Center, Los Angeles, California, United States, 90048

Sacramento

University of California, Davis, Sacramento, California, United States, 95817

San Francisco

California Pacific Medical Center Research Institute, San Francisco, California, United States, 94109

Aurora

University of Colorado - Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Washington

MedStar Georgetown University Hospital, Washington, District of Columbia, United States, 20007

Lakewood Ranch

Florida Research Institute, Lakewood Ranch, Florida, United States, 34211

Miami

University of Miami - Schiff Center for Liver Diseases, Miami, Florida, United States, 33136

Tampa

Tampa General Hospital, Tampa, Florida, United States, 33606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mirum Pharmaceuticals, Inc.,

Study Record Dates

2025-12