for people ages 12 years and up (full criteria)
at Sacramento, California and other locations
study started
completion around
Principal Investigator
by Christopher Bowlus, MD
Headshot of Christopher Bowlus
Christopher Bowlus



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.

Official Title

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


Primary Sclerosing Cholangitis, Pruritus, PSC, Itch, Itching, Cholestasis, Cholangitis, Sclerosing Cholangitis, Volixibat, Volixibat 20mg, Volixibat 80mg


You can join if…

Open to people ages 12 years and up

  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.

You CAN'T join if...

  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 diseases
  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


  • University of California, Davis accepting new patients
    Sacramento California 95817 United States
  • California Pacific Medical Center Research Institute accepting new patients
    San Francisco California 94109 United States

Lead Scientist at UC Davis

  • Christopher Bowlus, MD
    Professor, Gastroenterology and Hepatology, School of Medicine. Authored (or co-authored) 214 research publications


accepting new patients
Start Date
Completion Date
Mirum Pharmaceuticals, Inc.
Sign up for this study
Phase 2 research study
Study Type
Expecting 200 study participants
Last Updated