Summary
The purpose of this study is to evaluate the investigational use of a drug called volixibat for the treatment of pruritis (itching) associated with primary sclerosing cholangitis (PSC). In the first part of the study ("Core Study"), volixibat will be compared with a placebo (inactive substance) for a period of 28 weeks. Between 50% and 67% of participants will be randomly assigned to receive volixibat. In the next part of the study, ("Open-Label Extension"), all eligible participants who choose to continue will receive volixibat for up to 2 years. Researchers will evaluate the effects of volixibat (good and bad) against the effects of placebo and will watch carefully for any side effects and/or benefits.
Inclusion Criteria
- 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.
- Subjects aged ≥16 years for eligible regions
- Confirmed diagnosis of large duct or small duct PSC based on American Association for the Study of Liver Disease (AASLD) guidelines.
- Qualified pruritus associated with PSC as assessed by Adult ItchRO.
Study Location(s)
Beverly
More about this Clinical Trial
Full 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