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 (VISTAS)

Investigator: David Victor, MD

Study Coordinator: Rene Andrade Ruiz

Status: Enrolling

ClinicalTrials.gov Number: NCT04663308

Phone: 832.768.1924

Protocol Number: PRO00028517

Description

The primary objective of the Core Study is to evaluate the efficacy of volixibat versus placebo for the treatment of pruritus (as measured by the change in the Adult ItchRO tool) in participants with PSC on the basis of the following endpoint: Mean change in the Adult ItchRO comparing baseline with the average of the weekly averaged worst daily itch scores from Week 12 through Week 24 All participants with PSC who consent to the study will undergo the screening and single-blind placebo run-in period prior to being eligible for randomization into the double-blind, placebo-controlled study period. Participants who remain eligible after the screening and single-blind placebo run-in period will participate in a 3-arm, 24-week, randomized, double-blind, placebo-controlled, parallel-group study. Participants will be stratified by their baseline Adult ItchRO score (<4, =4 but <7, and =7) and IBD status (Yes/No) and randomized in a 1:1:1 ratio across the three treatment arms: - volixibat 20 mg BID, - volixibat 80 mg BID, and - placebo. In Part 2, the pivotal phase, participants who meet screening and single-blind placebo run-in eligibility will be randomized into the 24-week double-blind treatment period, where one volixibat treatment arm will be compared with placebo. Participants who successfully complete the core study through the Week 24 visit in Parts 1 and 2 and remain in compliance with the study protocol requirements will be allowed to participate in the OLE and receive the volixibat dose selected for the pivotal phase to allow for long-term safety follow-up and to assess long-term durability of the treatment effect.
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