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)

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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)

Brief description of study

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, single, inferentially seamless, adaptive design clinical study that will be conducted in 3 parts. The primary and secondary objectives and endpoints will be evaluated in participants with PSC who have a baseline score of =4 on the Adult Itch-Reported Outcome (ItchRO), as assessed during the single-blind placebo run-in period during the core study.

Clinical Study Identifier: s20-01067

ClinicalTrials.gov Identifier: NCT04663308

Principal Investigator: Ira M. Jacobson.

Other Investigators: Jennifer M. Vittorio, Monique Julia Carasso, Nadia Ovchinsky.

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