Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

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Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

Brief description of study

EP-547-201 is a randomized, double-blind, placebo-controlled study to evaluate the effects of EP547 on pruritus over 6 weeks in subjects with cholestatic pruritus due to primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC). The study includes a Screening Period of up to 4 weeks to assess subject eligibility; a 6-week Double-Blind Treatment Period; a 6-week Open-Label Extension Period; and a 2-week Safety Follow-Up Period after administration of the last dose of study drug (EP547 or placebo). Approximately 58 subjects will be randomized to receive either 100 mg doses of EP547 or placebo orally (PO) once daily (QD) in a 1:1 ratio. In the Open-Label Extension Period, all subjects will receive 100 mg doses of EP547.

Clinical Study Identifier: s22-01457

ClinicalTrials.gov Identifier: NCT05525520

Principal Investigator: Ira M. Jacobson.

Other Investigator: Monique Julia Carasso.

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