TRANSFORM: A 52-week Randomized Placebo-controlled Double-blind Adaptive Phase 2b/3 Trial of Setanaxib with a 52-week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness

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TRANSFORM: A 52-week Randomized Placebo-controlled Double-blind Adaptive Phase 2b/3 Trial of Setanaxib with a 52-week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness

Brief description of study

The Main Part of this study will be a randomized, placebo-controlled, double-blind, parallel-group, multicenter, adaptive Phase 2b/3 trial assessing oral setanaxib administered as an add-on therapy in patients with early PBC, elevated liver stiffness, and intolerance or inadequate response to UDCA. The safety and efficacy of 1200 mg/day and 1600 mg/day setanaxib will be assessed against matching placebo over up to 52 weeks of treatment. The safety and efficacy of setanaxib will be further assessed during a 52-week Extension Phase. It is planned to enroll up to a total of 318 patients at approximately 150 to 200 investigational centers in North America, Europe, Israel, Australia, and New Zealand.

Clinical Study Identifier: s21-00648

ClinicalTrials.gov Identifier: NCT05014672

Principal Investigator: Ira M. Jacobson.

Other Investigators: Monique Julia Carasso, Mary Christine Olson.

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