The purpose of this study is to determine the safety and effectiveness of an experimental drug called setanaxib for the treatment of primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis). PBC is a liver disease caused by an attack of the individual’s own immune system on specific structures of the liver and bile duct. Previous clinical results with setanaxib in PBC indicated that setanaxib achieved reductions in markers (indicators) of cholestatic injury, improved markers of liver fibrosis, and improved quality of life. Researchers hope to confirm these findings in the current study. Participants will be randomly assigned to 1 of 3 groups. One group will receive setanaxib 1200 mg/day; the second group will receive setanaxib 1600 mg/day; and the third group will receive placebo (inactive substance).
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 and Elevated Liver Stiffness