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

Calliditas Suisse SA (the Sponsor) is conducting a clinical research study to see if an experimental medicine named setanaxib, will help in the treatment of primary biliary cholangitis (PBC) and to see how safe it is to use in people. Setanaxib is an experimental medicine that has not been approved by any regulatory authorities in any country in the world. Experimental medicines like setanaxib may be tested in research studies such as this one.


Clinical Study Identifier: s21-00648
ClinicalTrials.gov Identifier: NCT05014672
Principal Investigator: Ira M. Jacobson.


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