Transform

Transform is an investigational study in patients with 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.

Study phase: Other

Study phase (if other): 2b/3

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Diagnosis of PBC with consistently elevated levels of alkaline phosphatase (ALP).

Primary disease category: Liver

Secondary disease categories: Autoimmune Disorders

Sponsor: Calliditas Therapeutics

Protocol number: GSN000350

Projected enrollment dates: May 2023 to May 2026

Official study title: 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

ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT05014672