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
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.
Transforming Tisch Hospital | NYU Langone Health
Tisch Hospital is undergoing a renovation that is a key component of the larger NYU Langone campus transformation.
Transgender Health | NYU Langone Health
At NYU Langone, we provide care for transgender and nonbinary adults and adolescents, including gender-affirming surgery and hormone therapy.
Transgender Health Doctors | NYU Langone Health
Find a doctor at the Transgender Health at NYU Langone.
Transgender Surgery Services | NYU Langone Health
NYU Langone’s surgeons provide gender-affirming surgery for transgender and nonbinary people.
Transgender Youth Health Program | NYU Langone Health
Experts at Hassenfeld Children’s Hospital at NYU Langone’s Transgender Youth Health Program provide medical care and psychosocial support.
Transition Services for Women with Disabilities | NYU Langone Health
NYU Langone’s Initiative for Women with Disabilities helps women as they transition from adolescence to adulthood.
Transplantation & Cellular Therapy Center | NYU Langone Health
Perlmutter Cancer Center’s Transplantation and Cellular Therapy Center offers outpatient blood and marrow transplants to treat blood cancers.
Transplantation for Kidney Disease | NYU Langone Health
NYU Langone experts perform kidney transplantation in adults with advanced kidney disease or kidney failure.
Transplants for Liver Cancer | NYU Langone Health
Doctors at NYU Langone’s Perlmutter Cancer Center may recommend a liver transplant for some people with liver cancer.