Extrait

This is a Phase 2 study that is divided into 2 parts. Part 1 is an open-label, proof-of-concept study. Part 2 is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and safety of ustekinumab in subjects with PBC who had an inadequate response to UDCA. PART 1: Open Label Primary Objectives: • To evaluate the efficacy of ustekinumab in reducing alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin in subjects with PBC. • To determine the ustekinumab regimen(s), based on safety and efficacy, for development in Part 2. PART 2: Double-blind Primary Objectives: • To evaluate the efficacy of ustekinumab in achieving ALP response (a decrease from baseline of > 40% in ALP) in subjects with PBC who had an inadequate response to UCDA. • To evaluate the safety of ustekinumab in subjects with PBC.

Critère d'inclusion

• Primary biliary cirrhosis

Liens

• euctr
• ictrp
• euctr
• ictrp