Canakinumab shows efficacy in Japanese AOSD patients in Phase 3 open-label study

Status: COMPLETED | Phase: PHASE3 Condition(s): Adult Onset Still's Disease Intervention(s): Canakinumab (BIOLOGICAL) This study was designed to evaluate the efficacy and safety of canakinumab administered subcutaneously every 4 weeks for at least 48 weeks in Japanese patients with Adult-Onset Still's Disease (AOSD). Interim analysis data collected at Weeks 28 and 48 supported the registration submission of canakinumab for the indication of Adult Still's Disease (ASD) in Japan. Detailed: This was a Phase III, open-label, single-arm active treatment study designed to evaluate the efficacy, safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of canakinumab at a dose of 4 mg/kg (up to a maximum of 300 mg) administered subcutaneously every 4 weeks for at least 48 weeks in Japanese participants with ASD. The study consisted of two epochs: * Screening epoch: Day -28 to Day -1 * Open-label treatment epoch: Day 1 until either regulatory approval and commercial availability of canakinumab for adult Still's disease (ASD) in Japan, or study termination (whichever occurred first). Primary Outcome(s): Percentage of Participants Who Achieved Adapted American College of Rheumatology (ACR) 30 Response at Week 8 Enrollment: 14 (ACTUAL) Lead Sponsor: Novartis Pharmaceuticals Start: 2021-03-30 | Primary Completion: 2025-04-16 Results posted: 2026-03-23