Study of Efficacy and Safety of Canakinumab in Japanese Patients With AOSD

Adult Onset Still's Disease Clinical Trial

Official title: An Open-label, Single-arm, Active-treatment Study to Evaluate Efficacy and Safety of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Adult Onset Still's Disease (AOSD)

Status Active, not recruiting

Clinical Trial Summary

This is a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Adult Onset Still's Disease (AOSD). Interim analysis (IA) data at Week 28 and 48 from this study supports a registration submission of canakinumab in the indication of Adult still's disease (ASD) in Japan.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Adult Onset Still's Disease
• Still's Disease, Adult-Onset

• NCT number: NCT04717635
• Study type: Interventional
• Source: Novartis
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 30, 2021
• Completion date: July 28, 2025