drugset / Trial / NCT04717635

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

NCT04717635

Phase 3 Completed 14 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2021-03-30
Primary completion
2025-04-16
Completion
2025-04-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Canakinumab Monoclonal antibody 4 mg/kg Subcutaneous