drugset / Trial / NCT04717635
Study of Efficacy and Safety of Canakinumab in Japanese Patients With AOSD
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Canakinumab | Monoclonal antibody | 4 mg/kg | Subcutaneous |