NCT04717635

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

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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 16 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Adult Onset Still's Disease

Interventions

Type	Name	Description
BIOLOGICAL	Canakinumab	Canakinumab was provided as a 150 mg/1 mL solution for subcutaneous injection, administered at a dose of 4 mg/kg every four weeks. The medication was supplied by Novartis in individual 2 mL glass vials, each containing 150 mg of liquid canakinumab. Throughout the study, participants received subcutaneous injections of canakinumab 4 mg/kg (up to a maximum of 300 mg) at the study site every four weeks. Any participant who required a dose greater than a single dose of 150 mg (participants \> 37.5 kg) received two s.c. injections per administration

Timeline

• Start date: 2021-03-30
• Primary completion: 2025-04-16
• Completion: 2025-04-16
• First posted: 2021-01-22
• Last updated: 2026-03-31
• Results posted: 2026-03-23

Locations

9 sites across 1 country: Japan