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

Conditions

• Adult Onset Still's Disease

Eligibility Criteria

Sex

ALL

Age

16 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Canakinumab — BIOLOGICAL
  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

Study Details

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.

Key Dates

Start date

Mar 30, 2021

Status verified

Mar 2026

Primary completion

Apr 16, 2025

Completion

Apr 16, 2025

Study Design

Enrollment

14 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Canakinumab
  All participants received canakinumab as open-label study medication. Canakinumab was administered subcutaneously at a dose of 4 mg/kg every four weeks, with a maximum allowable single dose of 300 mg.

Primary Outcome Measure

Percentage of Participants Who Achieved Adapted American College of Rheumatology (ACR) 30 Response at Week 8 [ Time Frame: Baseline, Week 8 ]