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)

ClinicalTrials.gov Identifier: NCT04717635

Novartis Reference Number: CACZ885G1302

Last Update: Jan 13, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

Adult Onset Still's Disease

Phase

Phase 3

Overall status

Recruiting

Start date

Mar 30, 2021

Completion date

Jan 26, 2024

Gender

All

Age(s)

16 Years and older (Child, Adult, Older Adult)

Interventions

Biological

Canakinumab

Provide as 150 mg/1 mL solution for subcutaneous injection and administer 4mg/kg every 4 weeks.

Biological

Canakinumab

Provide as 150 mg/1 mL solution for subcutaneous injection and administer 4mg/kg every 4 weeks.

Biological

Canakinumab

Provide as 150 mg/1 mL solution for subcutaneous injection and administer 4mg/kg every 4 weeks.

Eligibility Criteria

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study. Parent's or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for participants < 20 years of age
Japanese male and female participants aged ≥ 16 years
Confirmed diagnosis of AOSD as per Yamaguchi criteria (Yamaguchi M, 1992) with an onset of disease ≥ 16 years of age. Yamaguchi criteria requires at least five criteria, including two major criteria and no exclusion criteria
Active disease at the time of baseline defined as follows
Fever (body temperature > 38°C) due to AOSD for at least 1 day within 1 week before baseline
At least 2 active joints (tender or swollen)
CRP ≥ 10 mg/L

Exclusion Criteria:

Pregnant or nursing (lactating) female participants, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ mL) at screening visit.
History of significant hypersensitivity to study drug or to biologics.
History/evidence of active macrophage activation syndrome or disseminated intravascular coagulation prior to 6 months of enrollment.
With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator compromises the articipant and/ or places the participant at unacceptable risk for participation in an immunomodulatory therapy.
With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including participants with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection.
Participants with absolute neutrophil count < 1500/mm3 at screening.