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

Novartis

Status and phase: Completed; Phase 3

Conditions: Adult Onset Still's Disease

Treatments: Biological: Canakinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04717635

2021-003706-50 (EudraCT Number)

CACZ885G1302

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 16 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Canakinumab

Experimental group

Description:

All participants receive canakinumab (ACZ885) as open-label study medication. Participants are administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed is 300 mg.

Treatment:

Biological: Canakinumab