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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-30

Study Completion Date

2025-04-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Adult Onset Still's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Canakinumab

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.

Group Type EXPERIMENTAL

Canakinumab

Intervention Type BIOLOGICAL

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

Interventions

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Canakinumab

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

Intervention Type BIOLOGICAL

Other Intervention Names

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ACZ885

Eligibility Criteria

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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

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

* 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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No