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

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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.

Study Locations

Japan
Novartis Investigative Site
Recruiting
Nagoya, 460-0001
Aichi
Japan
Novartis Investigative Site
Recruiting
Sapporo city, 060 8648
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Ono, 675-1327
Hyogo
Japan
Novartis Investigative Site
Recruiting
Kanazawa-city, 920-8641
Ishikawa
Japan
Novartis Investigative Site
Recruiting
Kawasaki-city, 216-8511
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama-city, 236-0004
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Nagano-city, 380-8582
Nagano
Japan
Novartis Investigative Site
Recruiting
Nagasaki-city, 852-8501
Nagasaki
Japan
Novartis Investigative Site
Recruiting
Kawachinagano, 586-8521
Osaka
Japan
Novartis Investigative Site
Recruiting
Iruma-gun, 350-0495
Saitama
Japan
Novartis Investigative Site
Recruiting
Bunkyo ku, 113 8655
Tokyo
Japan
Novartis Investigative Site
Recruiting
Chuo ku, 104-8560
Tokyo
Japan
Novartis Investigative Site
Recruiting
Mitaka-city, 181-8611
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku-ku, 160 8582
Tokyo
Japan
Novartis Investigative Site
Recruiting
Chiba, 260 8677
-
Japan
Novartis Investigative Site
Recruiting
Nagoya, 460-0001
Aichi
Japan
Novartis Investigative Site
Recruiting
Sapporo city, 060 8648
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Ono, 675-1327
Hyogo
Japan
Novartis Investigative Site
Recruiting
Kanazawa-city, 920-8641
Ishikawa
Japan
Novartis Investigative Site
Recruiting
Kawasaki-city, 216-8511
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama-city, 236-0004
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Nagano-city, 380-8582
Nagano
Japan
Novartis Investigative Site
Recruiting
Nagasaki-city, 852-8501
Nagasaki
Japan
Novartis Investigative Site
Recruiting
Kawachinagano, 586-8521
Osaka
Japan
Novartis Investigative Site
Recruiting
Iruma-gun, 350-0495
Saitama
Japan
Novartis Investigative Site
Recruiting
Bunkyo ku, 113 8655
Tokyo
Japan
Novartis Investigative Site
Recruiting
Chuo ku, 104-8560
Tokyo
Japan
Novartis Investigative Site
Recruiting
Mitaka-city, 181-8611
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku-ku, 160 8582
Tokyo
Japan
Novartis Investigative Site
Recruiting
Chiba, 260 8677
-
Japan
Novartis Investigative Site
Recruiting
Nagoya, 460-0001
Aichi
Japan
Novartis Investigative Site
Recruiting
Sapporo city, 060 8648
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Ono, 675-1327
Hyogo
Japan
Novartis Investigative Site
Recruiting
Kanazawa-city, 920-8641
Ishikawa
Japan
Novartis Investigative Site
Recruiting
Kawasaki-city, 216-8511
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama-city, 236-0004
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Nagano-city, 380-8582
Nagano
Japan
Novartis Investigative Site
Recruiting
Nagasaki-city, 852-8501
Nagasaki
Japan
Novartis Investigative Site
Recruiting
Kawachinagano, 586-8521
Osaka
Japan
Novartis Investigative Site
Recruiting
Iruma-gun, 350-0495
Saitama
Japan
Novartis Investigative Site
Recruiting
Bunkyo ku, 113 8655
Tokyo
Japan
Novartis Investigative Site
Recruiting
Chuo ku, 104-8560
Tokyo
Japan
Novartis Investigative Site
Recruiting
Mitaka-city, 181-8611
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku-ku, 160 8582
Tokyo
Japan
Novartis Investigative Site
Recruiting
Chiba, 260 8677
-
Japan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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