Status:
COMPLETED
Study of Efficacy and Safety of Canakinumab in Japanese Patients With AOSD
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Adult Onset Still's Disease
Eligibility:
All Genders
16-100 years
Phase:
PHASE3
Brief Summary
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04717635
Start Date
March 30 2021
End Date
April 16 2025
Last Update
May 6 2025
Active Locations (9)
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1
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 060 8648
2
Novartis Investigative Site
Kanazawa, Ishikawa-ken, Japan, 920 8641
3
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 236-0004
4
Novartis Investigative Site
Iruma-gun, Saitama, Japan, 350-0495