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Canakinumab in Pediatric CAPS (≤ 4 years)
NCT01302860Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2010
- Primary completion
- Nov 2014
- Countries
- 7
- Sponsor
- Novartis
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- canakinumab
- Conditions
- Cryopyrin-associated periodic syndromes (CAPS)
01
Overview
Phase 3, open-label, single-arm trial of canakinumab in Cryopyrin-associated periodic syndromes (CAPS), sponsored by Novartis. Primary endpoint: Percentage of Participants Aged 4 Years or Younger With at Least One Complete Response at Week 56. Started Nov 2010; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Canakinumab
Canakinumab s.c. injection (2 mg/kg) administered every 8 weeks.
03
Who it enrols
Patients aged 28 days to 60 months with a clinical diagnosis of CAPS (FCAS, MWS, or NOMID) and symptoms requiring pharmacological intervention. Patients must weigh at least 2.5 kg. Prior IL-1 blocking agents must be discontinued.
04
Endpoints
Primary
Percentage of Participants Aged 4 Years or Younger With at Least One Complete Response at Week 56
Secondary
Percentage of Participants Aged 2 Years or Younger With at Least One Complete Response at Week 56
Percentage of Participants With Defined Grades in Physician's Global Assessment Score
Percentage of Participants With Defined Grades in Physician Assessment of Skin Disease
Change From Baseline in C-Reactive Protein (CRP)
Change From Baseline in Serum Amyloid A (SAA)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of Participants Receiving a Concomitant Vaccination During the Study
Number of Vaccination Cases With Protective Antibody Levels Following Immunization With Inactivated Vaccines
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