Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease
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The purpose of this trial is to evaluate whether, in Intravenous Immunoglobulin-naïve or refractory patients diagnosed with active Kawasaki disease, administration of canakinumab controls fever and acute phase reactants.
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Ages Eligible for Study:
up to 10 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key Inclusion Criteria:
-Active Kawasaki disease defined as:
fever ≥38.5°C for ≥5 days
four out of five of the following criteria: (i) conjunctival injection, (ii) oral mucous membrane changes, (e.g., injected pharynx, or strawberry tongue), (iii) erythema of hands or feet, (iv) polymorphous rash, (v) cervical lymphadenopathy
Key Exclusion Criteria:
Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
Patients who had fever for longer than a week (for Intravenous Immunoglobulin-naïve patients, Cohort 1), or longer than 14 days (for Intravenous Immunoglobulin-refractory patients, Cohort 2)
History of hypersensitivity to any of the study drugs or to drugs or similar chemical classes or excipients (e.g. citric acid and anhydrous sodium chloride disodium edetate dehydrate polysorbate 80; sodium hydroxide; water for injections)
Other protocol-defined inclusion/exclusion may apply.