Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease

Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease

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.

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:

• Previous Kawasaki Disease diagnosis, refractory and/or incomplete Kawasaki disease (for IVIG-naïve patients, Cohort 1)
• 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.