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

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Disease Information

Descriptive Information
Brief Title † Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease
Official Title † Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease
Brief Summary 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.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † resolution of fever
Secondary Outcome Measure † proportion of patients with C-reactive Protein reduction
Condition † Kawasaki Disease
Intervention † DrugCanakinumab
Study Arms / Comparison Groups Kawasaki patients
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 0
Start Date † November 15, 2016
Completion Date November 30, 2017
Primary Completion Date November 30, 2017
Eligibility Criteria † 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.
Gender All
Ages N/A - 10 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries †
Administrative Information
NCT ID † NCT02980263
Organization ID CACZ885D2208
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Novartis Pharmaceuticals
Collaborators ††
Investigators † Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Information Provided By
Verification Date February 2017
First Received Date † October 24, 2016
Last Updated Date February 15, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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