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

Study Overview
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Brief Summary
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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.

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

Conditions
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Kawasaki Disease

Intervention / Treatment
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* Drug: Canakinumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kawasaki patients<br> | Drug: Canakinumab<br> <br> * Other names: ACZ885;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resolution of fever |  | Day 3/4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with C-reactive Protein reduction |  | 12 weeks | 
| proportion of patients developing coronary artery aneurysms |  | 12 weeks | 
| time to resolution of fever |  | 12 weeks | 
| proportion of patients with remittent fever |  | 12 weeks | 
| size of coronary artery aneurysm |  | 24 weeks | 
| Coronary artery aneurysm evolution over time |  | 12 weeks | 
| proportion of patients with coronary artery aneurysm |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kawasaki disease, Coronary artery aneurysm, mucocutaneous lymph node syndrome, lymph node syndrome, canakinumab, intravenous immunoglobulin naïve (IVIG-naïve), intravenous immunoglobulin refractory (IVIG-refractory), pediatric