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

Novartis

Status and phase: Withdrawn; Phase 2

Conditions: Kawasaki Disease

Treatments: Drug: Canakinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02980263

CACZ885D2208

Details and patient eligibility

About

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.

Sex: All

Ages: 28 days to 10 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Kawasaki patients

Experimental group

Treatment:

Drug: Canakinumab