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

Phase 2

Withdrawn

• Conditions: Kawasaki Disease
• Interventions: Drug: Canakinumab

• Registration Number: NCT02980263
• Lead Sponsor: Novartis Pharmaceuticals

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

Not available

Study Timeline

• Study First Submitted: 2016-10-24
• Study Start: 2016-11-15
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-17
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kawasaki patients	Canakinumab	-

Primary Outcome Measures

Name	Time	Method
resolution of fever	Day 3/4

Secondary Outcome Measures

Name	Time	Method
size of coronary artery aneurysm	24 weeks
proportion of patients with coronary artery aneurysm	12 weeks
time to resolution of fever	12 weeks
proportion of patients with C-reactive Protein reduction	12 weeks
proportion of patients with remittent fever	12 weeks
Coronary artery aneurysm evolution over time	12 weeks
proportion of patients developing coronary artery aneurysms	12 weeks