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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02980263

Collaborator

(none)

Enrollment

Arm

12.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kawasaki Disease	Drug: Canakinumab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 15, 2016

Anticipated Primary Completion Date :

Nov 30, 2017

Anticipated Study Completion Date :

Nov 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kawasaki patients	Drug: Canakinumab Other Names: ACZ885

Arm

Intervention/Treatment

Experimental: Kawasaki patients

Drug: Canakinumab

Other Names:

ACZ885

Outcome Measures

Primary Outcome Measures

resolution of fever [Day 3/4]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Days to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.