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

Kawasaki Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02980263
• Other study ID #: CACZ885D2208
• Status: Withdrawn
• Phase: Phase 2
• First received: October 24, 2016
• Last updated: February 15, 2017
• Start date: November 15, 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

Intervention

Drug:
• Canakinumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resolution of fever		Day 3/4
Secondary	proportion of patients with C-reactive Protein reduction		12 weeks
Secondary	proportion of patients developing coronary artery aneurysms		12 weeks
Secondary	time to resolution of fever		12 weeks
Secondary	proportion of patients with remittent fever		12 weeks
Secondary	size of coronary artery aneurysm		24 weeks
Secondary	Coronary artery aneurysm evolution over time		12 weeks
Secondary	proportion of patients with coronary artery aneurysm		12 weeks