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

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

Sponsors

Lead Sponsor: Novartis Pharmaceuticals

Source Novartis
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.

Overall Status Withdrawn
Start Date November 15, 2016
Completion Date November 30, 2017
Primary Completion Date November 30, 2017
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
resolution of fever Day 3/4
Secondary Outcome
Measure 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
Condition
Intervention

Intervention Type: Drug

Intervention Name: Canakinumab

Arm Group Label: Kawasaki patients

Other Name: ACZ885

Eligibility

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.

Gender: All

Minimum Age: N/A

Maximum Age: 10 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Verification Date

February 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Kawasaki patients

Type: Experimental

Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov