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

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.

Study Overview

• Status: Withdrawn
• Conditions: Kawasaki Disease
• Intervention / Treatment: Drug: Canakinumab

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
resolution of fever	Day 3/4

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2016
• Primary Completion (Anticipated): November 30, 2017
• Study Completion (Anticipated): November 30, 2017

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (Estimate): December 2, 2016

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: pediatric; canakinumab; Kawasaki disease; Coronary artery aneurysm; mucocutaneous lymph node syndrome; lymph node syndrome; intravenous immunoglobulin naïve (IVIG-naïve); intravenous immunoglobulin refractory (IVIG-refractory)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Lymphatic Diseases; Vasculitis; Skin Diseases, Vascular; Mucocutaneous Lymph Node Syndrome
• Other Study ID Numbers: CACZ885D2208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided