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

NCT02980263 | Withdrawn Phase 2 DMC

• 1 other identifier: CACZ885D2208
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kawasaki Disease

Keywords

Kawasaki disease; Coronary artery aneurysm; mucocutaneous lymph node syndrome; lymph node syndrome; canakinumab; intravenous immunoglobulin naïve (IVIG-naïve); intravenous immunoglobulin refractory (IVIG-refractory); pediatric

Outcome Measures

Primary Outcomes (1)

• resolution of fever

  Day 3/4

Secondary Outcomes (7)

• 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

Study Arms (1)

Kawasaki patients

EXPERIMENTAL

Drug: Canakinumab

Interventions

Canakinumab DRUG

Also known as: ACZ885

Kawasaki patients

Eligibility Criteria

• Age: 28 Days - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome; Coronary Aneurysm

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Aneurysm

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: December 2, 2016
• Study Start: November 15, 2016
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: February 17, 2017

Record last verified: 2017-02