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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02980263
Recruitment Status : Withdrawn
First Posted : December 2, 2016
Last Update Posted : February 17, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Estimated Study Start Date : November 15, 2016
Estimated Primary Completion Date : November 30, 2017
Estimated Study Completion Date : November 30, 2017

Arm Intervention/treatment
Experimental: Kawasaki patients Drug: Canakinumab
Other Name: ACZ885

Primary Outcome Measures :
  1. resolution of fever [ Time Frame: Day 3/4 ]

Secondary Outcome Measures :
  1. proportion of patients with C-reactive Protein reduction [ Time Frame: 12 weeks ]
  2. proportion of patients developing coronary artery aneurysms [ Time Frame: 12 weeks ]
  3. time to resolution of fever [ Time Frame: 12 weeks ]
  4. proportion of patients with remittent fever [ Time Frame: 12 weeks ]
  5. size of coronary artery aneurysm [ Time Frame: 24 weeks ]
  6. Coronary artery aneurysm evolution over time [ Time Frame: 12 weeks ]
  7. proportion of patients with coronary artery aneurysm [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02980263

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT02980263     History of Changes
Other Study ID Numbers: CACZ885D2208
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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:
Mucocutaneous Lymph Node Syndrome
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Antibodies, Monoclonal
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs