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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980263
First Posted: December 2, 2016
Last Update Posted: February 17, 2017
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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 Intervention Phase
Kawasaki Disease Drug: Canakinumab Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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

Secondary Outcome Measures:
  • proportion of patients with C-reactive Protein reduction [ Time Frame: 12 weeks ]
  • proportion of patients developing coronary artery aneurysms [ Time Frame: 12 weeks ]
  • time to resolution of fever [ Time Frame: 12 weeks ]
  • proportion of patients with remittent fever [ Time Frame: 12 weeks ]
  • size of coronary artery aneurysm [ Time Frame: 24 weeks ]
  • Coronary artery aneurysm evolution over time [ Time Frame: 12 weeks ]
  • proportion of patients with coronary artery aneurysm [ Time Frame: 12 weeks ]

Enrollment: 0
Anticipated Study Start Date: November 15, 2016
Estimated Study Completion Date: November 30, 2017
Estimated Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kawasaki patients Drug: Canakinumab
Other Name: ACZ885

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02980263


Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02980263     History of Changes
Other Study ID Numbers: CACZ885D2208
First Submitted: October 24, 2016
First Posted: December 2, 2016
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
canakinumab
intravenous immunoglobulin naïve (IVIG-naïve)
intravenous immunoglobulin refractory (IVIG-refractory)
pediatric

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Immunoglobulins
Antibodies, Monoclonal
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs