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

Primary Purpose

Kawasaki Disease

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Canakinumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kawasaki Disease focused on measuring Kawasaki disease, Coronary artery aneurysm, mucocutaneous lymph node syndrome, lymph node syndrome, canakinumab, intravenous immunoglobulin naïve (IVIG-naïve), intravenous immunoglobulin refractory (IVIG-refractory), pediatric

Eligibility Criteria

28 Days - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Kawasaki patients

    Arm Description

    Outcomes

    Primary Outcome Measures

    resolution of fever

    Secondary Outcome Measures

    proportion of patients with C-reactive Protein reduction
    proportion of patients developing coronary artery aneurysms
    time to resolution of fever
    proportion of patients with remittent fever
    size of coronary artery aneurysm
    Coronary artery aneurysm evolution over time
    proportion of patients with coronary artery aneurysm

    Full Information

    First Posted
    October 24, 2016
    Last Updated
    February 15, 2017
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02980263
    Brief Title
    Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease
    Official Title
    Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    November 15, 2016 (Anticipated)
    Primary Completion Date
    November 30, 2017 (Anticipated)
    Study Completion Date
    November 30, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Kawasaki patients
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Canakinumab
    Other Intervention Name(s)
    ACZ885
    Primary Outcome Measure Information:
    Title
    resolution of fever
    Time Frame
    Day 3/4
    Secondary Outcome Measure Information:
    Title
    proportion of patients with C-reactive Protein reduction
    Time Frame
    12 weeks
    Title
    proportion of patients developing coronary artery aneurysms
    Time Frame
    12 weeks
    Title
    time to resolution of fever
    Time Frame
    12 weeks
    Title
    proportion of patients with remittent fever
    Time Frame
    12 weeks
    Title
    size of coronary artery aneurysm
    Time Frame
    24 weeks
    Title
    Coronary artery aneurysm evolution over time
    Time Frame
    12 weeks
    Title
    proportion of patients with coronary artery aneurysm
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    28 Days
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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