<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02980263</url>
  </required_header>
  <id_info>
    <org_study_id>CACZ885D2208</org_study_id>
    <nct_id>NCT02980263</nct_id>
  </id_info>
  <brief_title>Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease</brief_title>
  <official_title>Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to evaluate whether, in Intravenous Immunoglobulin-naïve or&#xD;
      refractory patients diagnosed with active Kawasaki disease, administration of canakinumab&#xD;
      controls fever and acute phase reactants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date type="Anticipated">November 15, 2016</start_date>
  <completion_date type="Anticipated">November 30, 2017</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>resolution of fever</measure>
    <time_frame>Day 3/4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>proportion of patients with C-reactive Protein reduction</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of patients developing coronary artery aneurysms</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to resolution of fever</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of patients with remittent fever</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>size of coronary artery aneurysm</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coronary artery aneurysm evolution over time</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of patients with coronary artery aneurysm</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Kawasaki Disease</condition>
  <arm_group>
    <arm_group_label>Kawasaki patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Canakinumab</intervention_name>
    <arm_group_label>Kawasaki patients</arm_group_label>
    <other_name>ACZ885</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
        -Active Kawasaki disease defined as:&#xD;
&#xD;
          -  fever ≥38.5°C for ≥5 days&#xD;
&#xD;
          -  four out of five of the following criteria: (i) conjunctival injection, (ii) oral&#xD;
             mucous membrane changes, (e.g., injected pharynx, or strawberry tongue), (iii)&#xD;
             erythema of hands or feet, (iv) polymorphous rash, (v) cervical lymphadenopathy&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
        Patients fulfilling any of the following criteria are not eligible for inclusion in this&#xD;
        study:&#xD;
&#xD;
          -  Previous Kawasaki Disease diagnosis, refractory and/or incomplete Kawasaki disease&#xD;
             (for IVIG-naïve patients, Cohort 1)&#xD;
&#xD;
          -  Patients who had fever for longer than a week (for Intravenous Immunoglobulin-naïve&#xD;
             patients, Cohort 1), or longer than 14 days (for Intravenous Immunoglobulin-refractory&#xD;
             patients, Cohort 2)&#xD;
&#xD;
          -  History of hypersensitivity to any of the study drugs or to drugs or similar chemical&#xD;
             classes or excipients (e.g. citric acid and anhydrous sodium chloride disodium edetate&#xD;
             dehydrate polysorbate 80; sodium hydroxide; water for injections)&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Days</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <removed_countries>
    <country>Belgium</country>
    <country>Italy</country>
  </removed_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>February 15, 2017</last_update_submitted>
  <last_update_submitted_qc>February 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Kawasaki disease</keyword>
  <keyword>Coronary artery aneurysm</keyword>
  <keyword>mucocutaneous lymph node syndrome</keyword>
  <keyword>lymph node syndrome</keyword>
  <keyword>canakinumab</keyword>
  <keyword>intravenous immunoglobulin naïve (IVIG-naïve)</keyword>
  <keyword>intravenous immunoglobulin refractory (IVIG-refractory)</keyword>
  <keyword>pediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mucocutaneous Lymph Node Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02980263
org study id: CACZ885D2208
nct id: NCT02980263
lead sponsor: 
has dmc: Yes
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: resolution of fever
time frame: Day 3/4
measure: proportion of patients with C-reactive Protein reduction
time frame: 12 weeks
measure: proportion of patients developing coronary artery aneurysms
time frame: 12 weeks
measure: time to resolution of fever
time frame: 12 weeks
measure: proportion of patients with remittent fever
time frame: 12 weeks
measure: size of coronary artery aneurysm
time frame: 24 weeks
measure: Coronary artery aneurysm evolution over time
time frame: 12 weeks
measure: proportion of patients with coronary artery aneurysm
time frame: 12 weeks
arm group label: Kawasaki patients
arm group type: Experimental
intervention type: Drug
intervention name: Canakinumab
arm group label: Kawasaki patients
other name: ACZ885
criteria: 
gender: All
minimum age: 28 Days
maximum age: 10 Years
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
country: Belgium
country: Italy
responsible party type: Sponsor
mesh term: Mucocutaneous Lymph Node Syndrome
sharing ipd: Undecided