<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/NCT02991469</url>
  </required_header>
  <id_info>
    <org_study_id>DRI13926</org_study_id>
    <secondary_id>2015-004000-35</secondary_id>
    <secondary_id>U1111-1177-3584</secondary_id>
    <nct_id>NCT02991469</nct_id>
  </id_info>
  <brief_title>A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)</brief_title>
  <official_title>An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, With Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 1-17 years with&#xD;
      Systemic Juvenile Idiopathic Arthritis (sJIA) in order to identify the dose and regimen for&#xD;
      adequate treatment of this population.&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
      To describe the pharmacodynamics (PD) profile, the efficacy, and the long term safety of&#xD;
      sarilumab in patients with sJIA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The total study duration per patient will be 166 weeks that will consist of a 4- week&#xD;
      screening, a 12-week core treatment phase, a 144-week extension phase, and a 6-week&#xD;
      post-treatment follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 9, 2018</start_date>
  <completion_date type="Anticipated">April 2027</completion_date>
  <primary_completion_date type="Anticipated">November 29, 2024</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>Assessment of PK parameter: maximum serum concentration observed (Cmax)</measure>
    <time_frame>Up to Week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of PK parameter: Area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval (AUC0-t)</measure>
    <time_frame>Up to Week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough)</measure>
    <time_frame>Up to Week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Core treatment phase: Up to Week 12. Extension phase: Up to Week 162</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with local site reactions</measure>
    <time_frame>Core treatment phase: Up to Week 12. Extension phase: Up to Week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Juvenile Idiopathic Arthritis ACR30/50/70/90/100 (in the absence of fever) response rate</measure>
    <time_frame>Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in JIA ACR component: Physician's global assessment of disease activity</measure>
    <time_frame>Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in JIA ACR Component: Patient / parent assessment of overall well-being</measure>
    <time_frame>Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in JIA ACR Component: Childhood Health Assessment Questionnaire (CHAQ) - Disability Index</measure>
    <time_frame>Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in JIA ACR Component: Number of joints with active arthritis</measure>
    <time_frame>Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in JIA ACR Component: Number of joints with limitation of motion</measure>
    <time_frame>Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in JIA ACR Component: High sensitivity C-reactive protein (hs-CRP)</measure>
    <time_frame>Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in JIA ACR Component: fever</measure>
    <time_frame>Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS)</measure>
    <time_frame>Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in glucocorticoid use</measure>
    <time_frame>Core treatment phase: Up to Week 12. Extension phase: Up to Week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in IL-6 associated biomarkers: IL6</measure>
    <time_frame>Up to Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in IL-6 associated biomarkers: sIL-6R</measure>
    <time_frame>Up to Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients receiving glucocorticoids by dose category (glucocorticoid equivalent prednisone dose ≥0.5 mg/kg, ≥0.2 mg/kg and &lt;0.5 mg/kg, &lt;0.2 mg/kg)</measure>
    <time_frame>At weeks 24, 48, and every 24 weeks up to Week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients free of glucocorticoids and without JIA flare</measure>
    <time_frame>At weeks 24, 48, and every 24 weeks up to Week 156</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <arm_group>
    <arm_group_label>Sarilumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive one of two ascending doses (or an additional intermediate dose based on available data) of sarilumab by subcutaneous (SC) injection based on body weight. All the participants will receive the selected dose once the selected dose is identified. Sarilumab will be given during 12-week core treatment phase followed by a 144- week extension treatment phase.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sarilumab SAR153191 (REGN88)</intervention_name>
    <description>Pharmaceutical form: Solution&#xD;
Route of administration: Subcutaneous</description>
    <arm_group_label>Sarilumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Male and female patients aged ≥1 and ≤17 years (or country specified age requirement,&#xD;
             12-17 years for Russia) at the time of the screening visit.&#xD;
&#xD;
          -  Diagnosis of systemic JIA subtype according to the International Associations against&#xD;
             Rheumatism (ILAR) 2001 Juvenile Idiopathic Arthritis (JIA) Classification Criteria&#xD;
             with the following features:&#xD;
&#xD;
               -  5 active joints at screening or&#xD;
&#xD;
               -  2 active joints at screening with systemic JIA fever &gt;37.5 0C in the 3 days&#xD;
                  preceding baseline or for at least 3 out of any 7 consecutive days during&#xD;
                  screening despite glucocorticoids at a dose stable for at least 3 days.&#xD;
&#xD;
          -  Patient with an inadequate response to current treatment and considered as a candidate&#xD;
             for a biologic disease modifying anti rheumatic drug (DMARD) as per investigator's&#xD;
             judgment.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Body weight &lt;10 kg or &gt;60 kg for patients enrolled in the ascending dose cohorts, then&#xD;
             body weight &lt;10 kg for patients subsequently enrolled at the selected dose.&#xD;
&#xD;
          -  Uncontrolled severe systemic symptoms and/or Macrophage Activation Syndrome (MAS)&#xD;
             within 6 months prior to screening.&#xD;
&#xD;
          -  History of or ongoing interstitial lung disease, pulmonary hypertension, pulmonary&#xD;
             alveolar proteinosis.&#xD;
&#xD;
          -  If nonsteroidal anti-inflammatory drugs (NSAIDs) (including cyclo oxygenase-2&#xD;
             inhibitors [COX-2]) taken, dose stable for less than 2 weeks prior to the baseline&#xD;
             visit and/or dosing prescribed outside of approved label.&#xD;
&#xD;
          -  If non-biologic DMARD taken, dose stable for less than 6 weeks prior to the baseline&#xD;
             visit or at a dose exceeding the recommended dose as per local labeling.&#xD;
&#xD;
          -  If oral glucocorticoid taken, dose exceeding equivalent prednisone dose 1 mg/kg/day&#xD;
             (or 60 mg/day) within 3 days prior to baseline.&#xD;
&#xD;
          -  Use of parenteral or intra-articular glucocorticoid injection within 4 weeks prior to&#xD;
             baseline.&#xD;
&#xD;
          -  Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist&#xD;
             therapies, including but not limited to tocilizumab or sarilumab.&#xD;
&#xD;
          -  Treatment with any biologic treatment for sJIA within 5 half-lives prior to the first&#xD;
             dose of sarilumab (the required off treatment periods and procedures may vary&#xD;
             according to local requirements).&#xD;
&#xD;
          -  Treatment with a Janus kinase inhibitor within 4 weeks prior to the first dose of&#xD;
             sarilumab; and treatment with growth hormone within 4 weeks prior to the first dose of&#xD;
             sarilumab (the required off treatment periods and procedures may vary according to&#xD;
             local requirements).&#xD;
&#xD;
          -  Treatment with any investigational biologic or non-biologic product within 8 weeks or&#xD;
             5 half-lives prior to baseline, whichever is longer.&#xD;
&#xD;
          -  Exclusion related to tuberculosis.&#xD;
&#xD;
          -  Exclusion criteria related to past or current infection other than tuberculosis.&#xD;
&#xD;
          -  Any live, attenuated vaccine within 4 weeks prior to the baseline visit, such as&#xD;
             varicella-zoster, oral polio, rubella vaccines. Killed or inactive vaccine may be&#xD;
             permitted based on the Investigator's judgment.&#xD;
&#xD;
          -  Exclusion related to history of a systemic hypersensitivity reaction to any biologic&#xD;
             drug and known hypersensitivity to any constituent of the product.&#xD;
&#xD;
          -  Laboratory abnormalities at the screening visit (identified by the central&#xD;
             laboratory).&#xD;
&#xD;
          -  Severe cardiac disease due to sJIA.&#xD;
&#xD;
          -  Pregnant or breast-feeding female adolescent patients.&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>For site information, send an email with site number to</last_name>
    <email>Contact-Us@sanofi.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Investigational Site Number :0320004</name>
      <address>
        <city>San Miguel De Tucumán</city>
        <state>Tucumán</state>
        <zip>T4000AXL</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1000001</name>
      <address>
        <city>Plovdiv</city>
        <zip>4000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240110</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3B 6A8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240112</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2460040</name>
      <address>
        <city>Helsinki</city>
        <zip>00029 HUS</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500041</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500042</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500040</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760064</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760065</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760061</name>
      <address>
        <city>Bremen</city>
        <zip>28205</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760062</name>
      <address>
        <city>Hamburg</city>
        <zip>22081</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760060</name>
      <address>
        <city>Sankt Augustin</city>
        <zip>53757</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760063</name>
      <address>
        <city>Sendenhorst</city>
        <zip>48324</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3720001</name>
      <address>
        <city>Dublin</city>
        <zip>D12 N512</zip>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800051</name>
      <address>
        <city>Genova</city>
        <zip>16147</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800054</name>
      <address>
        <city>Milano</city>
        <zip>20121</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800052</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430001</name>
      <address>
        <city>Moscow</city>
        <zip>115522</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430062</name>
      <address>
        <city>Moscow</city>
        <zip>117198</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430063</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430065</name>
      <address>
        <city>Ufa</city>
        <zip>450083</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240050</name>
      <address>
        <city>Esplugues de Llobregat</city>
        <state>Catalunya [Cataluña]</state>
        <zip>08950</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240052</name>
      <address>
        <city>Madrid</city>
        <state>Madrid, Comunidad De</state>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240053</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240051</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8260031</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8260034</name>
      <address>
        <city>Leeds</city>
        <zip>LS1 3EX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8260033</name>
      <address>
        <city>Liverpool</city>
        <zip>L12 2AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Chile</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>United States</country>
  </removed_countries>
  <verification_date>July 7, 2023</verification_date>
  <study_first_submitted>October 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Juvenile</mesh_term>
  </condition_browse>
  <!-- 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/NCT02991469
org study id: DRI13926
secondary id: 2015-004000-35
secondary id: U1111-1177-3584
nct id: NCT02991469
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Primary Objective:

      To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 1-17 years with
      Systemic Juvenile Idiopathic Arthritis (sJIA) in order to identify the dose and regimen for
      adequate treatment of this population.

      Secondary Objective:

      To describe the pharmacodynamics (PD) profile, the efficacy, and the long term safety of
      sarilumab in patients with sJIA.
The total study duration per patient will be 166 weeks that will consist of a 4- week
      screening, a 12-week core treatment phase, a 144-week extension phase, and a 6-week
      post-treatment follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of PK parameter: maximum serum concentration observed (Cmax)
time frame: Up to Week 12
measure: Assessment of PK parameter: Area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval (AUC0-t)
time frame: Up to Week 12
measure: Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough)
time frame: Up to Week 12
measure: Number of patients with adverse events
time frame: Core treatment phase: Up to Week 12. Extension phase: Up to Week 162
measure: Number of patients with local site reactions
time frame: Core treatment phase: Up to Week 12. Extension phase: Up to Week 156
measure: Juvenile Idiopathic Arthritis ACR30/50/70/90/100 (in the absence of fever) response rate
time frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
measure: Change from baseline in JIA ACR component: Physician's global assessment of disease activity
time frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
measure: Change from baseline in JIA ACR Component: Patient / parent assessment of overall well-being
time frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
measure: Change from baseline in JIA ACR Component: Childhood Health Assessment Questionnaire (CHAQ) - Disability Index
time frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
measure: Change from baseline in JIA ACR Component: Number of joints with active arthritis
time frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
measure: Change from baseline in JIA ACR Component: Number of joints with limitation of motion
time frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
measure: Change from baseline in JIA ACR Component: High sensitivity C-reactive protein (hs-CRP)
time frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
measure: Change from baseline in JIA ACR Component: fever
time frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
measure: Change from baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS)
time frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
measure: Changes in glucocorticoid use
time frame: Core treatment phase: Up to Week 12. Extension phase: Up to Week 156
measure: Changes in IL-6 associated biomarkers: IL6
time frame: Up to Week 12
measure: Changes in IL-6 associated biomarkers: sIL-6R
time frame: Up to Week 12
measure: Proportion of patients receiving glucocorticoids by dose category (glucocorticoid equivalent prednisone dose ≥0.5 mg/kg, ≥0.2 mg/kg and <0.5 mg/kg, <0.2 mg/kg)
time frame: At weeks 24, 48, and every 24 weeks up to Week 156
measure: Proportion of patients free of glucocorticoids and without JIA flare
time frame: At weeks 24, 48, and every 24 weeks up to Week 156
arm group label: Sarilumab
arm group type: Experimental
description: Participants will receive one of two ascending doses (or an additional intermediate dose based on available data) of sarilumab by subcutaneous (SC) injection based on body weight. All the participants will receive the selected dose once the selected dose is identified. Sarilumab will be given during 12-week core treatment phase followed by a 144- week extension treatment phase.
intervention type: Drug
intervention name: Sarilumab SAR153191 (REGN88)
description: Pharmaceutical form: Solution
Route of administration: Subcutaneous
arm group label: Sarilumab
criteria: 
gender: All
minimum age: 1 Year
maximum age: 17 Years
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
last name: For site information, send an email with site number to
email: Contact-Us@sanofi.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
country: Argentina
country: Bulgaria
country: Canada
country: Finland
country: France
country: Germany
country: Ireland
country: Italy
country: Russian Federation
country: Spain
country: United Kingdom
country: Chile
country: Czechia
country: Estonia
country: Netherlands
country: Poland
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Juvenile