<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/NCT03782532</url>
  </required_header>
  <id_info>
    <org_study_id>EFC13995</org_study_id>
    <secondary_id>U1111-1175-0772</secondary_id>
    <secondary_id>2022-002375-11</secondary_id>
    <nct_id>NCT03782532</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma</brief_title>
  <official_title>A Randomized, Double Blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma</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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To evaluate the efficacy of dupilumab in patients with persistent asthma&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To evaluate the safety and tolerability of dupilumab&#xD;
&#xD;
        -  To evaluate the effect of dupilumab on improving patient reported outcomes including&#xD;
           health related quality of life&#xD;
&#xD;
        -  To evaluate dupilumab systemic exposure and immunogenicity&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The total duration of study per patient is approximately 40 weeks, including 3 to 5 weeks of&#xD;
      screening period, 24 weeks of treatment period and 12 weeks of post-treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Actual">May 21, 2022</completion_date>
  <primary_completion_date type="Actual">May 21, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pre-bronchodilator forced expiratory volume (FEV1)</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Absolute change from baseline in pre-bronchodilator FEV1 at Week 12</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Annualized rate of severe exacerbation events</measure>
    <time_frame>During the 24-week placebo-controlled treatment period</time_frame>
    <description>Annualized rate of severe exacerbation events during the 24-week placebo-controlled treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline in pre-bronchodilator FEV1</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Percent change from baseline in pre-bronchodilator FEV1 at Week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized rate of loss of asthma control (LOAC) event</measure>
    <time_frame>During the 24-week placebo-controlled treatment period</time_frame>
    <description>Annualized rate of LOAC event during the 24-week placebo-controlled treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit</measure>
    <time_frame>During the 24-week placebo-controlled treatment period</time_frame>
    <description>Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 24-week placebo-controlled treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first severe exacerbation event</measure>
    <time_frame>During the 24-week placebo-controlled treatment period</time_frame>
    <description>Time to first severe exacerbation event during the 24-week placebo-controlled treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first LOAC</measure>
    <time_frame>During the 24-week placebo-controlled treatment period</time_frame>
    <description>Time to first LOAC during the 24-week placebo-controlled treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Asthma Control Questionnaire (ACQ)-5 score</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Change from baseline in ACQ-5 score at Week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in ACQ-7 score</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Change from baseline in ACQ-7 score at Week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morning/evening asthma symptom score (e-diary)</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Change from baseline at Week 24 in morning/evening asthma symptom score (e-diary)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nocturnal awakenings (e-diary)</measure>
    <time_frame>Baseline to week 24</time_frame>
    <description>Change from baseline at Week 24 in nocturnal awakenings (e-diary)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of daily puffs of rescue medication</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Change from baseline at Week 24 in use of daily puffs of rescue medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) with Standardized Activities (≥12 years) (AQLQ+12)</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Change from baseline in AQLQ with Standardized Activities (≥12 years) (AQLQ+12) at Week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L)</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Change from baseline in EQ-5D-5L at Week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of adverse events (AEs)</measure>
    <time_frame>Baseline to week 36</time_frame>
    <description>Number of participants with adverse events (AEs)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">486</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Dupilumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For patients without oral corticosteroids (OCS) maintenance therapy, dose 1 of dupilumab administered once in 2 weeks (q2w) with loading dose of dupilumab, two times dose 1; for patients on OCS maintenance therapy, the dose will be dupilumab dose 2 q2w with loading dose 2 times dose 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo for dupilumab</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>For patients without OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 1 q2w with loading dose; for patients on OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 2 q2w with loading dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dupilumab SAR231893</intervention_name>
    <description>Pharmaceutical form: Solution&#xD;
Route of administration: Subcutaneous</description>
    <arm_group_label>Dupilumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Pharmaceutical form: Solution&#xD;
Route of administration: Subcutaneous</description>
    <arm_group_label>Placebo for dupilumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Asthma Controller Therapies (include prednisone/prednisolone)</intervention_name>
    <description>Pharmaceutical form: Aerosol, capsules, tablets, oral solution&#xD;
Route of administration: Inhalation, oral</description>
    <arm_group_label>Dupilumab</arm_group_label>
    <arm_group_label>Placebo for dupilumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Asthma Reliever Therapies</intervention_name>
    <description>Pharmaceutical form: Nebulized, aerosol&#xD;
Route of administration: Inhaled</description>
    <arm_group_label>Dupilumab</arm_group_label>
    <arm_group_label>Placebo for dupilumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Adults and adolescent patients (≥12 years of age) with a physician diagnosis of asthma&#xD;
             for ≥12 months, based on the Global Initiative for Asthma 2017 Guidelines and the&#xD;
             following criteria:&#xD;
&#xD;
          -  Patients requiring a third controller for their asthma will be considered eligible for&#xD;
             this study, and it should also be used for at least 3 months with a stable dose ≥1&#xD;
             month prior to the screening visit (Visit 1).&#xD;
&#xD;
          -  Patients requiring maintenance oral corticosteroids (OCS) with a stable dose ≤10&#xD;
             mg/day prednisone or equivalent will be allowed; OCS should be used for at least 3&#xD;
             months with a stable dose ≥1 month prior to the screening visit (Visit 1).&#xD;
&#xD;
          -  Pre-bronchodilator FEV1 ≤ 80% of predicted normal for adults and ≤90% of predicted&#xD;
             normal for adolescents at the screening visit and the randomization visit (Visits 1&#xD;
             and 2), prior to randomization.&#xD;
&#xD;
          -  Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at the screening&#xD;
             visit and the randomization visit (Visits 1 and 2), prior to randomization.&#xD;
&#xD;
          -  For patients not requiring maintenance OCS, screening blood eosinophil count ≥150&#xD;
             cells/μL or Fractional Exhaled Nitric Oxide (FENO) ≥25 parts per billion (ppb); for&#xD;
             patients requiring maintenance OCS, there is no minimum requirement for blood&#xD;
             eosinophil count and FENO level.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients &lt;12 years of age or the minimum legal age for adolescents in the country of&#xD;
             the investigative site, whichever is higher (for those countries where local&#xD;
             regulations permit enrollment of adults only, patient recruitment will be restricted&#xD;
             to those who are ≥18 years of age).&#xD;
&#xD;
          -  Weight is less than 30 kg at the screening visit (Visit 1) or the randomization visit&#xD;
             (Visit 2).&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary&#xD;
             fibrosis) which may impair lung function.&#xD;
&#xD;
          -  A patient who experiences a severe asthma exacerbation (defined as deterioration of&#xD;
             asthma that results in emergency treatment, hospitalization due to asthma, treatment&#xD;
             with systemic steroids, or treatment with systemic steroid at least twice the previous&#xD;
             dose for patients on OCS maintenance) at any time from 1 month prior to the screening&#xD;
             visit (Visit 1) up to and including the randomization visit (Visit 2).&#xD;
&#xD;
          -  Evidence of lung disease(s) other than asthma, either clinical or imaging evidence&#xD;
             (eg, chest X-ray, computed tomography, and magnetic resonance imaging) within 3 months&#xD;
             prior to the screening visit (Visit 1) as per local standard of care.&#xD;
&#xD;
          -  Current smoker or cessation of smoking within 6 months prior to the screening visit&#xD;
             (Visit 1).&#xD;
&#xD;
          -  Previous smoker with a smoking history &gt;10 pack-years.&#xD;
&#xD;
          -  Comorbid disease that might interfere with the evaluation of investigational medicinal&#xD;
             product (IMP).&#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>12 Years</minimum_age>
    <maximum_age>N/A</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>
  <location>
    <facility>
      <name>Investigational Site Number :1560013</name>
      <address>
        <city>Baotou</city>
        <zip>014010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560016</name>
      <address>
        <city>Beijing</city>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560029</name>
      <address>
        <city>Beijing</city>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560015</name>
      <address>
        <city>Beijing</city>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560056</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560057</name>
      <address>
        <city>Changchun</city>
        <zip>130041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560010</name>
      <address>
        <city>Changsha</city>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560030</name>
      <address>
        <city>Chengdu</city>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560053</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560025</name>
      <address>
        <city>Chongqing</city>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560004</name>
      <address>
        <city>Guangzhou</city>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560001</name>
      <address>
        <city>Guangzhou</city>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560045</name>
      <address>
        <city>Guangzhou</city>
        <zip>510150</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560032</name>
      <address>
        <city>Guiyang</city>
        <zip>550002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560019</name>
      <address>
        <city>Hangzhou</city>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560007</name>
      <address>
        <city>Hangzhou</city>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560014</name>
      <address>
        <city>Hangzhou</city>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560026</name>
      <address>
        <city>Hangzhou</city>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560043</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560038</name>
      <address>
        <city>Hefei</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560044</name>
      <address>
        <city>Hohhot</city>
        <zip>010017</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560008</name>
      <address>
        <city>Hohhot</city>
        <zip>010050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560022</name>
      <address>
        <city>Lanzhou</city>
        <zip>730000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560024</name>
      <address>
        <city>Nanchang</city>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560051</name>
      <address>
        <city>Nanjing</city>
        <zip>210005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560054</name>
      <address>
        <city>Nanjing</city>
        <zip>210006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560037</name>
      <address>
        <city>Nanjing</city>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560035</name>
      <address>
        <city>Pingxiang</city>
        <zip>337055</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560050</name>
      <address>
        <city>Shanghai</city>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560049</name>
      <address>
        <city>Shanghai</city>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560005</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560011</name>
      <address>
        <city>Shanghai</city>
        <zip>200080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560017</name>
      <address>
        <city>Shanghai</city>
        <zip>200120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560006</name>
      <address>
        <city>Shanghai</city>
        <zip>200233</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560002</name>
      <address>
        <city>Shanghai</city>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560018</name>
      <address>
        <city>Shenyang</city>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560036</name>
      <address>
        <city>Shenyang</city>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560012</name>
      <address>
        <city>Shenzhen</city>
        <zip>518020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560042</name>
      <address>
        <city>Shenzhen</city>
        <zip>518102</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560003</name>
      <address>
        <city>Shijiazhuang</city>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560041</name>
      <address>
        <city>Shijiazhuang</city>
        <zip>050041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560031</name>
      <address>
        <city>Suzhou</city>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560048</name>
      <address>
        <city>Taiyuan</city>
        <zip>030001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560020</name>
      <address>
        <city>Tianjin</city>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560033</name>
      <address>
        <city>Urumchi</city>
        <zip>830054</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560021</name>
      <address>
        <city>Wenzhou</city>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560052</name>
      <address>
        <city>Wuhan</city>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560028</name>
      <address>
        <city>Wuhan</city>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560040</name>
      <address>
        <city>Xi'an</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560046</name>
      <address>
        <city>Xiamen</city>
        <zip>361004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560027</name>
      <address>
        <city>Xiangtan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560023</name>
      <address>
        <city>Xuzhou</city>
        <zip>221002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560055</name>
      <address>
        <city>Yangzhou</city>
        <zip>225001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1560047</name>
      <address>
        <city>Zhanjiang</city>
        <zip>524001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560006</name>
      <address>
        <city>Chandigarh</city>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560002</name>
      <address>
        <city>Coimbatore</city>
        <zip>641028</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560013</name>
      <address>
        <city>Hyderabad</city>
        <zip>500082</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560005</name>
      <address>
        <city>Jaipur</city>
        <zip>302023</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560015</name>
      <address>
        <city>Jaipur</city>
        <zip>302039</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560010</name>
      <address>
        <city>Kolkata</city>
        <zip>700107</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560011</name>
      <address>
        <city>Kozhikode</city>
        <zip>673008</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560012</name>
      <address>
        <city>Mohali</city>
        <zip>160062</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560003</name>
      <address>
        <city>Nagpur</city>
        <zip>440012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560016</name>
      <address>
        <city>Nagpur</city>
        <zip>440012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560001</name>
      <address>
        <city>New Delhi</city>
        <zip>110060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560009</name>
      <address>
        <city>Pune</city>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3560007</name>
      <address>
        <city>Vellore</city>
        <zip>632004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>India</country>
  </location_countries>
  <link>
    <url>https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002375-11/results</url>
    <description>2022-002375-11 EudraCT results</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 23, 2022</last_update_submitted>
  <last_update_submitted_qc>December 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2022</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>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </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/NCT03782532
org study id: EFC13995
secondary id: U1111-1175-0772
secondary id: 2022-002375-11
nct id: NCT03782532
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Primary Objective:

      To evaluate the efficacy of dupilumab in patients with persistent asthma

      Secondary Objectives:

        -  To evaluate the safety and tolerability of dupilumab

        -  To evaluate the effect of dupilumab on improving patient reported outcomes including
           health related quality of life

        -  To evaluate dupilumab systemic exposure and immunogenicity
The total duration of study per patient is approximately 40 weeks, including 3 to 5 weeks of
      screening period, 24 weeks of treatment period and 12 weeks of post-treatment period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in pre-bronchodilator forced expiratory volume (FEV1)
time frame: Baseline to Week 12
description: Absolute change from baseline in pre-bronchodilator FEV1 at Week 12
measure: Annualized rate of severe exacerbation events
time frame: During the 24-week placebo-controlled treatment period
description: Annualized rate of severe exacerbation events during the 24-week placebo-controlled treatment period
measure: Percent change from baseline in pre-bronchodilator FEV1
time frame: Baseline to Week 12
description: Percent change from baseline in pre-bronchodilator FEV1 at Week 12
measure: Annualized rate of loss of asthma control (LOAC) event
time frame: During the 24-week placebo-controlled treatment period
description: Annualized rate of LOAC event during the 24-week placebo-controlled treatment period
measure: Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit
time frame: During the 24-week placebo-controlled treatment period
description: Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 24-week placebo-controlled treatment period
measure: Time to first severe exacerbation event
time frame: During the 24-week placebo-controlled treatment period
description: Time to first severe exacerbation event during the 24-week placebo-controlled treatment period
measure: Time to first LOAC
time frame: During the 24-week placebo-controlled treatment period
description: Time to first LOAC during the 24-week placebo-controlled treatment period
measure: Change from baseline in Asthma Control Questionnaire (ACQ)-5 score
time frame: Baseline to Week 24
description: Change from baseline in ACQ-5 score at Week 24
measure: Change from baseline in ACQ-7 score
time frame: Baseline to Week 24
description: Change from baseline in ACQ-7 score at Week 24
measure: Morning/evening asthma symptom score (e-diary)
time frame: Baseline to Week 24
description: Change from baseline at Week 24 in morning/evening asthma symptom score (e-diary)
measure: Nocturnal awakenings (e-diary)
time frame: Baseline to week 24
description: Change from baseline at Week 24 in nocturnal awakenings (e-diary)
measure: Use of daily puffs of rescue medication
time frame: Baseline to Week 24
description: Change from baseline at Week 24 in use of daily puffs of rescue medication
measure: Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) with Standardized Activities (≥12 years) (AQLQ+12)
time frame: Baseline to Week 24
description: Change from baseline in AQLQ with Standardized Activities (≥12 years) (AQLQ+12) at Week 24
measure: Change from baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L)
time frame: Baseline to Week 24
description: Change from baseline in EQ-5D-5L at Week 24
measure: Assessment of adverse events (AEs)
time frame: Baseline to week 36
description: Number of participants with adverse events (AEs)
arm group label: Dupilumab
arm group type: Experimental
description: For patients without oral corticosteroids (OCS) maintenance therapy, dose 1 of dupilumab administered once in 2 weeks (q2w) with loading dose of dupilumab, two times dose 1; for patients on OCS maintenance therapy, the dose will be dupilumab dose 2 q2w with loading dose 2 times dose 2
arm group label: Placebo for dupilumab
arm group type: Placebo Comparator
description: For patients without OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 1 q2w with loading dose; for patients on OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 2 q2w with loading dose
intervention type: Drug
intervention name: Dupilumab SAR231893
description: Pharmaceutical form: Solution
Route of administration: Subcutaneous
arm group label: Dupilumab
intervention type: Drug
intervention name: Placebo
description: Pharmaceutical form: Solution
Route of administration: Subcutaneous
arm group label: Placebo for dupilumab
intervention type: Drug
intervention name: Asthma Controller Therapies (include prednisone/prednisolone)
description: Pharmaceutical form: Aerosol, capsules, tablets, oral solution
Route of administration: Inhalation, oral
arm group label: Dupilumab
arm group label: Placebo for dupilumab
intervention type: Drug
intervention name: Asthma Reliever Therapies
description: Pharmaceutical form: Nebulized, aerosol
Route of administration: Inhaled
arm group label: Dupilumab
arm group label: Placebo for dupilumab
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
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country: China
country: India
url: https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002375-11/results
description: 2022-002375-11 EudraCT results
responsible party type: Sponsor
mesh term: Asthma
mesh term: Prednisone
mesh term: Prednisolone
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org