<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/NCT04502862</url>
  </required_header>
  <id_info>
    <org_study_id>LPS16677</org_study_id>
    <secondary_id>2020-001217-20</secondary_id>
    <secondary_id>U1111-1249-6054</secondary_id>
    <nct_id>NCT04502862</nct_id>
  </id_info>
  <brief_title>A Phase 4, Randomized, Double-blind, Placebo-controlled,Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma</brief_title>
  <acronym>MORPHEO</acronym>
  <official_title>A Phase 4, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled 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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To assess the effect of dupilumab on sleep&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To evaluate the effect of dupilumab on additional patient reported sleep outcomes&#xD;
&#xD;
        -  To evaluate the effect of dupilumab on objective sleep assessment&#xD;
&#xD;
        -  To evaluate the effect of dupilumab on asthma symptoms&#xD;
&#xD;
        -  To evaluate the effect of dupilumab on lung function&#xD;
&#xD;
        -  To evaluate the safety of dupilumab&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study duration per participant will be approximately 16 weeks and up to 29 weeks including up&#xD;
      to 5 weeks screening period, a 12-week treatment period and up to 12 weeks post-treatment&#xD;
      follow-up period or until the participant switches to commercialized dupilumab (or other&#xD;
      biologic product), whichever comes first.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Anticipated">December 26, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 3, 2023</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Interim analysis for sample size re-estimation</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in sleep disturbance score in Asthma Sleep Disturbance Questionnaire</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Change from baseline to Week 12 in sleep disturbance score using the Asthma Sleep Disturbance Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the number of nocturnal awakenings in Sleep Diary</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Change from baseline to Week 12 in the number of nocturnal awakenings as recorded in Sleep Diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS sleep-related impairment assessment</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Change from baseline to Week 12 in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep-related impairment 8a scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep quality in Sleep Diary</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Change from baseline to Week 12 in sleep quality (Sleep Diary)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in restorative sleep in Sleep Diary</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Change from baseline to Week 12 in restorative sleep (Sleep Diary)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in WASO in Sleep Diary</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Change from baseline to Week 12 in wake after sleep onset (WASO) (Sleep Diary)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in WASO (actigraphy data)</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Change from baseline to Week 12 in WASO based on actigraphy data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in daytime and nighttime asthma symptoms in Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD)</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Change from baseline to Week 12 in Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pre-bronchodilator (BD) FEV1</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Change from baseline to Week 12 in prebronchodilator forced expiratory volume in 1 second (pre-BD FEV1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESI), including clinically significant changes in vital signs considered to be adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">202</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Dupilumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 x dupilumab injections as loading dose on Day 1, followed by 1 dupilumab maintenance dose injection every 2 weeks (Q2W) during 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 x placebo injections on Day 1, then 1 placebo injection Q2W during 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SAR231893</intervention_name>
    <description>Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous</description>
    <arm_group_label>Dupilumab</arm_group_label>
    <other_name>Dupixent</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physician diagnosis of asthma based on the Global Initiative for Asthma (GINA) 2020&#xD;
             Guidelines for ≥12 months treated with medium to high dose inhaled corticosteroid&#xD;
             (ICS) and a second controller (ie, long-acting beta agonist, leukotriene receptor&#xD;
             antagonist). A third controller is allowed but not mandatory. The dose regimen should&#xD;
             be stable for at least 1 month before the study and during the screening period&#xD;
&#xD;
          -  History of at least one severe asthma exacerbation within 1 year prior to screening.&#xD;
             Severe exacerbation is defined as deterioration of asthma that results in emergency&#xD;
             treatment, hospitalization due to asthma, or treatment with systemic steroids (oral or&#xD;
             injectable)&#xD;
&#xD;
          -  Eosinophils ≥150 cells/μL and fractional exhaled nitric oxide (FeNO) ≥25 ppb during&#xD;
             screening, prior to randomization&#xD;
&#xD;
               -  NOTES:&#xD;
&#xD;
               -  Historical values of blood eosinophil count meeting the eligibility criterion&#xD;
                  measured within 6 months prior to screening Visit 1 in the absence of oral&#xD;
                  corticosteroid (OCS) treatment are allowed&#xD;
&#xD;
               -  FeNO value to be checked for eligibility at Visit 2 as well&#xD;
&#xD;
          -  Asthma control questionnaire (ACQ)-5 ≥2.5 at screening Visit 1 and Visit 2, prior to&#xD;
             randomization&#xD;
&#xD;
          -  Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) ≤ 80% of predicted&#xD;
             normal during screening, prior to randomization&#xD;
&#xD;
          -  Exhibit bronchodilator reversibility (≥12% and 200 mL improvement in FEV1 post&#xD;
             short-acting beta agonist administration) during screening period, prior to&#xD;
             randomization, unless reversibility test meeting the inclusion criteria was done&#xD;
             within 6 months prior to screening Visit 1&#xD;
&#xD;
          -  Weekly average nocturnal awakenings due to asthma symptoms in the week prior to&#xD;
             screening Visit 1 is ≥1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current smoker&#xD;
&#xD;
          -  Former smoker for 10 years with a smoking history of &gt;10 pack-years&#xD;
&#xD;
          -  Severe asthma exacerbation during screening, prior to randomization&#xD;
&#xD;
          -  History or clinical evidence of chronic obstructive pulmonary disease (COPD) including&#xD;
             Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, lung&#xD;
             fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension,&#xD;
             bronchiectasis, Churg-Strauss Syndrome)&#xD;
&#xD;
          -  History of or current evidence of clinically significant non-respiratory diseases that&#xD;
             in the opinion of the investigator may interfere with the aims of the study or put the&#xD;
             participant at undue risk&#xD;
&#xD;
          -  Active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of&#xD;
             incompletely treated TB will be excluded unless it is well documented by a specialist&#xD;
             that the participant has been adequately treated and can now start treatment with a&#xD;
             biologic agent, in the medical judgment of the Investigator and/or infectious disease&#xD;
             specialist. Tuberculosis testing would be performed on a country by country basis,&#xD;
             according to local guidelines if required by Regulatory Authorities or ethics boards&#xD;
&#xD;
          -  Diagnosed active endoparasitic infection; suspected or high risk of endoparasitic&#xD;
             infection, unless clinical and (if necessary) laboratory assessment have ruled out&#xD;
             active infection before randomization&#xD;
&#xD;
          -  History of human immunodeficiency (HIV) infection or positive HIV test at screening&#xD;
             Visit 1&#xD;
&#xD;
          -  Active chronic or acute infection requiring treatment with systemic antibiotics,&#xD;
             antivirals, antiprotozoals, or antifungals within 2 weeks before screening&#xD;
&#xD;
          -  Known or suspected immunodeficiency including history of invasive opportunistic&#xD;
             infections, despite infection resolution&#xD;
&#xD;
          -  Current evidence of clinically significant oncological disease&#xD;
&#xD;
          -  History of systemic hypersensitivity or anaphylaxis to any biologic therapy&#xD;
&#xD;
          -  Severe uncontrolled depression&#xD;
&#xD;
          -  Sleep disturbances not related to asthma, including sleep apnea, hypersomnia, or&#xD;
             insomnia secondary to chronic pain, atopic dermatitis (AD), COPD or other conditions&#xD;
&#xD;
          -  Participant who works night shift (ie, any work between 8 pm and 6 am)&#xD;
&#xD;
          -  Erratic sleep habits, as determined by the Investigator&#xD;
&#xD;
          -  Restless leg syndrome or periodic limb movement disorder&#xD;
&#xD;
          -  Chronic treatment with oral corticosteroid (OCS) for more than 2 weeks before&#xD;
             screening Visit 1&#xD;
&#xD;
          -  Participant taking sedative, anxiolytic, or hypnotic treatments, including melatonin,&#xD;
             within 3 months before randomization&#xD;
&#xD;
          -  Participant taking systemic sedative antihistamines (excluding newer generations of&#xD;
             antihistamines) or theophylline&#xD;
&#xD;
          -  Current treatment with antidepressants, lipophilic beta blockers, clonidine, opioids,&#xD;
             or other medications known to interfere with sleep and may confound the study&#xD;
             assessments, as determined by the Investigator&#xD;
&#xD;
          -  Participant who has taken biologic therapy (including dupilumab)/systemic&#xD;
             immunosuppressant to treat inflammatory disease or autoimmune disease (eg, rheumatoid&#xD;
             arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus&#xD;
             erythematosus, multiple sclerosis, etc) within 2 months or 5 half-lives before&#xD;
             screening Visit 1, whichever is longer&#xD;
&#xD;
          -  Treatment with live (attenuated) vaccine within 4 weeks before screening Visit 1&#xD;
&#xD;
               -  NOTE: For participants who have vaccination with live, attenuated vaccines&#xD;
                  planned during the course of the study (based on national vaccination&#xD;
                  schedule/local guidelines), it will be determined, after consultation with a&#xD;
                  physician, whether the administration of vaccine can be postponed until after the&#xD;
                  end of the study, (i.e. after the 12 week follow-up period off-treatment or until&#xD;
                  the participant switches to commercialized dupilumab or other biologic product,&#xD;
                  whichever comes first), or preponed to before the start of the study without&#xD;
                  compromising the health of the participant:&#xD;
&#xD;
               -  Participant for whom administration of live (attenuated) vaccine can be safely&#xD;
                  postponed would be eligible to enroll into the study&#xD;
&#xD;
               -  Participant who have their vaccination preponed can enroll in the study only&#xD;
                  after a gap of 4 weeks following administration of the vaccine&#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>18 Years</minimum_age>
    <maximum_age>65 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>
  <location>
    <facility>
      <name>Kern Allergy and Medical Research. Inc.-Site Number:8400003</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Todd Astor MD-Site Number:8400016</name>
      <address>
        <city>Culver City</city>
        <state>California</state>
        <zip>90230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Institute for Respiratory Diseases-Site Number:8400009</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy &amp; Asthma Associates of Santa Clara Valley-Site Number:8400001</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asthma and Allergy Associates, PC-Site Number:8400011</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Clinical Research-Site Number:8400012</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy &amp; Asthma Specialists, PSC-Site Number:8400004</name>
      <address>
        <city>Owensboro</city>
        <state>Kentucky</state>
        <zip>42301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Asthma and Allergy Center-Site Number:8400010</name>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <zip>68123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OK Clinical Research LLC-Site Number:8400005</name>
      <address>
        <city>Edmond</city>
        <state>Oklahoma</state>
        <zip>73034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velocity Clinical Research, Medford-Site Number:8400007</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Allergy and Asthma Research, LLC-Site Number:8400008</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TTS Research-Site Number:8400006</name>
      <address>
        <city>Boerne</city>
        <state>Texas</state>
        <zip>78006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0320003</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1414AIF</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0320001</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1425FVH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0320004</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000DEJ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0320005</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2002OJP</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0320002</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1121ABE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240012</name>
      <address>
        <city>Ajax</city>
        <state>Ontario</state>
        <zip>L1S 2J5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240005</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M9V 4B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240009</name>
      <address>
        <city>Quebec</city>
        <zip>G1G 3Y8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240008</name>
      <address>
        <city>Windsor</city>
        <zip>N8X 5A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760002</name>
      <address>
        <city>Berlin</city>
        <zip>10787</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760005</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760003</name>
      <address>
        <city>Hannover</city>
        <zip>30173</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760001</name>
      <address>
        <city>Koblenz</city>
        <zip>56068</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760004</name>
      <address>
        <city>Leipzig</city>
        <zip>04347</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760006</name>
      <address>
        <city>Lübeck</city>
        <zip>23552</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800006</name>
      <address>
        <city>Monserrato</city>
        <state>Cagliari</state>
        <zip>09042</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800001</name>
      <address>
        <city>Orbassano</city>
        <state>Torino</state>
        <zip>10043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800004</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800005</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :5280005</name>
      <address>
        <city>Arnhem</city>
        <zip>6815 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :5280001</name>
      <address>
        <city>Breda</city>
        <zip>4818 CK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :5280002</name>
      <address>
        <city>Leeuwarden</city>
        <zip>8934 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200001</name>
      <address>
        <city>Aveiro</city>
        <zip>3810-501</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200008</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200007</name>
      <address>
        <city>Guimarães</city>
        <zip>4810-061</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200006</name>
      <address>
        <city>Lisboa</city>
        <zip>1769</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200003</name>
      <address>
        <city>Matosinhos</city>
        <zip>4464-513</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200004</name>
      <address>
        <city>Porto</city>
        <zip>4202-451</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430001</name>
      <address>
        <city>Moscow</city>
        <zip>115093</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430002</name>
      <address>
        <city>Moscow</city>
        <zip>115280</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430006</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430005</name>
      <address>
        <city>Moscow</city>
        <zip>117546</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430007</name>
      <address>
        <city>St-Petersburg</city>
        <zip>193231</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430004</name>
      <address>
        <city>St-Petersburg</city>
        <zip>194354</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240003</name>
      <address>
        <city>Barcelona</city>
        <state>Barcelona [Barcelona]</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240001</name>
      <address>
        <city>Lugo / Lugo</city>
        <state>Galicia [Galicia]</state>
        <zip>27003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240006</name>
      <address>
        <city>Pozuelo De Alarcón</city>
        <state>Madrid</state>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240002</name>
      <address>
        <city>Valencia</city>
        <state>Valenciana, Comunidad</state>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240005</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040002</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040006</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040003</name>
      <address>
        <city>Kharkiv</city>
        <zip>61166</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040008</name>
      <address>
        <city>Kyiv</city>
        <zip>01023</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040007</name>
      <address>
        <city>Kyiv</city>
        <zip>01033</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8040005</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8260001</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 2QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8260002</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>EC1M 6BQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 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>Asthma</mesh_term>
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
  </condition_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/NCT04502862
org study id: LPS16677
secondary id: 2020-001217-20
secondary id: U1111-1249-6054
nct id: NCT04502862
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Primary Objective:

      To assess the effect of dupilumab on sleep

      Secondary Objectives:

        -  To evaluate the effect of dupilumab on additional patient reported sleep outcomes

        -  To evaluate the effect of dupilumab on objective sleep assessment

        -  To evaluate the effect of dupilumab on asthma symptoms

        -  To evaluate the effect of dupilumab on lung function

        -  To evaluate the safety of dupilumab
Study duration per participant will be approximately 16 weeks and up to 29 weeks including up
      to 5 weeks screening period, a 12-week treatment period and up to 12 weeks post-treatment
      follow-up period or until the participant switches to commercialized dupilumab (or other
      biologic product), whichever comes first.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Interim analysis for sample size re-estimation
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in sleep disturbance score in Asthma Sleep Disturbance Questionnaire
time frame: Baseline to Week 12
description: Change from baseline to Week 12 in sleep disturbance score using the Asthma Sleep Disturbance Questionnaire
measure: Change in the number of nocturnal awakenings in Sleep Diary
time frame: Baseline to Week 12
description: Change from baseline to Week 12 in the number of nocturnal awakenings as recorded in Sleep Diary
measure: Change in PROMIS sleep-related impairment assessment
time frame: Baseline to Week 12
description: Change from baseline to Week 12 in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep-related impairment 8a scale
measure: Change in sleep quality in Sleep Diary
time frame: Baseline to Week 12
description: Change from baseline to Week 12 in sleep quality (Sleep Diary)
measure: Change in restorative sleep in Sleep Diary
time frame: Baseline to Week 12
description: Change from baseline to Week 12 in restorative sleep (Sleep Diary)
measure: Change in WASO in Sleep Diary
time frame: Baseline to Week 12
description: Change from baseline to Week 12 in wake after sleep onset (WASO) (Sleep Diary)
measure: Change in WASO (actigraphy data)
time frame: Baseline to Week 12
description: Change from baseline to Week 12 in WASO based on actigraphy data
measure: Change in daytime and nighttime asthma symptoms in Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD)
time frame: Baseline to Week 12
description: Change from baseline to Week 12 in Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD)
measure: Change in pre-bronchodilator (BD) FEV1
time frame: Baseline to Week 12
description: Change from baseline to Week 12 in prebronchodilator forced expiratory volume in 1 second (pre-BD FEV1)
measure: Incidence of adverse events
time frame: Baseline up to Week 24
description: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESI), including clinically significant changes in vital signs considered to be adverse events
arm group label: Dupilumab
arm group type: Experimental
description: 2 x dupilumab injections as loading dose on Day 1, followed by 1 dupilumab maintenance dose injection every 2 weeks (Q2W) during 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: 2 x placebo injections on Day 1, then 1 placebo injection Q2W during 12 weeks
intervention type: Drug
intervention name: SAR231893
description: Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
arm group label: Dupilumab
other name: Dupixent
intervention type: Drug
intervention name: Placebo
description: Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
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country: Argentina
country: Canada
country: Germany
country: Italy
country: Netherlands
country: Portugal
country: Russian Federation
country: Spain
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Asthma
mesh term: Dyssomnias
mesh term: Parasomnias
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