<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/NCT02260986</url>
  </required_header>
  <id_info>
    <org_study_id>R668-AD-1224</org_study_id>
    <nct_id>NCT02260986</nct_id>
  </id_info>
  <brief_title>Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis</brief_title>
  <acronym>CHRONOS</acronym>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Regeneron Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study was to demonstrate the efficacy of Dupilumab administered&#xD;
      concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with&#xD;
      moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with&#xD;
      TCS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">August 2015</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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Investigator's Global Assessment (IGA) Score of &quot;0&quot; or &quot;1&quot; and Reduction From Baseline of ≥2 Points at Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score &quot;0&quot; or &quot;1&quot; and a reduction from baseline of ≥2 points at Week 16 were reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Investigator's Global Assessment (IGA) Score of &quot;0&quot; or &quot;1&quot; and Reduction From Baseline of ≥2 Points at Week 52</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of &quot;0&quot; or &quot;1&quot; and a reduction from baseline of ≥2 points at Week 52 were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 52</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 24</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 24 were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>The POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Total Global Individual Signs Score (GISS) to Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Topical Atopic Dermatitis Medication-Free Days Through Week 52</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>Proportion of topical AD medication-free days through Week 52 was calculated as the number of days that a participant used neither topical corticosteroid (TCS)/ topical calcineurin inhibitors (TCI) nor system rescue therapy divided by the study days of each period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 2</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 52</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 52</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 52</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 52</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 52</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 52</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>The POEM was a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 52</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Flares Through Week 52</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>Atopic dermatitis (AD) flares were defined as worsening of the disease that required escalation/intensification of AD treatment. Number of flares occurred in the participants starting from first dose through Week 52 were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Serious Treatment Emergent Adverse Events (TEAEs) Leading to Study Drug Discontinuation Through Week 52</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. A Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) From Baseline Through Week 52</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>Any untoward medical occurrence in a participants who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = &quot;Infection and Infestations&quot; or SOC = &quot;Skin and Subcutaneous Tissue Disorders&quot;. Blinded adjudication was performed and finalized by the study medical monitor before database lock.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Skin Infection TEAEs (Excluding Herpetic Infections) From Baseline Through Week 52</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = &quot;Infection and Infestations&quot; or SOC = &quot;Skin and Subcutaneous Tissue Disorders&quot;. Blinded adjudication was performed and finalized by the study medical monitor before database lock.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = &quot;Infection and Infestations&quot; or SOC = &quot;Skin and Subcutaneous Tissue Disorders&quot;. Blinded adjudication was performed and finalized by the study medical monitor before database lock.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = &quot;Infection and Infestations&quot; or SOC = &quot;Skin and Subcutaneous Tissue Disorders&quot;. Blinded adjudication was performed and finalized by the study medical monitor before database lock.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change From Baseline in Sinonasal Outcome Test (SNOT-22) Score to Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>The SNOT 22 was a validated measure of health related quality of life in sinonasal disease. It was a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease) (lower scores represent better health related quality of life). The SNOT-22 was administered only to participants with chronic inflammatory conditions of the nasal mucosa and/or paranasal sinuses.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score to Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>ACQ-5 questionnaire was a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score was the mean of the 5 questions and range between 0 (totally controlled) and 6 (severely uncontrolled) (a higher score indicated lower asthma control). The ACQ-5 questionnaire was administered only to the participants with a medical history of asthma.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">740</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Placebo qw</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection weekly (qw) from Week 1 to Week 51.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dupilumab 300 mg q2w</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dupilumab 300 mg qw</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dupilumab</intervention_name>
    <description>Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs</description>
    <arm_group_label>Dupilumab 300 mg q2w</arm_group_label>
    <arm_group_label>Dupilumab 300 mg qw</arm_group_label>
    <other_name>REGN668</other_name>
    <other_name>SAR231893</other_name>
    <other_name>Dupixent</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (for Dupilumab)</intervention_name>
    <description>Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs</description>
    <arm_group_label>Dupilumab 300 mg q2w</arm_group_label>
    <arm_group_label>Placebo qw</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Topical Corticosteroid (TCS)</intervention_name>
    <description>All participants were required to treatment with a (TCS) using a standardized regimen. It was recommended that participants use triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment for medium potency, and hydrocortisone 1% cream for low potency.</description>
    <arm_group_label>Dupilumab 300 mg q2w</arm_group_label>
    <arm_group_label>Dupilumab 300 mg qw</arm_group_label>
    <arm_group_label>Placebo qw</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Chronic AD that had been present for at least 3 years before the screening visit;&#xD;
&#xD;
          2. Documented recent history (within 6 months before the screening visit) of inadequate&#xD;
             response to a sufficient course of out-patient treatment with topical AD&#xD;
             medication(s).&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Participation in a prior Dupilumab clinical trial;&#xD;
&#xD;
          2. Important side effects of topical medication (e.g. intolerance to treatment,&#xD;
             hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed&#xD;
             by the investigator or treating physician;&#xD;
&#xD;
          3. Having used any of the following treatments within 4 weeks before the baseline visit,&#xD;
             or any condition that, in the opinion of the investigator, was likely to require such&#xD;
             treatment(s) during the first 2 weeks of study treatment:&#xD;
&#xD;
               1. Immunosuppressive/immunomodulating drugs (e.g, systemic steroids, cyclosporine,&#xD;
                  mycophenolate-mofetil, Janus kinase inhibitors, interferon-gamma [IFN-γ],&#xD;
                  azathioprine, methotrexate, etc.);&#xD;
&#xD;
               2. Phototherapy for AD;&#xD;
&#xD;
          4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;&#xD;
&#xD;
          5. History of human immunodeficiency virus (HIV) infection or positive HIV serology at&#xD;
             screening;&#xD;
&#xD;
          6. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or&#xD;
             hepatitis C antibody at the screening visit;&#xD;
&#xD;
          7. Active or acute infection requiring systemic treatment within 2 weeks before baseline&#xD;
             visit;&#xD;
&#xD;
          8. Known or suspected history of immunosuppression;&#xD;
&#xD;
          9. Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during&#xD;
             the participant's participation in this study.&#xD;
&#xD;
        Note: The eligibility criteria listed above is not intended to contain all considerations&#xD;
        relevant to a participant's potential participation in a clinical trial therefore not all&#xD;
        inclusion/ exclusion criteria are listed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Palmdale</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Trumbull</city>
        <state>Connecticut</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edgewater</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Dundee</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Albany</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bay City</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Verona</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Corning</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Smithtown</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lake Oswego</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Exton</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hazleton</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>South Burlington</city>
        <state>Vermont</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Henrico</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Phillip</city>
        <state>Australian Capital Territory</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Benowa</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dulwich</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hectorville</city>
        <state>South Australia</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Carlton</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ajax</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barrie</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Markham</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>North Bay</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oakville</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Peterborough</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond Hill</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Drummondville</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Quebec</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hradec Kralove</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nachod</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Praha 10</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Praha 5</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Svitavy</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Usti nad Labem</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oroshaza</city>
        <state>Békés</state>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szolnok</city>
        <state>Jász-Nagykun-Szolnok</state>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Veszprem</city>
        <state>Veszprém</state>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ancona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Novara</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pavia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Perugia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Amagasaki</city>
        <state>Hyôgo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kamimashiki-gun</city>
        <state>Kumamoto</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saitama-shi</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yaizu</city>
        <state>Shizuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Koto-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Setagaya-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Adachi-ku</city>
        <state>Tôkyô</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chiyoda-ku</city>
        <state>Tôkyô</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nakano-ku</city>
        <state>Tôkyô</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nerima-ku</city>
        <state>Tôkyô</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shibuya-ku</city>
        <state>Tôkyô</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shinagawa-ku</city>
        <state>Tôkyô</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tôkyô</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Suginami-ku</city>
        <state>Tôkyô</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bucheon-si</city>
        <state>Gyeonggido</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Suwon</city>
        <state>Gyeonggido</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seodaemun-gu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Uijeongbu-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Breda</city>
        <state>Noord-Brabant</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rotterdam</city>
        <state>Zuid-Holland</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dunedin</city>
        <state>South Island</state>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wroclaw</city>
        <state>Dolnośląskie</state>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lublin</city>
        <state>Lubelskie</state>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Krakow</city>
        <state>Małopolskie</state>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Strzelce Opolskie</city>
        <state>Opolskie</state>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Iwonicz Zdroj</city>
        <state>Podkarpackie</state>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bialystok</city>
        <state>Podlaskie</state>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gdansk</city>
        <state>Pomorskie</state>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Poznan</city>
        <state>Wielkopolskie</state>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szczecin</city>
        <state>Zachodniopomorskie</state>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gdynia</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Łódź</city>
        <state>Łódzkie</state>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Katowice</city>
        <state>Śląskie</state>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Skarzysko-Kamienna</city>
        <state>Świętokrzyskie</state>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brasov</city>
        <state>Braşov</state>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bucuresti</city>
        <state>Bucureşti</state>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cluj-Napoca</city>
        <state>Cluj</state>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Craiova</city>
        <state>Dolj</state>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Targu Mures</city>
        <state>Mureş</state>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Alicante</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dundee</city>
        <state>Angus</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edgbaston</city>
        <state>Birmingham</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glasgow</city>
        <state>Glasgow City</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sidcup</city>
        <state>Kent</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Northwood</city>
        <state>Middlesex</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Reading</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>France</country>
    <country>Germany</country>
    <country>Latvia</country>
    <country>Russian Federation</country>
    <country>Taiwan</country>
  </removed_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <results_first_submitted>April 30, 2017</results_first_submitted>
  <results_first_submitted_qc>October 12, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 17, 2017</results_first_posted>
  <disposition_first_submitted>February 7, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>February 7, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">February 8, 2017</disposition_first_posted>
  <last_update_submitted>October 12, 2017</last_update_submitted>
  <last_update_submitted_qc>October 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2017</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>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted in 14 countries between 16 Sep 2014 and 19 Oct 2016. A total of 957 participants were screened in the study.</recruitment_details>
      <pre_assignment_details>Out of 957 participants, 740 participants were randomized and treated in the study. Participants were randomized in 3:1:3 ratio to receive Dupilumab 300 mg once weekly (qw) or Dupilumab 300 mg every 2 weeks (q2w) or placebo (for Dupilumab) qw.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo qw</title>
          <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
        </group>
        <group group_id="P2">
          <title>Dupilumab 300 mg q2w</title>
          <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
        </group>
        <group group_id="P3">
          <title>Dupilumab 300 mg qw</title>
          <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="315"/>
                <participants group_id="P2" count="106"/>
                <participants group_id="P3" count="319"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="315"/>
                <participants group_id="P2" count="110">4 participants from Dupilumab 300 mg qw arm analyzed in Dupilumab 300 mg q2w arm</participants>
                <participants group_id="P3" count="315">4 participants received fewer injections of Dupilumab 300 mg (analyzed in Dupilumab 300 mg q2w arm)</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="225"/>
                <participants group_id="P2" count="93"/>
                <participants group_id="P3" count="278"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="41"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Car accident</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Incorrect randomization</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of investigation product supply</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline population included all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo qw</title>
          <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
        </group>
        <group group_id="B2">
          <title>Dupilumab 300 mg q2w</title>
          <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
        </group>
        <group group_id="B3">
          <title>Dupilumab 300 mg qw</title>
          <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="315"/>
            <count group_id="B2" value="106"/>
            <count group_id="B3" value="319"/>
            <count group_id="B4" value="740"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.6" spread="13.01"/>
                    <measurement group_id="B2" value="39.6" spread="13.98"/>
                    <measurement group_id="B3" value="36.9" spread="13.67"/>
                    <measurement group_id="B4" value="37.1" spread="13.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="128"/>
                    <measurement group_id="B4" value="294"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="193"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="191"/>
                    <measurement group_id="B4" value="446"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="299"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="309"/>
                    <measurement group_id="B4" value="711"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="89"/>
                    <measurement group_id="B4" value="201"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="208"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="208"/>
                    <measurement group_id="B4" value="490"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Romania</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="59"/>
                    <measurement group_id="B4" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="47"/>
                    <measurement group_id="B4" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Zealand</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czech Republic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Korea, Republic of</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="64"/>
                    <measurement group_id="B4" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eczema Area and Severity Index (EASI) Score</title>
          <description>The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.6" spread="12.93"/>
                    <measurement group_id="B2" value="33.6" spread="13.30"/>
                    <measurement group_id="B3" value="32.1" spread="12.76"/>
                    <measurement group_id="B4" value="32.5" spread="12.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Investigator Global Assessment (IGA) Score</title>
          <description>IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.5" spread="0.50"/>
                    <measurement group_id="B2" value="3.5" spread="0.50"/>
                    <measurement group_id="B3" value="3.5" spread="0.50"/>
                    <measurement group_id="B4" value="3.5" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weekly Peak Averaged Pruritus Numeric Rating Scale (NRS)</title>
          <description>Pruritus NRS was an assessment tool that was used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at worst moment during previous 24 hours (for maximum itch intensity on a scale of 0-10 [0=no itch;10=worst itch imaginable]).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.3" spread="1.84"/>
                    <measurement group_id="B2" value="7.4" spread="1.66"/>
                    <measurement group_id="B3" value="7.1" spread="1.90"/>
                    <measurement group_id="B4" value="7.3" spread="1.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Surface Area (BSA) Involvement with Atopic Dermatitis</title>
          <description>Body surface area affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.</description>
          <units>Percentage of body surface area</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.9" spread="21.69"/>
                    <measurement group_id="B2" value="59.5" spread="20.84"/>
                    <measurement group_id="B3" value="54.1" spread="21.76"/>
                    <measurement group_id="B4" value="56.1" spread="21.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>SCORing Atopic Dermatitis (SCORAD) Score</title>
          <description>SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).</description>
          <population>Number of participants analyzed = participants with available data for this baseline parameter.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="313"/>
                    <count group_id="B2" value="105"/>
                    <count group_id="B3" value="316"/>
                    <count group_id="B4" value="734"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.0" spread="13.53"/>
                    <measurement group_id="B2" value="69.3" spread="15.24"/>
                    <measurement group_id="B3" value="65.9" spread="13.63"/>
                    <measurement group_id="B4" value="66.4" spread="13.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dermatology Life Quality Index (DLQI) Total Score</title>
          <description>DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.7" spread="7.37"/>
                    <measurement group_id="B2" value="14.5" spread="7.31"/>
                    <measurement group_id="B3" value="14.4" spread="7.17"/>
                    <measurement group_id="B4" value="14.5" spread="7.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Oriented Eczema Measure (POEM)</title>
          <description>The POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).</description>
          <population>Number of participants analyzed = participants with available data for this baseline parameter.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="314"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="739"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.0" spread="5.99"/>
                    <measurement group_id="B2" value="20.3" spread="5.68"/>
                    <measurement group_id="B3" value="20.1" spread="6.05"/>
                    <measurement group_id="B4" value="20.1" spread="5.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Global Individual Signs Score (GISS)</title>
          <description>Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.7" spread="1.84"/>
                    <measurement group_id="B2" value="8.9" spread="2.04"/>
                    <measurement group_id="B3" value="8.9" spread="1.80"/>
                    <measurement group_id="B4" value="8.8" spread="1.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Hospital Anxiety Depression Scale (HADS)</title>
          <description>The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="315"/>
                    <count group_id="B2" value="106"/>
                    <count group_id="B3" value="319"/>
                    <count group_id="B4" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.6" spread="8.06"/>
                    <measurement group_id="B2" value="12.9" spread="7.73"/>
                    <measurement group_id="B3" value="12.8" spread="8.01"/>
                    <measurement group_id="B4" value="12.7" spread="7.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Investigator's Global Assessment (IGA) Score of &quot;0&quot; or &quot;1&quot; and Reduction From Baseline of ≥2 Points at Week 16</title>
        <description>IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score &quot;0&quot; or &quot;1&quot; and a reduction from baseline of ≥2 points at Week 16 were reported.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>All efficacy analyses were performed on the Full Analysis Set (FAS), which included all randomized participants. Efficacy analyses were based on the treatment allocated by interactive voice response system/ interactive web response system (IVRS/IWRS) at randomization (as randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Investigator's Global Assessment (IGA) Score of &quot;0&quot; or &quot;1&quot; and Reduction From Baseline of ≥2 Points at Week 16</title>
          <description>IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score &quot;0&quot; or &quot;1&quot; and a reduction from baseline of ≥2 points at Week 16 were reported.</description>
          <population>All efficacy analyses were performed on the Full Analysis Set (FAS), which included all randomized participants. Efficacy analyses were based on the treatment allocated by interactive voice response system/ interactive web response system (IVRS/IWRS) at randomization (as randomized).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.4"/>
                    <measurement group_id="O2" value="38.7"/>
                    <measurement group_id="O3" value="39.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>26.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.34</ci_lower_limit>
            <ci_upper_limit>36.26</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>26.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20.33</ci_lower_limit>
            <ci_upper_limit>33.28</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg qw v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16</title>
        <description>The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16</title>
          <description>The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.2"/>
                    <measurement group_id="O2" value="68.9"/>
                    <measurement group_id="O3" value="63.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level for both comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>45.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>35.72</ci_lower_limit>
            <ci_upper_limit>55.66</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level for both comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>40.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>33.74</ci_lower_limit>
            <ci_upper_limit>47.81</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg qw v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16</title>
        <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16</title>
          <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="299"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.7"/>
                    <measurement group_id="O2" value="58.8"/>
                    <measurement group_id="O3" value="50.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>39.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>28.53</ci_lower_limit>
            <ci_upper_limit>49.65</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>31.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.84</ci_lower_limit>
            <ci_upper_limit>38.39</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg qw v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16</title>
        <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥3.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16</title>
          <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥3.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="306"/>
                <count group_id="O2" value="105"/>
                <count group_id="O3" value="309"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8"/>
                    <measurement group_id="O2" value="65.7"/>
                    <measurement group_id="O3" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>37.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>27.56</ci_lower_limit>
            <ci_upper_limit>48.31</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>34.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>27.31</ci_lower_limit>
            <ci_upper_limit>42.05</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg qw v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Investigator's Global Assessment (IGA) Score of &quot;0&quot; or &quot;1&quot; and Reduction From Baseline of ≥2 Points at Week 52</title>
        <description>IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of &quot;0&quot; or &quot;1&quot; and a reduction from baseline of ≥2 points at Week 52 were reported.</description>
        <time_frame>Baseline to Week 52</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Investigator's Global Assessment (IGA) Score of &quot;0&quot; or &quot;1&quot; and Reduction From Baseline of ≥2 Points at Week 52</title>
          <description>IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of &quot;0&quot; or &quot;1&quot; and a reduction from baseline of ≥2 points at Week 52 were reported.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="264"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="270"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5"/>
                    <measurement group_id="O2" value="36.0"/>
                    <measurement group_id="O3" value="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 52 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>23.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.72</ci_lower_limit>
            <ci_upper_limit>34.19</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 52 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>27.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20.42</ci_lower_limit>
            <ci_upper_limit>34.58</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg qw v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 52</title>
        <description>The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 52.</description>
        <time_frame>Baseline to Week 52</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 52</title>
          <description>The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 52.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="264"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="270"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6"/>
                    <measurement group_id="O2" value="65.2"/>
                    <measurement group_id="O3" value="64.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 52 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>43.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>32.50</ci_lower_limit>
            <ci_upper_limit>54.65</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 52 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>42.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>34.91</ci_lower_limit>
            <ci_upper_limit>50.06</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg qw v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16</title>
        <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16</title>
          <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.3" spread="2.36"/>
                    <measurement group_id="O2" value="-56.6" spread="3.95"/>
                    <measurement group_id="O3" value="-57.1" spread="2.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least square (LS) mean difference</param_type>
            <param_value>-26.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-35.04</ci_lower_limit>
            <ci_upper_limit>-17.43</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>-26.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-32.83</ci_lower_limit>
            <ci_upper_limit>-20.73</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg qw v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52</title>
        <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.</description>
        <time_frame>Baseline to Week 52</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52</title>
          <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="249"/>
                <count group_id="O2" value="86"/>
                <count group_id="O3" value="249"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9"/>
                    <measurement group_id="O2" value="51.2"/>
                    <measurement group_id="O3" value="39.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>38.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>26.96</ci_lower_limit>
            <ci_upper_limit>49.66</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>26.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>18.76</ci_lower_limit>
            <ci_upper_limit>33.45</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg qw v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52</title>
        <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.</description>
        <time_frame>Baseline to Week 52</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥3.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52</title>
          <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥3.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="256"/>
                <count group_id="O2" value="88"/>
                <count group_id="O3" value="261"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.6"/>
                    <measurement group_id="O2" value="55.7"/>
                    <measurement group_id="O3" value="42.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>40.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>28.76</ci_lower_limit>
            <ci_upper_limit>51.35</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>27.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>19.81</ci_lower_limit>
            <ci_upper_limit>34.76</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg qw v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 24</title>
        <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 24 were reported.</description>
        <time_frame>Baseline to Week 24</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 24</title>
          <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 24 were reported.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="299"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1"/>
                    <measurement group_id="O2" value="53.9"/>
                    <measurement group_id="O3" value="43.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 24 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>37.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>27.34</ci_lower_limit>
            <ci_upper_limit>48.40</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 24 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>27.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20.65</ci_lower_limit>
            <ci_upper_limit>34.70</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg qw v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4</title>
        <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported.</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4</title>
          <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="299"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.4"/>
                    <measurement group_id="O2" value="37.3"/>
                    <measurement group_id="O3" value="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>20.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>10.59</ci_lower_limit>
            <ci_upper_limit>31.15</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0021</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>10.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.15</ci_lower_limit>
            <ci_upper_limit>17.31</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg qw v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2</title>
        <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2</title>
          <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="299"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0"/>
                    <measurement group_id="O2" value="17.6"/>
                    <measurement group_id="O3" value="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0062</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>9.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.61</ci_lower_limit>
            <ci_upper_limit>17.63</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0344</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>difference in percentages</param_type>
            <param_value>5.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.56</ci_lower_limit>
            <ci_upper_limit>10.51</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg qw v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16</title>
        <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16</title>
          <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.36" spread="0.138"/>
                    <measurement group_id="O2" value="-4.17" spread="0.207"/>
                    <measurement group_id="O3" value="-4.27" spread="0.126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>-1.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.297</ci_lower_limit>
            <ci_upper_limit>-1.322</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16</title>
        <description>The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16</title>
          <description>The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="188"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="269"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-48.4" spread="3.82"/>
                    <measurement group_id="O2" value="-80.5" spread="6.34"/>
                    <measurement group_id="O3" value="-81.5" spread="5.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>-32.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-46.37</ci_lower_limit>
            <ci_upper_limit>-17.82</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 16</title>
        <description>BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 16</title>
          <description>BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
          <units>Percentage of BSA</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.01" spread="1.158"/>
                    <measurement group_id="O2" value="-40.39" spread="1.844"/>
                    <measurement group_id="O3" value="-39.58" spread="1.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>-18.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.583</ci_lower_limit>
            <ci_upper_limit>-14.187</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16</title>
        <description>SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16</title>
          <description>SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.2" spread="1.66"/>
                    <measurement group_id="O2" value="-63.9" spread="2.52"/>
                    <measurement group_id="O3" value="-65.9" spread="1.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>-27.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.46</ci_lower_limit>
            <ci_upper_limit>-21.9</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16</title>
        <description>The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16</title>
          <description>The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.8" spread="0.34"/>
                    <measurement group_id="O2" value="-10.0" spread="0.5"/>
                    <measurement group_id="O3" value="-10.7" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>-4.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.31</ci_lower_limit>
            <ci_upper_limit>-3.02</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16</title>
        <description>The POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16</title>
          <description>The POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" spread="0.41"/>
                    <measurement group_id="O2" value="-12.7" spread="0.64"/>
                    <measurement group_id="O3" value="-12.9" spread="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>-7.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.85</ci_lower_limit>
            <ci_upper_limit>-5.93</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16</title>
        <description>HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16</title>
          <description>HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.0" spread="0.37"/>
                    <measurement group_id="O2" value="-4.9" spread="0.58"/>
                    <measurement group_id="O3" value="-5.4" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1596</p_value>
            <p_value_desc>Threshold for significance at 0.025 level.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>-1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.27</ci_lower_limit>
            <ci_upper_limit>0.37</ci_upper_limit>
            <estimate_desc>Dupilumab 300 mg q2w v Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Total Global Individual Signs Score (GISS) to Week 16</title>
        <description>Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Total Global Individual Signs Score (GISS) to Week 16</title>
          <description>Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-33.3" spread="1.89"/>
                    <measurement group_id="O2" value="-55.4" spread="2.69"/>
                    <measurement group_id="O3" value="-59.3" spread="1.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Topical Atopic Dermatitis Medication-Free Days Through Week 52</title>
        <description>Proportion of topical AD medication-free days through Week 52 was calculated as the number of days that a participant used neither topical corticosteroid (TCS)/ topical calcineurin inhibitors (TCI) nor system rescue therapy divided by the study days of each period.</description>
        <time_frame>Baseline to Week 52</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Topical Atopic Dermatitis Medication-Free Days Through Week 52</title>
          <description>Proportion of topical AD medication-free days through Week 52 was calculated as the number of days that a participant used neither topical corticosteroid (TCS)/ topical calcineurin inhibitors (TCI) nor system rescue therapy divided by the study days of each period.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" spread="23.68"/>
                    <measurement group_id="O2" value="16.6" spread="30.08"/>
                    <measurement group_id="O3" value="22.5" spread="33.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 2</title>
        <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 2</title>
          <description>Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.7" spread="1.58"/>
                    <measurement group_id="O2" value="-27.3" spread="2.67"/>
                    <measurement group_id="O3" value="-25.7" spread="1.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 52</title>
        <description>The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.</description>
        <time_frame>Baseline to Week 52</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 52</title>
          <description>The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="264"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="270"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-60.9" spread="4.29"/>
                    <measurement group_id="O2" value="-84.9" spread="6.73"/>
                    <measurement group_id="O3" value="-87.8" spread="6.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 52</title>
        <description>BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.</description>
        <time_frame>Baseline to Week 52</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 52</title>
          <description>BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
          <units>Percentage of BSA</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="264"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="270"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.41" spread="1.443"/>
                    <measurement group_id="O2" value="-43.75" spread="1.874"/>
                    <measurement group_id="O3" value="-43.67" spread="1.143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 52</title>
        <description>SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).</description>
        <time_frame>Baseline to Week 52</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 52</title>
          <description>SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="264"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="270"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-47.3" spread="2.18"/>
                    <measurement group_id="O2" value="-69.7" spread="3.06"/>
                    <measurement group_id="O3" value="-70.4" spread="1.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 52</title>
        <description>Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).</description>
        <time_frame>Baseline to Week 52</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 52</title>
          <description>Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="264"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="270"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-40.8" spread="2.72"/>
                    <measurement group_id="O2" value="-62.8" spread="3.35"/>
                    <measurement group_id="O3" value="-64.4" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 52</title>
        <description>The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.</description>
        <time_frame>Baseline to Week 52</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 52</title>
          <description>The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="264"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="270"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.2" spread="0.4"/>
                    <measurement group_id="O2" value="-11.4" spread="0.57"/>
                    <measurement group_id="O3" value="-11.1" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 52</title>
        <description>The POEM was a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).</description>
        <time_frame>Baseline to Week 52</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 52</title>
          <description>The POEM was a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="264"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="270"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.0" spread="0.57"/>
                    <measurement group_id="O2" value="-14.2" spread="0.78"/>
                    <measurement group_id="O3" value="-13.2" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 52</title>
        <description>HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.</description>
        <time_frame>Baseline to Week 52</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 52</title>
          <description>HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="264"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="270"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.8" spread="0.47"/>
                    <measurement group_id="O2" value="-5.5" spread="0.71"/>
                    <measurement group_id="O3" value="-5.9" spread="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Flares Through Week 52</title>
        <description>Atopic dermatitis (AD) flares were defined as worsening of the disease that required escalation/intensification of AD treatment. Number of flares occurred in the participants starting from first dose through Week 52 were reported.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>All safety analysis were performed on safety analysis set (SAF) that included all randomized participants who received any study drug, and were analyzed as-treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Flares Through Week 52</title>
          <description>Atopic dermatitis (AD) flares were defined as worsening of the disease that required escalation/intensification of AD treatment. Number of flares occurred in the participants starting from first dose through Week 52 were reported.</description>
          <population>All safety analysis were performed on safety analysis set (SAF) that included all randomized participants who received any study drug, and were analyzed as-treated.</population>
          <units>flares</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="110"/>
                <count group_id="O3" value="315"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="216"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Serious Treatment Emergent Adverse Events (TEAEs) Leading to Study Drug Discontinuation Through Week 52</title>
        <description>Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. A Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Serious Treatment Emergent Adverse Events (TEAEs) Leading to Study Drug Discontinuation Through Week 52</title>
          <description>Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. A Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.</description>
          <population>All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="110"/>
                <count group_id="O3" value="315"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) From Baseline Through Week 52</title>
        <description>Any untoward medical occurrence in a participants who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = &quot;Infection and Infestations&quot; or SOC = &quot;Skin and Subcutaneous Tissue Disorders&quot;. Blinded adjudication was performed and finalized by the study medical monitor before database lock.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) From Baseline Through Week 52</title>
          <description>Any untoward medical occurrence in a participants who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = &quot;Infection and Infestations&quot; or SOC = &quot;Skin and Subcutaneous Tissue Disorders&quot;. Blinded adjudication was performed and finalized by the study medical monitor before database lock.</description>
          <population>All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="110"/>
                <count group_id="O3" value="315"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8"/>
                    <measurement group_id="O2" value="10.9"/>
                    <measurement group_id="O3" value="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Skin Infection TEAEs (Excluding Herpetic Infections) From Baseline Through Week 52</title>
        <description>Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = &quot;Infection and Infestations&quot; or SOC = &quot;Skin and Subcutaneous Tissue Disorders&quot;. Blinded adjudication was performed and finalized by the study medical monitor before database lock.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Skin Infection TEAEs (Excluding Herpetic Infections) From Baseline Through Week 52</title>
          <description>Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = &quot;Infection and Infestations&quot; or SOC = &quot;Skin and Subcutaneous Tissue Disorders&quot;. Blinded adjudication was performed and finalized by the study medical monitor before database lock.</description>
          <population>All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="110"/>
                <count group_id="O3" value="315"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52</title>
        <description>Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = &quot;Infection and Infestations&quot; or SOC = &quot;Skin and Subcutaneous Tissue Disorders&quot;. Blinded adjudication was performed and finalized by the study medical monitor before database lock.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52</title>
          <description>Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = &quot;Infection and Infestations&quot; or SOC = &quot;Skin and Subcutaneous Tissue Disorders&quot;. Blinded adjudication was performed and finalized by the study medical monitor before database lock.</description>
          <population>All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="110"/>
                <count group_id="O3" value="315"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5"/>
                    <measurement group_id="O2" value="5.5"/>
                    <measurement group_id="O3" value="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52</title>
        <description>Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = &quot;Infection and Infestations&quot; or SOC = &quot;Skin and Subcutaneous Tissue Disorders&quot;. Blinded adjudication was performed and finalized by the study medical monitor before database lock.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52</title>
          <description>Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = &quot;Infection and Infestations&quot; or SOC = &quot;Skin and Subcutaneous Tissue Disorders&quot;. Blinded adjudication was performed and finalized by the study medical monitor before database lock.</description>
          <population>All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="110"/>
                <count group_id="O3" value="315"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline in Sinonasal Outcome Test (SNOT-22) Score to Week 16</title>
        <description>The SNOT 22 was a validated measure of health related quality of life in sinonasal disease. It was a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease) (lower scores represent better health related quality of life). The SNOT-22 was administered only to participants with chronic inflammatory conditions of the nasal mucosa and/or paranasal sinuses.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Sinonasal Outcome Test (SNOT-22) Score to Week 16</title>
          <description>The SNOT 22 was a validated measure of health related quality of life in sinonasal disease. It was a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease) (lower scores represent better health related quality of life). The SNOT-22 was administered only to participants with chronic inflammatory conditions of the nasal mucosa and/or paranasal sinuses.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.77" spread="1.903"/>
                    <measurement group_id="O2" value="-6.38" spread="2.445"/>
                    <measurement group_id="O3" value="-10.39" spread="1.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score to Week 16</title>
        <description>ACQ-5 questionnaire was a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score was the mean of the 5 questions and range between 0 (totally controlled) and 6 (severely uncontrolled) (a higher score indicated lower asthma control). The ACQ-5 questionnaire was administered only to the participants with a medical history of asthma.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with ACQ-5 value at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo qw</title>
            <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
          </group>
          <group group_id="O2">
            <title>Dupilumab 300 mg q2w</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.</description>
          </group>
          <group group_id="O3">
            <title>Dupilumab 300 mg qw</title>
            <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score to Week 16</title>
          <description>ACQ-5 questionnaire was a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score was the mean of the 5 questions and range between 0 (totally controlled) and 6 (severely uncontrolled) (a higher score indicated lower asthma control). The ACQ-5 questionnaire was administered only to the participants with a medical history of asthma.</description>
          <population>All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with ACQ-5 value at baseline.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="154"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="0.082"/>
                    <measurement group_id="O2" value="-0.19" spread="0.113"/>
                    <measurement group_id="O3" value="-0.36" spread="0.068"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Time-frame was 'On treatment (Week 52) period' defined time from administration of first dose of study drug to study completion date of Week 52 visit (365 days starting from first dose of study drug if the date of Week 52 visit was unavailable).</time_frame>
      <desc>All Adverse Events (AEs) were collected from signature of informed consent form up to study completion date of the Week 52 visit regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'On treatment (Week 52) period'. Analysis was performed on SAF.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo qw</title>
          <description>Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.</description>
        </group>
        <group group_id="E2">
          <title>Dupilumab 300 mg q2w</title>
          <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.</description>
        </group>
        <group group_id="E3">
          <title>Dupilumab 300 mg qw</title>
          <description>Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>meddra (18.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="110"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Cystoid macular oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Soft tissue inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal wall abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Eczema herpeticum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Superinfection bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Limb traumatic amputation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pseudarthrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title vocab="medDRA (18.0)">Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title vocab="medDRA (18.0)">Spondylolisthesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cervix carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Penile squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of the tongue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title vocab="medDRA (18.0)">Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>meddra (18.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="216" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="74" subjects_at_risk="110"/>
                <counts group_id="E3" subjects_affected="228" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="315"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="110"/>
                <counts group_id="E3" events="14" subjects_affected="11" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" events="22" subjects_affected="19" subjects_at_risk="315"/>
                <counts group_id="E2" events="20" subjects_affected="13" subjects_at_risk="110"/>
                <counts group_id="E3" events="74" subjects_affected="54" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="102" subjects_affected="24" subjects_at_risk="315"/>
                <counts group_id="E2" events="34" subjects_affected="16" subjects_at_risk="110"/>
                <counts group_id="E3" events="224" subjects_affected="60" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="25" subjects_affected="17" subjects_at_risk="315"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="110"/>
                <counts group_id="E3" events="13" subjects_affected="9" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="89" subjects_affected="62" subjects_at_risk="315"/>
                <counts group_id="E2" events="40" subjects_affected="26" subjects_at_risk="110"/>
                <counts group_id="E3" events="88" subjects_affected="63" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="15" subjects_affected="10" subjects_at_risk="315"/>
                <counts group_id="E2" events="9" subjects_affected="4" subjects_at_risk="110"/>
                <counts group_id="E3" events="31" subjects_affected="17" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="315"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E3" events="20" subjects_affected="18" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="52" subjects_affected="34" subjects_at_risk="315"/>
                <counts group_id="E2" events="21" subjects_affected="11" subjects_at_risk="110"/>
                <counts group_id="E3" events="78" subjects_affected="46" subjects_at_risk="315"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="315"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E3" events="22" subjects_affected="16" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="30" subjects_affected="19" subjects_at_risk="315"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="110"/>
                <counts group_id="E3" events="48" subjects_affected="24" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="23" subjects_affected="19" subjects_at_risk="315"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="110"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" events="278" subjects_affected="161" subjects_at_risk="315"/>
                <counts group_id="E2" events="52" subjects_affected="40" subjects_at_risk="110"/>
                <counts group_id="E3" events="133" subjects_affected="91" subjects_at_risk="315"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Not less than 45 days prior to submission for publication or presentation, the Institution shall, or cause the Principal Investigator to, provide the Sponsor with a copy of the Manuscript. The Institution shall consider in good faith any comments from the Sponsor regarding the content, and shall delete Confidential Information upon written request of the Sponsor. At the Sponsor's request, the Institution shall delay publication for an additional 60 days to allow patent applications to be filed.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Management</name_or_title>
      <organization>Regeneron Pharmaceuticals, Inc.</organization>
      <email>clinicaltrials@regeneron.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02260986
org study id: R668-AD-1224
nct id: NCT02260986
lead sponsor: 
collaborator: 
has dmc: Yes
The primary objective of the study was to demonstrate the efficacy of Dupilumab administered
      concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with
      moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with
      TCS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16
time frame: Baseline to Week 16
description: IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported.
measure: Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16
time frame: Baseline to Week 16
description: The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16.
measure: Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
time frame: Baseline to Week 16
description: Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.
measure: Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
time frame: Baseline to Week 16
description: Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 52
time frame: Baseline to Week 52
description: IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 52 were reported.
measure: Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 52
time frame: Baseline to Week 52
description: The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 52.
measure: Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16
time frame: Baseline to Week 16
description: Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).
measure: Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52
time frame: Baseline to Week 52
description: Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.
measure: Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52
time frame: Baseline to Week 52
description: Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.
measure: Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 24
time frame: Baseline to Week 24
description: Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 24 were reported.
measure: Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4
time frame: Baseline to Week 4
description: Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported.
measure: Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2
time frame: Baseline to Week 2
description: Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported.
measure: Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16
time frame: Baseline to Week 16
description: Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16
time frame: Baseline to Week 16
description: The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
measure: Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 16
time frame: Baseline to Week 16
description: BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.
measure: Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16
time frame: Baseline to Week 16
description: SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16
time frame: Baseline to Week 16
description: The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.
measure: Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16
time frame: Baseline to Week 16
description: The POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).
measure: Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16
time frame: Baseline to Week 16
description: HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.
measure: Percent Change From Baseline in Total Global Individual Signs Score (GISS) to Week 16
time frame: Baseline to Week 16
description: Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).
measure: Proportion of Topical Atopic Dermatitis Medication-Free Days Through Week 52
time frame: Baseline to Week 52
description: Proportion of topical AD medication-free days through Week 52 was calculated as the number of days that a participant used neither topical corticosteroid (TCS)/ topical calcineurin inhibitors (TCI) nor system rescue therapy divided by the study days of each period.
measure: Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 2
time frame: Baseline to Week 2
description: Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 52
time frame: Baseline to Week 52
description: The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
measure: Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 52
time frame: Baseline to Week 52
description: BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.
measure: Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 52
time frame: Baseline to Week 52
description: SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
measure: Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 52
time frame: Baseline to Week 52
description: Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 52
time frame: Baseline to Week 52
description: The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.
measure: Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 52
time frame: Baseline to Week 52
description: The POEM was a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).
measure: Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 52
time frame: Baseline to Week 52
description: HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.
measure: Number of Flares Through Week 52
time frame: Baseline up to Week 52
description: Atopic dermatitis (AD) flares were defined as worsening of the disease that required escalation/intensification of AD treatment. Number of flares occurred in the participants starting from first dose through Week 52 were reported.
measure: Number of Serious Treatment Emergent Adverse Events (TEAEs) Leading to Study Drug Discontinuation Through Week 52
time frame: Baseline up to Week 52
description: Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. A Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
measure: Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) From Baseline Through Week 52
time frame: Baseline up to Week 52
description: Any untoward medical occurrence in a participants who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = "Infection and Infestations" or SOC = "Skin and Subcutaneous Tissue Disorders". Blinded adjudication was performed and finalized by the study medical monitor before database lock.
measure: Number of Skin Infection TEAEs (Excluding Herpetic Infections) From Baseline Through Week 52
time frame: Baseline up to Week 52
description: Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = "Infection and Infestations" or SOC = "Skin and Subcutaneous Tissue Disorders". Blinded adjudication was performed and finalized by the study medical monitor before database lock.
measure: Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52
time frame: Baseline up to Week 52
description: Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = "Infection and Infestations" or SOC = "Skin and Subcutaneous Tissue Disorders". Blinded adjudication was performed and finalized by the study medical monitor before database lock.
measure: Number of Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52
time frame: Baseline up to Week 52
description: Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = "Infection and Infestations" or SOC = "Skin and Subcutaneous Tissue Disorders". Blinded adjudication was performed and finalized by the study medical monitor before database lock.
measure: Change From Baseline in Sinonasal Outcome Test (SNOT-22) Score to Week 16
time frame: Baseline to Week 16
description: The SNOT 22 was a validated measure of health related quality of life in sinonasal disease. It was a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease) (lower scores represent better health related quality of life). The SNOT-22 was administered only to participants with chronic inflammatory conditions of the nasal mucosa and/or paranasal sinuses.
measure: Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score to Week 16
time frame: Baseline to Week 16
description: ACQ-5 questionnaire was a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score was the mean of the 5 questions and range between 0 (totally controlled) and 6 (severely uncontrolled) (a higher score indicated lower asthma control). The ACQ-5 questionnaire was administered only to the participants with a medical history of asthma.
arm group label: Placebo qw
arm group type: Experimental
description: Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection weekly (qw) from Week 1 to Week 51.
arm group label: Dupilumab 300 mg q2w
arm group type: Experimental
description: Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
arm group label: Dupilumab 300 mg qw
arm group type: Experimental
description: Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
intervention type: Drug
intervention name: Dupilumab
description: Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
arm group label: Dupilumab 300 mg q2w
arm group label: Dupilumab 300 mg qw
other name: REGN668
other name: SAR231893
other name: Dupixent
intervention type: Drug
intervention name: Placebo (for Dupilumab)
description: Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
arm group label: Dupilumab 300 mg q2w
arm group label: Placebo qw
intervention type: Other
intervention name: Topical Corticosteroid (TCS)
description: All participants were required to treatment with a (TCS) using a standardized regimen. It was recommended that participants use triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment for medium potency, and hydrocortisone 1% cream for low potency.
arm group label: Dupilumab 300 mg q2w
arm group label: Dupilumab 300 mg qw
arm group label: Placebo qw
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
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country: Australia
country: Canada
country: Czechia
country: Hungary
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: New Zealand
country: Poland
country: Romania
country: Spain
country: United Kingdom
country: United States
country: Czech Republic
country: France
country: Germany
country: Latvia
country: Russian Federation
country: Taiwan
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Antibodies, Monoclonal
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certain agreements: 
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