<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/NCT03761537</url>
  </required_header>
  <id_info>
    <org_study_id>LP0162-1346</org_study_id>
    <nct_id>NCT03761537</nct_id>
  </id_info>
  <brief_title>Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7</brief_title>
  <acronym>ECZTRA 7</acronym>
  <official_title>A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase 3 Trial Investigating the Efficacy, Safety, and Tolerability of Tralokinumab Administered in Combination With Topical Corticosteroids to Adult Subjects With Severe Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LEO Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LEO Pharma</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary objective:&#xD;
&#xD;
      To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is&#xD;
      superior to placebo in combination with TCS in treating severe AD in subjects who are not&#xD;
      adequately controlled with or have contraindications to oral cyclosporine A (CSA).&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
      To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of&#xD;
      AD, itch, and health-related quality of life compared to placebo in combination with TCS.&#xD;
&#xD;
      To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in&#xD;
      subjects who are not adequately controlled with or have contraindications to oral CSA&#xD;
      compared to placebo in combination with TCS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Actual">September 28, 2020</completion_date>
  <primary_completion_date type="Actual">April 21, 2020</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16</measure>
    <time_frame>Week 0 to Week 16</time_frame>
    <description>EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16</measure>
    <time_frame>Week 0 to Week 16</time_frame>
    <description>Subjects will assess their worst itch severity over the past 24 hours using an 11-point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 16</measure>
    <time_frame>Week 0 to Week 16</time_frame>
    <description>SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 16</measure>
    <time_frame>Week 0 to Week 16</time_frame>
    <description>DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 26</measure>
    <time_frame>Week 0 to Week 26</time_frame>
    <description>EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 26</measure>
    <time_frame>Week 0 to Week 26</time_frame>
    <description>Subjects will assess their worst itch severity over the past 24 hours using an 11-point numeric rating scale ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 26</measure>
    <time_frame>Week 0 to Week 26</time_frame>
    <description>SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 26</measure>
    <time_frame>Week 0 to Week 26</time_frame>
    <description>DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40</measure>
    <time_frame>Week 0 to Week 40</time_frame>
    <description>Presence of ADA from Week 0 to Week 40 was measured. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse Events From Week 0 to Week 40</measure>
    <time_frame>Week 0 to Week 40</time_frame>
    <description>All adverse events are presented below under Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">277</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Tralokinumab + TCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 subcutaneous (SC) injections of tralokinumab 150 mg as a loading dose on Day 0, followed by 2 SC injections of tralokinumab 150 mg every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + TCS</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>4 subcutaneous (SC) injections of placebo as a loading dose on Day 0, followed by 2 SC injections of placebo every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tralokinumab</intervention_name>
    <description>Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration.</description>
    <arm_group_label>Tralokinumab + TCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo contains the same excipients in the same concentration only lacking tralokinumab.</description>
    <arm_group_label>Placebo + TCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 and above&#xD;
&#xD;
          -  Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD&#xD;
&#xD;
          -  History of AD for 1 year or more&#xD;
&#xD;
          -  Subjects with a history within 1 year prior to screening of inadequate response to&#xD;
             treatment with topical medications or subjects for whom topical treatments are&#xD;
             otherwise medically inadvisable&#xD;
&#xD;
          -  AD involvement of 10% (or more) body surface area at screening and baseline (visit 3)&#xD;
             according to component A of SCORAD&#xD;
&#xD;
          -  Documented history of either no previous CSA exposure and not currently a candidate&#xD;
             for CSA treatment OR previous exposure to CSA in which case CSA treatment should not&#xD;
             be continued or restarted&#xD;
&#xD;
          -  Subjects must have applied a stable dose of emollient twice daily (or more, as needed)&#xD;
             for at least 14 days before randomisation&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Subjects for whom TCSs are medically inadvisable in the opinion of the investigator&#xD;
&#xD;
          -  Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 6 weeks prior to&#xD;
             randomisation&#xD;
&#xD;
          -  Treatment with immunomodulatory medications or bleach baths within 4 weeks prior to&#xD;
             randomisation&#xD;
&#xD;
          -  Treatment with topical phosphodiesterase-4 (PDE-4) inhibitor within 2 weeks prior to&#xD;
             randomisation&#xD;
&#xD;
          -  Receipt of any marketed or investigational biologic agent (e.g. cell-depleting agents&#xD;
             or dupilumab) within 6 months prior to randomisation or until cell counts return to&#xD;
             normal, whichever is longer&#xD;
&#xD;
          -  History of any active skin infection within 1 week prior to randomisation&#xD;
&#xD;
          -  History of a clinically significant infection (systemic infection or serious skin&#xD;
             infection requiring parenteral treatment) within 4 weeks prior to randomisation&#xD;
&#xD;
          -  A helminth parasitic infection within 6 months prior to the date informed consent is&#xD;
             obtained that has not been treated with, or has failed to respond to, standard of care&#xD;
             therapy&#xD;
&#xD;
          -  Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation&#xD;
             will be according to local guidelines as per local standard of care&#xD;
&#xD;
          -  History of any known primary immunodeficiency disorder including a positive HIV test&#xD;
             at screening, or the subject taking antiretroviral medications&#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>Medical Expert</last_name>
    <role>Study Director</role>
    <affiliation>LEO Pharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
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      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
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  </location>
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      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Edegem</city>
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      </address>
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        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
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        <zip>B-9000</zip>
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      <address>
        <city>Kraków</city>
        <zip>31-530</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Kraków</city>
        <zip>31-559</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Poznań</city>
        <zip>60-369</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Rzeszów</city>
        <zip>35-312</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Warszawa</city>
        <zip>01-817</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Warszawa</city>
        <zip>02-625</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Warszawa</city>
        <zip>02-953</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Wrocław</city>
        <zip>51-685</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Łódź</city>
        <zip>90-242</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Łódź</city>
        <zip>90-752</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Granada</city>
        <state>Andalucía</state>
        <zip>18014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Alicante</city>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Bilbao</city>
        <zip>48013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Madrid</city>
        <zip>28942</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Bradford</city>
        <zip>BD5 0NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Cottingham</city>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Kirkcaldy</city>
        <zip>KY2 5AH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>London</city>
        <zip>E11 1NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigationel Site</name>
      <address>
        <city>Wakefield</city>
        <zip>WF1 4DG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <results_first_submitted>September 27, 2021</results_first_submitted>
  <results_first_submitted_qc>September 27, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 26, 2021</results_first_posted>
  <disposition_first_submitted>March 15, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>March 15, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 19, 2021</disposition_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03761537/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03761537/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>After the participant gave informed consent, they went through a 2- to 6-week screening period. Eligibility was assessed at the (first) screening visit and on Day 0 (hereinafter &quot;baseline&quot;) prior to randomisation.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Tralokinumab + TCS</title>
          <description>Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.</description>
        </group>
        <group group_id="P2">
          <title>Placebo + TCS</title>
          <description>Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="140"/>
                <participants group_id="P2" count="137"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="125"/>
                <participants group_id="P2" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tralokinumab + TCS</title>
          <description>Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.</description>
        </group>
        <group group_id="B2">
          <title>Placebo + TCS</title>
          <description>Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.</description>
        </group>
        <group group_id="B3">
          <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="140"/>
            <count group_id="B2" value="137"/>
            <count group_id="B3" value="277"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.0" lower_limit="25.5" upper_limit="47.0"/>
                    <measurement group_id="B2" value="34.0" lower_limit="26.0" upper_limit="45.0"/>
                    <measurement group_id="B3" value="34.0" lower_limit="26.0" upper_limit="45.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>18-64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="134"/>
                    <measurement group_id="B2" value="131"/>
                    <measurement group_id="B3" value="265"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>65-84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </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="140"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="112"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="165"/>
                  </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="140"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="134"/>
                    <measurement group_id="B2" value="133"/>
                    <measurement group_id="B3" value="267"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="140"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="277"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="137"/>
                    <measurement group_id="B2" value="135"/>
                    <measurement group_id="B3" value="272"/>
                  </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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Belgium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" 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="140"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="77"/>
                  </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="140"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="40"/>
                  </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="140"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age at onset of atopic dermatitis</title>
          <population>The number of participants analysed is different from the number of participants randomised due to missing data.</population>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="136"/>
                    <count group_id="B3" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.5" lower_limit="1.0" upper_limit="12.5"/>
                    <measurement group_id="B2" value="3.0" lower_limit="1.0" upper_limit="17.0"/>
                    <measurement group_id="B3" value="3.0" lower_limit="1.0" upper_limit="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of atopic dermatitis</title>
          <population>The number of participants analysed is different from the number of participants randomised due to missing data.</population>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="136"/>
                    <count group_id="B3" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.0" lower_limit="18.0" upper_limit="35.0"/>
                    <measurement group_id="B2" value="25.0" lower_limit="17.0" upper_limit="34.0"/>
                    <measurement group_id="B3" value="26.0" lower_limit="18.0" upper_limit="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body surface area with atopic dermatitis</title>
          <units>Percentage affected</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.0" lower_limit="36.5" upper_limit="70.0"/>
                    <measurement group_id="B2" value="52.0" lower_limit="35.0" upper_limit="70.0"/>
                    <measurement group_id="B3" value="52.0" lower_limit="35.0" upper_limit="70.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Investigator's Global Assessment (IGA)</title>
          <description>IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).</description>
          <population>The number of participants analysed is different from the number of participants randomised due to missing data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Moderate Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="138"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="138"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eczema Area and Severity Index (EASI)</title>
          <description>EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.</description>
          <population>The number of participants analysed is different from the number of participants randomised due to missing data.</population>
          <units>Units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="138"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.60" lower_limit="22.40" upper_limit="38.00"/>
                    <measurement group_id="B2" value="29.10" lower_limit="22.80" upper_limit="40.15"/>
                    <measurement group_id="B3" value="28.80" lower_limit="22.40" upper_limit="39.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Scoring Atopic Dermatitis (SCORAD)</title>
          <description>SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition.</description>
          <population>The number of participants analysed is different from the number of participants randomised due to missing data.</population>
          <units>Units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="138"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.20" lower_limit="61.50" upper_limit="76.50"/>
                    <measurement group_id="B2" value="68.90" lower_limit="61.20" upper_limit="81.00"/>
                    <measurement group_id="B3" value="69.10" lower_limit="61.40" upper_limit="78.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dermatology Life Quality Index (DLQI)</title>
          <description>DLQI is used by the participant to evaluate the impact of their condition on 10 different aspects of health-related quality of life (HRQoL) over the last week. Each item is scored on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much). The total score which is the sum of the 10 items ranges from 0 to 30, with a higher score indicating a poorer HRQoL.</description>
          <population>The number of participants analysed is different from the number of participants randomised due to missing data.</population>
          <units>Units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="137"/>
                    <count group_id="B2" value="134"/>
                    <count group_id="B3" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.00" lower_limit="11.00" upper_limit="21.00"/>
                    <measurement group_id="B2" value="16.00" lower_limit="11.00" upper_limit="21.00"/>
                    <measurement group_id="B3" value="16.00" lower_limit="11.00" upper_limit="21.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Worst Daily Pruritus numeric rating scale (NRS) (weekly average)</title>
          <description>Worst Daily Pruritus NRS is used by the participant to evaluate their worst itch severity over the past 24 hours. The score ranges from 0 ('no itch') to 10 ('worst itch imaginable').</description>
          <population>The number of participants analysed is different from the number of participants randomised due to missing data.</population>
          <units>Units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="137"/>
                    <count group_id="B2" value="136"/>
                    <count group_id="B3" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.43" lower_limit="6.43" upper_limit="8.29"/>
                    <measurement group_id="B2" value="7.50" lower_limit="6.59" upper_limit="8.37"/>
                    <measurement group_id="B3" value="7.43" lower_limit="6.57" upper_limit="8.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16</title>
        <description>EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.</description>
        <time_frame>Week 0 to Week 16</time_frame>
        <population>Full analysis set (FAS). Of the 277 participants randomised to initial treatment, 275 were treated. Therefore, the FAS consisted of 275 participants (138 participants in the tralokinumab+TCS group + 137 participants in the placebo+TCS group).</population>
        <group_list>
          <group group_id="O1">
            <title>Tralokinumab+TCS</title>
            <description>Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+TCS</title>
            <description>Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.</description>
          </group>
        </group_list>
        <measure>
          <title>At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16</title>
          <description>EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.</description>
          <population>Full analysis set (FAS). Of the 277 participants randomised to initial treatment, 275 were treated. Therefore, the FAS consisted of 275 participants (138 participants in the tralokinumab+TCS group + 137 participants in the placebo+TCS group).</population>
          <units>Percentage of responders</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.2"/>
                    <measurement group_id="O2" value="50.5"/>
                  </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>Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.</non_inferiority_desc>
            <p_value>0.018</p_value>
            <p_value_desc>This endpoint was the first endpoint in the sequential testing hierarchy.</p_value_desc>
            <method>Mantel Haenszel</method>
            <method_desc>Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.</method_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>14.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.5</ci_lower_limit>
            <ci_upper_limit>25.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16</title>
        <description>Subjects will assess their worst itch severity over the past 24 hours using an 11-point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.</description>
        <time_frame>Week 0 to Week 16</time_frame>
        <population>Participants in the full analysis set with a Worst Daily Pruritus NRS (weekly average) of at least 4 at baseline (Week 0).</population>
        <group_list>
          <group group_id="O1">
            <title>Tralokinumab+TCS</title>
            <description>Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+TCS</title>
            <description>Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16</title>
          <description>Subjects will assess their worst itch severity over the past 24 hours using an 11-point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.</description>
          <population>Participants in the full analysis set with a Worst Daily Pruritus NRS (weekly average) of at least 4 at baseline (Week 0).</population>
          <units>Percentage of responders</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.5"/>
                    <measurement group_id="O2" value="35.6"/>
                  </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>Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.</non_inferiority_desc>
            <p_value>0.106</p_value>
            <p_value_desc>This endpoint was the second endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.</p_value_desc>
            <method>Mantel Haenszel</method>
            <method_desc>Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.</method_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>9.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.0</ci_lower_limit>
            <ci_upper_limit>21.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 16</title>
        <description>SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.</description>
        <time_frame>Week 0 to Week 16</time_frame>
        <population>Full analysis set (FAS).</population>
        <group_list>
          <group group_id="O1">
            <title>Tralokinumab+TCS</title>
            <description>Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+TCS</title>
            <description>Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 16</title>
          <description>SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.</description>
          <population>Full analysis set (FAS).</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="138"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-42.7" spread="1.6"/>
                    <measurement group_id="O2" value="-34.1" spread="1.6"/>
                  </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>Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>This was the third endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.</p_value_desc>
            <method>Repeated measurements model</method>
            <method_desc>Treatment effect at each visit adjusted for baseline SCORAD interacting with each visit, prior CSA, and baseline disease severity (IGA 3 or 4).</method_desc>
            <param_type>Difference</param_type>
            <param_value>-8.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.0</ci_lower_limit>
            <ci_upper_limit>-4.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 16</title>
        <description>DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL.</description>
        <time_frame>Week 0 to Week 16</time_frame>
        <population>Full Set Analysis (FAS).</population>
        <group_list>
          <group group_id="O1">
            <title>Tralokinumab+TCS</title>
            <description>Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+TCS</title>
            <description>Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 16</title>
          <description>DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL.</description>
          <population>Full Set Analysis (FAS).</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="137"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.2" spread="0.4"/>
                    <measurement group_id="O2" value="-9.6" spread="0.4"/>
                  </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>Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.</non_inferiority_desc>
            <p_value>0.009</p_value>
            <p_value_desc>This was the fourth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.</p_value_desc>
            <method>Repeated measurements model</method>
            <method_desc>Treatment effect at each visit adjusted for baseline DLQI interacting with each visit, prior CSA, and baseline disease severity (IGA 3 or 4).</method_desc>
            <param_type>Difference</param_type>
            <param_value>-1.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.6</ci_lower_limit>
            <ci_upper_limit>-0.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16</title>
        <description>IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).</description>
        <time_frame>Week 16</time_frame>
        <population>Full analysis set (FAS).</population>
        <group_list>
          <group group_id="O1">
            <title>Tralokinumab+TCS</title>
            <description>Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+TCS</title>
            <description>Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16</title>
          <description>IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).</description>
          <population>Full analysis set (FAS).</population>
          <units>Percentage of responders</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.9"/>
                    <measurement group_id="O2" value="26.0"/>
                  </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>Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.</non_inferiority_desc>
            <p_value>0.005</p_value>
            <p_value_desc>This endpoint was the fifth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.</p_value_desc>
            <method>Mantel Haenszel</method>
            <method_desc>Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.</method_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>15.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.8</ci_lower_limit>
            <ci_upper_limit>26.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 26</title>
        <description>EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.</description>
        <time_frame>Week 0 to Week 26</time_frame>
        <population>Full analysis set (FAS).</population>
        <group_list>
          <group group_id="O1">
            <title>Tralokinumab</title>
            <description>Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 26</title>
          <description>EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.</description>
          <population>Full analysis set (FAS).</population>
          <units>Percentage of responders</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.8"/>
                    <measurement group_id="O2" value="55.3"/>
                  </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>Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.</non_inferiority_desc>
            <p_value>0.014</p_value>
            <p_value_desc>This endpoint was the sixth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.</p_value_desc>
            <method>Mantel Haenszel</method>
            <method_desc>Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.</method_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>14.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.9</ci_lower_limit>
            <ci_upper_limit>25.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 26</title>
        <description>Subjects will assess their worst itch severity over the past 24 hours using an 11-point numeric rating scale ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.</description>
        <time_frame>Week 0 to Week 26</time_frame>
        <population>Participants in the full analysis set with a Worst Daily Pruritus NRS (weekly average) of at least 4 at baseline (Week 0).</population>
        <group_list>
          <group group_id="O1">
            <title>Tralokinumab+TCS</title>
            <description>Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+TCS</title>
            <description>Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 26</title>
          <description>Subjects will assess their worst itch severity over the past 24 hours using an 11-point numeric rating scale ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.</description>
          <population>Participants in the full analysis set with a Worst Daily Pruritus NRS (weekly average) of at least 4 at baseline (Week 0).</population>
          <units>Percentage of responders</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.2"/>
                    <measurement group_id="O2" value="39.7"/>
                  </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>Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.</non_inferiority_desc>
            <p_value>0.228</p_value>
            <p_value_desc>This endpoint was the seventh endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.</p_value_desc>
            <method>Mantel Haenszel</method>
            <method_desc>HaenszMantelel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.</method_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>7.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.6</ci_lower_limit>
            <ci_upper_limit>19.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 26</title>
        <description>SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.</description>
        <time_frame>Week 0 to Week 26</time_frame>
        <population>Full analysis set (FAS).</population>
        <group_list>
          <group group_id="O1">
            <title>Tralokinumab</title>
            <description>Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 26</title>
          <description>SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.</description>
          <population>Full analysis set (FAS).</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="138"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-46.3" spread="1.5"/>
                    <measurement group_id="O2" value="-37.3" spread="1.6"/>
                  </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>Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>This endpoint was the eighth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.</p_value_desc>
            <method>Repeated measurements model</method>
            <method_desc>Unstructured covariance matrix. Adjusted for baseline SCORAD in interaction with each visit, prior CSA use, and baseline disease severity (IGA 3 or 4)</method_desc>
            <param_type>Difference</param_type>
            <param_value>-8.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.2</ci_lower_limit>
            <ci_upper_limit>-4.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 26</title>
        <description>DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL.</description>
        <time_frame>Week 0 to Week 26</time_frame>
        <population>Full Set Analysis (FAS).</population>
        <group_list>
          <group group_id="O1">
            <title>Tralokinumab</title>
            <description>Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 26</title>
          <description>DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL.</description>
          <population>Full Set Analysis (FAS).</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="137"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.5" spread="0.4"/>
                    <measurement group_id="O2" value="-9.9" spread="0.4"/>
                  </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>Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.</non_inferiority_desc>
            <p_value>0.005</p_value>
            <p_value_desc>This endpoint was the ninth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.</p_value_desc>
            <method>Repeated measurements model</method>
            <method_desc>Unstructured covariance matrix. Adjusted for baseline DLQI in interaction with each visit, prior CSA use, and baseline disease severity (IGA 3 or 4)</method_desc>
            <param_type>Difference</param_type>
            <param_value>-1.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.7</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 26</title>
        <description>IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).</description>
        <time_frame>Week 26</time_frame>
        <population>Full analysis set (FAS).</population>
        <group_list>
          <group group_id="O1">
            <title>Tralokinumab+TCS</title>
            <description>Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+TCS</title>
            <description>Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 26</title>
          <description>IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).</description>
          <population>Full analysis set (FAS).</population>
          <units>Percentage of responders</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.0"/>
                    <measurement group_id="O2" value="33.4"/>
                  </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>Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.</non_inferiority_desc>
            <p_value>0.014</p_value>
            <p_value_desc>This endpoint was the tenth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.</p_value_desc>
            <method>Mantel Haenszel</method>
            <method_desc>Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.</method_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>14.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.9</ci_lower_limit>
            <ci_upper_limit>25.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40</title>
        <description>Presence of ADA from Week 0 to Week 40 was measured. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment.</description>
        <time_frame>Week 0 to Week 40</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tralokinumab+TCS</title>
            <description>Participants in the entire trial period, including the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed, and the safety follow-up period (up to Week 40).</description>
          </group>
          <group group_id="O2">
            <title>Placebo+TCS</title>
            <description>Participants in the entire trial period, including the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed, and the safety follow-up period (up to Week 40).</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40</title>
          <description>Presence of ADA from Week 0 to Week 40 was measured. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134"/>
                    <measurement group_id="O2" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Perishing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No post-baseline ADA assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Adverse Events From Week 0 to Week 40</title>
        <description>All adverse events are presented below under Adverse Events</description>
        <time_frame>Week 0 to Week 40</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tralokinumab+TCS</title>
            <description>Participants in the entire trial period, including the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed, and the safety follow-up period (up to Week 40).</description>
          </group>
          <group group_id="O2">
            <title>Placebo+TCS</title>
            <description>Participants in the entire trial period, including the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed, and the safety follow-up period (up to Week 40).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Adverse Events From Week 0 to Week 40</title>
          <description>All adverse events are presented below under Adverse Events</description>
          <units>number of adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="389"/>
                    <measurement group_id="O2" value="435"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40).</time_frame>
      <desc>The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo).&#xD;
In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment Period: Tralokinumab+TCS</title>
          <description>Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.&#xD;
For the treatment period, only AEs with a frequency above 2% will be reported. The exception is that AEs reported in the safety follow-up period will also be reported for the treatment period. The total AEs will represent all AEs reported in the treatment period.</description>
        </group>
        <group group_id="E2">
          <title>Treatment Period: Placebo+TCS</title>
          <description>Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed.&#xD;
Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.&#xD;
For the treatment period, only AEs with a frequency above 2% will be reported. The exception is that AEs reported in the safety follow-up period will also be reported for the treatment period. The total AEs will represent all AEs reported in the treatment period.</description>
        </group>
        <group group_id="E3">
          <title>Safety Follow-up Period: Tralokinumab+TCS</title>
          <description>Participants who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the participants during the safety follow-up period. Eligible participants were invited to enter a long-term extension trial conducted under a separate protocol (LP0162-1337, ECZTEND).&#xD;
For the safety follow-up period, all AEs will be reported.</description>
        </group>
        <group group_id="E4">
          <title>Safety Follow-up Period: Placebo+TCS</title>
          <description>Participants who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the participants during the safety follow-up period. Eligible participants were invited to enter a long-term extension trial conducted under a separate protocol (LP0162-1337, ECZTEND).&#xD;
For the safety follow-up period, all AEs will be reported.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Non-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="138"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="137"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Peripheral nerve injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </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="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </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="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Non-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="107" subjects_at_risk="138"/>
                <counts group_id="E2" subjects_affected="108" subjects_at_risk="137"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="138"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="138"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="138"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="138"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="138"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </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="138"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="53" subjects_affected="37" subjects_at_risk="138"/>
                <counts group_id="E2" events="46" subjects_affected="35" subjects_at_risk="137"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="138"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="138"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="138"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="138"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="138"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="138"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="138"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="138"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="138"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="138"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Dermatitis infected</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="138"/>
                <counts group_id="E2" events="10" subjects_affected="5" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="138"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="138"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="138"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="138"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="137"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="25" subjects_affected="21" subjects_at_risk="138"/>
                <counts group_id="E2" events="18" subjects_affected="13" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="83"/>
              </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="5" subjects_affected="4" subjects_at_risk="138"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="138"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </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="11" subjects_affected="7" subjects_at_risk="138"/>
                <counts group_id="E2" events="26" subjects_affected="16" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="12" subjects_affected="6" subjects_at_risk="138"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Diffuse alopecia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="138"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Alopecia areata</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="138"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Disclosure</name_or_title>
      <organization>LEO Pharma A/S</organization>
      <phone>44 94 58 88 ext +45</phone>
      <email>disclosure@leo-pharma.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/NCT03761537
org study id: LP0162-1346
nct id: NCT03761537
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Primary objective:

      To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is
      superior to placebo in combination with TCS in treating severe AD in subjects who are not
      adequately controlled with or have contraindications to oral cyclosporine A (CSA).

      Secondary objectives:

      To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of
      AD, itch, and health-related quality of life compared to placebo in combination with TCS.

      To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in
      subjects who are not adequately controlled with or have contraindications to oral CSA
      compared to placebo in combination with TCS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16
time frame: Week 0 to Week 16
description: EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
measure: Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16
time frame: Week 0 to Week 16
description: Subjects will assess their worst itch severity over the past 24 hours using an 11-point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.
measure: Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 16
time frame: Week 0 to Week 16
description: SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
measure: Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 16
time frame: Week 0 to Week 16
description: DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL.
measure: Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
time frame: Week 16
description: IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
measure: At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 26
time frame: Week 0 to Week 26
description: EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
measure: Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 26
time frame: Week 0 to Week 26
description: Subjects will assess their worst itch severity over the past 24 hours using an 11-point numeric rating scale ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.
measure: Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 26
time frame: Week 0 to Week 26
description: SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
measure: Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 26
time frame: Week 0 to Week 26
description: DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL.
measure: Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 26
time frame: Week 26
description: IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
measure: Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40
time frame: Week 0 to Week 40
description: Presence of ADA from Week 0 to Week 40 was measured. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment.
measure: Number of Adverse Events From Week 0 to Week 40
time frame: Week 0 to Week 40
description: All adverse events are presented below under Adverse Events
arm group label: Tralokinumab + TCS
arm group type: Experimental
description: 4 subcutaneous (SC) injections of tralokinumab 150 mg as a loading dose on Day 0, followed by 2 SC injections of tralokinumab 150 mg every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.
arm group label: Placebo + TCS
arm group type: Placebo Comparator
description: 4 subcutaneous (SC) injections of placebo as a loading dose on Day 0, followed by 2 SC injections of placebo every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.
intervention type: Drug
intervention name: Tralokinumab
description: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration.
arm group label: Tralokinumab + TCS
intervention type: Other
intervention name: Placebo
description: Placebo contains the same excipients in the same concentration only lacking tralokinumab.
arm group label: Placebo + TCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Expert
role: Study Director
affiliation: LEO Pharma
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country: Belgium
country: Czechia
country: France
country: Germany
country: Poland
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: Yes
provided document: 
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point of contact: 