<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/NCT03822832</url>
  </required_header>
  <id_info>
    <org_study_id>1368-0032</org_study_id>
    <nct_id>NCT03822832</nct_id>
  </id_info>
  <brief_title>A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated</brief_title>
  <official_title>Phase IIa, Multicentre, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Treatment With BI 655130 in Adult Patients With Moderate to Severe Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this trial is to investigate the safety, tolerability and efficacy&#xD;
      of BI 655130 in patients with Atopic Dermatitis (AD) following repeated intravenous&#xD;
      administrations compared to placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">July 22, 2020</completion_date>
  <primary_completion_date type="Actual">January 17, 2020</primary_completion_date>
  <phase>Phase 2</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>Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16</measure>
    <time_frame>Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.</time_frame>
    <description>Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.&#xD;
Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Drug Related Adverse Events (AEs)</measure>
    <time_frame>Up to 28 weeks, see endpoint description for more details.</time_frame>
    <description>Number of patients with drug related Adverse Events (AEs) reported separately in both for the double blind period as well as the re-allocation treatment period.&#xD;
Double blind period: Baseline (week 1) to the last study drug administration date (week 12) + Residual effects period (REP, 16 weeks). For patients who initiated the re-allocation treatment period the REP was shortened to the date of first re-allocation treatment period treatment administration. Up to a total time frame of 28 weeks.&#xD;
Re-allocation treatment period: Week 1 of re-allocation treatment period to the last study drug administration date (week 12 of re-allocation treatment period) + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4</measure>
    <time_frame>Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.</time_frame>
    <description>Absolute change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.&#xD;
Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4</measure>
    <time_frame>Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.</time_frame>
    <description>Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.&#xD;
Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With a 50% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16</measure>
    <time_frame>Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.</time_frame>
    <description>Proportion of patients with a 50% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With a 75% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16</measure>
    <time_frame>Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.</time_frame>
    <description>Proportion of patients with a 75% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 4</measure>
    <time_frame>Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.</time_frame>
    <description>SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed from none=0to severe=3. Severity scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale from 0 to 10, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.&#xD;
REML-based MMRM including fixed, categorical effects of treatment, visit, and Asian/Non-Asian as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 16</measure>
    <time_frame>Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.</time_frame>
    <description>SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed from none=0to severe=3. Severity scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale from 0 to 10, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.&#xD;
REML-based MMRM including fixed, categorical effects of treatment, visit, and Asian/Non-Asian as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16</measure>
    <time_frame>Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.</time_frame>
    <description>Number of patients achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16. IGA score allows investigators to assess the overall disease severity at one given time point. It is a 5-point scale with: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The overall IGA score includes the assessment of erythema, induration/papulation, lichenification, and oozing/crusting. For the first three sections the following scale will be used: &quot;None&quot;, &quot;Barely Perceptible&quot; (&quot;Minimal&quot; for lichenification), &quot;Slight but Definite&quot;, &quot;Clearly Perceptible&quot; or &quot;Marked&quot;. For oozing/crusting the available answers are &quot;None&quot; or &quot;Present.&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Dermatitis, Atopic</condition>
  <arm_group>
    <arm_group_label>Spesolimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>i.v.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>i.v.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 655130</intervention_name>
    <description>Solution for infusion</description>
    <arm_group_label>Spesolimab</arm_group_label>
    <other_name>Spesolimab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Solution for infusion</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed and dated written informed consent in accordance with Good Clinical Practice&#xD;
             (GCP) and local legislation prior to the start of any screening procedures&#xD;
&#xD;
          -  Male or female patients, 18 to 75 years of age at screening&#xD;
&#xD;
          -  Diagnosis of atopic dermatitis for at least 1 year&#xD;
&#xD;
          -  Moderate to severe atopic dermatitis defined as:&#xD;
&#xD;
               -  At least 10% Body Surface Area (BSA) of atopic dermatitis involvement at&#xD;
                  screening and baseline&#xD;
&#xD;
               -  Eczema Area and Severity Index (EASI) of at least 12 at screening and at least 16&#xD;
                  at baseline&#xD;
&#xD;
               -  Investigator Global Assessment (IGA) of at least 3 at screening and baseline&#xD;
&#xD;
          -  Documented history of inadequate response to topical corticosteroid as judged by the&#xD;
             investigator&#xD;
&#xD;
          -  Willing to use a standard emollient for the duration of the study&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) must be ready and able to use highly effective&#xD;
             methods of birth control per ICH M3 (R2) that result in a low failure rate of less&#xD;
             than 1% per year when used consistently and correctly. A list of contraception methods&#xD;
             meeting these criteria is provided in the patient information.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of topical corticosteroids or other agents for atopic dermatitis within 7 days&#xD;
             prior to first dose of trial treatment.&#xD;
&#xD;
          -  Use of systemic corticosteroids or other agents for atopic dermatitis within 4 weeks&#xD;
             prior to first dose of trial treatment.&#xD;
&#xD;
          -  Women who are pregnant, nursing, or who plan to become pregnant while in the trial.&#xD;
             Women who stop nursing before the study drug administration do not need to be excluded&#xD;
             from participating; they should refrain from breastfeeding up to 16 weeks after the&#xD;
             last study drug administration&#xD;
&#xD;
          -  Patient with a transplanted organ (with exception of a corneal transplant &gt; 12 weeks&#xD;
             prior to screening) or who have ever received stem cell therapy (e.g., Prochymal).&#xD;
&#xD;
          -  Any documented active or suspected malignancy or history of malignancy within 5 years&#xD;
             prior to the screening visit, except appropriately treated basal cell carcinoma of the&#xD;
             skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.&#xD;
&#xD;
          -  Use of any restricted medication or any drug considered likely to interfere with the&#xD;
             safe conduct of the study, as assessed by the investigator.&#xD;
&#xD;
          -  History of allergy/hypersensitivity to the systemically administered trial medication&#xD;
             agent or its excipients.&#xD;
&#xD;
          -  Active systemic infections (Fungal and bacterial disease) during the last 2 weeks&#xD;
             prior to first drug administration, per investigator assessment.&#xD;
&#xD;
          -  Relevant chronic or acute infections (exception: common cold) including human&#xD;
             immunodeficiency virus (HIV) or viral hepatitis. A patient can be re-screened if the&#xD;
             patient was treated and is cured from the acute infection.&#xD;
&#xD;
          -  Active or Latent Tuberculosis (TB):&#xD;
&#xD;
               -  Patients with active tuberculosis are excluded.&#xD;
&#xD;
               -  Patients with a positive QuantiFERON TB test during screening are excluded,&#xD;
                  unless:&#xD;
&#xD;
                    -  Patient had previous diagnosis of active or latent TB and has completed&#xD;
                       appropriate treatment per local practice/guidelines within the last 3 years&#xD;
                       and at least 6 months before first administration of trial medication under&#xD;
                       this protocol (patients may be re-screened once to meet this criterion)&#xD;
&#xD;
                    -  Patients with suspected false positive or indeterminate QuantiFERON TB&#xD;
                       result may be re-tested once&#xD;
&#xD;
                    -  If the QuantiFERON TB test result is not available or provides indeterminate&#xD;
                       results after repeat testing: A tuberculin skin test reaction ≥10mm (≥5mm if&#xD;
                       receiving ≥15mg/d prednisone or its equivalent) is considered positive.&#xD;
&#xD;
          -  Currently enrolled in another investigational device or drug trial, or less than 30&#xD;
             days or 5 half lives, whichever is longer since ending another investigational device&#xD;
             or drug trial(s), or receiving other investigational treatment(s).&#xD;
&#xD;
          -  Evidence of a current or previous disease, medical condition (including chronic&#xD;
             alcohol or drug abuse or any condition) other than AD, surgical procedure, psychiatric&#xD;
             or social problems, medical examination finding (including vital signs and ECG), or&#xD;
             laboratory value at the screening outside the reference range that in the opinion of&#xD;
             the investigator is clinically significant and would make the study participant&#xD;
             unreliable to adhere to the protocol, comply with all study visits/procedures or to&#xD;
             complete the trial, compromise the safety of the patient or compromise the quality of&#xD;
             the data.&#xD;
&#xD;
          -  Major surgery (major according to the investigator) performed within 12 weeks prior to&#xD;
             first study drug adminstration or planned during the study (e.g. hip replacement,&#xD;
             aneurysm removal, stomach ligation).&#xD;
&#xD;
          -  Severe, progressive, or uncontrolled hepatic disease, defined as &gt;3-fold Upper Limit&#xD;
             of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or &gt;2-fold ULN&#xD;
             elevation in total bilirubin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Center for Dermatology and Plastic Surgery</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Physiology Associates</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Finlay Medical Research Corp</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ForCare Clinical Research, Inc.</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Indiana Clinical Trials Center, PC</name>
      <address>
        <city>Plainfield</city>
        <state>Indiana</state>
        <zip>46168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unity Clinical Research</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Treatment and Research Center, PA</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Clinical Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Studies</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta Hospital (University of Alberta)</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NewLab Clinical Research Inc.</name>
      <address>
        <city>St. John's</city>
        <state>Newfoundland and Labrador</state>
        <zip>A1C 2H5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovaderm Research Inc.</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 2V1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Medical University Hospital</name>
      <address>
        <city>Aichi, Nagakute</city>
        <zip>480-1195</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Medical Center</name>
      <address>
        <city>Fukuoka, Fukuoka</city>
        <zip>810-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital</name>
      <address>
        <city>Fukuoka, Kurume</city>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosui General Medical Clinic</name>
      <address>
        <city>Hokkaido, Sapporo</city>
        <zip>064-0807</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennocho Ekimae Dermatology and Allergology</name>
      <address>
        <city>Kanagawa, Yokohama</city>
        <zip>240-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Kyoto Prefectural University of Medicine</name>
      <address>
        <city>Kyoto, Kyoto</city>
        <zip>602-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagasaki University Hospital</name>
      <address>
        <city>Nagasaki, Nagasaki</city>
        <zip>852-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka City University Hospital</name>
      <address>
        <city>Osaka, Osaka</city>
        <zip>545- 8586</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hachioji Medical Center</name>
      <address>
        <city>Tokyo, Hachioji</city>
        <zip>193-0998</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Showa University Hospital</name>
      <address>
        <city>Tokyo, Shinagawa-ku</city>
        <zip>142-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Japan</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <results_first_submitted>September 26, 2022</results_first_submitted>
  <results_first_submitted_qc>November 15, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 1, 2022</results_first_posted>
  <disposition_first_submitted>December 16, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>November 15, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 1, 2022</disposition_first_posted>
  <last_update_submitted>November 15, 2022</last_update_submitted>
  <last_update_submitted_qc>November 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed &quot;Document Sharing Agreement&quot;. Also, Researchers can use the following link http://trials.boehringer-ingelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.</ipd_time_frame>
    <ipd_access_criteria>For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.</ipd_access_criteria>
    <ipd_url>https://trials.boehringer-ingelheim.com</ipd_url>
  </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>February 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03822832/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>August 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03822832/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a phase IIa multicentre, randomized, double-blind, placebocontrolled, study to evaluate the safety, tolerability and efficacy of treatment with BI 655130 in adult patients with moderate to severe atopic dermatitis.</recruitment_details>
      <pre_assignment_details>All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo Intravenous Every 4 Weeks</title>
          <description>Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
        </group>
        <group group_id="P2">
          <title>Spesolimab 600 mg Intravenous Every 4 Weeks</title>
          <description>600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1 - Double Blind Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Re-allocation</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6">Patient re-allocated to open label Spesolimab treatment</participants>
                <participants group_id="P2" count="16">Patient re-allocated to open label Spesolimab treatment</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Not re-allocated to open label period</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2 - Open Label Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6">Patient re-allocated to open label Spesolimab treatment</participants>
                <participants group_id="P2" count="16">Patient re-allocated to open label Spesolimab treatment</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Randomized set (RS): this patient set includes all patients who were randomized into the trial. It will be used for display of patient disposition, baseline and demographic characteristics, and patients with IPDs (Important Protocol Deviations).</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo Intravenous Every 4 Weeks</title>
          <description>Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
        </group>
        <group group_id="B2">
          <title>Spesolimab 600 mg Intravenous Every 4 Weeks</title>
          <description>600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</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="18"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="51"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.4" spread="12.4"/>
                    <measurement group_id="B2" value="43.2" spread="15.9"/>
                    <measurement group_id="B3" value="39.4" spread="15.5"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="25"/>
                  </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>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="42"/>
                  </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>
              <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="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="24"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eczema Area and Severity Index (EASI) Score</title>
          <description>Eczema Area and Severity Index (EASI) Score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.</description>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.43" spread="8.60"/>
                    <measurement group_id="B2" value="26.53" spread="10.07"/>
                    <measurement group_id="B3" value="26.50" spread="9.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>SCORing of Atopic Dermatitis (SCORAD)</title>
          <description>SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to A (0-100). Intensity (B): intensity of each sign was assessed from none=0 to severe=3. Scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored using visual analogue scale from 0 to 10, higher scores=worse. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse.</description>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.82" spread="14.13"/>
                    <measurement group_id="B2" value="60.09" spread="10.36"/>
                    <measurement group_id="B3" value="61.06" spread="11.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Investigator's Global Assessment (IGA) score</title>
          <description>Investigator's Global Assessment (IGA) score allows investigators to assess the overall disease severity at one given time point. It is a 5-point scale with: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The overall IGA score includes the assessment of erythema, induration/papulation, lichenification, and oozing/crusting. For the first three sections the following scale will be used: &quot;None&quot;, &quot;Barely Perceptible&quot; (&quot;Minimal&quot; for lichenification), &quot;Slight but Definite&quot;, &quot;Clearly Perceptible&quot; or &quot;Marked&quot;. For oozing/crusting the available answers are &quot;None&quot; or &quot;Present.&quot;</description>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.4" spread="0.5"/>
                    <measurement group_id="B2" value="3.2" spread="0.4"/>
                    <measurement group_id="B3" value="3.3" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16</title>
        <description>Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.&#xD;
Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.</description>
        <time_frame>Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.</time_frame>
        <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Intravenous Every 4 Weeks</title>
            <description>Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
          <group group_id="O2">
            <title>Spesolimab 600 mg Intravenous Every 4 Weeks</title>
            <description>600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16</title>
          <description>Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.&#xD;
Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.</description>
          <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
          <units>Percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.3" spread="14.3"/>
                    <measurement group_id="O2" value="-37.9" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1492</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>See endpoint description for model description.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-25.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>17.4</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-54.9</ci_lower_limit>
            <ci_upper_limit>3.7</ci_upper_limit>
            <estimate_desc>Difference calculated as Spesolimab - Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Drug Related Adverse Events (AEs)</title>
        <description>Number of patients with drug related Adverse Events (AEs) reported separately in both for the double blind period as well as the re-allocation treatment period.&#xD;
Double blind period: Baseline (week 1) to the last study drug administration date (week 12) + Residual effects period (REP, 16 weeks). For patients who initiated the re-allocation treatment period the REP was shortened to the date of first re-allocation treatment period treatment administration. Up to a total time frame of 28 weeks.&#xD;
Re-allocation treatment period: Week 1 of re-allocation treatment period to the last study drug administration date (week 12 of re-allocation treatment period) + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks.</description>
        <time_frame>Up to 28 weeks, see endpoint description for more details.</time_frame>
        <population>Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial.&#xD;
Re-allocation treatment period: This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Intravenous Every 4 Weeks</title>
            <description>Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
          <group group_id="O2">
            <title>Spesolimab 600 mg Intravenous Every 4 Weeks</title>
            <description>600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Drug Related Adverse Events (AEs)</title>
          <description>Number of patients with drug related Adverse Events (AEs) reported separately in both for the double blind period as well as the re-allocation treatment period.&#xD;
Double blind period: Baseline (week 1) to the last study drug administration date (week 12) + Residual effects period (REP, 16 weeks). For patients who initiated the re-allocation treatment period the REP was shortened to the date of first re-allocation treatment period treatment administration. Up to a total time frame of 28 weeks.&#xD;
Re-allocation treatment period: Week 1 of re-allocation treatment period to the last study drug administration date (week 12 of re-allocation treatment period) + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks.</description>
          <population>Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial.&#xD;
Re-allocation treatment period: This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Double blind treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Re-allocation treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4</title>
        <description>Absolute change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.&#xD;
Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.</description>
        <time_frame>Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.</time_frame>
        <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Intravenous Every 4 Weeks</title>
            <description>Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
          <group group_id="O2">
            <title>Spesolimab 600 mg Intravenous Every 4 Weeks</title>
            <description>600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4</title>
          <description>Absolute change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.&#xD;
Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.</description>
          <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
          <units>Change in score 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="16"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.0" spread="3.0"/>
                    <measurement group_id="O2" value="-6.3" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8613</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>See endpoint description for model description.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.8</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.7</ci_lower_limit>
            <ci_upper_limit>7.0</ci_upper_limit>
            <estimate_desc>Difference calculated as Spesolimab - Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4</title>
        <description>Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.&#xD;
Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.</description>
        <time_frame>Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.</time_frame>
        <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Intravenous Every 4 Weeks</title>
            <description>Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
          <group group_id="O2">
            <title>Spesolimab 600 mg Intravenous Every 4 Weeks</title>
            <description>600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4</title>
          <description>Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.&#xD;
Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.</description>
          <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
          <units>Percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.6" spread="11.3"/>
                    <measurement group_id="O2" value="-23.8" spread="8.3"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8754</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>See endpoint description for model description.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>14.0</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.8</ci_lower_limit>
            <ci_upper_limit>21.4</ci_upper_limit>
            <estimate_desc>Difference calculated as Spesolimab - Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With a 50% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16</title>
        <description>Proportion of patients with a 50% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.</description>
        <time_frame>Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.</time_frame>
        <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Intravenous Every 4 Weeks</title>
            <description>Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
          <group group_id="O2">
            <title>Spesolimab 600 mg Intravenous Every 4 Weeks</title>
            <description>600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With a 50% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16</title>
          <description>Proportion of patients with a 50% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.</description>
          <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
          <units>Proportion of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.333"/>
                    <measurement group_id="O2" value="0.303"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.056"/>
                    <measurement group_id="O2" value="0.303"/>
                  </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>Risk difference at week 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-0.030</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.254</ci_lower_limit>
            <ci_upper_limit>0.176</ci_upper_limit>
            <estimate_desc>Difference calculated as Spesolimab - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Risk difference at week 16</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>0.247</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.053</ci_lower_limit>
            <ci_upper_limit>0.396</ci_upper_limit>
            <estimate_desc>Difference calculated as Spesolimab - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With a 75% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16</title>
        <description>Proportion of patients with a 75% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.</description>
        <time_frame>Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.</time_frame>
        <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Intravenous Every 4 Weeks</title>
            <description>Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
          <group group_id="O2">
            <title>Spesolimab 600 mg Intravenous Every 4 Weeks</title>
            <description>600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With a 75% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16</title>
          <description>Proportion of patients with a 75% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.</description>
          <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
          <units>Proportion of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.111"/>
                    <measurement group_id="O2" value="0.091"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.056"/>
                    <measurement group_id="O2" value="0.152"/>
                  </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>Risk difference at week 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-0.020</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.204</ci_lower_limit>
            <ci_upper_limit>0.117</ci_upper_limit>
            <estimate_desc>Difference calculated as Spesolimab - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Risk difference at week 16</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>0.096</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.080</ci_lower_limit>
            <ci_upper_limit>0.232</ci_upper_limit>
            <estimate_desc>Difference calculated as Spesolimab - Pl</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 4</title>
        <description>SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed from none=0to severe=3. Severity scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale from 0 to 10, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.&#xD;
REML-based MMRM including fixed, categorical effects of treatment, visit, and Asian/Non-Asian as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.</description>
        <time_frame>Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.</time_frame>
        <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Intravenous Every 4 Weeks</title>
            <description>Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
          <group group_id="O2">
            <title>Spesolimab 600 mg Intravenous Every 4 Weeks</title>
            <description>600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 4</title>
          <description>SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed from none=0to severe=3. Severity scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale from 0 to 10, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.&#xD;
REML-based MMRM including fixed, categorical effects of treatment, visit, and Asian/Non-Asian as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.</description>
          <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
          <units>Change in score 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="16"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.3" spread="7.0"/>
                    <measurement group_id="O2" value="-13.2" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9900</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>See endpoint description for model description.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.7</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.6</ci_lower_limit>
            <ci_upper_limit>14.8</ci_upper_limit>
            <estimate_desc>Difference calculated as Spesolimab - Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 16</title>
        <description>SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed from none=0to severe=3. Severity scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale from 0 to 10, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.&#xD;
REML-based MMRM including fixed, categorical effects of treatment, visit, and Asian/Non-Asian as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.</description>
        <time_frame>Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.</time_frame>
        <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Intravenous Every 4 Weeks</title>
            <description>Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
          <group group_id="O2">
            <title>Spesolimab 600 mg Intravenous Every 4 Weeks</title>
            <description>600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 16</title>
          <description>SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed from none=0to severe=3. Severity scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale from 0 to 10, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.&#xD;
REML-based MMRM including fixed, categorical effects of treatment, visit, and Asian/Non-Asian as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.</description>
          <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
          <units>Change in score 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="12"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.7" spread="10.0"/>
                    <measurement group_id="O2" value="-25.5" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2266</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>See endpoint description for model description.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-14.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>12.1</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-35.2</ci_lower_limit>
            <ci_upper_limit>5.5</ci_upper_limit>
            <estimate_desc>Difference calculated as Spesolimab - Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16</title>
        <description>Number of patients achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16. IGA score allows investigators to assess the overall disease severity at one given time point. It is a 5-point scale with: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The overall IGA score includes the assessment of erythema, induration/papulation, lichenification, and oozing/crusting. For the first three sections the following scale will be used: &quot;None&quot;, &quot;Barely Perceptible&quot; (&quot;Minimal&quot; for lichenification), &quot;Slight but Definite&quot;, &quot;Clearly Perceptible&quot; or &quot;Marked&quot;. For oozing/crusting the available answers are &quot;None&quot; or &quot;Present.&quot;</description>
        <time_frame>Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.</time_frame>
        <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Intravenous Every 4 Weeks</title>
            <description>Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
          <group group_id="O2">
            <title>Spesolimab 600 mg Intravenous Every 4 Weeks</title>
            <description>600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI&lt;75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16</title>
          <description>Number of patients achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16. IGA score allows investigators to assess the overall disease severity at one given time point. It is a 5-point scale with: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The overall IGA score includes the assessment of erythema, induration/papulation, lichenification, and oozing/crusting. For the first three sections the following scale will be used: &quot;None&quot;, &quot;Barely Perceptible&quot; (&quot;Minimal&quot; for lichenification), &quot;Slight but Definite&quot;, &quot;Clearly Perceptible&quot; or &quot;Marked&quot;. For oozing/crusting the available answers are &quot;None&quot; or &quot;Present.&quot;</description>
          <population>Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="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>Risk difference at week 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>0.005</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.159</ci_lower_limit>
            <ci_upper_limit>0.120</ci_upper_limit>
            <estimate_desc>Difference calculated as Spesolimab - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Risk difference at week 16</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>0.091</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.050</ci_lower_limit>
            <ci_upper_limit>0.207</ci_upper_limit>
            <estimate_desc>Difference calculated as Spesolimab - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44).</time_frame>
      <desc>Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial.&#xD;
Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo (Week 1-16) and if no Treatment, Week 16-28</title>
          <description>Placebo intravenous (i.v.) infusion in the double blind period from baseline to Week 12 (inclusive) - the drug administered 4 times in total. At Week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score. Patients with EASI&gt;=75 were classified as responders and were followed-up from Week 16 to 28, although receiving no further treatment. Patients with EASI&lt;75 were classified as nonresponders and were offered 600mg Spesolimab treatment in the open label period from Week 16 to 28.</description>
        </group>
        <group group_id="E2">
          <title>Spesolimab (Week 1-16) and no Treatment (Week 16-28)</title>
          <description>600mg Spesolimab (BI 655130) intravenous (i.v.) infusion in the double blind period from baseline to Week 12 (inclusive) - the drug administered 4 times in total. At Week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score. Patients with EASI&gt;=75 were classified as responders and were followed-up from Week 16 to 28, although receiving no further treatment. Patients with EASI&lt;75 were classified as non-responders and were offered 600mg Spesolimab treatment in the open label period from Week 16 to 28.</description>
        </group>
        <group group_id="E3">
          <title>Spesolimab (Open Label Period, Week 16-44)</title>
          <description>Following the double blind period (week 0 to 16) patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI&lt;75 were classified as nonresponders and were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28), end of study is at week 44.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
              </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" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dermatitis exfoliative generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Beta haemolytic streptococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Staphylococcal skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Blood urine present</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Cold urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </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>Boehringer Ingelheim, Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.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/NCT03822832
org study id: 1368-0032
nct id: NCT03822832
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this trial is to investigate the safety, tolerability and efficacy
      of BI 655130 in patients with Atopic Dermatitis (AD) following repeated intravenous
      administrations compared to placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16
time frame: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.
description: Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.
Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.
measure: Number of Patients With Drug Related Adverse Events (AEs)
time frame: Up to 28 weeks, see endpoint description for more details.
description: Number of patients with drug related Adverse Events (AEs) reported separately in both for the double blind period as well as the re-allocation treatment period.
Double blind period: Baseline (week 1) to the last study drug administration date (week 12) + Residual effects period (REP, 16 weeks). For patients who initiated the re-allocation treatment period the REP was shortened to the date of first re-allocation treatment period treatment administration. Up to a total time frame of 28 weeks.
Re-allocation treatment period: Week 1 of re-allocation treatment period to the last study drug administration date (week 12 of re-allocation treatment period) + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks.
measure: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4
time frame: Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.
description: Absolute change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.
Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.
measure: Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4
time frame: Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.
description: Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.
Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.
measure: Proportion of Patients With a 50% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16
time frame: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.
description: Proportion of patients with a 50% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.
measure: Proportion of Patients With a 75% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16
time frame: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.
description: Proportion of patients with a 75% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.
measure: Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 4
time frame: Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.
description: SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed from none=0to severe=3. Severity scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale from 0 to 10, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
REML-based MMRM including fixed, categorical effects of treatment, visit, and Asian/Non-Asian as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.
measure: Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 16
time frame: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.
description: SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed from none=0to severe=3. Severity scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale from 0 to 10, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
REML-based MMRM including fixed, categorical effects of treatment, visit, and Asian/Non-Asian as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.
measure: Number of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16
time frame: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.
description: Number of patients achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16. IGA score allows investigators to assess the overall disease severity at one given time point. It is a 5-point scale with: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The overall IGA score includes the assessment of erythema, induration/papulation, lichenification, and oozing/crusting. For the first three sections the following scale will be used: "None", "Barely Perceptible" ("Minimal" for lichenification), "Slight but Definite", "Clearly Perceptible" or "Marked". For oozing/crusting the available answers are "None" or "Present."
arm group label: Spesolimab
arm group type: Experimental
description: i.v.
arm group label: Placebo
arm group type: Placebo Comparator
description: i.v.
intervention type: Drug
intervention name: BI 655130
description: Solution for infusion
arm group label: Spesolimab
other name: Spesolimab
intervention type: Drug
intervention name: Placebo
description: Solution for infusion
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
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facility: 
country: Canada
country: Japan
country: United States
url: https://www.mystudywindow.com
description: Related Info
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
sharing ipd: Yes
ipd description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringer-ingelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
ipd access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
ipd url: https://trials.boehringer-ingelheim.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 