<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/NCT02194699</url>
  </required_header>
  <id_info>
    <org_study_id>D2210C00008</org_study_id>
    <nct_id>NCT02194699</nct_id>
  </id_info>
  <brief_title>A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma</brief_title>
  <acronym>STRATOS2</acronym>
  <official_title>A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</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>
      A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3&#xD;
      Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with&#xD;
      Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, parallel group, placebo-controlled study designed to&#xD;
      evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with&#xD;
      uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a&#xD;
      history of asthma exacerbations. Approximately 770 subjects will be randomized globally.&#xD;
      Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at&#xD;
      the study site, over a 52-week treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2014</start_date>
  <completion_date type="Actual">September 21, 2017</completion_date>
  <primary_completion_date type="Actual">May 10, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Annualised Asthma Exacerbation Rate (AAER) up to Week 52</measure>
    <time_frame>Baseline (Week 0) up to Week 52</time_frame>
    <description>Asthma exacerbation was defined as a worsening of asthma that led to any of the following:&#xD;
Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.&#xD;
An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for &lt;24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above).&#xD;
An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma.&#xD;
AAER = number of exacerbations*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).&#xD;
AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)</measure>
    <time_frame>Baseline (Week 0) and Week 52</time_frame>
    <description>Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorised delegate according to American Thoracic Society/European Respiratory Society guidelines. The mean percent change from baseline in pre-BD FEV1 at Week 52 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)</measure>
    <time_frame>Baseline (Week 0) and Week 52</time_frame>
    <description>Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary. Symptoms were recorded using a 4-point response scale, which ranged from 0 to 3, where 0 indicated no asthma symptoms. Asthma symptom daytime score (recorded in the evening), night-time score (recorded in the morning), and total score were calculated separately. The daily asthma symptom total score was calculated by taking the sum of the night-time and daytime asthma symptom scores recorded each day, ranging from 0 to 6. A lower symptom score indicated a better outcome. The change from baseline in bi-weekly mean daily asthma symptom total score is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score</measure>
    <time_frame>Baseline (Week 0) and Week 52</time_frame>
    <description>The AQLQ(S)+12 is a questionnaire that measures health-related quality of life for patients with asthma aged 12 and older. The questionnaire comprises 32 questions and has 4 separate domains (asthma symptoms, activity limitations, emotional function and environmental stimuli). Patients were asked to recall their experiences during the previous 2 weeks and to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The total score was calculated as the mean response to all questions, ranging from 1 (severe impairment) to 7 (no impairment). Individual AQLQ(S)+12 total score changes of ≥0.5 were considered to be clinically meaningful. The mean change from baseline in AQLQ(S)+12 score at Week 52 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score</measure>
    <time_frame>Baseline (Week 0) and Week 52</time_frame>
    <description>The ACQ-6 questionnaire is a shortened version of the ACQ (omitting FEV1 measurement) that assesses asthma symptoms (night-time awakenings, symptoms on waking, activity limitation, dyspnoea, wheezing) and rescue short-acting β2-agonists medication use during the past week. Questions were weighted equally and scored on a 7-point scale from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma and a score &gt;1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 were considered to be clinically meaningful. The mean change from baseline in ACQ-6 score at Week 52 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52</measure>
    <time_frame>Baseline (Week 0) up to Week 52</time_frame>
    <description>The annual rate of exacerbations associated with an ER/UC visit or hospitalisation up to Week 52 are presented for non-adjudicated data (i.e. events assessed by the Investigator and recorded in the electronic case report form).&#xD;
AAER = number of exacerbations*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52</measure>
    <time_frame>Baseline (Week 0) and Week 52</time_frame>
    <description>The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The patient was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The questionnaire also included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. The mean change from baseline in EQ-5D-5L VAS scores at Week 52 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means)</measure>
    <time_frame>Baseline (Week 0) and Week 52</time_frame>
    <description>Salbutamol, albuterol or levalbuterol were used as rescue medication during the study in the event of a worsening of asthma symptoms. Rescue medication use was measured by the bi-weekly mean number of inhalations (puffs) per day, calculated as: total morning puffs + total evening puffs + 2*(total morning nebuliser use + total evening nebuliser use)/ total number of days with data in bi-weekly period. The change from baseline in bi-weekly mean total asthma rescue medication use at Week 52 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52</measure>
    <time_frame>Baseline (Week 0) and Week 52</time_frame>
    <description>Home PEF testing was performed by the patient using an electronic, hand-held spirometer (peak flow meter) and was performed in the morning upon awakening (prior to taking their morning asthma controller) and in the evening at bedtime (prior to taking their evening asthma controller). The mean change from baseline in home PEF values at Week 52 are presented separately for morning and evening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage])</measure>
    <time_frame>Baseline (Week 0) and Week 52</time_frame>
    <description>The patient captured night-time awakenings (yes/no) and the use of rescue medication during these awakenings (yes/no) each morning in the Asthma Daily Diary. Night-time awakenings (percentage) was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data. The change from baseline in bi-weekly means (percentage) night-time awakenings due to asthma requiring rescue medication use at Week 52 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With ≥1 Asthma Exacerbation up to Week 52</measure>
    <time_frame>Baseline (Week 0) up to Week 52</time_frame>
    <description>The number of patients with ≥1 asthma exacerbation up to Week 52 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52</measure>
    <time_frame>At Week 52</time_frame>
    <description>The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days.&#xD;
The WPAI+CIQ outcomes for productivity loss are presented separately for those currently employed and for those currently in school and are expressed as mean productivity loss (percentage) at Week 52, with higher numbers indicating less productivity.&#xD;
Work Productivity Loss = {Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]}*100 (Absenteeism = Q2/(Q2+Q4)*100; Presenteeism = (Q5/10)*100).&#xD;
Class Productivity Loss = {Q7/(Q7+Q8) + [(1-Q7/(Q7+Q8))x(Q9/10)]}*100 (Absenteeism = Q7/(Q7+Q8)*100; Presenteeism = (Q9/10)*100).&#xD;
Note: QX refers to response to question number X on WPAI+CIQ questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WPAI+CIQ: Activity Impairment at Week 52</measure>
    <time_frame>At Week 52</time_frame>
    <description>The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days.&#xD;
The WPAI+CIQ outcomes for activity impairment are presented separately for those currently employed and for those currently in school and are expressed as mean impairment percentages at Week 52, with higher numbers indicating greater impairment.&#xD;
Activity impairment = (Q10/10)*100. Note: QX refers to response to question number X on WPAI+CIQ questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma-related Healthcare Encounters by Type up to Week 52</measure>
    <time_frame>Baseline (Week 0) up to Week 52</time_frame>
    <description>Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of times the healthcare encounter occurred was calculated across all patients for each of the following categories:&#xD;
Ambulance transport,&#xD;
Emergency room visits,&#xD;
Unscheduled outpatient visits (visit to specialist and/or visit to primary healthcare physician and/or other healthcare visit),&#xD;
Home visits (home visit, physician and/or other healthcare professional),&#xD;
Telephone calls (telephone calls to physician and/or nurse), and&#xD;
Advanced pulmonary function test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations</measure>
    <time_frame>Baseline (Week 0) up to Week 52</time_frame>
    <description>Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of days spent in hospital was calculated across all patients for the following healthcare encounter category:&#xD;
• Hospitalisations (hospitalisations, intensive care and/or general care).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry</measure>
    <time_frame>Baseline (Week 0) up to Week 52</time_frame>
    <description>Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of assessments was calculated across all patients for the following healthcare encounter category:&#xD;
• Spirometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72</measure>
    <time_frame>Blood samples were collected pre-dose at Baseline (Week 0), and at Week 2, Week 8, Week 26, Week 56 (follow-up) and Week 72 (follow-up)</time_frame>
    <description>To evaluate the pharmacokinetics (PK), pre-dose blood samples were collected at each visit and tralokinumab concentrations in serum were determined. Mean Ctrough concentrations are presented at each indicated visit up to Week 72.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential</measure>
    <time_frame>Baseline (Week 0), Week 26, Week 56 (follow-up) and Week 72 (follow-up)</time_frame>
    <description>Assessments of ADA were performed using a tiered approach (screening, confirmatory and titering assays). Confirmed ADA positive samples were also tested for the presence of neutralising antibodies (nAb). ADA prevalence was defined as proportion of the study population having drug-reactive antibodies at any point in time. ADA incidence (treatment-emergent ADA) was defined as the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher level following drug administration. Note: 'positive' is denoted by 'pos' in some category titles.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">856</enrollment>
  <condition>Uncontrolled Asthma</condition>
  <arm_group>
    <arm_group_label>Tralokinumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tralokinumab subcutaneous injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo subcutaneous injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Experimental: Tralokinumab</intervention_name>
    <description>Tralokinumab subcutaneous injection</description>
    <arm_group_label>Tralokinumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo subcutaneous injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 12 -75&#xD;
&#xD;
          2. Documented physician-diagnosed asthma.&#xD;
&#xD;
          3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg&#xD;
             fluticasone propionate dry powder formulation equivalents) and a LABA&#xD;
&#xD;
          4. Morning pre-BD FEV1 value of ≥40 and &lt;80% value (&lt;90% for patients 12 to 17 years of&#xD;
             age) of their PNV.&#xD;
&#xD;
          5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1&#xD;
&#xD;
          6. ACQ-6 score ≥1.5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pulmonary disease other than asthma&#xD;
&#xD;
          2. History of anaphylaxis following any biologic therapy&#xD;
&#xD;
          3. Hepatitis B, C or HIV&#xD;
&#xD;
          4. Pregnant or breastfeeding&#xD;
&#xD;
          5. History of cancer&#xD;
&#xD;
          6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years&#xD;
&#xD;
          7. Previous receipt of tralokinumab&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher Brightling, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Lung Health, United Kingdom</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hoover</city>
        <state>Alabama</state>
        <zip>35244</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Buena Park</city>
        <state>California</state>
        <zip>90620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lakewood</city>
        <state>California</state>
        <zip>90805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lomita</city>
        <state>California</state>
        <zip>90717</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Palmdale</city>
        <state>California</state>
        <zip>93551</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>91360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003-3099</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Celebration</city>
        <state>Florida</state>
        <zip>34747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33142</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
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        <city>Kharkiv</city>
        <zip>61035</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kharkiv</city>
        <zip>61075</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kremenchuk</city>
        <zip>39617</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyiv</city>
        <zip>03049</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyiv</city>
        <zip>03680</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyiv</city>
        <zip>04050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lviv</city>
        <zip>79010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Odesa</city>
        <zip>65025</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sumy</city>
        <zip>40000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sumy</city>
        <zip>40022</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Uzhgorod</city>
        <zip>88009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zaporizhzhya</city>
        <zip>69068</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zaporizhzhya</city>
        <zip>69114</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bradford</city>
        <zip>BD9 6RJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chertsey</city>
        <zip>KT16 0PZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Glasgow</city>
        <zip>G12 OYN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leicester</city>
        <zip>LE3 9QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Liverpool</city>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9QZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Northwood</city>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sidcup</city>
        <zip>DA14 6LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wishaw</city>
        <zip>ML2 0DP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Chile</country>
    <country>Czechia</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Mexico</country>
    <country>Philippines</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <results_first_submitted>February 23, 2018</results_first_submitted>
  <results_first_submitted_qc>February 23, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 21, 2018</results_first_posted>
  <last_update_submitted>April 13, 2018</last_update_submitted>
  <last_update_submitted_qc>April 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This is commercially sensitive information.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 9, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT02194699/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT02194699/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>First patient enrolled: 30 Oct 2014; Last Patient Last Visit: 21 Sep 2017. Study performed at 242 sites in 13 countries.&#xD;
Patients were maintained on their currently prescribed inhaled corticosteroid long-acting β2-agonist therapy and any additional maintenance asthma controller medications throughout the study period.</recruitment_details>
      <pre_assignment_details>1696 patients signed informed consent, 1163 entered screening/run-in period, 856 patients were randomised to receive investigational product (IP) and 849 received treatment.&#xD;
The primary population was the biomarker positive population, defined as all patients with baseline fractional exhaled nitric oxide (FeNO) ≥37 parts per billion (ppb).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Tralo 300 mg Q2W</title>
          <description>Tralokinumab 300 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) over a 52-week treatment period (up to 26 doses).</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Randomised</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="428"/>
                <participants group_id="P2" count="428"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="420"/>
                <participants group_id="P2" count="417"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not receive treatment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Without potential for 52 weeks of IP</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Duplicate patient</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>With Potential to Receive 52 Weeks of IP</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="420">Includes all patients randomised with the potential to receive 52 weeks of IP and receiving any IP.</participants>
                <participants group_id="P2" count="417">Includes all patients randomised with the potential to receive 52 weeks of IP and receiving any IP.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="370"/>
                <participants group_id="P2" count="365"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <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="5"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All patients in the full analysis set (FAS) with the potential to receive 52 weeks of IP and who received any IP (tralokinumab or placebo) were included in the baseline analysis.</population>
      <group_list>
        <group group_id="B1">
          <title>Tralo 300 mg Q2W</title>
          <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</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="420"/>
            <count group_id="B2" value="417"/>
            <count group_id="B3" value="837"/>
          </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="47.3" spread="15.6"/>
                    <measurement group_id="B2" value="48.0" spread="15.5"/>
                    <measurement group_id="B3" value="47.6" 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="276"/>
                    <measurement group_id="B2" value="290"/>
                    <measurement group_id="B3" value="566"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="144"/>
                    <measurement group_id="B2" value="127"/>
                    <measurement group_id="B3" value="271"/>
                  </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="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="171"/>
                  </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="27"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="283"/>
                    <measurement group_id="B2" value="281"/>
                    <measurement group_id="B3" value="564"/>
                  </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="24"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Annualised Asthma Exacerbation Rate (AAER) up to Week 52</title>
        <description>Asthma exacerbation was defined as a worsening of asthma that led to any of the following:&#xD;
Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.&#xD;
An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for &lt;24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above).&#xD;
An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma.&#xD;
AAER = number of exacerbations*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).&#xD;
AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses.</description>
        <time_frame>Baseline (Week 0) up to Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>Annualised Asthma Exacerbation Rate (AAER) up to Week 52</title>
          <description>Asthma exacerbation was defined as a worsening of asthma that led to any of the following:&#xD;
Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.&#xD;
An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for &lt;24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above).&#xD;
An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma.&#xD;
AAER = number of exacerbations*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).&#xD;
AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses.</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.</population>
          <units>Events/year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="121"/>
                <count group_id="O3" value="308"/>
                <count group_id="O4" value="290"/>
                <count group_id="O5" value="420"/>
                <count group_id="O6" value="417"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" lower_limit="0.57" upper_limit="1.11"/>
                    <measurement group_id="O2" value="0.95" lower_limit="0.68" upper_limit="1.31"/>
                    <measurement group_id="O3" value="0.87" lower_limit="0.71" upper_limit="1.06"/>
                    <measurement group_id="O4" value="0.77" lower_limit="0.63" upper_limit="0.95"/>
                    <measurement group_id="O5" value="0.84" lower_limit="0.71" upper_limit="1.00"/>
                    <measurement group_id="O6" value="0.82" lower_limit="0.69" upper_limit="0.97"/>
                  </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>Comparison of AAER (rate ratio): Biomarker positive population; Tralo 300 mg Q2W vs placebo.&#xD;
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.</non_inferiority_desc>
            <p_value>0.4656</p_value>
            <method>Negative binomial</method>
            <param_type>Rate ratio</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>1.34</ci_upper_limit>
            <estimate_desc>Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of AAER (rate ratio): Biomarker negative population; Tralo 300 mg Q2W vs placebo.&#xD;
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.</non_inferiority_desc>
            <p_value>0.4126</p_value>
            <method>Negative binomial</method>
            <param_type>Rate ratio</param_type>
            <param_value>1.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.50</ci_upper_limit>
            <estimate_desc>Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of AAER (rate reduction): Biomarker positive population; Tralo 300 mg Q2W vs placebo.&#xD;
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.</non_inferiority_desc>
            <p_value>0.4656</p_value>
            <method>Negative binominal</method>
            <param_type>Rate reduction</param_type>
            <param_value>15.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.71</ci_lower_limit>
            <ci_upper_limit>47.01</ci_upper_limit>
            <estimate_desc>Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Comparison of AAER (rate ratio): FAS population; Tralo 300 mg Q2W vs placebo.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.</non_inferiority_desc>
            <p_value>0.8027</p_value>
            <method>Negative binomial</method>
            <param_type>Rate ratio</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.31</ci_upper_limit>
            <estimate_desc>Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Comparison of AAER (rate reduction): FAS population; Tralo 300 mg Q2W vs placebo.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.</non_inferiority_desc>
            <p_value>0.8027</p_value>
            <method>Negative binominal</method>
            <param_type>Rate reduction</param_type>
            <param_value>-3.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-31.46</ci_lower_limit>
            <ci_upper_limit>19.08</ci_upper_limit>
            <estimate_desc>Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)</title>
        <description>Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorised delegate according to American Thoracic Society/European Respiratory Society guidelines. The mean percent change from baseline in pre-BD FEV1 at Week 52 is presented.</description>
        <time_frame>Baseline (Week 0) and Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)</title>
          <description>Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorised delegate according to American Thoracic Society/European Respiratory Society guidelines. The mean percent change from baseline in pre-BD FEV1 at Week 52 is presented.</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
          <units>Percent change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="103"/>
                <count group_id="O3" value="282"/>
                <count group_id="O4" value="250"/>
                <count group_id="O5" value="384"/>
                <count group_id="O6" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.769" spread="29.628"/>
                    <measurement group_id="O2" value="16.632" spread="31.906"/>
                    <measurement group_id="O3" value="13.103" spread="24.641"/>
                    <measurement group_id="O4" value="8.395" spread="21.962"/>
                    <measurement group_id="O5" value="14.546" spread="26.065"/>
                    <measurement group_id="O6" value="10.528" spread="25.475"/>
                  </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>Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.&#xD;
Restricted maximum likelihood (REML) based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.&#xD;
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6033</p_value>
            <method>Repeated measures analysis</method>
            <param_type>Least square (LS) Mean difference</param_type>
            <param_value>1.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.16</ci_lower_limit>
            <ci_upper_limit>8.88</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.&#xD;
REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.&#xD;
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1276</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>3.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.97</ci_lower_limit>
            <ci_upper_limit>7.70</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1164</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>2.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.73</ci_lower_limit>
            <ci_upper_limit>6.62</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)</title>
        <description>Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary. Symptoms were recorded using a 4-point response scale, which ranged from 0 to 3, where 0 indicated no asthma symptoms. Asthma symptom daytime score (recorded in the evening), night-time score (recorded in the morning), and total score were calculated separately. The daily asthma symptom total score was calculated by taking the sum of the night-time and daytime asthma symptom scores recorded each day, ranging from 0 to 6. A lower symptom score indicated a better outcome. The change from baseline in bi-weekly mean daily asthma symptom total score is presented.</description>
        <time_frame>Baseline (Week 0) and Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)</title>
          <description>Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary. Symptoms were recorded using a 4-point response scale, which ranged from 0 to 3, where 0 indicated no asthma symptoms. Asthma symptom daytime score (recorded in the evening), night-time score (recorded in the morning), and total score were calculated separately. The daily asthma symptom total score was calculated by taking the sum of the night-time and daytime asthma symptom scores recorded each day, ranging from 0 to 6. A lower symptom score indicated a better outcome. The change from baseline in bi-weekly mean daily asthma symptom total score is presented.</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="215"/>
                <count group_id="O4" value="223"/>
                <count group_id="O5" value="297"/>
                <count group_id="O6" value="309"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.18" spread="0.98"/>
                    <measurement group_id="O2" value="-1.06" spread="1.25"/>
                    <measurement group_id="O3" value="-0.98" spread="1.04"/>
                    <measurement group_id="O4" value="-1.02" spread="1.24"/>
                    <measurement group_id="O5" value="-1.04" spread="1.04"/>
                    <measurement group_id="O6" value="-1.02" spread="1.24"/>
                  </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>Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.&#xD;
REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1456</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>-0.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.47</ci_lower_limit>
            <ci_upper_limit>0.07</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.&#xD;
REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6548</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.13</ci_lower_limit>
            <ci_upper_limit>0.20</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Comparison of mean change from baseline in total asthma symptom score at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5763</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>-0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.18</ci_lower_limit>
            <ci_upper_limit>0.10</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score</title>
        <description>The AQLQ(S)+12 is a questionnaire that measures health-related quality of life for patients with asthma aged 12 and older. The questionnaire comprises 32 questions and has 4 separate domains (asthma symptoms, activity limitations, emotional function and environmental stimuli). Patients were asked to recall their experiences during the previous 2 weeks and to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The total score was calculated as the mean response to all questions, ranging from 1 (severe impairment) to 7 (no impairment). Individual AQLQ(S)+12 total score changes of ≥0.5 were considered to be clinically meaningful. The mean change from baseline in AQLQ(S)+12 score at Week 52 is presented.</description>
        <time_frame>Baseline (Week 0) and Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score</title>
          <description>The AQLQ(S)+12 is a questionnaire that measures health-related quality of life for patients with asthma aged 12 and older. The questionnaire comprises 32 questions and has 4 separate domains (asthma symptoms, activity limitations, emotional function and environmental stimuli). Patients were asked to recall their experiences during the previous 2 weeks and to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The total score was calculated as the mean response to all questions, ranging from 1 (severe impairment) to 7 (no impairment). Individual AQLQ(S)+12 total score changes of ≥0.5 were considered to be clinically meaningful. The mean change from baseline in AQLQ(S)+12 score at Week 52 is presented.</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="84"/>
                <count group_id="O3" value="242"/>
                <count group_id="O4" value="230"/>
                <count group_id="O5" value="321"/>
                <count group_id="O6" value="318"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.35" spread="1.06"/>
                    <measurement group_id="O2" value="1.20" spread="1.22"/>
                    <measurement group_id="O3" value="1.13" spread="1.07"/>
                    <measurement group_id="O4" value="1.23" spread="1.25"/>
                    <measurement group_id="O5" value="1.18" spread="1.07"/>
                    <measurement group_id="O6" value="1.21" spread="1.24"/>
                  </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>Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.&#xD;
REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0874</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>0.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.04</ci_lower_limit>
            <ci_upper_limit>0.57</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.&#xD;
REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9083</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>-0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.20</ci_lower_limit>
            <ci_upper_limit>0.17</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4506</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>0.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.10</ci_lower_limit>
            <ci_upper_limit>0.22</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score</title>
        <description>The ACQ-6 questionnaire is a shortened version of the ACQ (omitting FEV1 measurement) that assesses asthma symptoms (night-time awakenings, symptoms on waking, activity limitation, dyspnoea, wheezing) and rescue short-acting β2-agonists medication use during the past week. Questions were weighted equally and scored on a 7-point scale from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma and a score &gt;1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 were considered to be clinically meaningful. The mean change from baseline in ACQ-6 score at Week 52 is presented.</description>
        <time_frame>Baseline (Week 0) and Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score</title>
          <description>The ACQ-6 questionnaire is a shortened version of the ACQ (omitting FEV1 measurement) that assesses asthma symptoms (night-time awakenings, symptoms on waking, activity limitation, dyspnoea, wheezing) and rescue short-acting β2-agonists medication use during the past week. Questions were weighted equally and scored on a 7-point scale from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma and a score &gt;1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 were considered to be clinically meaningful. The mean change from baseline in ACQ-6 score at Week 52 is presented.</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="86"/>
                <count group_id="O3" value="254"/>
                <count group_id="O4" value="243"/>
                <count group_id="O5" value="341"/>
                <count group_id="O6" value="334"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.26" spread="1.01"/>
                    <measurement group_id="O2" value="-1.14" spread="1.12"/>
                    <measurement group_id="O3" value="-1.07" spread="1.02"/>
                    <measurement group_id="O4" value="-1.11" spread="1.13"/>
                    <measurement group_id="O5" value="-1.12" spread="1.02"/>
                    <measurement group_id="O6" value="-1.11" spread="1.13"/>
                  </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>Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.&#xD;
REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0400</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>-0.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.53</ci_lower_limit>
            <ci_upper_limit>-0.01</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.&#xD;
REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9735</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>0.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.16</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Comparison of change in mean score from baseline for ACQ-6 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2432</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>-0.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.21</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52</title>
        <description>The annual rate of exacerbations associated with an ER/UC visit or hospitalisation up to Week 52 are presented for non-adjudicated data (i.e. events assessed by the Investigator and recorded in the electronic case report form).&#xD;
AAER = number of exacerbations*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).</description>
        <time_frame>Baseline (Week 0) up to Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52</title>
          <description>The annual rate of exacerbations associated with an ER/UC visit or hospitalisation up to Week 52 are presented for non-adjudicated data (i.e. events assessed by the Investigator and recorded in the electronic case report form).&#xD;
AAER = number of exacerbations*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.</population>
          <units>Events/year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="121"/>
                <count group_id="O3" value="308"/>
                <count group_id="O4" value="290"/>
                <count group_id="O5" value="420"/>
                <count group_id="O6" value="417"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" lower_limit="0.03" upper_limit="0.14"/>
                    <measurement group_id="O2" value="0.16" lower_limit="0.09" upper_limit="0.29"/>
                    <measurement group_id="O3" value="0.09" lower_limit="0.06" upper_limit="0.14"/>
                    <measurement group_id="O4" value="0.11" lower_limit="0.07" upper_limit="0.17"/>
                    <measurement group_id="O5" value="0.08" lower_limit="0.06" upper_limit="0.12"/>
                    <measurement group_id="O6" value="0.12" lower_limit="0.09" upper_limit="0.18"/>
                  </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>Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker positive population; Tralo 300 mg Q2W vs placebo.&#xD;
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0576</p_value>
            <method>Negative binomial</method>
            <param_type>Rate ratio</param_type>
            <param_value>0.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.15</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
            <estimate_desc>Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker negative population; Tralo 300 mg Q2W vs placebo.&#xD;
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5249</p_value>
            <method>Negative binomial</method>
            <param_type>Rate ratio</param_type>
            <param_value>0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>1.48</ci_upper_limit>
            <estimate_desc>Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Comparison of AAER associated with an ER/UC visit or hospitalisation: FAS population; Tralo 300 mg Q2W vs placebo.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1155</p_value>
            <method>Negative binomial</method>
            <param_type>Rate ratio</param_type>
            <param_value>0.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.41</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
            <estimate_desc>Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52</title>
        <description>The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The patient was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The questionnaire also included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. The mean change from baseline in EQ-5D-5L VAS scores at Week 52 is presented.</description>
        <time_frame>Baseline (Week 0) and Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52</title>
          <description>The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The patient was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The questionnaire also included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. The mean change from baseline in EQ-5D-5L VAS scores at Week 52 is presented.</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="85"/>
                <count group_id="O3" value="233"/>
                <count group_id="O4" value="224"/>
                <count group_id="O5" value="317"/>
                <count group_id="O6" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.58" spread="15.21"/>
                    <measurement group_id="O2" value="11.58" spread="17.26"/>
                    <measurement group_id="O3" value="11.67" spread="17.18"/>
                    <measurement group_id="O4" value="12.01" spread="17.43"/>
                    <measurement group_id="O5" value="12.46" spread="16.67"/>
                    <measurement group_id="O6" value="11.66" spread="17.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means)</title>
        <description>Salbutamol, albuterol or levalbuterol were used as rescue medication during the study in the event of a worsening of asthma symptoms. Rescue medication use was measured by the bi-weekly mean number of inhalations (puffs) per day, calculated as: total morning puffs + total evening puffs + 2*(total morning nebuliser use + total evening nebuliser use)/ total number of days with data in bi-weekly period. The change from baseline in bi-weekly mean total asthma rescue medication use at Week 52 is presented.</description>
        <time_frame>Baseline (Week 0) and Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means)</title>
          <description>Salbutamol, albuterol or levalbuterol were used as rescue medication during the study in the event of a worsening of asthma symptoms. Rescue medication use was measured by the bi-weekly mean number of inhalations (puffs) per day, calculated as: total morning puffs + total evening puffs + 2*(total morning nebuliser use + total evening nebuliser use)/ total number of days with data in bi-weekly period. The change from baseline in bi-weekly mean total asthma rescue medication use at Week 52 is presented.</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
          <units>Puffs/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="215"/>
                <count group_id="O4" value="223"/>
                <count group_id="O5" value="297"/>
                <count group_id="O6" value="309"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.86" spread="3.26"/>
                    <measurement group_id="O2" value="-1.73" spread="4.59"/>
                    <measurement group_id="O3" value="-2.01" spread="2.93"/>
                    <measurement group_id="O4" value="-2.08" spread="4.28"/>
                    <measurement group_id="O5" value="-2.25" spread="3.03"/>
                    <measurement group_id="O6" value="-1.97" spread="4.34"/>
                  </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>Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.&#xD;
REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0360</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>-0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.85</ci_lower_limit>
            <ci_upper_limit>-0.06</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.&#xD;
REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5864</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>0.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.40</ci_lower_limit>
            <ci_upper_limit>0.70</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Comparison of mean change from baseline in rescue medication use at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4689</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>-0.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.63</ci_lower_limit>
            <ci_upper_limit>0.29</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52</title>
        <description>Home PEF testing was performed by the patient using an electronic, hand-held spirometer (peak flow meter) and was performed in the morning upon awakening (prior to taking their morning asthma controller) and in the evening at bedtime (prior to taking their evening asthma controller). The mean change from baseline in home PEF values at Week 52 are presented separately for morning and evening.</description>
        <time_frame>Baseline (Week 0) and Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52</title>
          <description>Home PEF testing was performed by the patient using an electronic, hand-held spirometer (peak flow meter) and was performed in the morning upon awakening (prior to taking their morning asthma controller) and in the evening at bedtime (prior to taking their evening asthma controller). The mean change from baseline in home PEF values at Week 52 are presented separately for morning and evening.</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
          <units>L/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="86"/>
                <count group_id="O3" value="233"/>
                <count group_id="O4" value="222"/>
                <count group_id="O5" value="322"/>
                <count group_id="O6" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Morning PEF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="231"/>
                    <count group_id="O4" value="222"/>
                    <count group_id="O5" value="318"/>
                    <count group_id="O6" value="308"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.35" spread="74.00"/>
                    <measurement group_id="O2" value="18.80" spread="86.24"/>
                    <measurement group_id="O3" value="6.72" spread="73.82"/>
                    <measurement group_id="O4" value="6.10" spread="72.28"/>
                    <measurement group_id="O5" value="10.66" spread="73.88"/>
                    <measurement group_id="O6" value="9.43" spread="76.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Evening PEF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="233"/>
                    <count group_id="O4" value="222"/>
                    <count group_id="O5" value="322"/>
                    <count group_id="O6" value="313"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.15" spread="69.20"/>
                    <measurement group_id="O2" value="8.88" spread="79.72"/>
                    <measurement group_id="O3" value="1.72" spread="79.58"/>
                    <measurement group_id="O4" value="0.17" spread="73.66"/>
                    <measurement group_id="O5" value="5.72" spread="77.01"/>
                    <measurement group_id="O6" value="2.91" spread="74.94"/>
                  </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>Comparison of mean change from baseline in morning PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.&#xD;
REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5094</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>6.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.13</ci_lower_limit>
            <ci_upper_limit>24.43</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of mean change from baseline in morning PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.&#xD;
REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5984</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>3.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.22</ci_lower_limit>
            <ci_upper_limit>14.26</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of mean change from baseline in evening PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.&#xD;
REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3971</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>7.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.32</ci_lower_limit>
            <ci_upper_limit>26.00</ci_upper_limit>
            <estimate_desc>Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of mean change from baseline in evening PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.&#xD;
REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5310</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>3.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.65</ci_lower_limit>
            <ci_upper_limit>14.83</ci_upper_limit>
            <estimate_desc>Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Comparison of mean change from baseline in morning PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4764</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>3.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.06</ci_lower_limit>
            <ci_upper_limit>12.97</ci_upper_limit>
            <estimate_desc>Model included fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Comparison of mean change from baseline in evening PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4221</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>3.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.60</ci_lower_limit>
            <ci_upper_limit>13.37</ci_upper_limit>
            <estimate_desc>Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage])</title>
        <description>The patient captured night-time awakenings (yes/no) and the use of rescue medication during these awakenings (yes/no) each morning in the Asthma Daily Diary. Night-time awakenings (percentage) was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data. The change from baseline in bi-weekly means (percentage) night-time awakenings due to asthma requiring rescue medication use at Week 52 is presented.</description>
        <time_frame>Baseline (Week 0) and Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage])</title>
          <description>The patient captured night-time awakenings (yes/no) and the use of rescue medication during these awakenings (yes/no) each morning in the Asthma Daily Diary. Night-time awakenings (percentage) was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data. The change from baseline in bi-weekly means (percentage) night-time awakenings due to asthma requiring rescue medication use at Week 52 is presented.</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
          <units>Percentage of nights with awakenings</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="270"/>
                <count group_id="O4" value="247"/>
                <count group_id="O5" value="368"/>
                <count group_id="O6" value="348"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.86" spread="38.36"/>
                    <measurement group_id="O2" value="-34.06" spread="34.96"/>
                    <measurement group_id="O3" value="-34.65" spread="34.34"/>
                    <measurement group_id="O4" value="-35.67" spread="37.37"/>
                    <measurement group_id="O5" value="-35.60" spread="35.40"/>
                    <measurement group_id="O6" value="-35.05" spread="36.63"/>
                  </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>Comparison of mean change from baseline in number (%) of awakenings at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.&#xD;
REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1099</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>-5.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.21</ci_lower_limit>
            <ci_upper_limit>1.14</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of mean change from baseline in number (%) of awakenings at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.&#xD;
REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8112</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>0.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.33</ci_lower_limit>
            <ci_upper_limit>4.25</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Comparison of mean change from baseline in number (%) of awakenings at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4645</p_value>
            <method>Repeated measures analysis</method>
            <param_type>LS Mean difference</param_type>
            <param_value>-1.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.40</ci_lower_limit>
            <ci_upper_limit>2.01</ci_upper_limit>
            <estimate_desc>Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With ≥1 Asthma Exacerbation up to Week 52</title>
        <description>The number of patients with ≥1 asthma exacerbation up to Week 52 is presented.</description>
        <time_frame>Baseline (Week 0) up to Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With ≥1 Asthma Exacerbation up to Week 52</title>
          <description>The number of patients with ≥1 asthma exacerbation up to Week 52 is presented.</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.</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="108"/>
                <count group_id="O2" value="121"/>
                <count group_id="O3" value="308"/>
                <count group_id="O4" value="290"/>
                <count group_id="O5" value="420"/>
                <count group_id="O6" value="417"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="125"/>
                    <measurement group_id="O4" value="117"/>
                    <measurement group_id="O5" value="163"/>
                    <measurement group_id="O6" value="171"/>
                  </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>Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3440</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.44</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
            <estimate_desc>The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7768</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
            <estimate_desc>The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: FAS population; Tralo 300 mg Q2W vs placebo.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5276</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
            <estimate_desc>The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52</title>
        <description>The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days.&#xD;
The WPAI+CIQ outcomes for productivity loss are presented separately for those currently employed and for those currently in school and are expressed as mean productivity loss (percentage) at Week 52, with higher numbers indicating less productivity.&#xD;
Work Productivity Loss = {Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]}*100 (Absenteeism = Q2/(Q2+Q4)*100; Presenteeism = (Q5/10)*100).&#xD;
Class Productivity Loss = {Q7/(Q7+Q8) + [(1-Q7/(Q7+Q8))x(Q9/10)]}*100 (Absenteeism = Q7/(Q7+Q8)*100; Presenteeism = (Q9/10)*100).&#xD;
Note: QX refers to response to question number X on WPAI+CIQ questionnaire.</description>
        <time_frame>At Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52</title>
          <description>The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days.&#xD;
The WPAI+CIQ outcomes for productivity loss are presented separately for those currently employed and for those currently in school and are expressed as mean productivity loss (percentage) at Week 52, with higher numbers indicating less productivity.&#xD;
Work Productivity Loss = {Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]}*100 (Absenteeism = Q2/(Q2+Q4)*100; Presenteeism = (Q5/10)*100).&#xD;
Class Productivity Loss = {Q7/(Q7+Q8) + [(1-Q7/(Q7+Q8))x(Q9/10)]}*100 (Absenteeism = Q7/(Q7+Q8)*100; Presenteeism = (Q9/10)*100).&#xD;
Note: QX refers to response to question number X on WPAI+CIQ questionnaire.</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
          <units>Percent productivity loss</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="105"/>
                <count group_id="O4" value="104"/>
                <count group_id="O5" value="154"/>
                <count group_id="O6" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Productivity loss - currently employed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="90"/>
                    <count group_id="O5" value="137"/>
                    <count group_id="O6" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.51" spread="24.47"/>
                    <measurement group_id="O2" value="28.15" spread="27.39"/>
                    <measurement group_id="O3" value="23.36" spread="23.39"/>
                    <measurement group_id="O4" value="31.05" spread="27.20"/>
                    <measurement group_id="O5" value="23.43" spread="23.66"/>
                    <measurement group_id="O6" value="30.17" spread="27.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Productivity loss - currently in school</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="17"/>
                    <count group_id="O6" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.89" spread="34.21"/>
                    <measurement group_id="O2" value="37.92" spread="28.72"/>
                    <measurement group_id="O3" value="25.99" spread="32.17"/>
                    <measurement group_id="O4" value="19.67" spread="29.06"/>
                    <measurement group_id="O5" value="28.03" spread="31.01"/>
                    <measurement group_id="O6" value="28.09" spread="29.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WPAI+CIQ: Activity Impairment at Week 52</title>
        <description>The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days.&#xD;
The WPAI+CIQ outcomes for activity impairment are presented separately for those currently employed and for those currently in school and are expressed as mean impairment percentages at Week 52, with higher numbers indicating greater impairment.&#xD;
Activity impairment = (Q10/10)*100. Note: QX refers to response to question number X on WPAI+CIQ questionnaire.</description>
        <time_frame>At Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>WPAI+CIQ: Activity Impairment at Week 52</title>
          <description>The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days.&#xD;
The WPAI+CIQ outcomes for activity impairment are presented separately for those currently employed and for those currently in school and are expressed as mean impairment percentages at Week 52, with higher numbers indicating greater impairment.&#xD;
Activity impairment = (Q10/10)*100. Note: QX refers to response to question number X on WPAI+CIQ questionnaire.</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.</population>
          <units>Percent impairment</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="116"/>
                <count group_id="O4" value="110"/>
                <count group_id="O5" value="169"/>
                <count group_id="O6" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Activity Impairment - currently employed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="100"/>
                    <count group_id="O4" value="94"/>
                    <count group_id="O5" value="147"/>
                    <count group_id="O6" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.89" spread="18.81"/>
                    <measurement group_id="O2" value="25.28" spread="28.63"/>
                    <measurement group_id="O3" value="20.50" spread="20.42"/>
                    <measurement group_id="O4" value="26.49" spread="23.59"/>
                    <measurement group_id="O5" value="20.68" spread="19.82"/>
                    <measurement group_id="O6" value="26.11" spread="24.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity Impairment - currently in school</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.00" spread="18.71"/>
                    <measurement group_id="O2" value="33.85" spread="26.63"/>
                    <measurement group_id="O3" value="26.88" spread="30.49"/>
                    <measurement group_id="O4" value="23.13" spread="30.27"/>
                    <measurement group_id="O5" value="24.55" spread="27.38"/>
                    <measurement group_id="O6" value="27.93" spread="28.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Asthma-related Healthcare Encounters by Type up to Week 52</title>
        <description>Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of times the healthcare encounter occurred was calculated across all patients for each of the following categories:&#xD;
Ambulance transport,&#xD;
Emergency room visits,&#xD;
Unscheduled outpatient visits (visit to specialist and/or visit to primary healthcare physician and/or other healthcare visit),&#xD;
Home visits (home visit, physician and/or other healthcare professional),&#xD;
Telephone calls (telephone calls to physician and/or nurse), and&#xD;
Advanced pulmonary function test.</description>
        <time_frame>Baseline (Week 0) up to Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>Asthma-related Healthcare Encounters by Type up to Week 52</title>
          <description>Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of times the healthcare encounter occurred was calculated across all patients for each of the following categories:&#xD;
Ambulance transport,&#xD;
Emergency room visits,&#xD;
Unscheduled outpatient visits (visit to specialist and/or visit to primary healthcare physician and/or other healthcare visit),&#xD;
Home visits (home visit, physician and/or other healthcare professional),&#xD;
Telephone calls (telephone calls to physician and/or nurse), and&#xD;
Advanced pulmonary function test.</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.</population>
          <units>Encounters</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="121"/>
                <count group_id="O3" value="308"/>
                <count group_id="O4" value="290"/>
                <count group_id="O5" value="420"/>
                <count group_id="O6" value="417"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ambulance transport</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="21"/>
                    <measurement group_id="O4" value="20"/>
                    <measurement group_id="O5" value="35"/>
                    <measurement group_id="O6" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emergency room visits</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="65"/>
                    <measurement group_id="O4" value="70"/>
                    <measurement group_id="O5" value="87"/>
                    <measurement group_id="O6" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unscheduled outpatient visits</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="513"/>
                    <measurement group_id="O2" value="579"/>
                    <measurement group_id="O3" value="1274"/>
                    <measurement group_id="O4" value="1216"/>
                    <measurement group_id="O5" value="1798"/>
                    <measurement group_id="O6" value="1834"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Home visits</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="49"/>
                    <measurement group_id="O4" value="26"/>
                    <measurement group_id="O5" value="59"/>
                    <measurement group_id="O6" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Telephone calls</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="76"/>
                    <measurement group_id="O3" value="112"/>
                    <measurement group_id="O4" value="117"/>
                    <measurement group_id="O5" value="163"/>
                    <measurement group_id="O6" value="196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Advanced pulmonary function test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="35"/>
                    <measurement group_id="O4" value="26"/>
                    <measurement group_id="O5" value="51"/>
                    <measurement group_id="O6" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations</title>
        <description>Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of days spent in hospital was calculated across all patients for the following healthcare encounter category:&#xD;
• Hospitalisations (hospitalisations, intensive care and/or general care).</description>
        <time_frame>Baseline (Week 0) up to Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations</title>
          <description>Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of days spent in hospital was calculated across all patients for the following healthcare encounter category:&#xD;
• Hospitalisations (hospitalisations, intensive care and/or general care).</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.</population>
          <units>Days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="121"/>
                <count group_id="O3" value="308"/>
                <count group_id="O4" value="290"/>
                <count group_id="O5" value="420"/>
                <count group_id="O6" value="417"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="175"/>
                    <measurement group_id="O3" value="334"/>
                    <measurement group_id="O4" value="414"/>
                    <measurement group_id="O5" value="417"/>
                    <measurement group_id="O6" value="590"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry</title>
        <description>Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of assessments was calculated across all patients for the following healthcare encounter category:&#xD;
• Spirometry.</description>
        <time_frame>Baseline (Week 0) up to Week 52</time_frame>
        <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Positive - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O4">
            <title>Biomarker Negative - Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O5">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry</title>
          <description>Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of assessments was calculated across all patients for the following healthcare encounter category:&#xD;
• Spirometry.</description>
          <population>The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.</population>
          <units>Assessments</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="121"/>
                <count group_id="O3" value="308"/>
                <count group_id="O4" value="290"/>
                <count group_id="O5" value="420"/>
                <count group_id="O6" value="417"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148"/>
                    <measurement group_id="O2" value="151"/>
                    <measurement group_id="O3" value="284"/>
                    <measurement group_id="O4" value="270"/>
                    <measurement group_id="O5" value="434"/>
                    <measurement group_id="O6" value="426"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72</title>
        <description>To evaluate the pharmacokinetics (PK), pre-dose blood samples were collected at each visit and tralokinumab concentrations in serum were determined. Mean Ctrough concentrations are presented at each indicated visit up to Week 72.</description>
        <time_frame>Blood samples were collected pre-dose at Baseline (Week 0), and at Week 2, Week 8, Week 26, Week 56 (follow-up) and Week 72 (follow-up)</time_frame>
        <population>All patients in the FAS who received tralokinumab and who had PK blood samples were included in the PK analysis set. Only patients in the biomarker positive and negative PK populations and with data available at the timepoints of testing were included in the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Biomarker Positive - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.</description>
          </group>
          <group group_id="O2">
            <title>Biomarker Negative - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO &lt;37 ppb.</description>
          </group>
          <group group_id="O3">
            <title>Total - Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). 'Total' treatment arm represents all patients receiving tralokinumab in both the biomarker positive and biomarker negative patient populations.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72</title>
          <description>To evaluate the pharmacokinetics (PK), pre-dose blood samples were collected at each visit and tralokinumab concentrations in serum were determined. Mean Ctrough concentrations are presented at each indicated visit up to Week 72.</description>
          <population>All patients in the FAS who received tralokinumab and who had PK blood samples were included in the PK analysis set. Only patients in the biomarker positive and negative PK populations and with data available at the timepoints of testing were included in the analyses.</population>
          <units>micrograms/millilitre</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="302"/>
                <count group_id="O3" value="410"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="302"/>
                    <count group_id="O3" value="410"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Value was not calculable since below level of detection.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Value was not calculable since below level of detection.</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">Value was not calculable since below level of detection.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="293"/>
                    <count group_id="O3" value="396"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.049" spread="172.475"/>
                    <measurement group_id="O2" value="20.916" spread="280.452"/>
                    <measurement group_id="O3" value="21.690" spread="248.876"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="280"/>
                    <count group_id="O3" value="385"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.887" spread="206.478"/>
                    <measurement group_id="O2" value="52.324" spread="226.298"/>
                    <measurement group_id="O3" value="53.272" spread="220.301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="274"/>
                    <count group_id="O3" value="373"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.375" spread="145.256"/>
                    <measurement group_id="O2" value="47.707" spread="319.456"/>
                    <measurement group_id="O3" value="50.332" spread="264.686"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 56 (follow-up)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="275"/>
                    <count group_id="O3" value="371"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.363" spread="591.282"/>
                    <measurement group_id="O2" value="12.513" spread="707.267"/>
                    <measurement group_id="O3" value="12.474" spread="671.922"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (follow-up)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="264"/>
                    <count group_id="O3" value="356"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.325" spread="251.436"/>
                    <measurement group_id="O2" value="0.384" spread="242.035"/>
                    <measurement group_id="O3" value="0.368" spread="244.398"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential</title>
        <description>Assessments of ADA were performed using a tiered approach (screening, confirmatory and titering assays). Confirmed ADA positive samples were also tested for the presence of neutralising antibodies (nAb). ADA prevalence was defined as proportion of the study population having drug-reactive antibodies at any point in time. ADA incidence (treatment-emergent ADA) was defined as the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher level following drug administration. Note: 'positive' is denoted by 'pos' in some category titles.</description>
        <time_frame>Baseline (Week 0), Week 26, Week 56 (follow-up) and Week 72 (follow-up)</time_frame>
        <population>The ADA evaluable population included all patients in the safety analysis set (i.e. those who had received any IP) who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result.</population>
        <group_list>
          <group group_id="O1">
            <title>Tralo 300 mg Q2W</title>
            <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential</title>
          <description>Assessments of ADA were performed using a tiered approach (screening, confirmatory and titering assays). Confirmed ADA positive samples were also tested for the presence of neutralising antibodies (nAb). ADA prevalence was defined as proportion of the study population having drug-reactive antibodies at any point in time. ADA incidence (treatment-emergent ADA) was defined as the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher level following drug administration. Note: 'positive' is denoted by 'pos' in some category titles.</description>
          <population>The ADA evaluable population included all patients in the safety analysis set (i.e. those who had received any IP) who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result.</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="405"/>
                <count group_id="O2" value="394"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA prevalence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA incidence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive post-baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA pos post-baseline and pos at baseline</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>
              <title>ADA pos post-baseline and not detected at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA not detected post-baseline and pos at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistent Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transient Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-boosted ADA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>nAB positive at any visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>72 weeks</time_frame>
      <desc>Serious and Other (non-serious) adverse event (AE) data is reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received at least one dose of IP.&#xD;
All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72.</desc>
      <group_list>
        <group group_id="E1">
          <title>Tralo 300 mg Q2W</title>
          <description>Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</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="1" subjects_at_risk="425"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="425"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Oesophageal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Eosinophilic granulomatosis with polyangiitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Hepatitis A</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Laryngitis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="425"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Patellofemoral pain syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Adnexa uteri pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="425"/>
                <counts group_id="E2" events="30" subjects_affected="23" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Bronchitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Nasal polyps</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="425"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Vitiligo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="425"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</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="159" subjects_at_risk="425"/>
                <counts group_id="E2" subjects_affected="152" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="93" subjects_affected="23" subjects_at_risk="425"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="59" subjects_affected="34" subjects_at_risk="425"/>
                <counts group_id="E2" events="50" subjects_affected="31" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="49" subjects_affected="29" subjects_at_risk="425"/>
                <counts group_id="E2" events="39" subjects_affected="31" subjects_at_risk="422"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="71" subjects_affected="50" subjects_at_risk="425"/>
                <counts group_id="E2" events="80" subjects_affected="52" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="76" subjects_affected="40" subjects_at_risk="425"/>
                <counts group_id="E2" events="49" subjects_affected="32" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="51" subjects_affected="35" subjects_at_risk="425"/>
                <counts group_id="E2" events="79" subjects_affected="47" subjects_at_risk="422"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Clinical Lead</name_or_title>
      <organization>AstraZeneca</organization>
      <phone>+1 301-398-0582</phone>
      <email>ClinicalTrialTransparency@astrazeneca.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/NCT02194699
org study id: D2210C00008
nct id: NCT02194699
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3
      Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with
      Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
This is a randomized, double-blind, parallel group, placebo-controlled study designed to
      evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with
      uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a
      history of asthma exacerbations. Approximately 770 subjects will be randomized globally.
      Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at
      the study site, over a 52-week treatment period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Annualised Asthma Exacerbation Rate (AAER) up to Week 52
time frame: Baseline (Week 0) up to Week 52
description: Asthma exacerbation was defined as a worsening of asthma that led to any of the following:
Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.
An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for <24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above).
An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma.
AAER = number of exacerbations*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).
AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses.
measure: Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)
time frame: Baseline (Week 0) and Week 52
description: Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorised delegate according to American Thoracic Society/European Respiratory Society guidelines. The mean percent change from baseline in pre-BD FEV1 at Week 52 is presented.
measure: Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)
time frame: Baseline (Week 0) and Week 52
description: Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary. Symptoms were recorded using a 4-point response scale, which ranged from 0 to 3, where 0 indicated no asthma symptoms. Asthma symptom daytime score (recorded in the evening), night-time score (recorded in the morning), and total score were calculated separately. The daily asthma symptom total score was calculated by taking the sum of the night-time and daytime asthma symptom scores recorded each day, ranging from 0 to 6. A lower symptom score indicated a better outcome. The change from baseline in bi-weekly mean daily asthma symptom total score is presented.
measure: Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score
time frame: Baseline (Week 0) and Week 52
description: The AQLQ(S)+12 is a questionnaire that measures health-related quality of life for patients with asthma aged 12 and older. The questionnaire comprises 32 questions and has 4 separate domains (asthma symptoms, activity limitations, emotional function and environmental stimuli). Patients were asked to recall their experiences during the previous 2 weeks and to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The total score was calculated as the mean response to all questions, ranging from 1 (severe impairment) to 7 (no impairment). Individual AQLQ(S)+12 total score changes of ≥0.5 were considered to be clinically meaningful. The mean change from baseline in AQLQ(S)+12 score at Week 52 is presented.
measure: Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score
time frame: Baseline (Week 0) and Week 52
description: The ACQ-6 questionnaire is a shortened version of the ACQ (omitting FEV1 measurement) that assesses asthma symptoms (night-time awakenings, symptoms on waking, activity limitation, dyspnoea, wheezing) and rescue short-acting β2-agonists medication use during the past week. Questions were weighted equally and scored on a 7-point scale from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma and a score >1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 were considered to be clinically meaningful. The mean change from baseline in ACQ-6 score at Week 52 is presented.
measure: AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52
time frame: Baseline (Week 0) up to Week 52
description: The annual rate of exacerbations associated with an ER/UC visit or hospitalisation up to Week 52 are presented for non-adjudicated data (i.e. events assessed by the Investigator and recorded in the electronic case report form).
AAER = number of exacerbations*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).
measure: Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52
time frame: Baseline (Week 0) and Week 52
description: The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The patient was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The questionnaire also included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. The mean change from baseline in EQ-5D-5L VAS scores at Week 52 is presented.
measure: Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means)
time frame: Baseline (Week 0) and Week 52
description: Salbutamol, albuterol or levalbuterol were used as rescue medication during the study in the event of a worsening of asthma symptoms. Rescue medication use was measured by the bi-weekly mean number of inhalations (puffs) per day, calculated as: total morning puffs + total evening puffs + 2*(total morning nebuliser use + total evening nebuliser use)/ total number of days with data in bi-weekly period. The change from baseline in bi-weekly mean total asthma rescue medication use at Week 52 is presented.
measure: Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52
time frame: Baseline (Week 0) and Week 52
description: Home PEF testing was performed by the patient using an electronic, hand-held spirometer (peak flow meter) and was performed in the morning upon awakening (prior to taking their morning asthma controller) and in the evening at bedtime (prior to taking their evening asthma controller). The mean change from baseline in home PEF values at Week 52 are presented separately for morning and evening.
measure: Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage])
time frame: Baseline (Week 0) and Week 52
description: The patient captured night-time awakenings (yes/no) and the use of rescue medication during these awakenings (yes/no) each morning in the Asthma Daily Diary. Night-time awakenings (percentage) was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data. The change from baseline in bi-weekly means (percentage) night-time awakenings due to asthma requiring rescue medication use at Week 52 is presented.
measure: Number of Patients With ≥1 Asthma Exacerbation up to Week 52
time frame: Baseline (Week 0) up to Week 52
description: The number of patients with ≥1 asthma exacerbation up to Week 52 is presented.
measure: Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52
time frame: At Week 52
description: The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days.
The WPAI+CIQ outcomes for productivity loss are presented separately for those currently employed and for those currently in school and are expressed as mean productivity loss (percentage) at Week 52, with higher numbers indicating less productivity.
Work Productivity Loss = {Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]}*100 (Absenteeism = Q2/(Q2+Q4)*100; Presenteeism = (Q5/10)*100).
Class Productivity Loss = {Q7/(Q7+Q8) + [(1-Q7/(Q7+Q8))x(Q9/10)]}*100 (Absenteeism = Q7/(Q7+Q8)*100; Presenteeism = (Q9/10)*100).
Note: QX refers to response to question number X on WPAI+CIQ questionnaire.
measure: WPAI+CIQ: Activity Impairment at Week 52
time frame: At Week 52
description: The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days.
The WPAI+CIQ outcomes for activity impairment are presented separately for those currently employed and for those currently in school and are expressed as mean impairment percentages at Week 52, with higher numbers indicating greater impairment.
Activity impairment = (Q10/10)*100. Note: QX refers to response to question number X on WPAI+CIQ questionnaire.
measure: Asthma-related Healthcare Encounters by Type up to Week 52
time frame: Baseline (Week 0) up to Week 52
description: Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of times the healthcare encounter occurred was calculated across all patients for each of the following categories:
Ambulance transport,
Emergency room visits,
Unscheduled outpatient visits (visit to specialist and/or visit to primary healthcare physician and/or other healthcare visit),
Home visits (home visit, physician and/or other healthcare professional),
Telephone calls (telephone calls to physician and/or nurse), and
Advanced pulmonary function test.
measure: Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations
time frame: Baseline (Week 0) up to Week 52
description: Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of days spent in hospital was calculated across all patients for the following healthcare encounter category:
• Hospitalisations (hospitalisations, intensive care and/or general care).
measure: Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry
time frame: Baseline (Week 0) up to Week 52
description: Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of assessments was calculated across all patients for the following healthcare encounter category:
• Spirometry.
measure: Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72
time frame: Blood samples were collected pre-dose at Baseline (Week 0), and at Week 2, Week 8, Week 26, Week 56 (follow-up) and Week 72 (follow-up)
description: To evaluate the pharmacokinetics (PK), pre-dose blood samples were collected at each visit and tralokinumab concentrations in serum were determined. Mean Ctrough concentrations are presented at each indicated visit up to Week 72.
measure: Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential
time frame: Baseline (Week 0), Week 26, Week 56 (follow-up) and Week 72 (follow-up)
description: Assessments of ADA were performed using a tiered approach (screening, confirmatory and titering assays). Confirmed ADA positive samples were also tested for the presence of neutralising antibodies (nAb). ADA prevalence was defined as proportion of the study population having drug-reactive antibodies at any point in time. ADA incidence (treatment-emergent ADA) was defined as the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher level following drug administration. Note: 'positive' is denoted by 'pos' in some category titles.
arm group label: Tralokinumab
arm group type: Experimental
description: Tralokinumab subcutaneous injection
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo subcutaneous injection
intervention type: Biological
intervention name: Experimental: Tralokinumab
description: Tralokinumab subcutaneous injection
arm group label: Tralokinumab
intervention type: Other
intervention name: Placebo
description: Placebo subcutaneous injection
arm group label: Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: 75 Years
healthy volunteers: No
last name: Christopher Brightling, MD
role: Principal Investigator
affiliation: Institute for Lung Health, United Kingdom
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country: Canada
country: Chile
country: Czechia
country: Italy
country: Japan
country: Mexico
country: Philippines
country: Russian Federation
country: South Africa
country: Taiwan
country: Ukraine
country: United Kingdom
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No
ipd description: This is commercially sensitive information.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 