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    Clinical Trial Results:
    A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults with Uncontrolled, Severe Asthma

    Summary
    EudraCT number
    		 2011-001360-21
    Trial protocol
    		 GB   DE   CZ   ES   PL  
    Global end of trial date
    22 Feb 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    22 Mar 2017
    First version publication date
    15 Apr 2016
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    CD-RI-CAT-354-1049
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01402986
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    Milstein Building, Granta Park,, Cambridge, United Kingdom, CB21 6GH
    Public contact
    Meena Jain, MB BChir, Director, Clinical Development,, MedImmune, LLC, JainM@medimmune.com
    Scientific contact
    Meena Jain, MB BChir, Director, Clinical Development,, MedImmune, LLC, JainM@medimmune.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate two subcutaneous (SC) treatment regimens of 300 milligram (mg) tralokinumab compared with placebo by assessing the effect on asthma exacerbation rate over 52 weeks in adults with uncontrolled, severe asthma requiring high-dose inhaled corticosteroids (ICS) and long-acting beta2-agonists (LABA), with or without additional asthma controller medications.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Participating participant signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Aug 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 25
    Country: Number of subjects enrolled
    Canada: 10
    Country: Number of subjects enrolled
    France: 42
    Country: Number of subjects enrolled
    Spain: 11
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Germany: 37
    Country: Number of subjects enrolled
    Poland: 23
    Country: Number of subjects enrolled
    Philippines: 60
    Country: Number of subjects enrolled
    Mexico: 30
    Country: Number of subjects enrolled
    Argentina: 40
    Country: Number of subjects enrolled
    Russian Federation: 33
    Country: Number of subjects enrolled
    Chile: 22
    Country: Number of subjects enrolled
    Czech Republic: 20
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 32
    Country: Number of subjects enrolled
    Japan: 64
    Worldwide total number of subjects
    452
    EEA total number of subjects
    136
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    397
    From 65 to 84 years
    55
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 689 participants were screened out of which 452 participants were randomized into this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo, Q2W - Cohort 1
    Arm description
    		 Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo Q2W
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.

    Arm title
    		 Tralokinumab 300 mg, Q2W - Cohort 1
    Arm description
    		 Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tralokinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.

    Arm title
    		 Placebo, Q2/4W - Cohort 2
    Arm description
    		 Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo, Q2/4W
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

    Arm title
    		 Tralokinumab 300 mg, Q2/4W - Cohort 2
    Arm description
    		 Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tralokinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

    Number of subjects in period 1
    		Placebo, Q2W - Cohort 1 Tralokinumab 300 mg, Q2W - Cohort 1 Placebo, Q2/4W - Cohort 2 Tralokinumab 300 mg, Q2/4W - Cohort 2
    Started
    76
    150
    75
    151
    Completed
    67
    135
    67
    129
    Not completed
    9
    15
    8
    22
         Adverse event, serious fatal
    -
    -
    -
    2
         Consent withdrawn by subject
    7
    10
    7
    13
         Unspecified
    2
    5
    1
    6
         Lost to follow-up
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo, Q2W - Cohort 1
    Reporting group description
    		 Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.

    Reporting group title
    Tralokinumab 300 mg, Q2W - Cohort 1
    Reporting group description
    		 Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.

    Reporting group title
    Placebo, Q2/4W - Cohort 2
    Reporting group description
    		 Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

    Reporting group title
    Tralokinumab 300 mg, Q2/4W - Cohort 2
    Reporting group description
    		 Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

    Reporting group values
    		 Placebo, Q2W - Cohort 1 Tralokinumab 300 mg, Q2W - Cohort 1 Placebo, Q2/4W - Cohort 2 Tralokinumab 300 mg, Q2/4W - Cohort 2 Total
    Number of subjects
    		 76 150 75 151 452
    Age categorical
    Units: Subjects
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 48.8 ± 12.1 49.7 ± 12.2 51.7 ± 13.6 50.5 ± 11.8 -
    Gender, Male/Female
    Units: participants
        Female
    		 51 100 46 100 297
        Male
    		 25 50 29 51 155

    End points

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    End points reporting groups
    Reporting group title
    Placebo, Q2W - Cohort 1
    Reporting group description
    		 Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.

    Reporting group title
    Tralokinumab 300 mg, Q2W - Cohort 1
    Reporting group description
    		 Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.

    Reporting group title
    Placebo, Q2/4W - Cohort 2
    Reporting group description
    		 Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

    Reporting group title
    Tralokinumab 300 mg, Q2/4W - Cohort 2
    Reporting group description
    		 Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

    Subject analysis set title
    Placebo Total
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for a total of 16 doses up to 38 weeks.

    Subject analysis set title
    Intent-to-treat (ITT) population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population included all participants who were randomized into the study.

    Primary: Annual Asthma Exacerbation Rate (AER)

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    End point title
    		 Annual Asthma Exacerbation Rate (AER) [1]
    End point description
    The annual asthma exacerbation rate (AER) in participants, was calculated as the total number of observed exacerbations in each group up to week 53, divided by total duration of person-year follow-up in each group. An asthma exacerbation defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids (tablets, suspension or injection) or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 days. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The intent-to-treat (ITT) population included all participants who were randomized into the study.
    End point type
    Primary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: AER events/person-year
        number (confidence interval 95%)
    0.91 (0.76 to 1.08)
    0.97 (0.81 to 1.14)
    0.9 (0.75 to 1.08)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The 95 percent (%) confidence interval (CI) for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 versus [vs] more than [>] 2 but less than or equal to [=<] 6), atopic asthma status (atopic/non-atopic), chronic oral corticosteroid (OCS) use (presence vs absence) and geographical region as the covariates.
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.709
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.31
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs > 2 but =< 6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.904
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.46

    Secondary: Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53

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    End point title
    		 Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 [2]
    End point description
    Pre- and post-bronchodilator FEV1 at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 53
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: liters
    arithmetic mean (standard error)
        Pre-bronchodilator: Baseline (n=147,146,146)
    1.922 ± 0.056
    1.934 ± 0.059
    1.926 ± 0.05
        Post-bronchodilator: Baseline (n=147,141,146)
    2.094 ± 0.061
    2.11 ± 0.061
    2.153 ± 0.053
        Pre-bronchodilator: Week 53 (n=125,130,122)
    0.128 ± 0.032
    0.032 ± 0.026
    0.018 ± 0.035
        Post-bronchodilator: Week 53 (n=125,126,120)
    0.085 ± 0.029
    -0.009 ± 0.025
    -0.058 ± 0.027
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53

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    End point title
    		 Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53 [3]
    End point description
    Pre- and post-bronchodilator FEV6 at clinic visits (morning) were measured. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 53
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: liters
    arithmetic mean (standard error)
        Pre-bronchodilator: Baseline (n=147,146,146)
    2.809 ± 0.072
    2.827 ± 0.074
    2.83 ± 0.064
        Post-bronchodilator: Baseline (n=147,141,146)
    2.981 ± 0.075
    2.98 ± 0.076
    3.055 ± 0.067
        Pre-bronchodilator: Week 53 (n=125,130,122)
    0.117 ± 0.037
    0.003 ± 0.031
    0.007 ± 0.036
        Post-bronchodilator: Week 53 (n=125,126,120)
    0.06 ± 0.033
    -0.024 ± 0.029
    -0.057 ± 0.03
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53

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    End point title
    		 Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53 [4]
    End point description
    Pre- and post-bronchodilator FVC at clinic visits (morning) were measured. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 53
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: liters
    arithmetic mean (standard error)
        Pre-bronchodilator: Baseline (n=147,146,146)
    2.955 ± 0.075
    2.993 ± 0.079
    3.003 ± 0.069
        Post-bronchodilator: Baseline (n=147,141,146)
    3.133 ± 0.078
    3.125 ± 0.08
    3.225 ± 0.072
        Pre-bronchodilator: Week 53 (n=125,130,122)
    0.11 ± 0.042
    -0.018 ± 0.032
    -0.001 ± 0.039
        Post-bronchodilator: Week 53 (n=125,126,120)
    0.045 ± 0.034
    -0.03 ± 0.031
    -0.071 ± 0.032
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53

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    End point title
    		 Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53 [5]
    End point description
    Pre- and post-bronchodilator FEV1 and FVC at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Ratio of FEV1/FVC was analysed. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 53
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: percentage of ratio
    arithmetic mean (standard error)
        Pre-bronchodilator: Baseline (n=147,146,146)
    65.071 ± 1.013
    65.008 ± 1.009
    64.508 ± 0.986
        Post-bronchodilator: Baseline (n=147,141,146)
    66.831 ± 1.056
    67.883 ± 1.01
    67.152 ± 0.997
        Pre-bronchodilator: Week 53 (n=125,130,122)
    1.695 ± 0.517
    1.155 ± 0.527
    0.32 ± 0.685
        Post-bronchodilator: Week 53 (n=125,126,120)
    1.593 ± 0.563
    0.032 ± 0.484
    -0.512 ± 0.513
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53

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    End point title
    		 Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53 [6]
    End point description
    Pre- and post-bronchodilator IC at clinic visits (morning) were measured. IC was measured by spirometry. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 53
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: liters
    arithmetic mean (standard error)
        Pre-bronchodilator: Baseline (n=140,138,143)
    0.023 ± 0.001
    0.023 ± 0.001
    0.022 ± 0.001
        Post-bronchodilator: Baseline (n=140,133,135)
    0.024 ± 0.001
    0.024 ± 0.001
    0.024 ± 0.001
        Pre-bronchodilator: Week 53 (n=108,109,103)
    0 ± 0
    0.001 ± 0.001
    0.001 ± 0.001
        Post-bronchodilator: Week 53 (n=108,109,104)
    0.001 ± 0.001
    0 ± 0.001
    0 ± 0.001
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home

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    End point title
    		 Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home [7]
    End point description
    Pre- and post-bronchodilator FEV1 at home (morning and evening) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: liters
    arithmetic mean (standard error)
        Day 1-7: Morning (n=151,149,149)
    1.61 ± 0.05
    1.66 ± 0.05
    1.63 ± 0.05
        Change at Day 365-371: Morning (n=124,119,114)
    0.01 ± 0.04
    -0.07 ± 0.06
    -0.12 ± 0.06
        Day 1-7: Evening (n=149,147,148)
    1.68 ± 0.05
    1.65 ± 0.05
    1.61 ± 0.05
        Change at Day 365-371: Evening (n=120,116,112)
    -0.08 ± 0.05
    -0.12 ± 0.05
    -0.08 ± 0.05
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home

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    End point title
    		 Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home [8]
    End point description
    The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: liters per minute
    arithmetic mean (standard error)
        Day 1-7: Morning (n=151,149,149)
    271 ± 9.7
    281.2 ± 9.9
    273.7 ± 8.7
        Change at Day 365-371: Morning (n=124,119,114)
    -8 ± 7.9
    -24 ± 9.6
    -23.1 ± 8.8
        Day 1-7: Evening (n=149,147,148)
    287.6 ± 9.9
    283.8 ± 10
    276 ± 8.9
        Change at Day 365-371: Evening (n=120,116,112)
    -27 ± 8.2
    -36.5 ± 8.8
    -16.4 ± 8.7
    No statistical analyses for this end point

    Secondary: Change from Baseline in Mean Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 53

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    End point title
    		 Change from Baseline in Mean Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 53 [9]
    End point description
    Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Results were reported for overall ACQ score. Data was summarized together for placebo arm groups. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 53
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: units on a scale
    arithmetic mean (standard error)
        Baseline (n=149,147,148)
    2.59 ± 0.09
    2.54 ± 0.08
    2.52 ± 0.07
        Change at Week 53 (n=118,115,112)
    -1.02 ± 0.1
    -0.93 ± 0.11
    -0.82 ± 0.1
    No statistical analyses for this end point

    Secondary: Change from Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53

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    End point title
    		 Change from Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53 [10]
    End point description
    AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 53
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: units on a scale
    arithmetic mean (standard error)
        Baseline: Overall (n=147,142,141)
    3.98 ± 0.09
    4.08 ± 0.09
    4.05 ± 0.09
        Week 53: Overall (n=107,109,101)
    1.04 ± 0.1
    1 ± 0.12
    0.85 ± 0.1
        Baseline: Symptoms (n=147,142,141)
    4.03 ± 0.09
    4.13 ± 0.09
    4.1 ± 0.09
        Week 53: Symptoms (n=107,109,101)
    1.14 ± 0.12
    1.05 ± 0.13
    0.85 ± 0.11
        Baseline: Activity limitation (n=147,142,141)
    4.04 ± 0.09
    4.13 ± 0.09
    4.04 ± 0.08
        Week 53: Activity limitation (n=107,109,101)
    0.96 ± 0.1
    0.93 ± 0.12
    0.81 ± 0.1
        Baseline: Emotional Function (n=147,142,141)
    3.91 ± 0.12
    4.02 ± 0.11
    4.14 ± 0.12
        Week 53: Emotional Function (n=107,109,101)
    1.1 ± 0.12
    1.09 ± 0.15
    0.89 ± 0.12
        Baseline: Environmental stimuli (n=147,142,141)
    3.76 ± 0.12
    3.89 ± 0.12
    3.8 ± 0.11
        Week 53: Environmental stimuli (n=107,109,101)
    0.86 ± 0.14
    0.97 ± 0.14
    0.88 ± 0.13
    No statistical analyses for this end point

    Secondary: Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53

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    End point title
    		 Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 [11]
    End point description
    The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems). The minimum possible value is 5 (one point for each dimension) and the maximum possible values is 15 (3 points for each dimension). Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study.
    End point type
    Secondary
    End point timeframe
    Week 53
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: participants
        Mobility - No problem
    118
    106
    107
        Mobility - Moderate problem
    18
    23
    26
        Mobility - Severe Problem
    0
    1
    1
        Mobility - Missing
    14
    21
    17
        Self-care - No Problem
    127
    122
    122
        Self-care - Moderate Problem
    9
    7
    12
        Self-care - Severe Problem
    0
    1
    0
        Self-care - Missing
    14
    21
    17
        Usual activities - No Problem
    106
    100
    89
        Usual activities - Moderate Problem
    30
    30
    43
        Usual activities - Severe Problem
    0
    0
    2
        Usual activities - Missing
    14
    21
    17
        Pain/discomfort - No problem
    100
    77
    84
        Pain/discomfort - Moderate problem
    34
    51
    46
        Pain/discomfort - Severe problem
    2
    2
    4
        Pain/discomfort - Missing
    14
    21
    17
        Anxiety/depression - No problem
    101
    101
    102
        Anxiety/depression - Moderate problem
    34
    29
    29
        Anxiety/depression - Severe problem
    1
    0
    3
        Anxiety/depression - Missing
    14
    21
    17
    No statistical analyses for this end point

    Secondary: Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Week 53

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    End point title
    		 Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Week 53 [12]
    End point description
    The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 53
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    136 [13]
    127 [14]
    130 [15]
    Units: units on a scale
        arithmetic mean (standard error)
    9.3 ± 1.9
    7.3 ± 1.8
    8.4 ± 1.6
    Notes
    [13] - ITT population with evaluable participants for this endpoint for the specified time-point.
    [14] - ITT population with evaluable participants for this endpoint for the specified time-point.
    [15] - ITT population with evaluable participants for this endpoint for the specified time-point.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Assessing Symptoms of Moderate-to-severe Asthma (ASMA) at Week 53

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    End point title
    		 Change From Baseline in Assessing Symptoms of Moderate-to-severe Asthma (ASMA) at Week 53 [16]
    End point description
    There were 3 symptom questions in the ASMA diary: daytime frequency (question 1), daytime severity (question 2) and nighttime severity (question 6). All symptom questions were scored from 0 to 4 averaged, where a higher score indicated greater frequency or severity. Asthma symptom scores were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated from Day -7 to Day -1. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -7 – Day -1) and Week 53 (Day 365 – Day 371)
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: units on a scale
    arithmetic mean (standard deviation)
        Day -7 - Day -1 (Baseline) (n=151,147,145)
    1.49 ± 0.77
    1.56 ± 0.69
    1.6 ± 0.71
        Change at Day 365 - Day 371 (n=113,108,108)
    -0.42 ± 0.73
    -0.49 ± 0.78
    -0.43 ± 0.75
    No statistical analyses for this end point

    Secondary: Change From Baseline in Rescue Medication use at Week 53

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    End point title
    		 Change From Baseline in Rescue Medication use at Week 53 [17]
    End point description
    Rescue medication use was collected from 3 questions: daytime use in response to symptoms (question 3), daytime prophylactic use (question 4) and nighttime use (question 7). Rescue medication use questions were first assessed using a dichotomous response option (YES/NO). If the participants reported YES, there was a subsequent question about the number of times rescue medication was used (questions 3a, 4a, and 7a). Daily average scores were summarized each week for all participants with at least 4 non-missing records each week. Days with no reported rescue medication use were represented as 0 and included in the calculation with participants who reported yes and completed questions 3a, 4a and 7a. The baseline scores were calculated from Day -7 to Day -1. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -7 – Day -1) and Week 53 (Day 365 – Day 371)
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150 [18]
    151 [19]
    151 [20]
    Units: use per day
    arithmetic mean (standard deviation)
        Day -7 - Day -1 (Baseline) (n=151,147,145)
    2.77 ± 3.78
    2.38 ± 2.58
    2.56 ± 2.73
        Change at Day 365 - Day 371 (n=113,108,108)
    -0.77 ± 2.59
    -1.02 ± 2.3
    -0.86 ± 2.2
    Notes
    [18] - ITT population
    [19] - ITT population
    [20] - ITT population
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) [21]
    End point description
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Week 75 that were absent before treatment or that worsened relative to pre-treatment state. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The safety population included all participants who received any investigational product and had safety data available for analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 75
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: participants
        TEAEs
    134
    128
    129
        TESAEs
    18
    25
    21
    No statistical analyses for this end point

    Secondary: Observed Serum Tralokinumab Concentration at Week 53

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    End point title
    		 Observed Serum Tralokinumab Concentration at Week 53 [22]
    End point description
    Tralokinumab concentrations that were below limit of quantification (LOQ) of the pharmacokinetic (PK) assay (LOQ = 0.500 microgram per milliliter [mcg/mL]) were replaced by LOQ/2 = 0.250 mcg/mL; results were reported to 3 significant figures level of precision. Observed serum tralokinumab concentration at Week 53 was reported. The PK population included all participants who received at least one dose of tralokinumab and had at least one quantifiable PK observation. Here "N" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Week 53
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
    Number of subjects analysed
    136
    128
    Units: microgram per milliliter
        arithmetic mean (standard deviation)
    71.3 ± 34.2
    25.8 ± 11.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Anti-Drug Antibodies (ADA) to Tralokinumab

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    End point title
    		 Percentage of Participants with Anti-Drug Antibodies (ADA) to Tralokinumab [23]
    End point description
    Immunogenicity assessment included determination of anti-drug (tralokinumab) antibodies in serum samples. ADA positive was defined as a titer greater than or equal to (>=13) at any point in the study. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The PK population included all participants who received at least one dose of tralokinumab and had at least one quantifiable PK observation. Here "N" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 75
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: percentage of participants
    number (not applicable)
        Baseline (Week 1) (n=151,150,151)
    0.67
    1.3
    1.3
        Week 75 (n=151,150,150)
    0
    4
    3.3
    No statistical analyses for this end point

    Secondary: Severe Annual Asthma Exacerbation Rate (AER)

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    End point title
    		 Severe Annual Asthma Exacerbation Rate (AER) [24]
    End point description
    Severe annualized AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed or administered by the investigator; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. An asthma exacerbation event was considered resolved 7 days after the last dose of oral corticosteroids is administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150 [25]
    151 [26]
    151 [27]
    Units: AER events/person-year
        number (confidence interval 95%)
    0.11 (0.06 to 0.17)
    0.1 (0.05 to 0.17)
    0.17 (0.1 to 0.25)
    Notes
    [25] - ITT population
    [26] - ITT population
    [27] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.293
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.26
         upper limit
    		 1.51
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.27
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.27
         upper limit
    		 1.44

    Secondary: Time to First Exacerbation Through Week 53

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    End point title
    		 Time to First Exacerbation Through Week 53 [28]
    End point description
    Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. In the below table, '99999' indicates the median and lower and upper limits of the 95% Confidence Interval were incalculable due to an insufficient number of events. The ITT population included all participants who were randomized into the study.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: days
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.257
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 1.16
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.225
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.15

    Secondary: Time to First Severe Exacerbation Through Week 53

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    End point title
    		 Time to First Severe Exacerbation Through Week 53 [29]
    End point description
    Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. In the below table, '99999' indicates the median and lower and upper limits of the 95% Confidence Interval were incalculable due to an insufficient number of events. The ITT population included all participants who were randomized into the study.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: days
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.538
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 1.68
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.561
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 1.71

    Secondary: Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin

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    End point title
    		 Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin [30]
    End point description
    Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER was evaluated by subgroup baseline serum periostin >= or <median, >= or < 25th percentile and >= or < 75th percentile. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Here "n" signifies evaluable participants for this measure.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150 [31]
    151 [32]
    151 [33]
    Units: AER events/person-year
    number (confidence interval 95%)
        >= median (n=67,81,79)
    0.85 (0.65 to 1.08)
    1.27 (1.03 to 1.55)
    1.13 (0.88 to 1.43)
        < median (n=84,69,71)
    0.98 (0.76 to 1.25)
    0.63 (0.45 to 0.85)
    0.73 (0.55 to 0.95)
        >= 25th Percentile (n=105,115,119)
    0.84 (0.67 to 1.03)
    1.05 (0.87 to 1.25)
    0.94 (0.75 to 1.15)
        < 25th Percentile (n=46,35,31)
    1.14 (0.81 to 1.56)
    0.65 (0.38 to 1.05)
    0.83 (0.58 to 1.16)
        >= 75th Percentile (n=32,43,39)
    0.91 (0.65 to 1.25)
    2.03 (1.6 to 2.55)
    1.13 (0.76 to 1.6)
        < 75th Percentile (n=119,107,111)
    0.91 (0.73 to 1.11)
    0.6 (0.46 to 0.77)
    0.85 (0.69 to 1.04)
    Notes
    [31] - ITT population
    [32] - ITT population
    [33] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Baseline serum periostin >= median
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.19
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 1.17
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Baseline serum periostin >= median
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.856
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.61
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Baseline serum periostin < median
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.602
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.81
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Baseline serum periostin < median
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.703
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 1.5
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Baseline serum periostin >= 25th Percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.455
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 1.28
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Baseline serum periostin >= 25th Percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.929
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.57
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Baseline serum periostin < 25th Percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.507
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 2.51
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Baseline serum periostin < 25th Percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.805
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 1.89
    Statistical analysis title
    		 Statistical analysis 9
    Statistical analysis description
    Baseline serum periostin >= 75th Percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.716
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 1.75
    Statistical analysis title
    		 Statistical analysis 10
    Statistical analysis description
    Baseline serum periostin >= 75th Percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.328
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 3.43
    Statistical analysis title
    		 Statistical analysis 11
    Statistical analysis description
    Baseline serum periostin < 75th Percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.804
    Method
    		 Poission regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.41
    Statistical analysis title
    		 Statistical analysis 12
    Statistical analysis description
    Baseline serum periostin < 75th Percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.088
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 1.05

    Secondary: Annual Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status

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    End point title
    		 Annual Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status [34]
    End point description
    Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. AER was evaluated by subgroup Th2 status. Th2-high included those participants who had immunoglobulin E (IgE) >100 international unit per milliliter (IU/mL) and blood eosinophils >= 0.14 * 10 power 9 per Liter. Th2 low would include those participants who do not meet Th2 high status. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Here "n" signifies evaluable participants for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150 [35]
    151 [36]
    151 [37]
    Units: AER events/person-year
    number (confidence interval 95%)
        Th2 high (n=70,74,67)
    0.94 (0.73 to 1.2)
    1.09 (0.85 to 1.39)
    0.96 (0.74 to 1.23)
        Th2 Low (n=73,61,72)
    0.88 (0.66 to 1.16)
    0.85 (0.64 to 1.11)
    0.9 (0.69 to 1.16)
    Notes
    [35] - ITT population
    [36] - ITT population
    [37] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Th2 high
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.365
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 1.29
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Th2 high
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.922
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.68
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Th2 Low
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.685
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.84
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Th2 Low
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.813
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.7

    Secondary: Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count

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    End point title
    		 Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count [38]
    End point description
    Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroups baseline peripheral blood eosinophil counts. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Here "n" signifies evaluable participants for this measure.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150 [39]
    151 [40]
    151 [41]
    Units: AER events/person-year
    number (confidence interval 95%)
        >= 150 cells/mcgL (n=95,104,92)
    0.84 (0.66 to 1.04)
    0.96 (0.77 to 1.19)
    0.95 (0.76 to 1.18)
        < 150 cells/mcgL (n=48,38,52)
    1.09 (0.78 to 1.48)
    0.95 (0.69 to 1.27)
    0.9 (0.64 to 1.22)
        >= 300 cells/mcgL (n=54,60,50)
    1.01 (0.76 to 1.31)
    1.56 (1.23 to 1.97)
    1 (0.74 to 1.32)
        < 300 cells/mcgL (n=89,82,94)
    0.83 (0.64 to 1.06)
    0.63 (0.47 to 0.82)
    0.89 (0.7 to 1.12)
    Notes
    [39] - ITT population
    [40] - ITT population
    [41] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Baseline eosinophil count >=150 cells/mcgL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.335
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.22
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Baseline eosinophil count >=150 cells/mcgL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.586
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.41
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Baseline eosinophil count <150 cells/mcgL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.331
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 2.52
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Baseline eosinophil count <150 cells/mcgL
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.311
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 2.71
    Statistical analysis title
    		 statistical analysis 5
    Statistical analysis description
    Baseline eosinophil count >=300 cells/mcgL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.414
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 1.35
    Statistical analysis title
    		 statistical analysis 6
    Statistical analysis description
    Baseline eosinophil count >=300 cells/mcgL
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.463
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 2.36
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Baseline eosinophil count <300 cells/mcgL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.793
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.68
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Baseline eosinophil count <300 cells/mcgL
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.264
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.22

    Secondary: Annual Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility

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    End point title
    		 Annual Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility [42]
    End point description
    Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup baseline FEV1 reversibility >=12% and <12%. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Here "n" signifies evaluable participants for this measure.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150 [43]
    151 [44]
    151 [45]
    Units: AER events/person-year
    number (confidence interval 95%)
        Reversibility >=12% (n=57,43,49)
    0.68 (0.45 to 0.99)
    1.08 (0.8 to 1.42)
    0.88 (0.65 to 1.18)
        Reversibility <12% (n=91,101,97)
    0.99 (0.8 to 1.21)
    0.9 (0.71 to 1.12)
    0.93 (0.73 to 1.16)
    Notes
    [43] - ITT population
    [44] - ITT population
    [45] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Baseline FEV1 reversibility >=12%
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.245
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 1.32
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Baseline FEV1 reversibility >=12%
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.438
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 1.54
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Baseline FEV1 reversibility <12%
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.947
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.57
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Baseline FEV1 reversibility <12%
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.916
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.59

    Secondary: Annual Asthma Exacerbation Rate (AER) by Baseline FEV1% Predicted

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    End point title
    		 Annual Asthma Exacerbation Rate (AER) by Baseline FEV1% Predicted [46]
    End point description
    Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER was evaluated by subgroup baseline FEV1% predicaed. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Here "n" signifies evaluable participants for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150 [47]
    151 [48]
    151 [49]
    Units: AER events/person-year
    number (confidence interval 95%)
        FEV1% Predicted <=60% (n=49,45,56)
    0.95 (0.68 to 1.29)
    1.67 (1.34 to 2.07)
    1.05 (0.77 to 1.4)
        FEV1% Predicted <=80% (n=119,109,105)
    0.88 (0.71 to 1.08)
    1.13 (0.93 to 1.36)
    0.93 (0.76 to 1.13)
    Notes
    [47] - ITT population
    [48] - ITT population
    [49] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Baseline FEV1% predicted <=60%
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.723
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 1.56
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Baseline FEV1% predicted <=60%
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.852
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.86
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Baseline FEV1% predicted <=80%
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.409
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.23
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Baseline FEV1% predicted <=80%
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.744
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.58

    Secondary: Annual Asthma Exacerbation Rate (AER) by Asthma Exacerbations in the Past Year

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    End point title
    		 Annual Asthma Exacerbation Rate (AER) by Asthma Exacerbations in the Past Year [50]
    End point description
    Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup as asthma exacerbations in the past year. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Here "n" signifies evaluable participants for this measure at specified time points.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150 [51]
    151 [52]
    151 [53]
    Units: AER events/person-year
    number (confidence interval 95%)
        2 asthma exacerbations (n=97,96,95)
    0.61 (0.45 to 0.79)
    0.45 (0.32 to 0.61)
    0.62 (0.47 to 0.81)
        > 2 but < 6 asthma exacerbations (n=54,54,56)
    1.42 (1.12 to 1.78)
    1.88 (1.52 to 2.3)
    1.44 (1.12 to 1.82)
    Notes
    [51] - ITT population
    [52] - ITT population
    [53] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    2 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.802
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 1.52
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    2 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.05
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 1
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    > 2 but < 6 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.792
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.56
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    > 2 but < 6 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.231
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 2.38

    Secondary: Severe Asthma Exacerbation Rate (AER) by Baseline Serum Periostin

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    End point title
    		 Severe Asthma Exacerbation Rate (AER) by Baseline Serum Periostin [54]
    End point description
    Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER evaluated by subgroup baseline serum periostin. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Here "n" signifies evaluable participants for this measure.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150 [55]
    151 [56]
    151 [57]
    Units: AER events/person-year
    number (confidence interval 95%)
        >= median (n=67,81,79)
    0.08 (0.03 to 0.17)
    0.12 (0.06 to 0.23)
    0.25 (0.14 to 0.4)
        < median (n=84,69,71)
    0.14 (0.06 to 0.26)
    0.08 (0.03 to 0.18)
    0.1 (0.04 to 0.2)
    Notes
    [55] - ITT population
    [56] - ITT population
    [57] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Baseline Serum Periostin >=Median
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.046
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 0.98
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Baseline Serum Periostin >=Median
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.197
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 1.48
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Baseline Serum Periostin < Median
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.708
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 2.79
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Baseline Serum Periostin < Median
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.594
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 3.57

    Secondary: Severe Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility

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    End point title
    		 Severe Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility [58]
    End point description
    Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup FEV1 reversibility. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Here "n" signifies evaluable participants for this measure.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150 [59]
    151 [60]
    151 [61]
    Units: AER events/person-year
    number (confidence interval 95%)
        Reversibility >=12% (n=57,43,49)
    0.13 (0.04 to 0.29)
    0.13 (0.05 to 0.28)
    0.11 (0.04 to 0.25)
        Reversibility <12% (n=91,101,97)
    0.1 (0.05 to 0.19)
    0.09 (0.04 to 0.18)
    0.2 (0.12 to 0.32)
    Notes
    [59] - ITT population
    [60] - ITT population
    [61] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Baseline FEV1 reversibility >=12%
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.975
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.14
         upper limit
    		 7.67
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Baseline FEV1 reversibility >=12%
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.473
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    1.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 6.67
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Baseline FEV1 reversibility <12%
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.099
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.21
         upper limit
    		 1.14
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Baseline FEV1 reversibility <12%
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.148
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 1.36

    Secondary: Severe Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status

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    End point title
    		 Severe Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status [62]
    End point description
    Severe AER was assessed based on AER data up to Week 53. An asthma exacerbation is a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 days. It was considered resolved 7 days after last dose of OCS (10 days after injectable corticosteroid). Corticosteroids initiated after this time period were considered separate new asthma exacerbation. Severe AER was evaluated by subgroup Th2 status. Th2-high include who had IgE >100 IU/mL and blood eosinophils >=0.14*10^9/L. Th2 low would include who do not meet Th2 high status. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Here "n" signifies evaluable participants for this measure.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [62] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150 [63]
    151 [64]
    151 [65]
    Units: AER events/person-year
    number (confidence interval 95%)
        Th2 high (n=70,74,67)
    0.12 (0.05 to 0.23)
    0.06 (0.02 to 0.16)
    0.12 (0.05 to 0.24)
        Th2 Low (n=73,61,72)
    0.05 (0.01 to 0.15)
    0.12 (0.05 to 0.24)
    0.21 (0.11 to 0.35)
    Notes
    [63] - ITT population
    [64] - ITT population
    [65] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Th2 high
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.698
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.31
         upper limit
    		 2.19
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Th2 high
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.299
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.18
         upper limit
    		 1.7
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Th2 Low
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.105
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 1.34
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Th2 Low
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.576
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 2.47

    Secondary: Severe Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count

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    End point title
    		 Severe Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count [66]
    End point description
    Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS (10 days after an injectable corticosteroid). Corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup baseline peripheral blood eosinophil count. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Here "n" signifies evaluable participants for this measure.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [66] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150 [67]
    151 [68]
    151 [69]
    Units: AER events/person-year
    number (confidence interval 95%)
        >= 300 cells/mcgL (n=54,60,50)
    0.16 (0.07 to 0.31)
    0.15 (0.06 to 0.31)
    0.22 (0.11 to 0.4)
        < 300 cells/mcgL (n=89,82,94)
    0.08 (0.03 to 0.16)
    0.08 (0.03 to 0.17)
    0.13 (0.07 to 0.24)
    Notes
    [67] - ITT population
    [68] - ITT population
    [69] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Baseline eosinophil count >=300 cells/mcgL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.133
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.19
         upper limit
    		 1.25
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Baseline eosinophil count >=300 cells/mcgL
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.241
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 1.67
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Baseline eosinophil count <300 cells/mcgL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.51
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.12
         upper limit
    		 2.84
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Baseline eosinophil count <300 cells/mcgL
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.661
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.19
         upper limit
    		 2.85

    Secondary: Percent Change from Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups [70]
    End point description
    Prebronchodilator FEV1 was evaluated by subgroups. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: Percent change
    arithmetic mean (standard error)
        Baseline SP >=median (n=54,71,65)
    10.48 ± 3.01
    4.36 ± 2.25
    4.17 ± 2.75
        Baseline SP <median (n=71,59,56)
    7.46 ± 3
    1.3 ± 2.12
    1.23 ± 2.82
        Baseline SP >=25th Percentile (n=88,102,100)
    10.4 ± 2.43
    2.31 ± 1.66
    4.1 ± 2.29
        Baseline SP <25th Percentile (n=37,28,21)
    4.4 ± 4.39
    5.99 ± 4.22
    -1.29 ± 3.92
        Baseline SP >=75th Percentile (n=25,40,32)
    11.05 ± 4.67
    2.97 ± 3.33
    2.32 ± 4.07
        Baseline SP <75th Percentile (n=100,90,89)
    8.25 ± 2.29
    2.94 ± 1.75
    2.55 ± 2.28
        Th2 high (n=63,62,57)
    11.62 ± 3.23
    4.52 ± 2.39
    2.1 ± 2.62
        Th2 low (n=57,55,55)
    3.87 ± 2.5
    0.13 ± 1.72
    1.9 ± 3.09
        Baseline PBEC >=150 cells/mcgL (n=81,89,75)
    10.97 ± 2.71
    4.67 ± 2.17
    1.98 ± 2.32
        Baseline PBEC <150 cells/mcgL (n=39,34,40)
    5.75 ± 3.75
    -0.4 ± 2
    2.05 ± 3.89
        Baseline PBEC >=300 cells/mcgL (n=45,51,39)
    14.04 ± 3.88
    4.65 ± 2.9
    0.59 ± 2.88
        Baseline PBEC <300 cells/mcgL (n=75,72,76)
    6.33 ± 2.57
    2.01 ± 1.89
    2.85 ± 2.71
        Baseline FEV1 reversibility >=12% (n=49,36,41)
    22.78 ± 5.2
    11.8 ± 3.48
    11.02 ± 3.85
        Baseline FEV1 reversibility <12% (n=76,92,80)
    3.98 ± 1.97
    -1.66 ± 1.28
    -2.99 ± 1.9
        2 asthma exacerbations (n=84,81,82)
    8.99 ± 2.41
    3.57 ± 2.04
    0.76 ± 2.16
        > 2 but < 6 asthma exacerbations (n=41,49,40)
    9.32 ± 4.05
    1.63 ± 2.17
    6.08 ± 4.12
        Chronic OCS use (n=20,21,16)
    6.96 ± 6.56
    -0.48 ± 5.31
    3.44 ± 5.82
        Without chronic OCS use (n=105,109,106)
    9.52 ± 2.22
    3.45 ± 1.59
    2.32 ± 2.1
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Baseline serum periostin >= median
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.057
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    6.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.21
         upper limit
    		 13.79
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Baseline serum periostin >= median
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.874
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.54
         upper limit
    		 7.68
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Baseline serum periostin < median
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.028
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    7.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 13.95
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Baseline serum periostin < median
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.745
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.48
         upper limit
    		 7.66
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Baseline serum periostin >= 25th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.011
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    7.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.66
         upper limit
    		 12.58
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Baseline serum periostin >= 25th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.863
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.93
         upper limit
    		 4.97
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Baseline serum periostin < 25th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.221
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    6.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.8
         upper limit
    		 16.27
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Baseline serum periostin < 25th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.108
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    8.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.91
         upper limit
    		 19.07
    Statistical analysis title
    		 Statistical analysis 9
    Statistical analysis description
    Baseline serum periostin >= 75th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.09
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    9.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.57
         upper limit
    		 21.35
    Statistical analysis title
    		 Statistical analysis 10
    Statistical analysis description
    Baseline serum periostin >= 75th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.908
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.19
         upper limit
    		 12.59
    Statistical analysis title
    		 Statistical analysis 11
    Statistical analysis description
    Baseline serum periostin < 75th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.013
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    6.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.41
         upper limit
    		 11.64
    Statistical analysis title
    		 Statistical analysis 12
    Statistical analysis description
    Baseline serum periostin < 75th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.635
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.84
         upper limit
    		 6.29
    Statistical analysis title
    		 Statistical analysis 13
    Statistical analysis description
    Th2 high
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.014
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    8.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.84
         upper limit
    		 15.94
    Statistical analysis title
    		 Statistical analysis 14
    Statistical analysis description
    Th2 high
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.28
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    3.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.19
         upper limit
    		 11.02
    Statistical analysis title
    		 Statistical analysis 15
    Statistical analysis description
    Th2 low
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.292
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    3.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.78
         upper limit
    		 9.22
    Statistical analysis title
    		 Statistical analysis 16
    Statistical analysis description
    Th2 low
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.691
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.99
         upper limit
    		 4.64
    Statistical analysis title
    		 Statistical analysis 17
    Statistical analysis description
    Baseline peripheral blood eosinophil count >= 150 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    8.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.85
         upper limit
    		 14.81
    Statistical analysis title
    		 Statistical analysis 18
    Statistical analysis description
    Baseline peripheral blood eosinophil count >= 150 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.177
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    4.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.92
         upper limit
    		 10.43
    Statistical analysis title
    		 Statistical analysis 19
    Statistical analysis description
    Baseline peripheral blood eosinophil count < 150 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.159
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    6.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.39
         upper limit
    		 14.5
    Statistical analysis title
    		 Statistical analysis 20
    Statistical analysis description
    Baseline peripheral blood eosinophil count < 150 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.857
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.63
         upper limit
    		 7.18
    Statistical analysis title
    		 Statistical analysis 21
    Statistical analysis description
    Baseline peripheral blood eosinophil count >= 300 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    13.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.28
         upper limit
    		 22.22
    Statistical analysis title
    		 Statistical analysis 22
    Statistical analysis description
    Baseline peripheral blood eosinophil count >= 300 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.243
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    5.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.56
         upper limit
    		 14.02
    Statistical analysis title
    		 Statistical analysis 23
    Statistical analysis description
    Baseline peripheral blood eosinophil count < 300 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.144
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    4.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 10.24
    Statistical analysis title
    		 Statistical analysis 24
    Statistical analysis description
    Baseline peripheral blood eosinophil count < 300 cells/μ
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.804
    Method
    		 Baseline peripheral blood eosinophil cou
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.01
         upper limit
    		 6.46
    Statistical analysis title
    		 Statistical analysis 25
    Statistical analysis description
    Baseline FEV1 reversibility >= 12%
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.029
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    11.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.15
         upper limit
    		 21.23
    Statistical analysis title
    		 Statistical analysis 26
    Statistical analysis description
    Baseline FEV1 reversibility >= 12%
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.887
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.19
         upper limit
    		 10.62
    Statistical analysis title
    		 Statistical analysis 27
    Statistical analysis description
    Baseline FEV1 reversibility < 12%
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    7.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.76
         upper limit
    		 12.59
    Statistical analysis title
    		 Statistical analysis 28
    Statistical analysis description
    Baseline FEV1 reversibility < 12%
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.268
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    2.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.15
         upper limit
    		 7.74
    Statistical analysis title
    		 Statistical analysis 29
    Statistical analysis description
    2 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    7.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.64
         upper limit
    		 13.01
    Statistical analysis title
    		 Statistical analysis 30
    Statistical analysis description
    2 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.361
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    2.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.78
         upper limit
    		 7.62
    Statistical analysis title
    		 Statistical analysis 31
    Statistical analysis description
    > 2 but < 6 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.185
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    6.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.06
         upper limit
    		 15.75
    Statistical analysis title
    		 Statistical analysis 32
    Statistical analysis description
    > 2 but < 6 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.986
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.5
         upper limit
    		 9.34
    Statistical analysis title
    		 Statistical analysis 33
    Statistical analysis description
    Chronic OCS use
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.912
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.7
         upper limit
    		 16.44
    Statistical analysis title
    		 Statistical analysis 34
    Statistical analysis description
    Chronic OCS use
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.86
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -1.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.76
         upper limit
    		 14.84
    Statistical analysis title
    		 Statistical analysis 35
    Statistical analysis description
    Without chronic OCS use
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    7.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.76
         upper limit
    		 12.36
    Statistical analysis title
    		 Statistical analysis 36
    Statistical analysis description
    Without chronic OCS use
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.601
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.51
         upper limit
    		 6.06

    Secondary: Change from Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups

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    End point title
    		 Change from Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups [71]
    End point description
    Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [71] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: units on a scale
    arithmetic mean (standard error)
        Baseline SP >= Median (n= 51, 65, 60)
    -1.18 ± 0.13
    -0.85 ± 0.14
    -0.88 ± 0.15
        Baseline SP < Median (n= 67, 50, 52)
    -0.81 ± 0.15
    -1.03 ± 0.17
    -0.77 ± 0.14
        Baseline SP >= 25th Percentile (n= 82, 92, 91)
    -1.04 ± 0.11
    -0.93 ± 0.13
    -0.86 ± 0.12
        Baseline SP <25th Percentile (n= 36, 23, 21)
    -0.95 ± 0.24
    -0.92 ± 0.24
    -0.73 ± 0.19
        Baseline SP >=75th Percentile (n= 25, 34, 27)
    -1.25 ± 0.18
    -1.01 ± 0.23
    -0.75 ± 0.14
        Baseline SP <75th Percentile (n= 93, 81, 85)
    -0.92 ± 0.12
    -0.91 ± 0.13
    -0.84 ± 0.12
        Th2 High (n= 59, 56, 55)
    -1.1 ± 0.15
    -1.02 ± 0.15
    -0.95 ± 0.13
        Th2 Low (n= 55, 47, 50)
    -0.94 ± 0.14
    -0.87 ± 0.17
    -0.7 ± 0.16
        Baseline EC >= 150 Cells/UL (n= 77, 78, 70)
    -1.07 ± 0.13
    -0.94 ± 0.13
    -0.84 ± 0.13
        Baseline EC < 150 Cells/UL (n= 37, 31, 37)
    -0.92 ± 0.16
    -1.02 ± 0.21
    -0.81 ± 0.18
        Baseline EC >= 300 Cells/UL (n= 43, 44, 37)
    -1.24 ± 0.16
    -0.91 ± 0.17
    -0.77 ± 0.15
        Baseline EC < 300 Cells/UL (n= 71, 65, 70)
    -0.88 ± 0.12
    -1 ± 0.15
    -0.86 ± 0.14
        Baseline FEV1 Reversibility >=12% (n= 43, 33, 35)
    -0.9 ± 0.18
    -0.76 ± 0.2
    -0.47 ± 0.19
        Baseline FEV1 Reversibility <12% (n= 73, 78, 75)
    -1.12 ± 0.12
    -1.02 ± 0.13
    -1.03 ± 0.11
        2 Asthma Exacerbations (n= 79, 72, 75)
    -0.94 ± 0.13
    -0.95 ± 0.14
    -0.77 ± 0.13
        >2 Asthma Exacerbations (n= 39, 43, 37)
    -1.15 ± 0.15
    -0.9 ± 0.19
    -0.93 ± 0.17
        With Chronic OCS Use (n= 20, 17, 18)
    -0.89 ± 0.28
    -0.16 ± 0.23
    -0.39 ± 0.25
        Without Chronic OCS Use (n= 98, 98, 94)
    -1.04 ± 0.11
    -1.08 ± 0.12
    -0.91 ± 0.11
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Baseline serum periostin >= median
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.145
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.57
         upper limit
    		 0.08
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Baseline serum periostin >= median
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.759
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.38
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Baseline serum periostin < median
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.936
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.38
         upper limit
    		 0.35
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Baseline serum periostin < median
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.127
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.64
         upper limit
    		 0.08
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Baseline serum periostin>= 25th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.343
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 0.14
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Baseline serum periostin>= 25th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.928
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 0.27
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Baseline serum periostin < 25th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.374
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.74
         upper limit
    		 0.28
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Baseline serum periostin < 25th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.259
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.81
         upper limit
    		 0.22
    Statistical analysis title
    		 Statistical analysis 9
    Statistical analysis description
    Baseline serum periostin >= 75th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.127
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.84
         upper limit
    		 0.11
    Statistical analysis title
    		 Statistical analysis 10
    Statistical analysis description
    Baseline serum periostin >= 75th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.775
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.56
         upper limit
    		 0.42
    Statistical analysis title
    		 Statistical analysis 11
    Statistical analysis description
    Baseline serum periostin < 75th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.512
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.38
         upper limit
    		 0.19
    Statistical analysis title
    		 Statistical analysis 12
    Statistical analysis description
    Baseline serum periostin < 75th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.404
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.16
    Statistical analysis title
    		 Statistical analysis 13
    Statistical analysis description
    Th2 high
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.181
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.59
         upper limit
    		 0.11
    Statistical analysis title
    		 Statistical analysis 14
    Statistical analysis description
    Th2 high
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.161
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.1
    Statistical analysis title
    		 Statistical analysis 15
    Statistical analysis description
    Th2 low
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.54
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.47
         upper limit
    		 0.25
    Statistical analysis title
    		 Statistical analysis 16
    Statistical analysis description
    Th2 low
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.674
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 0.27
    Statistical analysis title
    		 Statistical analysis 17
    Statistical analysis description
    Baseline peripheral blood eosinophil count >= 150 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.154
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 0.08
    Statistical analysis title
    		 Statistical analysis 18
    Statistical analysis description
    Baseline peripheral blood eosinophil count >= 150 cells/μ
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.271
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 0.13
    Statistical analysis title
    		 Statistical analysis 19
    Statistical analysis description
    Baseline peripheral blood eosinophil count < 150 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.725
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.51
         upper limit
    		 0.36
    Statistical analysis title
    		 Statistical analysis 20
    Statistical analysis description
    Baseline peripheral blood eosinophil count < 150 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.559
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.53
         upper limit
    		 0.28
    Statistical analysis title
    		 Statistical analysis 21
    Statistical analysis description
    Baseline peripheral blood eosinophil count >= 300 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.019
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.87
         upper limit
    		 -0.08
    Statistical analysis title
    		 Statistical analysis 22
    Statistical analysis description
    Baseline peripheral blood eosinophil count >= 300 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.348
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.61
         upper limit
    		 0.21
    Statistical analysis title
    		 Statistical analysis 23
    Statistical analysis description
    Baseline peripheral blood eosinophil count < 300 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.855
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.35
         upper limit
    		 0.29
    Statistical analysis title
    		 Statistical analysis 24
    Statistical analysis description
    Baseline peripheral blood eosinophil count < 300 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.203
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.11
    Statistical analysis title
    		 Statistical analysis 25
    Statistical analysis description
    Baseline FEV1 reversibility >= 12%
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.055
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.89
         upper limit
    		 0.01
    Statistical analysis title
    		 Statistical analysis 26
    Statistical analysis description
    Baseline FEV1 reversibility >= 12%
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.104
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.82
         upper limit
    		 0.08
    Statistical analysis title
    		 Statistical analysis 27
    Statistical analysis description
    Baseline FEV1 reversibility < 12%
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.652
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 0.23
    Statistical analysis title
    		 Statistical analysis 28
    Statistical analysis description
    Baseline FEV1 reversibility < 12%
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.905
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.32
    Statistical analysis title
    		 Statistical analysis 29
    Statistical analysis description
    2 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.198
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 0.1
    Statistical analysis title
    		 Statistical analysis 30
    Statistical analysis description
    2 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.226
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.47
         upper limit
    		 0.11
    Statistical analysis title
    		 Statistical analysis 31
    Statistical analysis description
    > 2 but < 6 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.513
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.56
         upper limit
    		 0.28
    Statistical analysis title
    		 Statistical analysis 32
    Statistical analysis description
    > 2 but < 6 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.974
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.42
    Statistical analysis title
    		 Statistical analysis 33
    Statistical analysis description
    Chronic OCS use
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.226
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.97
         upper limit
    		 0.23
    Statistical analysis title
    		 Statistical analysis 34
    Statistical analysis description
    Chronic OCS use
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.613
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.44
         upper limit
    		 0.75
    Statistical analysis title
    		 Statistical analysis 35
    Statistical analysis description
    Without chronic OCS use
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.198
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.09
    Statistical analysis title
    		 Statistical analysis 36
    Statistical analysis description
    Without chronic OCS use
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.165
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 0.08

    Secondary: Change from Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups

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    End point title
    		 Change from Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups [72]
    End point description
    AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [72] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: units on a scale
    arithmetic mean (standard error)
        Baseline SP >=Median (n= 46, 63, 56)
    1.1 ± 0.14
    0.95 ± 0.17
    0.89 ± 0.15
        Baseline SP <Median ( n= 61, 46, 45)
    0.95 ± 0.15
    1.07 ± 0.17
    0.82 ± 0.14
        Baseline SP >=25th Percentile (n= 73, 88, 82)
    1.08 ± 0.11
    0.98 ± 0.14
    0.87 ± 0.12
        Baseline SP <25th Percentile (n= 34, 21, 19)
    0.84 ± 0.24
    1.09 ± 0.24
    0.81 ± 0.19
        Baseline SP >=75th Percentile (n= 23, 33, 24)
    1.2 ± 0.19
    1.13 ± 0.28
    0.76 ± 0.17
        Baseline SP <75th Percentile (n= 84, 76, 77)
    0.97 ± 0.12
    0.96 ± 0.13
    0.87 ± 0.12
        Th2 high (n=54,52,50)
    1.12 ± 0.15
    1.12 ± 0.18
    0.88 ± 0.13
        Th2 low (n= 49, 45, 44 )
    0.88 ± 0.15
    0.94 ± 0.17
    0.79 ± 0.17
        Baseline EC >=150 Cells/UL (n=69, 72, 64)
    1.06 ± 0.13
    1.02 ± 0.15
    0.91 ± 0.11
        Baseline EC<150 Cells/UL (n= 34, 31, 32)
    0.93 ± 0.13
    1.05 ± 0.2
    0.68 ± 0.2
        Baseline EC >=300 Cells/UL (n= 39, 40, 35)
    0.98 ± 0.17
    0.82 ± 0.2
    0.81 ± 0.15
        Baseline EC <300 Cells/UL (N= 64, 63, 61)
    1.05 ± 0.13
    1.15 ± 0.15
    0.84 ± 0.14
        Baseline FEV1 Reversibility >=12% (n= 39, 29, 32)
    1.14 ± 0.16
    0.95 ± 0.22
    0.75 ± 0.17
        Baseline FEV1 Reversibility <12% (n= 66, 76, 67)
    1.04 ± 0.13
    1.04 ± 0.14
    0.94 ± 0.13
        2 Asthma Exacerbations (n=73, 68, 68)
    1.09 ± 0.14
    1.14 ± 0.15
    0.88 ± 0.13
        >2 Asthma Exacerbations (n= 34, 41, 33)
    0.96 ± 0.14
    0.73 ± 0.2
    0.78 ± 0.16
        With Chronic OCS Use (n= 17, 16, 16)
    0.87 ± 0.29
    0.26 ± 0.26
    0.53 ± 0.19
        Without Chronic OCS Use (n= 90, 93, 85)
    1.07 ± 0.11
    1.14 ± 0.13
    0.91 ± 0.11
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Baseline serum periostin >= median
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.211
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.6
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Baseline serum periostin >= median
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.397
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.21
         upper limit
    		 0.53
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Baseline serum periostin < median
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.315
    Method
    		 Repeated Measure Model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.56
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Baseline serum periostin < median
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.166
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.63
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Baseline serum periostin >= 25th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.262
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.47
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Baseline serum periostin >= 25th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.379
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.44
    Statistical analysis title
    		 Statistical analysis 7
    Statistical analysis description
    Baseline serum periostin < 25th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.387
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.32
         upper limit
    		 0.81
    Statistical analysis title
    		 Statistical analysis 8
    Statistical analysis description
    Baseline serum periostin < 25th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.303
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26
         upper limit
    		 0.84
    Statistical analysis title
    		 Statistical analysis 9
    Statistical analysis description
    Baseline serum periostin >=75th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.127
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.84
         upper limit
    		 0.11
    Statistical analysis title
    		 Statistical analysis 10
    Statistical analysis description
    Baseline serum periostin >=75th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.775
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.56
         upper limit
    		 0.42
    Statistical analysis title
    		 Statistical analysis 11
    Statistical analysis description
    Baseline serum periostin < 75th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.512
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.38
         upper limit
    		 0.19
    Statistical analysis title
    		 Statistical analysis 12
    Statistical analysis description
    Baseline serum periostin < 75th percentile
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.404
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.16
    Statistical analysis title
    		 Statistical analysis 13
    Statistical analysis description
    Th2 high
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.102
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.69
    Statistical analysis title
    		 Statistical analysis 14
    Statistical analysis description
    Th2 high
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.116
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.68
    Statistical analysis title
    		 Statistical analysis 15
    Statistical analysis description
    Th2 low
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.54
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.47
         upper limit
    		 0.25
    Statistical analysis title
    		 Statistical analysis 16
    Statistical analysis description
    Th2 low
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.674
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 0.27
    Statistical analysis title
    		 Statistical analysis 17
    Statistical analysis description
    Baseline peripheral blood eosinophil count >=150 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.295
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.49
    Statistical analysis title
    		 Statistical analysis 18
    Statistical analysis description
    Baseline peripheral blood eosinophil count >=150 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.342
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.49
    Statistical analysis title
    		 Statistical analysis 19
    Statistical analysis description
    Baseline peripheral blood eosinophil count < 150 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.406
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 0.6
    Statistical analysis title
    		 Statistical analysis 20
    Statistical analysis description
    Baseline peripheral blood eosinophil count < 150 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.069
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0.79
    Statistical analysis title
    		 Statistical analysis 21
    Statistical analysis description
    Baseline peripheral blood eosinophil count >= 300 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.371
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.23
         upper limit
    		 0.62
    Statistical analysis title
    		 Statistical analysis 22
    Statistical analysis description
    Baseline peripheral blood eosinophil count >= 300 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.766
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 0.51
    Statistical analysis title
    		 Statistical analysis 23
    Statistical analysis description
    Baseline peripheral blood eosinophil count < 300 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.147
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.57
    Statistical analysis title
    		 Statistical analysis 24
    Statistical analysis description
    Baseline peripheral blood eosinophil count < 300 cells/μL
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.031
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 0.68
    Statistical analysis title
    		 Statistical analysis 25
    Statistical analysis description
    Baseline FEV1 reversibility >= 12%
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.02
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 1.09
    Statistical analysis title
    		 Statistical analysis 26
    Statistical analysis description
    Baseline FEV1 reversibility >= 12%
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.226
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.77
    Statistical analysis title
    		 Statistical analysis 27
    Statistical analysis description
    Baseline FEV1 reversibility < 12%
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.964
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.31
         upper limit
    		 0.33
    Statistical analysis title
    		 Statistical analysis 28
    Statistical analysis description
    Baseline FEV1 reversibility < 12%
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.533
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.42
    Statistical analysis title
    		 Statistical analysis 29
    Statistical analysis description
    2 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.292
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.5
    Statistical analysis title
    		 Statistical analysis 30
    Statistical analysis description
    2 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.097
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.59
    Statistical analysis title
    		 Statistical analysis 31
    Statistical analysis description
    > 2 but < 6 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.26
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.67
    Statistical analysis title
    		 Statistical analysis 32
    Statistical analysis description
    > 2 but < 6 asthma exacerbations in the past year
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.648
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.33
         upper limit
    		 0.53
    Statistical analysis title
    		 Statistical analysis 33
    Statistical analysis description
    Chronic OCS use
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.398
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 0.93
    Statistical analysis title
    		 Statistical analysis 34
    Statistical analysis description
    Chronic OCS use
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.327
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    -0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.95
         upper limit
    		 0.32
    Statistical analysis title
    		 Statistical analysis 35
    Statistical analysis description
    Without chronic OCS use
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.105
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.52
    Statistical analysis title
    		 Statistical analysis 36
    Statistical analysis description
    Without chronic OCS use
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.03
    Method
    		 Repeated measure model
    Parameter type
    		 Difference of LS-mean
    Point estimate
    0.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 0.6

    Secondary: Annual Asthma Exacerbation Rate (AER) by Atopic Asthma Status

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    End point title
    		 Annual Asthma Exacerbation Rate (AER) by Atopic Asthma Status [73]
    End point description
    Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. AER was evaluated by subgroup Atopic and Non-atopic asthma status. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [73] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: AER events/person-year
    number (confidence interval 95%)
        Atopic asthma (n=96,105,92)
    0.9 (0.73 to 1.11)
    0.85 (0.67 to 1.06)
    0.85 (0.67 to 1.06)
        Non-atopic asthma (n=51,42,55)
    0.82 (0.56 to 1.15)
    1.1 (0.82 to 1.44)
    1.05 (0.77 to 1.39)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other [74]
    P-value
    		 = 0.803
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio (RR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.44
    Notes
    [74] - Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1 - Atopic Asthma
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other [75]
    P-value
    		 = 0.457
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio (RR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 1.35
    Notes
    [75] - Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2 - Atopic Asthma
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other [76]
    P-value
    		 = 0.25
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio (RR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 1.27
    Notes
    [76] - Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1 - Non-atopic asthma
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other [77]
    P-value
    		 = 0.794
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio (RR)
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.74
    Notes
    [77] - Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2 - Non-atopic asthma

    Secondary: Annual Asthma Exacerbation Rate (AER) by Chronic OCS Use

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    End point title
    		 Annual Asthma Exacerbation Rate (AER) by Chronic OCS Use [78]
    End point description
    Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS (10 days after an injectable corticosteroid). Corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup chronic OCS use. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies evaluable participants for this measure.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 53
    Notes
    [78] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: AER events/person-year
    number (confidence interval 95%)
        With chronic OCS use (n=27,26,24)
    2.04 (1.51 to 2.69)
    2.2 (1.62 to 2.91)
    1.37 (0.93 to 1.94)
        Without chronic OCS use (124,124,127)
    0.68 (0.54 to 0.84)
    0.74 (0.59 to 0.91)
    0.81 (0.66 to 1)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other [79]
    P-value
    		 = 0.614
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio (RR)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 2.46
    Notes
    [79] - Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1 - With Chronic OCS Use
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other [80]
    P-value
    		 = 0.506
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio (RR)
    Point estimate
    1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 2.74
    Notes
    [80] - Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2 - With Chronic OCS use
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
    Comparison groups
    Tralokinumab 300 mg, Q2W - Cohort 1 v Placebo Total
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other [81]
    P-value
    		 = 0.243
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.18
    Notes
    [81] - Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1 - Without Chronic OCS Use
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
    Comparison groups
    Tralokinumab 300 mg, Q2/4W - Cohort 2 v Placebo Total
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other [82]
    P-value
    		 = 0.531
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 1.34
    Notes
    [82] - Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2 - Without chronic OCS use

    Secondary: Change From Baseline in Percentage of Nighttime Awakening at Week 53

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    End point title
    		 Change From Baseline in Percentage of Nighttime Awakening at Week 53 [83]
    End point description
    Scores for nighttime awakenings were generated based on the single item (question 5) that had a dichotomous response option (YES/NO). Nighttime awakenings were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated with data from Day -7 to Day -1. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)
    Notes
    [83] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: percentage change
    arithmetic mean (standard deviation)
        Day -7 - Day -1 (Baseline) (n=151,147,145)
    0.42 ± 0.43
    0.43 ± 0.43
    0.44 ± 0.42
        Change at Day 365 - Day 371 (n=113,108,108)
    -0.18 ± 0.37
    -0.23 ± 0.45
    -0.22 ± 0.43
    No statistical analyses for this end point

    Secondary: Change From Baseline in Overall Activity Limitations at Week 53

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    End point title
    		 Change From Baseline in Overall Activity Limitations at Week 53 [84]
    End point description
    There were 3 activity limitation questions in the ASMA diary. All activity questions were scored from 0 to 4 and averaged, where the higher score indicated greater limitation. Activity limitation scores were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated from Day -7 to Day -1. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)
    Notes
    [84] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: units on a scale
    arithmetic mean (standard deviation)
        Day -7 - Day -1 (Baseline) (n=151,147,145)
    1.52 ± 0.9
    1.63 ± 0.85
    1.71 ± 0.86
        Change at Day 365 - Day 371 (n=113,108,108)
    -0.38 ± 0.84
    -0.48 ± 0.87
    -0.45 ± 0.81
    No statistical analyses for this end point

    Secondary: Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53

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    End point title
    		 Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 [85]
    End point description
    Pre- and post-bronchodilator FEV1 at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Baseline for FEV1 was measured in liters.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 53
    Notes
    [85] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: percentage change in liters
    arithmetic mean (standard error)
        Pre-bronchodilator(BD): Baseline (n=147,146,146)
    1.922 ± 0.056
    1.934 ± 0.059
    1.926 ± 0.05
        Post-BD: Baseline (n=147,141,146)
    2.094 ± 0.061
    2.11 ± 0.061
    2.153 ± 0.053
        Pre-BD:Change from baseline to W53 (n=125,130,122)
    9.11 ± 2.13
    2.94 ± 1.54
    2.5 ± 1.99
        Post-BD:Change from baseline to W53(n=125,126,120)
    5.98 ± 1.85
    0.18 ± 1.25
    -1.65 ± 1.39
    No statistical analyses for this end point

    Secondary: Mean Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53

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    End point title
    		 Mean Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53 [86]
    End point description
    Pre- and post-bronchodilator FEV6 at clinic visits (morning) were measured. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Baseline for FEV6 was measured in liters.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 53
    Notes
    [86] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: percentage change in liters
    arithmetic mean (standard error)
        Pre-bronchodilator(BD): Baseline (n=147,146,146)
    2.809 ± 0.072
    2.827 ± 0.074
    2.83 ± 0.064
        Post-BD: Baseline (n=147,141,146)
    2.981 ± 0.075
    2.98 ± 0.076
    3.055 ± 0.067
        Pre-BD:Change from baseline to W53 (n=125,130,122)
    5.75 ± 1.53
    1.1 ± 1.18
    1.06 ± 1.29
        Post-BD:Change from baseline to W53(n=125,126,120)
    3.27 ± 1.36
    -0.11 ± 1.01
    -1.16 ± 1.04
    No statistical analyses for this end point

    Secondary: Mean Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53

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    End point title
    		 Mean Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53 [87]
    End point description
    Pre- and post-bronchodilator FVC at clinic visits (morning) were measured. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Baseline for FVC was measured in liters.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 53
    Notes
    [87] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: percentage in liters
    arithmetic mean (standard error)
        Prebronchodilator(BD): Baseline (n=147,146,146)
    2.955 ± 0.075
    2.993 ± 0.079
    3.003 ± 0.069
        Post-BD:Baseline (n=147,141,146)
    3.133 ± 0.078
    3.125 ± 0.08
    3.225 ± 0.072
        PreBD:Change from baseline to W53 (n=125,130,122)
    5.43 ± 1.6
    0.46 ± 1.17
    0.87 ± 1.31
        PostBD:Change from baseline to W53 (n=125,126,120)
    2.56 ± 1.27
    -0.26 ± 1.03
    -1.51 ± 1.01
    No statistical analyses for this end point

    Secondary: Mean Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53

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    End point title
    		 Mean Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53 [88]
    End point description
    Pre- and post-bronchodilator IC at clinic visits (morning) were measured. IC was measured by spirometry. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Baseline for IC was measured in liters.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 53
    Notes
    [88] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: percentage change in liters
    arithmetic mean (standard error)
        Pre-bronchodilator(BD): Baseline (n=140,138,143)
    0.023 ± 0.001
    0.023 ± 0.001
    0.022 ± 0.001
        Post-BD: Baseline (n=140,133,135)
    0.024 ± 0.001
    0.024 ± 0.001
    0.024 ± 0.001
        Pre-BD:Change from baseline to W53 (n=108,109,103)
    0.15 ± 2.21
    11.38 ± 3.71
    8.56 ± 3.42
        Post-BD:Change from baseline to W53(n=108,109,104)
    8.33 ± 3.14
    3.17 ± 2.91
    3.64 ± 3.17
    No statistical analyses for this end point

    Secondary: Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home

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    End point title
    		 Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home [89]
    End point description
    Pre- and post-bronchodilator FEV1 at home (morning and evening) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)
    Notes
    [89] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: percentage change
    arithmetic mean (standard error)
        Change at Day 365-371: Morning (n=123,119,113)
    1.67 ± 2.83
    1.7 ± 5.41
    -4.96 ± 3.27
        Change at Day 365-371: Evening (n=119,116,111)
    -2.69 ± 3.17
    -5.78 ± 3.63
    -2.83 ± 3.01
    No statistical analyses for this end point

    Secondary: Mean Percent Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home

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    End point title
    		 Mean Percent Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home [90]
    End point description
    The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)
    Notes
    [90] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was reporting data for total number of participants of both the placebo reporting group, hence not reporting statistics for all the arms in the baseline period.
    End point values
    		 Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2 Placebo Total
    Number of subjects analysed
    150
    151
    151
    Units: percentage change
    arithmetic mean (standard error)
        Change at Day 365-371: Morning (n=123,119,113)
    -0.64 ± 3.26
    -2.8 ± 5.41
    -6.89 ± 3.09
        Change at Day 365-371: Evening (n=129,116,111)
    -6.62 ± 3.13
    -11.45 ± 3.33
    -4.95 ± 2.99
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 75
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Tralokinumab 300 mg Q2W
    Reporting group description
    		 Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

    Reporting group title
    Placebo Total
    Reporting group description
    		 Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

    Reporting group title
    Tralokinumab 300 mg Q2/4W
    Reporting group description
    		 Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

    Serious adverse events
    		 Tralokinumab 300 mg Q2W Placebo Total Tralokinumab 300 mg Q2/4W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 150 (12.00%)
    21 / 151 (13.91%)
    25 / 151 (16.56%)
         number of deaths (all causes)
    0
    0
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the cervix
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Dysfunctional uterine bleeding
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Menometrorrhagia
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Allergic sinusitis
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    9 / 150 (6.00%)
    6 / 151 (3.97%)
    10 / 151 (6.62%)
         occurrences causally related to treatment / all
    1 / 13
    0 / 9
    2 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental poisoning
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Excoriation
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    2 / 151 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Testicular injury
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    2 / 151 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    2 / 151 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sick sinus syndrome
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic gastropathy
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral hernia
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric disorder
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 151 (1.32%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Amoebiasis
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Beta haemolytic streptococcal infection
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 150 (2.00%)
    2 / 151 (1.32%)
    2 / 151 (1.32%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 151 (0.00%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 151 (0.66%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Tralokinumab 300 mg Q2W Placebo Total Tralokinumab 300 mg Q2/4W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    133 / 150 (88.67%)
    128 / 151 (84.77%)
    128 / 151 (84.77%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    8 / 150 (5.33%)
    6 / 151 (3.97%)
    9 / 151 (5.96%)
         occurrences all number
    8
    8
    10
    General disorders and administration site conditions
    Administration site rash
         subjects affected / exposed
    3 / 150 (2.00%)
    0 / 151 (0.00%)
    3 / 151 (1.99%)
         occurrences all number
    13
    0
    3
    Asthenia
         subjects affected / exposed
    0 / 150 (0.00%)
    6 / 151 (3.97%)
    1 / 151 (0.66%)
         occurrences all number
    0
    8
    1
    Fatigue
         subjects affected / exposed
    2 / 150 (1.33%)
    2 / 151 (1.32%)
    3 / 151 (1.99%)
         occurrences all number
    4
    3
    4
    Injection site erythema
         subjects affected / exposed
    12 / 150 (8.00%)
    1 / 151 (0.66%)
    7 / 151 (4.64%)
         occurrences all number
    58
    1
    15
    Injection site haemorrhage
         subjects affected / exposed
    1 / 150 (0.67%)
    3 / 151 (1.99%)
    2 / 151 (1.32%)
         occurrences all number
    3
    3
    3
    Injection site pain
         subjects affected / exposed
    7 / 150 (4.67%)
    15 / 151 (9.93%)
    11 / 151 (7.28%)
         occurrences all number
    23
    90
    61
    Injection site pruritus
         subjects affected / exposed
    8 / 150 (5.33%)
    1 / 151 (0.66%)
    1 / 151 (0.66%)
         occurrences all number
    12
    1
    2
    Injection site reaction
         subjects affected / exposed
    7 / 150 (4.67%)
    0 / 151 (0.00%)
    2 / 151 (1.32%)
         occurrences all number
    32
    0
    4
    Injection site swelling
         subjects affected / exposed
    2 / 150 (1.33%)
    2 / 151 (1.32%)
    2 / 151 (1.32%)
         occurrences all number
    2
    3
    2
    Pyrexia
         subjects affected / exposed
    2 / 150 (1.33%)
    6 / 151 (3.97%)
    4 / 151 (2.65%)
         occurrences all number
    3
    10
    6
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    68 / 150 (45.33%)
    73 / 151 (48.34%)
    58 / 151 (38.41%)
         occurrences all number
    192
    175
    188
    Cough
         subjects affected / exposed
    7 / 150 (4.67%)
    6 / 151 (3.97%)
    8 / 151 (5.30%)
         occurrences all number
    7
    9
    11
    Dysphonia
         subjects affected / exposed
    4 / 150 (2.67%)
    5 / 151 (3.31%)
    3 / 151 (1.99%)
         occurrences all number
    4
    6
    4
    Dyspnoea
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 151 (1.32%)
    7 / 151 (4.64%)
         occurrences all number
    0
    2
    16
    Nasal congestion
         subjects affected / exposed
    3 / 150 (2.00%)
    1 / 151 (0.66%)
    3 / 151 (1.99%)
         occurrences all number
    3
    1
    3
    Oropharyngeal pain
         subjects affected / exposed
    3 / 150 (2.00%)
    7 / 151 (4.64%)
    6 / 151 (3.97%)
         occurrences all number
    3
    8
    7
    Productive cough
         subjects affected / exposed
    1 / 150 (0.67%)
    5 / 151 (3.31%)
    1 / 151 (0.66%)
         occurrences all number
    1
    6
    2
    Rhinitis allergic
         subjects affected / exposed
    11 / 150 (7.33%)
    3 / 151 (1.99%)
    3 / 151 (1.99%)
         occurrences all number
    13
    5
    3
    Rhinorrhoea
         subjects affected / exposed
    4 / 150 (2.67%)
    2 / 151 (1.32%)
    1 / 151 (0.66%)
         occurrences all number
    5
    2
    1
    Upper respiratory tract inflammation
         subjects affected / exposed
    3 / 150 (2.00%)
    2 / 151 (1.32%)
    4 / 151 (2.65%)
         occurrences all number
    5
    4
    9
    Wheezing
         subjects affected / exposed
    1 / 150 (0.67%)
    3 / 151 (1.99%)
    1 / 151 (0.66%)
         occurrences all number
    1
    4
    2
    Psychiatric disorders
    Depression
         subjects affected / exposed
    3 / 150 (2.00%)
    2 / 151 (1.32%)
    6 / 151 (3.97%)
         occurrences all number
    3
    2
    6
    Insomnia
         subjects affected / exposed
    0 / 150 (0.00%)
    4 / 151 (2.65%)
    1 / 151 (0.66%)
         occurrences all number
    0
    4
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    3 / 150 (2.00%)
    2 / 151 (1.32%)
    4 / 151 (2.65%)
         occurrences all number
    6
    8
    4
    Fall
         subjects affected / exposed
    1 / 150 (0.67%)
    3 / 151 (1.99%)
    2 / 151 (1.32%)
         occurrences all number
    3
    4
    2
    Foot fracture
         subjects affected / exposed
    0 / 150 (0.00%)
    4 / 151 (2.65%)
    2 / 151 (1.32%)
         occurrences all number
    0
    4
    2
    Ligament sprain
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 151 (1.32%)
    5 / 151 (3.31%)
         occurrences all number
    0
    2
    6
    Rib fracture
         subjects affected / exposed
    3 / 150 (2.00%)
    1 / 151 (0.66%)
    3 / 151 (1.99%)
         occurrences all number
    3
    2
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 150 (1.33%)
    9 / 151 (5.96%)
    3 / 151 (1.99%)
         occurrences all number
    3
    17
    3
    Headache
         subjects affected / exposed
    17 / 150 (11.33%)
    17 / 151 (11.26%)
    17 / 151 (11.26%)
         occurrences all number
    38
    36
    22
    Migraine
         subjects affected / exposed
    1 / 150 (0.67%)
    3 / 151 (1.99%)
    1 / 151 (0.66%)
         occurrences all number
    2
    14
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 150 (0.67%)
    4 / 151 (2.65%)
    0 / 151 (0.00%)
         occurrences all number
    1
    4
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    5 / 150 (3.33%)
    0 / 151 (0.00%)
    3 / 151 (1.99%)
         occurrences all number
    5
    0
    3
    Conjunctivitis allergic
         subjects affected / exposed
    3 / 150 (2.00%)
    2 / 151 (1.32%)
    2 / 151 (1.32%)
         occurrences all number
    3
    2
    2
    Eye pruritus
         subjects affected / exposed
    2 / 150 (1.33%)
    0 / 151 (0.00%)
    3 / 151 (1.99%)
         occurrences all number
    2
    0
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 150 (0.67%)
    9 / 151 (5.96%)
    1 / 151 (0.66%)
         occurrences all number
    1
    12
    3
    Abdominal pain upper
         subjects affected / exposed
    1 / 150 (0.67%)
    3 / 151 (1.99%)
    2 / 151 (1.32%)
         occurrences all number
    4
    4
    2
    Constipation
         subjects affected / exposed
    3 / 150 (2.00%)
    4 / 151 (2.65%)
    2 / 151 (1.32%)
         occurrences all number
    3
    5
    2
    Diarrhoea
         subjects affected / exposed
    5 / 150 (3.33%)
    12 / 151 (7.95%)
    7 / 151 (4.64%)
         occurrences all number
    7
    19
    10
    Dyspepsia
         subjects affected / exposed
    0 / 150 (0.00%)
    5 / 151 (3.31%)
    0 / 151 (0.00%)
         occurrences all number
    0
    5
    0
    Gastritis
         subjects affected / exposed
    1 / 150 (0.67%)
    4 / 151 (2.65%)
    2 / 151 (1.32%)
         occurrences all number
    1
    5
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 150 (2.67%)
    6 / 151 (3.97%)
    2 / 151 (1.32%)
         occurrences all number
    4
    6
    2
    Nausea
         subjects affected / exposed
    2 / 150 (1.33%)
    7 / 151 (4.64%)
    3 / 151 (1.99%)
         occurrences all number
    7
    15
    4
    Toothache
         subjects affected / exposed
    3 / 150 (2.00%)
    2 / 151 (1.32%)
    0 / 151 (0.00%)
         occurrences all number
    3
    2
    0
    Vomiting
         subjects affected / exposed
    4 / 150 (2.67%)
    8 / 151 (5.30%)
    1 / 151 (0.66%)
         occurrences all number
    6
    20
    2
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    3 / 150 (2.00%)
    2 / 151 (1.32%)
    0 / 151 (0.00%)
         occurrences all number
    3
    6
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 150 (0.67%)
    2 / 151 (1.32%)
    2 / 151 (1.32%)
         occurrences all number
    1
    2
    2
    Pruritus
         subjects affected / exposed
    7 / 150 (4.67%)
    4 / 151 (2.65%)
    3 / 151 (1.99%)
         occurrences all number
    7
    4
    3
    Pruritus generalised
         subjects affected / exposed
    3 / 150 (2.00%)
    4 / 151 (2.65%)
    1 / 151 (0.66%)
         occurrences all number
    3
    7
    2
    Rash
         subjects affected / exposed
    1 / 150 (0.67%)
    2 / 151 (1.32%)
    3 / 151 (1.99%)
         occurrences all number
    1
    3
    3
    Urticaria
         subjects affected / exposed
    2 / 150 (1.33%)
    5 / 151 (3.31%)
    2 / 151 (1.32%)
         occurrences all number
    2
    6
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    10 / 150 (6.67%)
    6 / 151 (3.97%)
    9 / 151 (5.96%)
         occurrences all number
    15
    8
    11
    Back pain
         subjects affected / exposed
    8 / 150 (5.33%)
    9 / 151 (5.96%)
    10 / 151 (6.62%)
         occurrences all number
    11
    11
    12
    Muscle spasms
         subjects affected / exposed
    5 / 150 (3.33%)
    2 / 151 (1.32%)
    6 / 151 (3.97%)
         occurrences all number
    8
    2
    6
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 150 (1.33%)
    2 / 151 (1.32%)
    1 / 151 (0.66%)
         occurrences all number
    2
    2
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 150 (0.00%)
    4 / 151 (2.65%)
    3 / 151 (1.99%)
         occurrences all number
    0
    4
    3
    Myalgia
         subjects affected / exposed
    6 / 150 (4.00%)
    1 / 151 (0.66%)
    8 / 151 (5.30%)
         occurrences all number
    7
    1
    11
    Pain in extremity
         subjects affected / exposed
    2 / 150 (1.33%)
    5 / 151 (3.31%)
    8 / 151 (5.30%)
         occurrences all number
    2
    6
    9
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    2 / 150 (1.33%)
    5 / 151 (3.31%)
    3 / 151 (1.99%)
         occurrences all number
    2
    6
    4
    Bronchitis
         subjects affected / exposed
    27 / 150 (18.00%)
    22 / 151 (14.57%)
    20 / 151 (13.25%)
         occurrences all number
    44
    48
    27
    Cystitis
         subjects affected / exposed
    2 / 150 (1.33%)
    4 / 151 (2.65%)
    1 / 151 (0.66%)
         occurrences all number
    2
    4
    1
    Gastroenteritis
         subjects affected / exposed
    7 / 150 (4.67%)
    9 / 151 (5.96%)
    6 / 151 (3.97%)
         occurrences all number
    9
    9
    6
    Herpes zoster
         subjects affected / exposed
    1 / 150 (0.67%)
    3 / 151 (1.99%)
    1 / 151 (0.66%)
         occurrences all number
    1
    3
    1
    Influenza
         subjects affected / exposed
    11 / 150 (7.33%)
    13 / 151 (8.61%)
    14 / 151 (9.27%)
         occurrences all number
    13
    15
    15
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 150 (2.00%)
    4 / 151 (2.65%)
    0 / 151 (0.00%)
         occurrences all number
    3
    5
    0
    Nasopharyngitis
         subjects affected / exposed
    35 / 150 (23.33%)
    40 / 151 (26.49%)
    26 / 151 (17.22%)
         occurrences all number
    57
    83
    62
    Oral candidiasis
         subjects affected / exposed
    6 / 150 (4.00%)
    3 / 151 (1.99%)
    2 / 151 (1.32%)
         occurrences all number
    6
    5
    2
    Pharyngitis
         subjects affected / exposed
    6 / 150 (4.00%)
    9 / 151 (5.96%)
    11 / 151 (7.28%)
         occurrences all number
    9
    15
    18
    Pneumonia
         subjects affected / exposed
    2 / 150 (1.33%)
    3 / 151 (1.99%)
    3 / 151 (1.99%)
         occurrences all number
    2
    3
    3
    Respiratory tract infection
         subjects affected / exposed
    6 / 150 (4.00%)
    3 / 151 (1.99%)
    1 / 151 (0.66%)
         occurrences all number
    10
    4
    1
    Rhinitis
         subjects affected / exposed
    5 / 150 (3.33%)
    9 / 151 (5.96%)
    8 / 151 (5.30%)
         occurrences all number
    5
    10
    9
    Sinusitis
         subjects affected / exposed
    5 / 150 (3.33%)
    10 / 151 (6.62%)
    8 / 151 (5.30%)
         occurrences all number
    5
    15
    10
    Upper respiratory tract infection
         subjects affected / exposed
    20 / 150 (13.33%)
    18 / 151 (11.92%)
    20 / 151 (13.25%)
         occurrences all number
    36
    28
    25
    Urinary tract infection
         subjects affected / exposed
    11 / 150 (7.33%)
    9 / 151 (5.96%)
    8 / 151 (5.30%)
         occurrences all number
    16
    19
    8
    Viral infection
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 151 (0.66%)
    4 / 151 (2.65%)
         occurrences all number
    0
    1
    5
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 150 (0.00%)
    3 / 151 (1.99%)
    2 / 151 (1.32%)
         occurrences all number
    0
    4
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Feb 2012
    The overall reason for the amendment was to include the following changes: 1) there were multiple minor changes to the design and inclusion- and exclusion criteria to add additional clarity, 2) the ACQ cut-point for uncontrolled asthma in Asthma Control Questionnaire and effect of tralokinumab on Patient Reported Outcomes was updated with the correct cut-point of >= 1.5, 3) recruitment of participants from Japan was included to meet the requirements of the Japanese Agency, Pharmaceutical and Medical Devices Agency (PMDA), 4) primary endpoint, chronic oral corticosteroid (OCS) use was added as a potential covariate.
    11 Oct 2012
    The overall reason for the amendment was to include the following changes: 1) Study abstract was amended to describe an increased alpha significance level for the primary endpoint, 2) The text was amended to describe the evaluable population for PK to include all subjects who received at least one dose of investigational product and had at least one detectable PK sample. Pharmacokinetic parameters were not computed for the CSR because of the sparse sampling PK scheme. The description of the per protocol population was also clarified to include all subjects who had no major protocol violations, completed the treatment period, and had received at least 80% of the intended doses of investigational product during the treatment period.
    26 Feb 2013
    The overall reason for the amendment was to include the following changes: 1) changed medical monitor, 2) included interim analysis as a formal analysis, and included unblinding procedures for the interim analysis.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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