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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function with Benralizumab in Severe, Uncontrolled Asthma Patients with Eosinophilic Inflammation

    Summary
    EudraCT number
    		 2016-002094-36
    Trial protocol
    		 HU   DE  
    Global end of trial date
    30 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jul 2019
    First version publication date
    26 Jul 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D3250C00038
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02869438
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    Vastra Malarehamnen 9, So dertalje, Sweden, 151 85
    Public contact
    Ubaldo Martin, Global Clinical Lead Benralizumab, AstraZeneca AB, Ubaldo.Martin@astrazeneca.com
    Scientific contact
    Clinical Study Information, AstraZeneca AB, 46 855 32600, information.center@astrazeneca.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
    30 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study is to determine the effect of Benralizumab on the time course of change (onset and maintenance of effect) on lung function
    Protection of trial subjects
    The study is performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice, applicable regulatory requirements and the AstraZeneca policy on Bioethics and Human Biological samples. Each PI is responsible for providing the ECs/institutional review boards (IRBs) with reports of any serious and unexpected adverse drug reactions from any other study conducted with the investigational product. AstraZeneca provides this information to the PI so that he/she can meet these reporting requirements. During the study, AstraZeneca representative have regular contacts with the study site, ie, monitoring the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Chile: 38
    Country: Number of subjects enrolled
    Germany: 36
    Country: Number of subjects enrolled
    Hungary: 41
    Country: Number of subjects enrolled
    Philippines: 37
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 40
    Country: Number of subjects enrolled
    United States: 41
    Worldwide total number of subjects
    233
    EEA total number of subjects
    77
    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)
    195
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 721 patients enrolled into D3250C00038 (Solana). 233 participants were randomized to receive treatment with benralizumab 30 mg or placebo. Of the 233 patients randomised, all (100.0%) received treatment with study drug. 118 (50.6%) patients received benralizumab 30 mg and 115 (49.4%) patients received placebo.

    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, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Benra 30 mg
    Arm description
    		 12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benralizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30 mg

    Arm title
    		 Placebo
    Arm description
    		 12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30 mg

    Number of subjects in period 1
    		Benra 30 mg Placebo
    Started
    118
    115
    Completed
    115
    113
    Not completed
    3
    2
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Benra 30 mg
    Reporting group description
    		 12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).

    Reporting group title
    Placebo
    Reporting group description
    		 12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).

    Reporting group values
    		 Benra 30 mg Placebo Total
    Number of subjects
    		 118 115 233
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 97 98 195
        From 65-84 years
    		 21 17 38
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.9 ( 13.62 ) 50.9 ( 12.34 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 74 83 157
        Male
    		 44 32 76
    Race/Ethnicity, Customized
    Units: Subjects
        White|
    		 69 67 136
        Black or African American|
    		 3 4 7
        Asian|
    		 39 40 79
        Other|
    		 7 4 11

    End points

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    End points reporting groups
    Reporting group title
    Benra 30 mg
    Reporting group description
    		 12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).

    Reporting group title
    Placebo
    Reporting group description
    		 12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).

    Primary: Change from baseline (visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in pre-BD FEV1

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    End point title
    		 Change from baseline (visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in pre-BD FEV1
    End point description
    The average over the mean differences between benralizumab and placebo for change from baseline in pre-BD FEV1 is used to determine if the study is positive and to determine maintenance of effect. The first post baseline time point where the p-value for the mean difference between benralizumab and placebo is less than or equal to 0.05 is used to determine time to onset of effect.
    End point type
    Primary
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    118
    115
    Units: Liter
    arithmetic mean (standard deviation)
        Day 28
    0.21 ( 0.335 )
    0.132 ( 0.316 )
        Day 56
    0.22 ( 0.367 )
    0.203 ( 0.349 )
        Day 84
    0.209 ( 0.344 )
    0.149 ( 0.366 )
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0707
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.077
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.007
         upper limit
    		 0.161
    Notes
    [1] - For Day 28
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.7747
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.013
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.077
         upper limit
    		 0.104
    Notes
    [2] - For Day 56
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.0969
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.079
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.014
         upper limit
    		 0.173
    Notes
    [3] - For Day 84
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.1558
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.057
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.022
         upper limit
    		 0.135
    Notes
    [4] - For average of Day 28, 56, 84

    Primary: Change from baseline (Visit 4) to end of treatment Day 84 (Visit 10) in Residual volume (RV)

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    End point title
    		 Change from baseline (Visit 4) to end of treatment Day 84 (Visit 10) in Residual volume (RV)
    End point description
    Body plethysmography was performed for sub-study patients. Lung volume subdivisions measures were performed by the investigator or qualified designee according to ATS/ERS guidelines.
    End point type
    Primary
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    18
    22
    Units: Liter
        arithmetic mean (standard deviation)
    -0.415 ( 0.609 )
    -0.208 ( 0.528 )
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.2847
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.176
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.505
         upper limit
    		 0.153
    Notes
    [5] - For Day 84

    Secondary: Percent change from baseline to end of treatment in eosinophils counts

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    End point title
    		 Percent change from baseline to end of treatment in eosinophils counts
    End point description
    Percent change from baseline to Day 84
    End point type
    Secondary
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    118
    115
    Units: cell/uL
        arithmetic mean (full range (min-max))
    -88.55 (-100 to -12.5)
    11.55 (-91.4 to 833.3)
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -101
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -118.9
         upper limit
    		 -83.06
    Notes
    [6] - For Day 84

    Secondary: Change from baseline (Visit 4) to post baseline visits in pre-BD FEV1

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    End point title
    		 Change from baseline (Visit 4) to post baseline visits in pre-BD FEV1
    End point description
    Post baseline visits include Day 3, Day 7, Day 14, Day 28, Day 56, Day 84. [Note: Day 28, 56, 84 are presented in the Primary measure.]
    End point type
    Secondary
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    118
    115
    Units: Liter
    arithmetic mean (standard deviation)
        Day 3
    0.104 ( 0.223 )
    0.081 ( 0.269 )
        Day 7
    0.125 ( 0.229 )
    0.081 ( 0.263 )
        Day 14
    0.126 ( 0.3 )
    0.1 ( 0.287 )
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.6384
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.015
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.049
         upper limit
    		 0.08
    Notes
    [7] - For Day 3
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.148
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.046
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.016
         upper limit
    		 0.109
    Notes
    [8] - For Day 7
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.4959
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.026
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.049
         upper limit
    		 0.101
    Notes
    [9] - For Day 14

    Secondary: Change from baseline to post baseline for pre-BD FVC

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    End point title
    		 Change from baseline to post baseline for pre-BD FVC
    End point description
    Post baseline visits include Day 3, Day 7, Day 14, Day 28, Day 56, and Day 84.
    End point type
    Secondary
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    118
    115
    Units: Liter
    arithmetic mean (standard deviation)
        Day 3
    0.122 ( 0.247 )
    0.11 ( 0.267 )
        Day 7
    0.138 ( 0.277 )
    0.099 ( 0.292 )
        Day 14
    0.126 ( 0.331 )
    0.111 ( 0.312 )
        Day 28
    0.21 ( 0.347 )
    0.134 ( 0.34 )
        Day 56
    0.211 ( 0.404 )
    0.187 ( 0.369 )
        Day 84
    0.213 ( 0.376 )
    0.131 ( 0.359 )
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 = 0.8667
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.006
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.062
         upper limit
    		 0.073
    Notes
    [10] - For Day 3
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 = 0.2734
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.041
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.033
         upper limit
    		 0.115
    Notes
    [11] - For Day 7
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    P-value
    		 = 0.7252
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.015
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.068
         upper limit
    		 0.098
    Notes
    [12] - For Day 14
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 = 0.0976
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.075
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.014
         upper limit
    		 0.164
    Notes
    [13] - For Day 28
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [14]
    P-value
    		 = 0.6536
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.023
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.077
         upper limit
    		 0.122
    Notes
    [14] - For Day 56
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 = 0.0595
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.092
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.004
         upper limit
    		 0.188
    Notes
    [15] - For Day 84
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [16]
    P-value
    		 = 0.1377
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.063
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.147
    Notes
    [16] - For average of Day 28, 56, 84

    Secondary: Percentage of pre-BD FEV1 responder

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    End point title
    		 Percentage of pre-BD FEV1 responder
    End point description
    Pre-BD FEV1 responder is defined as change from baseline in FEV1 >=100 ml
    End point type
    Secondary
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    118
    115
    Units: Percentage
    number (not applicable)
        Day 3
    48.2
    37.4
        Day 7
    48.3
    42.0
        Day 14
    50.0
    38.9
        Day 28
    57.6
    46.9
        Day 56
    62.1
    55.8
        Day 84
    57.9
    51.8
    Statistical analysis title
    		 Logistic Regression analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 = 0.1604
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 2.58
    Notes
    [17] - For Day 3
    Statistical analysis title
    		 Logistic Regression analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [18]
    P-value
    		 = 0.34
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 2.19
    Notes
    [18] - For Day 7
    Statistical analysis title
    		 Logistic Regression analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [19]
    P-value
    		 = 0.0924
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 2.7
    Notes
    [19] - For Day 14
    Statistical analysis title
    		 Logistic Regression analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [20]
    P-value
    		 = 0.1052
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 2.71
    Notes
    [20] - For Day 28
    Statistical analysis title
    		 Logistic Regression analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [21]
    P-value
    		 = 0.3271
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 2.21
    Notes
    [21] - For Day 56
    Statistical analysis title
    		 Logistic Regression analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [22]
    P-value
    		 = 0.3017
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 2.29
    Notes
    [22] - For Day 84

    Secondary: Change from baseline in ACQ-6

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    End point title
    		 Change from baseline in ACQ-6
    End point description
    ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
    End point type
    Secondary
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    118
    115
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Day 14
    -0.989 ( 0.901 )
    -0.665 ( 0.837 )
        Day 28
    -1.126 ( 0.947 )
    -0.693 ( 0.869 )
        Day 56
    -1.164 ( 1.132 )
    -0.827 ( 1.023 )
        Day 84
    -1.355 ( 1.146 )
    -0.867 ( 1.114 )
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [23]
    P-value
    		 = 0.0024
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.293
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.481
         upper limit
    		 -0.105
    Notes
    [23] - For Day 14
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [24]
    P-value
    		 = 0.0002
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.402
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.609
         upper limit
    		 -0.195
    Notes
    [24] - For Day 28
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [25]
    P-value
    		 = 0.0117
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.312
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.554
         upper limit
    		 -0.07
    Notes
    [25] - For Day 56
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [26]
    P-value
    		 = 0.0004
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.472
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.731
         upper limit
    		 -0.213
    Notes
    [26] - For Day 84
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [27]
    P-value
    		 = 0.0002
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.395
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.603
         upper limit
    		 -0.188
    Notes
    [27] - For average of Day 28, 56, 84

    Secondary: Change from baseline in St. George's Respiratory Questionnaire (SGRQ)

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    End point title
    		 Change from baseline in St. George's Respiratory Questionnaire (SGRQ)
    End point description
    The SGRQ is designed to measure health impairment in patients with asthma and COPD. It contains two parts: Part 1 (Questions 1 to 8) covers the patients’ recollection of their symptoms over a preceding 4 weeks; Part 2, 42 items, relates to the daily activity and psychosocial impacts of the individual's respiratory condition. Total score is presented as a percentage of overall impairment, in which 100 represents the worst possible health status, while 0 indicates the best.
    End point type
    Secondary
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    118
    115
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Day 28
    -16.956 ( 15.51 )
    -9.444 ( 14.136 )
        Day 56
    -19.941 ( 21.528 )
    -13.802 ( 16.705 )
        Day 84
    -23.343 ( 20.302 )
    -14.385 ( 18.836 )
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [28]
    P-value
    		 = 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.229
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.832
         upper limit
    		 -3.626
    Notes
    [28] - For Day 28
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [29]
    P-value
    		 = 0.0115
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.942
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.538
         upper limit
    		 -1.346
    Notes
    [29] - For Day 56
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [30]
    P-value
    		 = 0.0004
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.599
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.3
         upper limit
    		 -3.898
    Notes
    [30] - For Day 84
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [31]
    P-value
    		 = 0.0003
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.257
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.133
         upper limit
    		 -3.38
    Notes
    [31] - For average of Day 28, 56, 84

    Secondary: Change from baseline to end of treatment in FeNO

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    End point title
    		 Change from baseline to end of treatment in FeNO
    End point description
    Airway inflammation was evaluated via fractional exhaled nitric oxide (FeNO) measurement.
    End point type
    Secondary
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    118
    115
    Units: ppb
        arithmetic mean (standard deviation)
    5.92 ( 45.295 )
    0.05 ( 27.634 )
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [32]
    P-value
    		 = 0.2825
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.414
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.492
         upper limit
    		 15.321
    Notes
    [32] - For Day 84

    Secondary: Change from baseline to end of treatment in total lung capacity (TLC) for sub-study patients

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    End point title
    		 Change from baseline to end of treatment in total lung capacity (TLC) for sub-study patients
    End point description
    Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
    End point type
    Secondary
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    18
    22
    Units: Liter
        arithmetic mean (standard deviation)
    -0.276 ( 0.677 )
    -0.175 ( 0.418 )
    No statistical analyses for this end point

    Secondary: Change from baseline to end of treatment in ratio of residual volume (RV) and total lung capacity (TLC) for sub-study patients

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    End point title
    		 Change from baseline to end of treatment in ratio of residual volume (RV) and total lung capacity (TLC) for sub-study patients
    End point description
    Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
    End point type
    Secondary
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    18
    22
    Units: ratio
        arithmetic mean (standard deviation)
    -0.05 ( 0.056 )
    -0.026 ( 0.087 )
    No statistical analyses for this end point

    Secondary: Change from baseline to end of treatment in inspiratory capacity (IC) for sub-study patients

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    End point title
    		 Change from baseline to end of treatment in inspiratory capacity (IC) for sub-study patients
    End point description
    Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
    End point type
    Secondary
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    18
    22
    Units: Liter
        arithmetic mean (standard deviation)
    0.119 ( 0.447 )
    -0.268 ( 0.603 )
    No statistical analyses for this end point

    Secondary: Change from baseline to end of treatment in functional residual capacity (FRC) for sub-study patients

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    End point title
    		 Change from baseline to end of treatment in functional residual capacity (FRC) for sub-study patients
    End point description
    Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
    End point type
    Secondary
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    18
    22
    Units: Liter
        arithmetic mean (standard deviation)
    -0.394 ( 0.783 )
    0.093 ( 0.466 )
    No statistical analyses for this end point

    Secondary: Change from baseline to end of treatment in vital capacity (VC) for sub-study patients

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    End point title
    		 Change from baseline to end of treatment in vital capacity (VC) for sub-study patients
    End point description
    Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
    End point type
    Secondary
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    18
    22
    Units: Liter
        arithmetic mean (standard deviation)
    0.139 ( 0.245 )
    0.033 ( 0.676 )
    No statistical analyses for this end point

    Secondary: Duration of IP administration

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    End point title
    		 Duration of IP administration
    End point description
    Duration of IP administration is last IP dose date - first IP dose +1.
    End point type
    Secondary
    End point timeframe
    From first IP to last IP
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    118
    115
    Units: Days
        arithmetic mean (standard deviation)
    55.9 ( 7.83 )
    56.2 ( 7.61 )
    No statistical analyses for this end point

    Other pre-specified: Serum concentration of Benralizumab

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    End point title
    		 Serum concentration of Benralizumab [33]
    End point description
    PK sample was collected pre-dose at each visit
    End point type
    Other pre-specified
    End point timeframe
    From first IP dose to end of treatment
    Notes
    [33] - 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 is serum concentration with benralizumab, so is only applicable for the active treatment arm
    End point values
    		 Benra 30 mg
    Number of subjects analysed
    117
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Baseline|
    1.95 ( 0 )
        Day 3|
    1266.78 ( 199.59 )
        Day 7|
    1449.47 ( 125.02 )
        Day 14|
    1317.92 ( 79.53 )
        Day 28|
    738.47 ( 80.77 )
        Day 56|
    1015.72 ( 59.74 )
        Day 84|
    1079.22 ( 73.24 )
    No statistical analyses for this end point

    Other pre-specified: PK parameter of Benralizumab (Cmax)

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    End point title
    		 PK parameter of Benralizumab (Cmax) [34]
    End point description
    PK parameters are derived in patients with at least three qualifiable serum PK concentrations post first dose (collected on Day 3, 7, and either 14, or 28)
    End point type
    Other pre-specified
    End point timeframe
    From first IP dose to end of treatment
    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 is serum concentration with benralizumab, so is only applicable for the active treatment arm
    End point values
    		 Benra 30 mg
    Number of subjects analysed
    117
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    1729.6 ( 36.8 )
    No statistical analyses for this end point

    Other pre-specified: Anti-drug antibody responses

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    End point title
    		 Anti-drug antibody responses
    End point description
    Anti-drug antibody responses at baseline and post baseline, including nAb responses
    End point type
    Other pre-specified
    End point timeframe
    From first IP dose to end of treatment
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    118
    115
    Units: Participants
        ADA prevalence|
    7
    2
        nAb prevalence|
    2
    0
        Both baseline and post baseline positive|
    1
    2
        Only post baseline positive|
    5
    0
        Only baseline positive|
    1
    0
    No statistical analyses for this end point

    Other pre-specified: Change from baseline to end of treatment in PGI-S

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    End point title
    		 Change from baseline to end of treatment in PGI-S
    End point description
    The patient global impression of severity (PGI-S) is a single item designed to capture the patient's perception of overall symptom severity at the time of the completion using a 6-point categorical response scale (no symptom [0] to very severe symptom [5])
    End point type
    Other pre-specified
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    118
    115
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -1.2 ( 1.31 )
    -0.8 ( 1.21 )
    Statistical analysis title
    		 Repeated measurement analyses
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [35]
    P-value
    		 = 0.012
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.365
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.649
         upper limit
    		 -0.081
    Notes
    [35] - For Day 84

    Other pre-specified: Change from baseline to end of treatment in CGI-C

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    End point title
    		 Change from baseline to end of treatment in CGI-C
    End point description
    Clinician global impression of change (CGI-C) is used for an overall evaluation of response to treatment. The investigator is asked to rate the degree of change in overall asthma status compare to the start of treatment. A 7-point rating scale is used from 1=very much improved to 7=very much worse.
    End point type
    Other pre-specified
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    118
    115
    Units: Participants
        Very much improved
    18
    10
        Much improved
    39
    36
        Minimally improved
    39
    28
        No change
    17
    28
        Minimally worse
    0
    7
        Much worse
    0
    1
        Very much worse
    0
    0
        Missing
    5
    5
    Statistical analysis title
    		 Logistic regression analyses
    Statistical analysis description
    Responder analysis: responder is defined as Very much improved, improved, and minimally improved.
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [36]
    P-value
    		 = 0.0018
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.5
         upper limit
    		 5.88
    Notes
    [36] - For Day 84

    Other pre-specified: Change from baseline to end of treatment in PGI-C

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    End point title
    		 Change from baseline to end of treatment in PGI-C
    End point description
    Patient global impression of change (PGI-C) is used for an overall evaluation of response to treatment. The patient is asked to rate the degree of change in overall asthma status compare to the start of treatment. A 7-point rating scale is used from 1=very much improved to 7=very much worse.
    End point type
    Other pre-specified
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    118
    115
    Units: Participants
        Very much improved
    32
    17
        Much improved
    42
    35
        Minimally improved
    23
    29
        No change
    14
    27
        Minimally worse
    1
    4
        Much worse
    1
    1
        Very much worse
    1
    0
        Missing
    4
    2
    Statistical analysis title
    		 Logistic regression analyses
    Statistical analysis description
    Responder analysis: responder is defined as Very much improved, improved, and minimally improved.
    Comparison groups
    Benra 30 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [37]
    P-value
    		 = 0.0107
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.24
         upper limit
    		 5.09
    Notes
    [37] - For Day 84

    Other pre-specified: Change from baseline to end of treatment in specific airway resistance (SGaw) for sub-study patients

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    End point title
    		 Change from baseline to end of treatment in specific airway resistance (SGaw) for sub-study patients
    End point description
    Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
    End point type
    Other pre-specified
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    18
    22
    Units: 1/(kPa*sec)
        arithmetic mean (standard deviation)
    -0.05 ( 0.146 )
    0.052 ( 0.224 )
    No statistical analyses for this end point

    Other pre-specified: Change from baseline to end of treatment in airway resistance (Raw) for sub-study patients

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    End point title
    		 Change from baseline to end of treatment in airway resistance (Raw) for sub-study patients
    End point description
    Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
    End point type
    Other pre-specified
    End point timeframe
    From first IP dose to Day 84
    End point values
    		 Benra 30 mg Placebo
    Number of subjects analysed
    18
    22
    Units: kPa/L/sec
        arithmetic mean (standard deviation)
    -0.233 ( 1.509 )
    -0.2 ( 0.532 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent form was signed to end of study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).

    Reporting group title
    Benra 30 mg
    Reporting group description
    		 12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).

    Serious adverse events
    		 Placebo Benra 30 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 115 (6.09%)
    1 / 118 (0.85%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 115 (1.74%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 115 (1.74%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Benra 30 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 115 (26.09%)
    28 / 118 (23.73%)
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    18 / 115 (15.65%)
    11 / 118 (9.32%)
         occurrences all number
    22
    11
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 115 (2.61%)
    6 / 118 (5.08%)
         occurrences all number
    3
    6
    Nasopharyngitis
         subjects affected / exposed
    6 / 115 (5.22%)
    8 / 118 (6.78%)
         occurrences all number
    7
    9
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 115 (5.22%)
    6 / 118 (5.08%)
         occurrences all number
    8
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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