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    Clinical Trial Results:
    A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma (NAVIGATOR)

    Summary
    EudraCT number
    		 2017-003078-15
    Trial protocol
    		 GB   DE   FR   AT  
    Global end of trial date
    12 Nov 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    14 Nov 2021
    First version publication date
    28 May 2021
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    D5180C00007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03347279
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    151 85, Sodertalje, Sweden,
    Public contact
    Global Clinical Head, AstraZeneca, information.center@astrazeneca.com
    Scientific contact
    AstraZeneca Clinical Study Information, AstraZeneca, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001613-PIP01-14
    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
    12 Nov 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of 210 mg tezepelumab SC Q4W on asthma exacerbations in adult and adolescent subjects with severe uncontrolled asthma compared with placebo
    Protection of trial subjects
    The protocol, protocol amendments, informed consent form (ICF), Investigator Brochure (IB), and other relevant documents (eg, advertisements) were submitted to an Institutional Review Board/Independent Ethics Committee (IRB/IEC) by the Investigator and reviewed and approved by the IRB/IEC before the study was initiated. The Investigator or his/her representative explained the nature of the study to the subject or his/her legally authorised representative and answered all questions regarding the study. Subjects were informed that their participation was voluntary. Subjects or their legally authorised representative were required to sign a statement of informed consent that met the requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance Portability and Accountability Act (HIPAA) requirements, where applicable, and the IRB/IEC or study centre. For subjects under the age of majority (adolescent subjects), the subject’s legal guardian provided their informed consent in addition to the subject’s informed consent. The medical record must have included a statement that written informed consent was obtained before the subject was enrolled in the study and the date the written consent was obtained. The authorised person obtaining the informed consent must have also signed the ICF. Subjects must have been re-consented to the most current version of the ICF(s) during their participation in the study. A copy of the ICF(s) was provided to the subject or the subject’s legally authorised representative.
    Background therapy
    		 Subjects who had received a physician-prescribed asthma controller medication with medium- or high-dose ICS as per GINA guideline (GINA 2017) for at least 12 months prior to Visit 1. Documented treatment with a total daily dose of either medium or high-dose ICS (>=500μg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months prior to Visit 1. The ICS could be contained within an ICS/LABA combination product. At least one additional maintenance asthma controller medication was required according to standard practice of care. Use of additional asthma controller medications must have been documented for at least 3 months prior to Visit 1.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 126
    Country: Number of subjects enrolled
    Japan: 97
    Country: Number of subjects enrolled
    Vietnam: 20
    Country: Number of subjects enrolled
    Taiwan: 9
    Country: Number of subjects enrolled
    United States: 186
    Country: Number of subjects enrolled
    Canada: 36
    Country: Number of subjects enrolled
    Brazil: 93
    Country: Number of subjects enrolled
    Argentina: 81
    Country: Number of subjects enrolled
    Germany: 103
    Country: Number of subjects enrolled
    France: 41
    Country: Number of subjects enrolled
    Australia: 19
    Country: Number of subjects enrolled
    Austria: 8
    Country: Number of subjects enrolled
    South Africa: 109
    Country: Number of subjects enrolled
    Israel: 47
    Country: Number of subjects enrolled
    Saudi Arabia: 7
    Country: Number of subjects enrolled
    Russian Federation: 51
    Country: Number of subjects enrolled
    Ukraine: 26
    Worldwide total number of subjects
    1059
    EEA total number of subjects
    152
    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)
    82
    Adults (18-64 years)
    807
    From 65 to 84 years
    170
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 2420 subjects were enrolled at 297 centres in 18 countries;

    Pre-assignment
    Screening details
    		 1061 subjects were randomised to receive treatment with tezepelumab 210mg Q4W or placebo. Of the 1061 randomised, 1059 (99.8%) subjects received treatment. 82 (7.7%) of the subjects randomised and treated were adolescents.

    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
    		 Tezepelumab 210mg Q4W
    Arm description
    		 Tezepelumab administered every 4 weeks subcutaneously
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tezepelumab administered every 4 weeks subcutaneously
    Investigational medicinal product code
    Other name
    Tezepelumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    210 mg Q4W

    Arm title
    		 Placebo
    Arm description
    		 Placebo administered subcutaneously
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Q4W

    Number of subjects in period 1
    		Tezepelumab 210mg Q4W Placebo
    Started
    528
    531
    Completed
    513
    509
    Not completed
    15
    22
         Adverse event, serious fatal
    -
    2
         Consent withdrawn by subject
    8
    15
         Other reasons
    2
    3
         Lost to follow-up
    5
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tezepelumab 210mg Q4W
    Reporting group description
    		 Tezepelumab administered every 4 weeks subcutaneously

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered subcutaneously

    Reporting group values
    		 Tezepelumab 210mg Q4W Placebo Total
    Number of subjects
    		 528 531 1059
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 41 41 82
        Adults (18-64 years)
    		 391 416 807
        From 65-84 years
    		 96 74 170
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.9 ( 16.3 ) 49.0 ( 15.9 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 335 337 672
        Male
    		 193 194 387

    End points

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    End points reporting groups
    Reporting group title
    Tezepelumab 210mg Q4W
    Reporting group description
    		 Tezepelumab administered every 4 weeks subcutaneously

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered subcutaneously

    Primary: Annual asthma exacerbation rate in adult and adolescent patients with uncontrolled asthma

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    End point title
    		 Annual asthma exacerbation rate in adult and adolescent patients with uncontrolled asthma
    End point description
    The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF. The analysis is based on the primary population (Full Analysis Set)
    End point type
    Primary
    End point timeframe
    From randomisation to Study Week 52.
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    528
    531
    Units: annual rate of event over time at risk
    least squares mean (confidence interval 95%)
        Least squares means (95% confidence interval)
    0.93 (0.80 to 1.07)
    2.10 (1.84 to 2.39)
    Statistical analysis title
    		 Negative binomial analysis
    Comparison groups
    Tezepelumab 210mg Q4W v Placebo
    Number of subjects included in analysis
    1059
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Negative Binomial
    Parameter type
    		 Rate ratio
    Point estimate
    0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 0.53

    Primary: Annual asthma exacerbation rate in adult and adolescent patients with uncontrolled asthma in subjects with baseline eosinophils < 300 cells/uL

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    End point title
    		 Annual asthma exacerbation rate in adult and adolescent patients with uncontrolled asthma in subjects with baseline eosinophils < 300 cells/uL
    End point description
    End point type
    Primary
    End point timeframe
    From randomisation to Study Week 52.
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    309
    309
    Units: Annual rate of event over time at risk
    least squares mean (confidence interval 95%)
        Least squares means (95% confidence interval)
    1.02 (0.84 to 1.23)
    1.73 (1.46 to 2.05)
    Statistical analysis title
    		 Negative Binomial model
    Comparison groups
    Tezepelumab 210mg Q4W v Placebo
    Number of subjects included in analysis
    618
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Negative Binomial
    Parameter type
    		 Rate ratio
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 0.75

    Secondary: Mean change from baseline at Week 52 in pre-bronchodilator FEV1 (L) (key secondary endpoint)

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    End point title
    		 Mean change from baseline at Week 52 in pre-bronchodilator FEV1 (L) (key secondary endpoint)
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    471
    453
    Units: Litre
    least squares mean (standard error)
        Least square means (standard error)
    0.23 ( 0.018 )
    0.10 ( 0.018 )
    Statistical analysis title
    		 Repeated measures model
    Comparison groups
    Tezepelumab 210mg Q4W v Placebo
    Number of subjects included in analysis
    924
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 0.18

    Secondary: Mean change from baseline at Week 52 in ACQ-6 (key secondary endpoint)

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    End point title
    		 Mean change from baseline at Week 52 in ACQ-6 (key secondary endpoint)
    End point description
    End point type
    Secondary
    End point timeframe
    From Randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    485
    472
    Units: Scale of score
    least squares mean (standard error)
        Least squares mean (standard error)
    -1.53 ( 0.045 )
    -1.20 ( 0.046 )
    Statistical analysis title
    		 Repeated measures model
    Comparison groups
    Tezepelumab 210mg Q4W v Placebo
    Number of subjects included in analysis
    957
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 -0.2

    Secondary: Mean change from baseline at Week 52 in AQLQ(S)+12 total score (key secondary endpoint)

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    End point title
    		 Mean change from baseline at Week 52 in AQLQ(S)+12 total score (key secondary endpoint)
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    480
    467
    Units: Scale of score
    least squares mean (standard error)
        Least squares mean (standard error)
    1.48 ( 0.049 )
    1.14 ( 0.049 )
    Statistical analysis title
    		 Repeated measures model
    Comparison groups
    Tezepelumab 210mg Q4W v Placebo
    Number of subjects included in analysis
    947
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 0.47

    Secondary: Mean change from baseline at Week 52 in Asthma Symptom Diary (key secondary endpoint)

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    End point title
    		 Mean change from baseline at Week 52 in Asthma Symptom Diary (key secondary endpoint)
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    374
    355
    Units: Scale of score
    least squares mean (standard error)
        Least squares mean (standard error)
    -0.70 ( 0.027 )
    -0.59 ( 0.027 )
    Statistical analysis title
    		 Repeated measures model
    Comparison groups
    Tezepelumab 210mg Q4W v Placebo
    Number of subjects included in analysis
    729
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 -0.04

    Secondary: Annual asthma exacerbation rate resulting in emergency room visit or hospitalisation

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    End point title
    		 Annual asthma exacerbation rate resulting in emergency room visit or hospitalisation
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    528
    531
    Units: Annual rate of event over time at risk
    least squares mean (confidence interval 95%)
        Least squares mean (95% confidence interval)
    0.06 (0.04 to 0.09)
    0.28 (0.20 to 0.39)
    No statistical analyses for this end point

    Secondary: Annual asthma exacerbations associated with hospitalisations

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    End point title
    		 Annual asthma exacerbations associated with hospitalisations
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    528
    531
    Units: Annual rate of event over time at risk
    least squares mean (confidence interval 95%)
        Least squares mean (95% Confidence interval)
    0.03 (0.01 to 0.06)
    0.19 (0.12 to 0.30)
    No statistical analyses for this end point

    Secondary: Annual asthma exacerbation rate using adjudicated data

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    End point title
    		 Annual asthma exacerbation rate using adjudicated data
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    528
    531
    Units: Annual rate of event over time at risk
    least squares mean (confidence interval 95%)
        Least squares mean (95% confidence interval)
    0.94 (0.81 to 1.09)
    2.14 (1.88 to 2.44)
    No statistical analyses for this end point

    Secondary: Annual asthma exacerbation rate associated with emergency room visit or hospitalisation using adjudicated data

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    End point title
    		 Annual asthma exacerbation rate associated with emergency room visit or hospitalisation using adjudicated data
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52.
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    528
    531
    Units: Annual rate of event over time at risk
    least squares mean (confidence interval 95%)
        Least squares mean (95% confidence interval)
    0.08 (0.05 to 0.12)
    0.31 (0.22 to 0.42)
    No statistical analyses for this end point

    Secondary: Proportion of subjects with >= 1 asthma exacerbation and time to first asthma exacerbation

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    End point title
    		 Proportion of subjects with >= 1 asthma exacerbation and time to first asthma exacerbation
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    528
    531
    Units: Count
        Number of subjects with >=1 asthma exacerbation
    231
    319
    No statistical analyses for this end point

    Secondary: Proportion of subjects who had no asthma exacerbations

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    End point title
    		 Proportion of subjects who had no asthma exacerbations
    End point description
    The proportion of subjects with no exacerbations is defined as subjects who meet both the following criteria: (1) completed the 52 week treatment period and (2) did not report an exacerbation during this period.
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    528
    531
    Units: Number of subjects
        Number of subjects with no asthma exacerbations
    286
    205
    No statistical analyses for this end point

    Secondary: Proportion of subjects with >=1 asthma exacerbation associated with emergency room visit or hospitalisation and time to first asthma exacerbation associated with emergency room visit or hospitalisation

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    End point title
    		 Proportion of subjects with >=1 asthma exacerbation associated with emergency room visit or hospitalisation and time to first asthma exacerbation associated with emergency room visit or hospitalisation
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    528
    531
    Units: Count
        Number of subjects with >= 1 event
    25
    65
    No statistical analyses for this end point

    Secondary: Proportion of subjects with no asthma exacerbations associated with emergency room visit or hospitalisation.

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    End point title
    		 Proportion of subjects with no asthma exacerbations associated with emergency room visit or hospitalisation.
    End point description
    The proportion of subjects with no exacerbations associated with emergency room visit or hospitalisation. is defined as subjects who meet both the following criteria: (1) completed the 52 week treatment period and (2) did not report an exacerbation associated with emergency room visit or hospitalisation.during this period.
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    528
    531
    Units: Number of subjects
        Number of subjects with no events
    488
    452
    No statistical analyses for this end point

    Secondary: Mean change from baseline at Week 52 in clinic FeNO (ppb)

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    End point title
    		 Mean change from baseline at Week 52 in clinic FeNO (ppb)
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    440
    426
    Units: ppb
    least squares mean (standard error)
        Least squares mean (SE)
    -17.29 ( 1.156 )
    -3.46 ( 1.165 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline at Week 52 in Eosinophils (cells/uL)

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    End point title
    		 Mean change from baseline at Week 52 in Eosinophils (cells/uL)
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    458
    451
    Units: cells/uL
        least squares mean (standard error)
    -170.02 ( 9.222 )
    -40.15 ( 9.254 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline at Week 52 in IgE (IU/mL)

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    End point title
    		 Mean change from baseline at Week 52 in IgE (IU/mL)
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    482
    471
    Units: IU/mL
        least squares mean (standard error)
    -164.38 ( 34.414 )
    43.61 ( 34.542 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline in daily rescue medication use at Week 52

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    End point title
    		 Mean change from baseline in daily rescue medication use at Week 52
    End point description
    Daily rescue medication use is defined as: Number of night inhaler puffs + 2 x [number of night nebulizer times] + number of daytime inhaler puffs + 2 x [number of day nebulizer times].
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    439
    428
    Units: weekly mean use
        least squares mean (standard error)
    -2.53 ( 0.137 )
    -2.36 ( 0.137 )
    No statistical analyses for this end point

    Secondary: Mean change in night time awakenings due to asthma at Week 52

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    End point title
    		 Mean change in night time awakenings due to asthma at Week 52
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    418
    395
    Units: percentage of nights with awakenings
        least squares mean (standard error)
    -33.51 ( 1.381 )
    -30.22 ( 1.387 )
    No statistical analyses for this end point

    Secondary: Mean change in home based morning PEF (L/min) at Week 52

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    End point title
    		 Mean change in home based morning PEF (L/min) at Week 52
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    414
    391
    Units: Weekly mean (L/min)
        least squares mean (standard error)
    34.57 ( 3.051 )
    18.01 ( 3.074 )
    No statistical analyses for this end point

    Secondary: Mean change in home based evening PEF (L/min) at Week 52

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    End point title
    		 Mean change in home based evening PEF (L/min) at Week 52
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    405
    390
    Units: weekly mean (L/min)
        least squares mean (standard error)
    23.87 ( 3.075 )
    9.01 ( 3.094 )
    No statistical analyses for this end point

    Secondary: Clinicians global impression of change at Week 52

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    End point title
    		 Clinicians global impression of change at Week 52
    End point description
    CGIC (Clinical global impression of change), is an overall evaluation of response to treatment, conducted by investigator using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse)
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    483
    477
    Units: Number of subjects
        Very much improved
    96
    60
        Much improved
    199
    132
        Minimally Improved
    98
    131
        No change
    77
    130
        Minimally worse
    11
    19
        Much worse
    2
    4
        Very much worse
    0
    1
    No statistical analyses for this end point

    Secondary: Patients global impression of change at Week 52

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    End point title
    		 Patients global impression of change at Week 52
    End point description
    PGIC (Patient global impression of change) is an overall evaluation of response to treatment, conducted by the patient using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse).
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    479
    466
    Units: Number of subjects
        Very much Improved
    255
    182
        Much improved
    103
    94
        Minimally improved
    71
    76
        No Change
    39
    99
        Minimally worse
    6
    8
        Much worse
    4
    6
        Very much worse
    1
    1
    No statistical analyses for this end point

    Secondary: Patients global impression of severity at Week 52

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    End point title
    		 Patients global impression of severity at Week 52
    End point description
    PGI-S (Patient global impression of severity) is an overall evaluation of patient's perception of overall symptom severity using a 6-point rating scale, ranging from 0 = No symptoms, 1=Very mild symptoms, 2=Mild symptoms, 3=Moderate symptoms, 4=Severe symptoms, 5=Very severe symptoms
    End point type
    Secondary
    End point timeframe
    At Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    479
    466
    Units: Number of subjects
        No symptoms
    118
    78
        Very mild symptoms
    138
    128
        Mild symptoms
    110
    128
        Moderate symptoms
    99
    111
        Severe symptoms
    14
    19
        Very severe symptoms
    0
    2
    No statistical analyses for this end point

    Secondary: Number of healthcare utilization over 52 weeks

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    End point title
    		 Number of healthcare utilization over 52 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    528
    531
    Units: Number of subjects
        Hospitalisation
    17
    37
        Emergency room visit
    23
    50
        Unscheduled visit to specialist
    187
    231
        Home visit
    9
    10
        Telephone call
    101
    133
        Ambulance transport
    4
    12
    No statistical analyses for this end point

    Secondary: Mean change from baseline in work productivity loss due to asthma at Week 52

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    End point title
    		 Mean change from baseline in work productivity loss due to asthma at Week 52
    End point description
    WPAI+CIQ work productivity loss at Week 52
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    185
    177
    Units: Percentage
        arithmetic mean (standard deviation)
    -20.16 ( 30.31 )
    -16.58 ( 29.46 )
    No statistical analyses for this end point

    Secondary: Activity impairment at Week 52

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    End point title
    		 Activity impairment at Week 52
    End point description
    WPAI+CIQ activity impairment
    End point type
    Secondary
    End point timeframe
    From randomisation to Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    207
    196
    Units: Percentage
        arithmetic mean (standard deviation)
    -20.0 ( 28.6 )
    -17.9 ( 27.1 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline in class productivity loss due to asthma at Week 52

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    End point title
    		 Mean change from baseline in class productivity loss due to asthma at Week 52
    End point description
    WPAI+CIQ productivity loss at Week 52 for subjects currently attending school.
    End point type
    Secondary
    End point timeframe
    From randomisation to study week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    15
    19
    Units: Percentage
        arithmetic mean (standard deviation)
    -14.03 ( 33.00 )
    -24.72 ( 26.48 )
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of tezpelumab

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    End point title
    		 Pharmacokinetics of tezpelumab
    End point description
    Mean serum trough PK concentrations at each visit
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 12, Week 24, Week 36, Week 52, Week 64
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    528
    0 [1]
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        Baseline (n=524)
    0 ( 0 )
    ( )
        Week 4 (n=514)
    10.1573 ( 74.51 )
    ( )
        Week 12 (n=491)
    18.7396 ( 48.53 )
    ( )
        Week 24 (n=461)
    20.1924 ( 51.77 )
    ( )
        Week 36 (n=464)
    19.5246 ( 55.58 )
    ( )
        Week 52 (n=452)
    19.8894 ( 70.04 )
    ( )
        Week 64 (n=72)
    1.7675 ( 171.86 )
    ( )
    Notes
    [1] - Not applicable since it is not the experimental product.
    No statistical analyses for this end point

    Secondary: Immunogenecity of tezepelumab

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    End point title
    		 Immunogenecity of tezepelumab
    End point description
    Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post baseline assessments (with >=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment boosted ADA defined as baseline positive ADA that was boosted to a 4 fold or higher level following treatment. Treatment emergent ADA defined as sum of treatment induced ADA and treatment boosted ADA.
    End point type
    Secondary
    End point timeframe
    Baseline, and from time of first dose to end of study
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    527
    530
    Units: Number of subjects
        ADA positive at baseline and/or post-baseline
    26
    44
        Any baseline ADA positive
    17
    25
        Only baseline ADA positive
    14
    8
        Any post-baseline ADA positive
    12
    36
        Both baseline and >= 1 post-baseline ADA positive
    3
    17
        Treatment induced ADA positive
    9
    18
        Treatment boosted ADA positive
    1
    2
        Treatment emergent ADA positive
    10
    20
        ADA persistently positive
    4
    18
        ADA transiently positive
    8
    18
    No statistical analyses for this end point

    Secondary: Mean change from baseline at Week 52 in EQ-5D-5L VAS

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    End point title
    		 Mean change from baseline at Week 52 in EQ-5D-5L VAS
    End point description
    End point type
    Secondary
    End point timeframe
    At Study Week 52
    End point values
    		 Tezepelumab 210mg Q4W Placebo
    Number of subjects analysed
    448
    435
    Units: scale of score
        least squares mean (standard error)
    14.64 ( 0.708 )
    11.86 ( 0.712 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until last study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Teze 210 mg Q4W
    Reporting group description
    		 Tezepelumab administered every 4 weeks subcutaneously

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered subcutaneously

    Serious adverse events
    		 Teze 210 mg Q4W Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    52 / 528 (9.85%)
    73 / 531 (13.75%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 528 (0.19%)
    2 / 531 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    2 / 528 (0.38%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Cyanosis
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    2 / 528 (0.38%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (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
    Anaphylactic reaction
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         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
    14 / 528 (2.65%)
    39 / 531 (7.34%)
         occurrences causally related to treatment / all
    2 / 15
    0 / 81
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eosinophilic pneumonia
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal polyps
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    2 / 528 (0.38%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Aortic valve stenosis
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    2 / 528 (0.38%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (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
    Cubital tunnel syndrome
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic generalised epilepsy
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 528 (0.19%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 528 (0.19%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uveitis
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal achalasia
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis necrotising
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 528 (0.19%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 528 (0.19%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone cyst
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle necrosis
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 528 (0.19%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast abscess
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 528 (0.00%)
    2 / 531 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 528 (0.19%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 528 (0.00%)
    2 / 531 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster oticus
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    0 / 528 (0.00%)
    2 / 531 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (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
    1 / 528 (0.19%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    2 / 528 (0.38%)
    2 / 531 (0.38%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 528 (0.19%)
    0 / 531 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 528 (0.00%)
    1 / 531 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Teze 210 mg Q4W Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    306 / 528 (57.95%)
    331 / 531 (62.34%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    23 / 528 (4.36%)
    22 / 531 (4.14%)
         occurrences all number
    27
    29
    Nervous system disorders
    Headache
         subjects affected / exposed
    43 / 528 (8.14%)
    45 / 531 (8.47%)
         occurrences all number
    96
    68
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    19 / 528 (3.60%)
    22 / 531 (4.14%)
         occurrences all number
    21
    26
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    14 / 528 (2.65%)
    23 / 531 (4.33%)
         occurrences all number
    17
    25
    Rhinitis allergic
         subjects affected / exposed
    16 / 528 (3.03%)
    17 / 531 (3.20%)
         occurrences all number
    19
    25
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    20 / 528 (3.79%)
    13 / 531 (2.45%)
         occurrences all number
    25
    14
    Back pain
         subjects affected / exposed
    21 / 528 (3.98%)
    15 / 531 (2.82%)
         occurrences all number
    26
    16
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    25 / 528 (4.73%)
    33 / 531 (6.21%)
         occurrences all number
    39
    36
    Gastroenteritis
         subjects affected / exposed
    17 / 528 (3.22%)
    14 / 531 (2.64%)
         occurrences all number
    18
    15
    Bronchitis bacterial
         subjects affected / exposed
    24 / 528 (4.55%)
    17 / 531 (3.20%)
         occurrences all number
    26
    20
    Nasopharyngitis
         subjects affected / exposed
    113 / 528 (21.40%)
    114 / 531 (21.47%)
         occurrences all number
    172
    188
    Pharyngitis
         subjects affected / exposed
    17 / 528 (3.22%)
    15 / 531 (2.82%)
         occurrences all number
    18
    17
    Rhinitis
         subjects affected / exposed
    14 / 528 (2.65%)
    17 / 531 (3.20%)
         occurrences all number
    18
    37
    Sinusitis
         subjects affected / exposed
    19 / 528 (3.60%)
    40 / 531 (7.53%)
         occurrences all number
    22
    56
    Upper respiratory tract infection
         subjects affected / exposed
    58 / 528 (10.98%)
    88 / 531 (16.57%)
         occurrences all number
    94
    129
    Urinary tract infection
         subjects affected / exposed
    22 / 528 (4.17%)
    22 / 531 (4.14%)
         occurrences all number
    33
    24
    Viral upper respiratory tract infection
         subjects affected / exposed
    17 / 528 (3.22%)
    13 / 531 (2.45%)
         occurrences all number
    21
    18

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Nov 2017
    Inclusion of St George's Respiratory Questionnaire, clarifications on outcomes of secondary endpoints, amended inclusion/exclusion criteria, changes to concomitant medication
    16 Mar 2018
    Change in collection times of SNOT-22, added details regarding enrolment in separate extension study, clarification on adjudication committee, amended inclusion/exclusion criteria, clarification on concomitant/prohibited medication
    15 Apr 2019
    Neutralizing antibodies moved to exploratory endpoint, additional of baseline eosinophils <300/uL subgroup into the confirmatory hierarchical testing strategy, revised inclusion/exclusion criteria, clarification on dose preparation/administration, clarification on laboratories requiring treatment information for sample analyses, addition of a primary database lock, clarification on procedures for discontinuation of IP,
    14 May 2020
    Added appendix with guidance for changes related to the COVID-19 pandemic, clarification on subjects enrolling into long term extension study can continue with follow-up visits until an on-site visit is possible, clarification on schedule of assessments due to the COVID-19 pandemic, secondary endpoint proportion of subjects with >= 1 asthma exacerbation updated to proportion of subjects who did not experience an asthma exacerbation, clarification that pulmonology, cardiology, neurology and oncology specialists will form part of the independent adjudication committee, safety reporting period updated from post-treatment to on-study.

    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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