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    Clinical Trial Results:
    A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Tezepelumab on Airway Inflammation in Adults with Inadequately Controlled Asthma on Inhaled Corticosteroids and at least one additional asthma controller (CASCADE)

    Summary
    EudraCT number
    		 2018-002069-21
    Trial protocol
    		 DK   GB   DE  
    Global end of trial date
    16 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Nov 2021
    First version publication date
    26 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5180C00013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03688074
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    151 85, Södertälje, Sweden,
    Public contact
    AstraZeneca Clinical Study Information, AstraZeneca, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Head, AstraZeneca, 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
    11 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Nov 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To explore the airway anti-inflammatory effect of tezepelumab
    Protection of trial subjects
    Data safety monitoring board is utilized for this study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2018
    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
    Canada: 22
    Country: Number of subjects enrolled
    United States: 7
    Country: Number of subjects enrolled
    Denmark: 34
    Country: Number of subjects enrolled
    United Kingdom: 29
    Country: Number of subjects enrolled
    Germany: 24
    Worldwide total number of subjects
    116
    EEA total number of subjects
    58
    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)
    100
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 116 subjects randomized to Tezepelumab 210 mg Q4W or Placebo in 1:1 treatment allocation. All randomized subjects were treated. 59 (50.9%) were randomized to Tezepelumab 210 mg Q4W, and 57 (49.1%) were randomized to Placebo.

    Pre-assignment
    Screening details
    		 The study randomized subjects across the spectrum of T2 status. Randomization was stratified by baseline blood eosinophil level (< 50 , 150 - <300, >= 300 cells/µL).

    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, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Teze 210 mg Q4W
    Arm description
    		 Tezepelumab subcutaneous injection
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tezepelumab
    Investigational medicinal product code
    MEDI9929 anti-TSLP mAb (AMG157)
    Other name
    AMG 157
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    210 mg

    Arm title
    		 Placebo
    Arm description
    		 Placebo subcutaneous injection
    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
    1

    Number of subjects in period 1
    		Teze 210 mg Q4W Placebo
    Started
    59
    57
    Completed
    58
    56
    Not completed
    1
    1
         Adverse event, non-fatal
    -
    1
         Other
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Teze 210 mg Q4W
    Reporting group description
    		 Tezepelumab subcutaneous injection

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo subcutaneous injection

    Reporting group values
    		 Teze 210 mg Q4W Placebo Total
    Number of subjects
    		 59 57 116
    Age Categorical
    Full Analysis Set - Include all subjects randomised to study treatment who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.
    Units: Participants
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 51 49 100
        >=65 years
    		 8 8 16
    Age Continuous
    Full Analysis Set - Include all subjects randomised to study treatment who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.
    Units: years
        arithmetic mean (standard deviation)
    		 50.4 ( 12.7 ) 50.4 ( 13.9 ) -
    Sex: Female, Male
    Full Analysis Set - Include all subjects randomised to study treatment who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.
    Units: Participants
        Female
    		 39 26 65
        Male
    		 20 31 51
    Race/Ethnicity, Customized
    Race - Full Analysis Set - Include all subjects randomised to study treatment who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.
    Units: Subjects
        White
    		 54 55 109
        Black or African American
    		 2 1 3
        Asian
    		 2 1 3
        Other
    		 1 0 1
    Race/Ethnicity, Customized
    Ethnicity - Full Analysis Set - Include all subjects randomised to study treatment who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic or Latino
    		 59 57 116

    End points

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    End points reporting groups
    Reporting group title
    Teze 210 mg Q4W
    Reporting group description
    		 Tezepelumab subcutaneous injection

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo subcutaneous injection

    Primary: Airway submucosal inflammatory cells ratio change from baseline to EOT.

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    End point title
    		 Airway submucosal inflammatory cells ratio change from baseline to EOT.
    End point description
    The change from baseline to end of treatment (EOT) expressed as a ratio i.e. (EOT/baseline) in numbers of each of the airway submucosal inflammatory cells, determined by microscopic evaluation of bronchoscopic biopsies.
    End point type
    Primary
    End point timeframe
    First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
    End point values
    		 Teze 210 mg Q4W Placebo
    Number of subjects analysed
    48
    51
    Units: Ratio
    geometric mean (confidence interval 90%)
        Eosinophils
    0.11 (0.06 to 0.21)
    0.75 (0.41 to 1.38)
        Neutrophils
    1.11 (0.88 to 1.39)
    0.81 (0.66 to 1.01)
        T cells CD3+
    0.91 (0.78 to 1.07)
    0.81 (0.70 to 0.95)
        T cells CD4+
    0.96 (0.82 to 1.14)
    0.81 (0.70 to 0.95)
        Mast cells Tryptase+
    0.84 (0.70 to 1.02)
    1.01 (0.84 to 1.22)
        Mast cells Chymase+
    1.07 (0.76 to 1.52)
    0.90 (0.65 to 1.26)
    Statistical analysis title
    		 Eosinophils (cells/mm2)
    Statistical analysis description
    All subjects randomised to study treatment who completed at least 20 weeks of study treatment and had a baseline assessment and an EOT assessment not greater than 8 weeks after date of last dose of IP.
    Comparison groups
    Teze 210 mg Q4W v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.001 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of Geometric LSMeans
    Point estimate
    0.15
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 0.35
    Notes
    [1] - Ratio change from baseline to EOT treatment comparison
    [2] - Model includes treatment+log transformed baseline value+stratification factor (screening eos count [<150, 150-<300, >=300 cells/uL])
    Statistical analysis title
    		 Neutrophils (cells/mm2)
    Statistical analysis description
    All subjects randomised to study treatment who completed at least 20 weeks of study treatment and had a baseline assessment and an EOT assessment not greater than 8 weeks after date of last dose of IP.
    Comparison groups
    Teze 210 mg Q4W v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.106 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of Geometric LSMeans
    Point estimate
    1.36
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.99
         upper limit
    		 1.86
    Notes
    [3] - Ratio change from baseline to EOT treatment comparisons
    [4] - Model includes treatment+log transformed baseline value+stratification factor (screening eos count [<150, 150-<300, >=300 cells/uL])
    Statistical analysis title
    		 T cells CD3+ (cells/mm2)
    Statistical analysis description
    All subjects randomised to study treatment who completed at least 20 weeks of study treatment and had a baseline assessment and an EOT assessment not greater than 8 weeks after date of last dose of IP.
    Comparison groups
    Teze 210 mg Q4W v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.389 [6]
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of Geometric LSMeans
    Point estimate
    1.12
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.4
    Notes
    [5] - Ratio change from baseline to EOT treatment comparisons
    [6] - Model includes treatment+log transformed baseline value+stratification factor (screening eos count [<150, 150-<300, >=300 cells/uL])
    Statistical analysis title
    		 T cells CD4+ (cells/mm2)
    Statistical analysis description
    All subjects randomised to study treatment who completed at least 20 weeks of study treatment and had a baseline assessment and an EOT assessment not greater than 8 weeks after date of last dose of IP.
    Comparison groups
    Teze 210 mg Q4W v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.216 [8]
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of Geometric LSMeans
    Point estimate
    1.18
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.48
    Notes
    [7] - Ratio change from baseline to EOT treatment comparisons
    [8] - Model includes treatment+log transformed baseline value+stratification factor (screening eos count [<150, 150-<300, >=300 cells/uL])
    Statistical analysis title
    		 Mast cells Tryptase+ (cells/mm2)
    Statistical analysis description
    All subjects randomised to study treatment who completed at least 20 weeks of study treatment and had a baseline assessment and an EOT assessment not greater than 8 weeks after date of last dose of IP.
    Comparison groups
    Teze 210 mg Q4W v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 = 0.26 [10]
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of Geometric LSMeans
    Point estimate
    0.83
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.09
    Notes
    [9] - Ratio change from baseline to EOT treatment comparisons
    [10] - Model includes treatment+log transformed baseline value+stratification factor (screening eos count [<150, 150-<300, >=300 cells/uL])
    Statistical analysis title
    		 Mast cells Chymase+ (cells/mm2)
    Statistical analysis description
    All subjects randomised to study treatment who completed at least 20 weeks of study treatment and had a baseline assessment and an EOT assessment not greater than 8 weeks after date of last dose of IP.
    Comparison groups
    Teze 210 mg Q4W v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 = 0.546 [12]
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of Geometric LSMeans
    Point estimate
    1.19
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.92
    Notes
    [11] - Ratio change from baseline to EOT treatment comparisons
    [12] - Model includes treatment+log transformed baseline value+stratification factor (screening eos count [<150, 150-<300, >=300 cells/uL])

    Secondary: Reticular basement membrane (RBM) thickness ratio change from baseline to EOT.

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    End point title
    		 Reticular basement membrane (RBM) thickness ratio change from baseline to EOT.
    End point description
    The change from baseline to EOT expressed as a ratio i.e. (EOT/baseline) in RBM thickness, determined by microscopic evaluation of bronchoscopic biopsies.
    End point type
    Secondary
    End point timeframe
    First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
    End point values
    		 Teze 210 mg Q4W Placebo
    Number of subjects analysed
    42
    40
    Units: Ratio
        geometric mean (confidence interval 90%)
    0.87 (0.79 to 0.95)
    0.90 (0.81 to 0.99)
    No statistical analyses for this end point

    Secondary: Percent (%) airway epithelial integrity ratio change from baseline to EOT.

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    End point title
    		 Percent (%) airway epithelial integrity ratio change from baseline to EOT.
    End point description
    The change from baseline to EOT expressed as a ratio i.e. (EOT/baseline) in % airway epithelial, determined by microscopic evaluation of bronchoscopic biopsies.
    End point type
    Secondary
    End point timeframe
    First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
    End point values
    		 Teze 210 mg Q4W Placebo
    Number of subjects analysed
    45
    46
    Units: Ratio
    geometric mean (confidence interval 90%)
        Intact epithelium
    0.87 (0.61 to 1.23)
    0.84 (0.59 to 1.19)
        Damaged epithelium
    1.01 (0.92 to 1.12)
    0.95 (0.86 to 1.04)
        Denuded epithelium
    1.05 (0.83 to 1.31)
    1.34 (1.07 to 1.68)
    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 investigational product till the end of the study.
    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 subcutaneous injection

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo subcutaneous injection

    Serious adverse events
    		 Teze 210 mg Q4W Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 59 (5.08%)
    7 / 57 (12.28%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Meningioma
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural complication
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocarditis
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         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
    48 / 59 (81.36%)
    45 / 57 (78.95%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 57 (0.00%)
         occurrences all number
    5
    0
    Fall
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 57 (1.75%)
         occurrences all number
    4
    1
    Post procedural complication
         subjects affected / exposed
    11 / 59 (18.64%)
    10 / 57 (17.54%)
         occurrences all number
    11
    12
    Post procedural fever
         subjects affected / exposed
    4 / 59 (6.78%)
    2 / 57 (3.51%)
         occurrences all number
    4
    2
    Procedural pain
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 57 (0.00%)
         occurrences all number
    3
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 59 (1.69%)
    2 / 57 (3.51%)
         occurrences all number
    1
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 59 (10.17%)
    8 / 57 (14.04%)
         occurrences all number
    9
    8
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    3 / 59 (5.08%)
    3 / 57 (5.26%)
         occurrences all number
    3
    3
    Injection site erythema
         subjects affected / exposed
    5 / 59 (8.47%)
    2 / 57 (3.51%)
         occurrences all number
    14
    12
    Injection site granuloma
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Injection site pruritus
         subjects affected / exposed
    4 / 59 (6.78%)
    1 / 57 (1.75%)
         occurrences all number
    5
    1
    Oedema peripheral
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 57 (0.00%)
         occurrences all number
    3
    0
    Pyrexia
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 57 (0.00%)
         occurrences all number
    3
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 59 (8.47%)
    0 / 57 (0.00%)
         occurrences all number
    6
    0
    Vomiting
         subjects affected / exposed
    2 / 59 (3.39%)
    3 / 57 (5.26%)
         occurrences all number
    2
    3
    Nausea
         subjects affected / exposed
    2 / 59 (3.39%)
    2 / 57 (3.51%)
         occurrences all number
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 59 (10.17%)
    4 / 57 (7.02%)
         occurrences all number
    9
    5
    Dysphonia
         subjects affected / exposed
    2 / 59 (3.39%)
    2 / 57 (3.51%)
         occurrences all number
    2
    2
    Oropharyngeal pain
         subjects affected / exposed
    6 / 59 (10.17%)
    2 / 57 (3.51%)
         occurrences all number
    6
    2
    Nasal congestion
         subjects affected / exposed
    1 / 59 (1.69%)
    2 / 57 (3.51%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 59 (5.08%)
    3 / 57 (5.26%)
         occurrences all number
    3
    4
    Back pain
         subjects affected / exposed
    2 / 59 (3.39%)
    2 / 57 (3.51%)
         occurrences all number
    2
    2
    Bursitis
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 57 (3.51%)
         occurrences all number
    0
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 59 (1.69%)
    2 / 57 (3.51%)
         occurrences all number
    1
    3
    Myalgia
         subjects affected / exposed
    3 / 59 (5.08%)
    1 / 57 (1.75%)
         occurrences all number
    3
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Candida infection
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Chronic sinusitis
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 57 (3.51%)
         occurrences all number
    0
    2
    Conjunctivitis
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 59 (1.69%)
    2 / 57 (3.51%)
         occurrences all number
    1
    2
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 57 (1.75%)
         occurrences all number
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    22 / 59 (37.29%)
    21 / 57 (36.84%)
         occurrences all number
    28
    22
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    1 / 59 (1.69%)
    2 / 57 (3.51%)
         occurrences all number
    1
    2
    Oral candidiasis
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 57 (0.00%)
         occurrences all number
    4
    0
    Pneumonia
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 57 (1.75%)
         occurrences all number
    2
    1
    Rhinitis
         subjects affected / exposed
    1 / 59 (1.69%)
    2 / 57 (3.51%)
         occurrences all number
    1
    2
    Tonsillitis
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Sinusitis
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 57 (3.51%)
         occurrences all number
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 59 (5.08%)
    4 / 57 (7.02%)
         occurrences all number
    3
    4
    Urinary tract infection
         subjects affected / exposed
    3 / 59 (5.08%)
    2 / 57 (3.51%)
         occurrences all number
    4
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Nov 2018
    Changes are summarized in the CSP version 2.0
    03 May 2019
    Changes are summarized in the CSP version 3.0
    30 Apr 2020
    Most of the changes to the trial due to COVID-19 and other changes are summarized in the CSP version 4.0

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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