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    Clinical Trial Results:
    A Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tezepelumab Alone or Combined With Topical Corticosteroids in Moderate-to-Severe Atopic Dermatitis

    Summary
    EudraCT number
    		 2018-001997-52
    Trial protocol
    		 EE   GB   LV   DE   CZ   HU   PL   ES  
    Global end of trial date
    22 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20170755
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03809663
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States,
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Dec 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect of tezepelumab compared with placebo, assessed using the Investigator’s Global Assessment (IGA) and Eczema Area and Severity Index (EASI).
    Protection of trial subjects
    This study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 2019
    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
    Japan: 35
    Country: Number of subjects enrolled
    Korea, Republic of: 14
    Country: Number of subjects enrolled
    Czechia: 16
    Country: Number of subjects enrolled
    Estonia: 10
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Latvia: 12
    Country: Number of subjects enrolled
    Poland: 41
    Country: Number of subjects enrolled
    Ukraine: 18
    Country: Number of subjects enrolled
    Canada: 23
    Country: Number of subjects enrolled
    United States: 36
    Country: Number of subjects enrolled
    Australia: 10
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    United Kingdom: 9
    Worldwide total number of subjects
    251
    EEA total number of subjects
    106
    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)
    237
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled in 78 centers in 14 countries including Australia, Canada, Czech Republic, Estonia, Germany, Hungary, Japan, Latvia, Poland, Republic of Korea, Spain, Ukraine, the United Kingdom, and the United States.

    Pre-assignment
    Screening details
    		 Part A was stopped as of 27 July 2020 and the study was terminated prior to the enrollment of any participants into Part B.

    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
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks. Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index [EASI] at Week 16 compared to baseline) switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching placebo administered via SC injection.

    Arm title
    		 Tezepelumab 210 mg Q4W
    Arm description
    		 Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks. All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding. Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI at Week 16 compared to baseline) switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tezepelumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Tezepelumab administered via SC injection.

    Arm title
    		 Tezepelumab 280 mg Q2W
    Arm description
    		 Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks. All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2. Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI at Week 16 compared to baseline) switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tezepelumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Tezepelumab administered via SC injection.

    Arm title
    		 Tezepelumab 420 mg Q2W
    Arm description
    		 Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tezepelumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Tezepelumab administered via SC injection.

    Number of subjects in period 1
    		Placebo Tezepelumab 210 mg Q4W Tezepelumab 280 mg Q2W Tezepelumab 420 mg Q2W
    Started
    63
    62
    63
    63
    Received investigational product
    63
    61
    63
    63
    EASI 50 non-responder at Week 16
    40
    26
    30
    38
    Switched after Week 16
    39
    24
    30
    38
    Completed
    12
    18
    15
    16
    Not completed
    51
    44
    48
    47
         Consent withdrawn by subject
    26
    22
    27
    26
         Lost to follow-up
    1
    4
    1
    1
         Decision by sponsor
    24
    18
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks. Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index [EASI] at Week 16 compared to baseline) switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.

    Reporting group title
    Tezepelumab 210 mg Q4W
    Reporting group description
    		 Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks. All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding. Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI at Week 16 compared to baseline) switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.

    Reporting group title
    Tezepelumab 280 mg Q2W
    Reporting group description
    		 Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks. All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2. Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI at Week 16 compared to baseline) switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.

    Reporting group title
    Tezepelumab 420 mg Q2W
    Reporting group description
    		 Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.

    Reporting group values
    		 Placebo Tezepelumab 210 mg Q4W Tezepelumab 280 mg Q2W Tezepelumab 420 mg Q2W Total
    Number of subjects
    		 63 62 63 63 251
    Age categorical
    Units: Subjects
        18 - 35 years
    		 33 33 35 24 125
        36 - 75 years
    		 30 29 28 39 126
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 35.7 ( 13.4 ) 38.5 ( 15.0 ) 36.9 ( 13.4 ) 40.7 ( 14.3 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 27 32 23 27 109
        Male
    		 36 30 40 36 142
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 6 4 1 4 15
        Not Hispanic or Latino
    		 57 58 62 59 236
        Unknown or Not Reported
    		 0 0 0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 0 0 1
        Asian
    		 21 16 16 13 66
        Black or African-American
    		 1 3 1 3 8
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        White
    		 41 42 45 47 175
        Unknown
    		 0 0 0 0 0
        Other
    		 0 0 1 0 1
    Investigator's Global Assessment Score
    The IGA allows investigators to assess overall disease severity at 1 given time point and consists of a 5-point severity scale from clear to severe disease * 0 = clear * 1 = almost clear * 2 = mild disease * 3 = moderate disease * 4 = severe disease * 5 = very severe disease The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment (Breuer et al, 2004).
    Units: Subjects
        IGA Score of 3
    		 26 37 26 37 126
        IGA Score of 4
    		 32 17 30 18 97
        IGA Score of 5
    		 5 8 7 8 28
    Eczema Area and Severity Index (EASI)
    The EASI was designed by modifying the Psoriasis Area and Severity Index (Schmitt et al, 2007). The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease.
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 32.0 ( 11.1 ) 28.4 ( 13.2 ) 30.3 ( 10.7 ) 28.6 ( 12.4 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks. Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index [EASI] at Week 16 compared to baseline) switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.

    Reporting group title
    Tezepelumab 210 mg Q4W
    Reporting group description
    		 Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks. All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding. Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI at Week 16 compared to baseline) switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.

    Reporting group title
    Tezepelumab 280 mg Q2W
    Reporting group description
    		 Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks. All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2. Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI at Week 16 compared to baseline) switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.

    Reporting group title
    Tezepelumab 420 mg Q2W
    Reporting group description
    		 Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.

    Subject analysis set title
    Tezepelumab 210 mg Q4W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Tezepelumab 210 mg administered via SC once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks. All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.

    Subject analysis set title
    Tezepelumab 280 mg Q2W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks. All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.

    Subject analysis set title
    Tezepelumab 420 mg Q2W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks. Also includes participants randomized to lower doses of tezepelumab but who only received 420 mg and discontinued before receiving their randomized treatment. In addition, includes participants who were randomized to placebo, tezepelumab 210 mg and 280 mg, but switched to tezepelumab 420 mg in error after Week 16.

    Subject analysis set title
    Placebo; Tezepelumab 420 mg Switchers
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All participants who received the matching placebo Q2W up to Week 16 and were assessed as EASI 50 non-responders and switched to receive tezepelumab 420 mg Q2W up to Week 52 (switchers). Tezepelumab 420 mg administered via SC injection Q2W from Week 18 to Week 52.

    Subject analysis set title
    Tezepelumab 210 mg; Tezepelumab 420 mg Switchers
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All participants who received tezepelumab 210 mg Q4W up to Week 16 and were assessed as EASI 50 non-responders and switched to receive tezepelumab 420 mg Q2W up to Week 52 (switchers). Tezepelumab 420 mg administered via SC injection Q2W from Week 18 to Week 52.

    Subject analysis set title
    Tezepelumab 280 mg; Tezepelumab 420 mg Switchers
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All participants who received tezepelumab 280 mg Q2W up to Week 16 and were assessed as EASI 50 non-responders and switched to receive tezepelumab 420 mg Q2W up to Week 52 (switchers). Tezepelumab 420 mg administered via SC injection Q2W from Week 18 to Week 52.

    Subject analysis set title
    Tezepelumab 420 mg; Tezepelumab 420 mg Switchers
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All participants who received tezepelumab 420 mg Q2W up to Week 16 and were assessed as EASI 50 non-responders and continued to receive tezepelumab 420 mg Q2W up to Week 52 (switchers). Tezepelumab 420 mg administered via SC injection Q2W from Week 18 to Week 52.

    Primary: Number of Participants with Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) (IGA 0/1) at Week 16

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    End point title
    		 Number of Participants with Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) (IGA 0/1) at Week 16
    End point description
    The IGA allows investigators to assess overall disease severity at 1 given time point and consists of a 5-point severity scale from clear to severe disease * 0 = clear * 1 = almost clear * 2 = mild disease * 3 = moderate disease * 4 = severe disease * 5 = very severe disease The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment (Breuer et al, 2004). Participants who took rescue medication between Day 29 to Week 16 were considered non-responders
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Placebo Tezepelumab 210 mg Q4W Tezepelumab 280 mg Q2W Tezepelumab 420 mg Q2W
    Number of subjects analysed
    63
    62
    63
    63
    Units: Participants
    2
    4
    2
    5
    Statistical analysis title
    		 Placebo vs Tezepelumab 210 mg
    Comparison groups
    Tezepelumab 210 mg Q4W v Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.56 [1]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.686
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 9.809
    Notes
    [1] - Nominal p-value
    Statistical analysis title
    		 Placebo vs Tezepelumab 420 mg
    Comparison groups
    Placebo v Tezepelumab 420 mg Q2W
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.38 [2]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.146
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 11.8
    Notes
    [2] - Nominal p-value
    Statistical analysis title
    		 Placebo vs Tezepelumab 280 mg
    Comparison groups
    Placebo v Tezepelumab 280 mg Q2W
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.99 [3]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.011
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.135
         upper limit
    		 7.551
    Notes
    [3] - Nominal p-value

    Primary: Number of Participants who Experienced a 75% Reduction from Baseline in Eczema Area and Severity Index (EASI 75) at Week 16

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    End point title
    		 Number of Participants who Experienced a 75% Reduction from Baseline in Eczema Area and Severity Index (EASI 75) at Week 16
    End point description
    The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification). A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.
    End point type
    Primary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo Tezepelumab 210 mg Q4W Tezepelumab 280 mg Q2W Tezepelumab 420 mg Q2W
    Number of subjects analysed
    63
    62
    63
    63
    Units: Participants
    8
    9
    10
    7
    Statistical analysis title
    		 Placebo vs Tezepelumab 210 mg
    Comparison groups
    Placebo v Tezepelumab 210 mg Q4W
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.97 [4]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.982
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.344
         upper limit
    		 2.803
    Notes
    [4] - Nominal p-value
    Statistical analysis title
    		 Placebo vs Tezepelumab 420 mg
    Comparison groups
    Placebo v Tezepelumab 420 mg Q2W
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.58 [5]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.243
         upper limit
    		 2.197
    Notes
    [5] - Nominal p-value
    Statistical analysis title
    		 Placebo vs Tezepelumab 280 mg
    Comparison groups
    Placebo v Tezepelumab 280 mg Q2W
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7 [6]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.217
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.441
         upper limit
    		 3.356
    Notes
    [6] - Nominal p-value

    Secondary: Number of Participants who Experienced a 50% or 90% Reduction from Baseline in Eczema Area and Severity Index (EASI 50/90) at Week 16

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    End point title
    		 Number of Participants who Experienced a 50% or 90% Reduction from Baseline in Eczema Area and Severity Index (EASI 50/90) at Week 16
    End point description
    The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification). A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders. Rescue medication = topical corticosteroids (TCS)/topical calcineurin inhibitors (TCI).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo Tezepelumab 210 mg Q4W Tezepelumab 280 mg Q2W Tezepelumab 420 mg Q2W
    Number of subjects analysed
    56 [7]
    58 [8]
    58 [9]
    56 [10]
    Units: Participants
        EASI 50
    11
    21
    18
    11
        EASI 90
    3
    3
    3
    3
    Notes
    [7] - All participants with non-missing response or who had received rescue medication prior to Week 16
    [8] - All participants with non-missing response or who had received rescue medication prior to Week 16
    [9] - All participants with non-missing response or who had received rescue medication prior to Week 16
    [10] - All participants with non-missing response or who had received rescue medication prior to Week 16
    No statistical analyses for this end point

    Secondary: Time to Achievement of 50%, 75% or 90% Reduction from Day 1 in Eczema Area and Severity Index (EASI 50/75/90)

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    End point title
    		 Time to Achievement of 50%, 75% or 90% Reduction from Day 1 in Eczema Area and Severity Index (EASI 50/75/90)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 up to End of Study Visit (Week 70)
    End point values
    		 Placebo Tezepelumab 210 mg Q4W Tezepelumab 280 mg Q2W Tezepelumab 420 mg Q2W
    Number of subjects analysed
    63
    62
    63
    63
    Units: Weeks
    median (full range (min-max))
        Time to EASI 50
    6.143 (4.14 to 19.57)
    8.143 (3.86 to 16.14)
    6.286 (3.86 to 22.14)
    5.857 (3.86 to 16.14)
        Time to EASI 75
    6.143 (4.14 to 19.57)
    6.286 (4.00 to 16.43)
    6.714 (4.14 to 22.14)
    6.429 (4.14 to 16.14)
        Time to EASI 90
    8.286 (4.43 to 19.57)
    10.929 (4.00 to 16.14)
    10.071 (6.14 to 16.14)
    7.286 (4.14 to 16.29)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 16

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    End point title
    		 Change from Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 16
    End point description
    The SCORAD is a clinical tool for assessing the severity (ie, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with subjective symptoms (Kunz et al, 1997). The total score ranges from 0 to 103, with higher values indicating more severe disease. A negative change from baseline indicates an improvement in severity of disease.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo Tezepelumab 210 mg Q4W Tezepelumab 280 mg Q2W Tezepelumab 420 mg Q2W
    Number of subjects analysed
    63
    62
    63
    63
    Units: Score on a scale
        least squares mean (standard error)
    -8.00 ( 2.55 )
    -16.75 ( 2.40 )
    -11.87 ( 2.49 )
    -9.32 ( 2.48 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16

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    End point title
    		 Change from Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16
    End point description
    Pruritus was assessed using an NRS (0-10) with 0 = no itch and 10 = worst imaginable itch. A negative change from baseline indicates an improvement in symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo Tezepelumab 210 mg Q4W Tezepelumab 280 mg Q2W Tezepelumab 420 mg Q2W
    Number of subjects analysed
    63
    62
    63
    63
    Units: Score on a scale
        least squares mean (standard error)
    -0.71 ( 0.30 )
    -1.40 ( 0.27 )
    -0.94 ( 0.28 )
    -0.38 ( 0.28 )
    No statistical analyses for this end point

    Secondary: Serum Trough Concentrations of Tezepelumab after Q2W or Q4W Administration.

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    End point title
    		 Serum Trough Concentrations of Tezepelumab after Q2W or Q4W Administration.
    End point description
    Switchers were included up to Week 16 and were then excluded from the analysis after switching. All Tezepelumab participants received 420 mg of Tezepelumab on Day 1. 99999 = Not calculated: Insufficient samples to measure standard deviation.
    End point type
    Secondary
    End point timeframe
    Pre-dose on Day 1, Week 2, 4, 12, 16, 24, 32, 40, 48, 50, 52, 58 and 70
    End point values
    		 Tezepelumab 210 mg Q4W Tezepelumab 280 mg Q2W Tezepelumab 420 mg Q2W
    Number of subjects analysed
    58
    58
    66
    Units: µg/mL
    arithmetic mean (standard deviation)
        Day 1 (N=58, 58, 66)
    0.00031 ( 0.00236 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Week 2 (N=51, 49, 60)
    34.9 ( 10.9 )
    36.3 ( 12.9 )
    34.8 ( 12.9 )
        Week 4 (N=56, 48, 53)
    23.4 ( 9.03 )
    48.8 ( 16.0 )
    58.9 ( 21.4 )
        Week 12 (N=49, 48 ,47)
    21.7 ( 8.47 )
    66.7 ( 22.9 )
    97.0 ( 35.0 )
        Week 16 (N=47, 46 ,44)
    22.2 ( 9.42 )
    77.4 ( 33.0 )
    98.0 ( 37.8 )
        Week 24 (N=20, 17 ,11)
    23.2 ( 10.6 )
    83.6 ( 31.2 )
    107 ( 29.5 )
        Week 32 (N=16, 15, 5)
    25.4 ( 17.0 )
    75.1 ( 36.3 )
    81.4 ( 26.4 )
        Week 40 (N=11, 6, 4)
    22.9 ( 12.7 )
    76.8 ( 19.7 )
    112 ( 63.3 )
        Week 48 (N=5, 5, 5)
    18.2 ( 6.49 )
    76.4 ( 26.4 )
    118 ( 48.3 )
        Week 50 (N=5, 4, 4)
    29.2 ( 9.11 )
    86.8 ( 27.7 )
    113 ( 44.4 )
        Week 52 (N=4, 5, 4)
    18.3 ( 7.24 )
    67.2 ( 33.2 )
    102 ( 31.2 )
        Week 58 (N=3, 3, 2)
    5.41 ( 2.56 )
    18.0 ( 7.09 )
    20.9 ( 99999 )
        Week 70 (N=4, 3, 3)
    0.699 ( 0.380 )
    1.87 ( 1.74 )
    5.36 ( 3.20 )
    No statistical analyses for this end point

    Secondary: Serum Trough Concentrations of Tezepelumab after Switching to 420 mg Q2W Administration After Week 16

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    End point title
    		 Serum Trough Concentrations of Tezepelumab after Switching to 420 mg Q2W Administration After Week 16
    End point description
    Participants who switched to 420 mg Q2W at Week 16 were included in the analyses (including participants who did not respond to 420 mg Q2W at Week 16 and continued to take 420 mg Q2W). 99999 = Not calculated: Insufficient samples to measure standard deviation.
    End point type
    Secondary
    End point timeframe
    Pre-dose on Week 24, 32, 40, 48, 50, 52, 58 and 70
    End point values
    		 Placebo; Tezepelumab 420 mg Switchers Tezepelumab 210 mg; Tezepelumab 420 mg Switchers Tezepelumab 280 mg; Tezepelumab 420 mg Switchers Tezepelumab 420 mg; Tezepelumab 420 mg Switchers
    Number of subjects analysed
    30
    22
    21
    25
    Units: µg/mL
    arithmetic mean (standard deviation)
        Week 24 (N=30, 22, 21, 25)
    70.5 ( 28.3 )
    87.2 ( 24.0 )
    96.6 ( 29.2 )
    100 ( 38.2 )
        Week 32 (N=23, 15, 17, 24)
    91.0 ( 38.7 )
    104 ( 38.8 )
    97.8 ( 39.3 )
    105 ( 39.1 )
        Week 40 (N=15, 11, 9, 15)
    117 ( 42.7 )
    93.8 ( 35.5 )
    113 ( 31.1 )
    101 ( 37.7 )
        Week 48 (N=9, 6, 5, 9)
    134 ( 60.2 )
    121 ( 29.1 )
    89.6 ( 35.1 )
    103 ( 29.9 )
        Week 50 (N=10, 5, 5, 8)
    115 ( 39.0 )
    125 ( 42.2 )
    79.1 ( 38.6 )
    106 ( 27.0 )
        Week 52 (N=9, 6, 4, 8)
    125 ( 30.8 )
    113 ( 45.0 )
    88.3 ( 33.0 )
    105 ( 30.2 )
        Week 58 (N=4, 1, 1, 4)
    26.0 ( 21.6 )
    52.6 ( 99999 )
    36.7 ( 99999 )
    17.6 ( 9.28 )
        Week 70 (N=9, 5, 4, 7)
    5.07 ( 5.10 )
    4.47 ( 3.39 )
    2.60 ( 1.72 )
    3.49 ( 2.42 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants who took placebo from Week 1 to Week 16.

    Reporting group title
    Tezepelumab 280 mg Q2W
    Reporting group description
    		 Participants who took 280 mg Q2W from Week 1 to Week 16.

    Reporting group title
    Tezepelumab 420 mg Q2W
    Reporting group description
    		 Participants who took 420 mg Q2W from Week 1 to Week 16. Includes 7 subjects randomized to the lower doses of Tezepelumab but received only the first dose of Tezepelumab 420 mg SC and early discontinued.

    Reporting group title
    Placebo - Placebo
    Reporting group description
    		 Non-switching participants who took placebo from Week 16 to Week 52.

    Reporting group title
    Tezepelumab 210 mg Q4W
    Reporting group description
    		 Participants who took 210 mg Q4W from Week 1 to Week 16.

    Reporting group title
    Tezepelumab 210 mg Q4W - 210 mg Q4W
    Reporting group description
    		 Non-switching participants who took 210 mg Q4W from Week 16 to Week 52.

    Reporting group title
    Tezepelumab 280 mg Q2W - 280 mg Q2W
    Reporting group description
    		 Non-switching participants who took 280 mg Q2W from Week 16 to Week 52.

    Reporting group title
    Tezepelumab 420 mg Q2W - 420 mg Q2W
    Reporting group description
    		 Non-switching participants who continued to take 420 mg Q2W from Week 16 to Week 52. Includes 6 participants who were randomized to placebo (n=2), 210 mg Q4W (n=3) and 280 mg Q2W (n=1) but switched to Tezepelumab 420 mg SC Q2W in error after Week 16.

    Reporting group title
    Placebo- Tezepelumab 420 mg Q2W
    Reporting group description
    		 Participants who switched after Week 16 to take 420 mg Q2W.

    Reporting group title
    Tezepelumab 210 mg Q4W-420 mg Q2W
    Reporting group description
    		 Participants who switched after Week 16 to take 420 mg Q2W.

    Reporting group title
    Tezepelumab 280 mg Q2W-420 mg Q2W
    Reporting group description
    		 Participants who switched after Week 16 to take 420 mg Q2W.

    Reporting group title
    Tezepelumab 420 mg Q2W-420 mg Q2W
    Reporting group description
    		 Participants who switched after week 16 who continued to take 420 mg Q2W.

    Serious adverse events
    		 Placebo Tezepelumab 280 mg Q2W Tezepelumab 420 mg Q2W Placebo - Placebo Tezepelumab 210 mg Q4W Tezepelumab 210 mg Q4W - 210 mg Q4W Tezepelumab 280 mg Q2W - 280 mg Q2W Tezepelumab 420 mg Q2W - 420 mg Q2W Placebo- Tezepelumab 420 mg Q2W Tezepelumab 210 mg Q4W-420 mg Q2W Tezepelumab 280 mg Q2W-420 mg Q2W Tezepelumab 420 mg Q2W-420 mg Q2W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    1 / 70 (1.43%)
    0 / 12 (0.00%)
    2 / 59 (3.39%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    2 / 39 (5.13%)
    0 / 24 (0.00%)
    1 / 30 (3.33%)
    4 / 38 (10.53%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    1 / 39 (2.56%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    1 / 70 (1.43%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Corneal degeneration
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    1 / 30 (3.33%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    1 / 39 (2.56%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis herpetiformis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin erosion
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device failure
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Tezepelumab 280 mg Q2W Tezepelumab 420 mg Q2W Placebo - Placebo Tezepelumab 210 mg Q4W Tezepelumab 210 mg Q4W - 210 mg Q4W Tezepelumab 280 mg Q2W - 280 mg Q2W Tezepelumab 420 mg Q2W - 420 mg Q2W Placebo- Tezepelumab 420 mg Q2W Tezepelumab 210 mg Q4W-420 mg Q2W Tezepelumab 280 mg Q2W-420 mg Q2W Tezepelumab 420 mg Q2W-420 mg Q2W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 63 (39.68%)
    29 / 58 (50.00%)
    30 / 70 (42.86%)
    6 / 12 (50.00%)
    20 / 59 (33.90%)
    10 / 25 (40.00%)
    11 / 20 (55.00%)
    5 / 22 (22.73%)
    18 / 39 (46.15%)
    9 / 24 (37.50%)
    10 / 30 (33.33%)
    19 / 38 (50.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 63 (1.59%)
    3 / 58 (5.17%)
    2 / 70 (2.86%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    1 / 24 (4.17%)
    0 / 30 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    1
    3
    2
    0
    0
    0
    1
    0
    0
    1
    0
    1
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 58 (0.00%)
    1 / 70 (1.43%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    1 / 25 (4.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    1
    Seasonal allergy
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    2 / 25 (8.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    1 / 39 (2.56%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    1 / 22 (4.55%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    1 / 30 (3.33%)
    2 / 38 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    2
    Rhinitis allergic
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    1 / 22 (4.55%)
    1 / 39 (2.56%)
    2 / 24 (8.33%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    1
    3
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 58 (0.00%)
    1 / 70 (1.43%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Investigations
    SARS-CoV-2 antibody test positive
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    2 / 24 (8.33%)
    1 / 30 (3.33%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 63 (4.76%)
    1 / 58 (1.72%)
    4 / 70 (5.71%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    4 / 39 (10.26%)
    1 / 24 (4.17%)
    0 / 30 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    3
    1
    4
    0
    1
    0
    0
    0
    11
    2
    0
    2
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 58 (1.72%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Eye disorders
    Chalazion
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 58 (1.72%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    2 / 39 (5.13%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 58 (1.72%)
    3 / 70 (4.29%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    1 / 39 (2.56%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    2
    3
    0
    0
    0
    0
    0
    1
    0
    0
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    1 / 24 (4.17%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    1 / 39 (2.56%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    Dermatitis atopic
         subjects affected / exposed
    12 / 63 (19.05%)
    13 / 58 (22.41%)
    13 / 70 (18.57%)
    2 / 12 (16.67%)
    9 / 59 (15.25%)
    5 / 25 (20.00%)
    2 / 20 (10.00%)
    3 / 22 (13.64%)
    9 / 39 (23.08%)
    2 / 24 (8.33%)
    4 / 30 (13.33%)
    6 / 38 (15.79%)
         occurrences all number
    14
    17
    17
    2
    12
    14
    2
    6
    12
    5
    6
    9
    Eczema
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 58 (3.45%)
    1 / 70 (1.43%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    1 / 25 (4.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    1 / 24 (4.17%)
    0 / 30 (0.00%)
    3 / 38 (7.89%)
         occurrences all number
    0
    2
    2
    0
    2
    3
    0
    0
    0
    2
    0
    7
    Erythema
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Intertrigo
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    2 / 63 (3.17%)
    3 / 58 (5.17%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 58 (1.72%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    1 / 39 (2.56%)
    0 / 24 (0.00%)
    1 / 30 (3.33%)
    2 / 38 (5.26%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    1
    1
    0
    1
    2
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    2 / 39 (5.13%)
    1 / 24 (4.17%)
    0 / 30 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    0
    0
    2
    1
    0
    5
    Conjunctivitis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    2 / 70 (2.86%)
    0 / 12 (0.00%)
    2 / 59 (3.39%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    2 / 24 (8.33%)
    0 / 30 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    0
    2
    0
    2
    0
    0
    0
    0
    2
    0
    2
    Herpes zoster
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    2 / 59 (3.39%)
    1 / 25 (4.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    1 / 39 (2.56%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    0
    0
    1
    0
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    6 / 63 (9.52%)
    10 / 58 (17.24%)
    6 / 70 (8.57%)
    0 / 12 (0.00%)
    5 / 59 (8.47%)
    3 / 25 (12.00%)
    3 / 20 (15.00%)
    3 / 22 (13.64%)
    3 / 39 (7.69%)
    0 / 24 (0.00%)
    3 / 30 (10.00%)
    3 / 38 (7.89%)
         occurrences all number
    10
    11
    6
    0
    6
    4
    3
    4
    3
    0
    3
    6
    Oral herpes
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 58 (1.72%)
    1 / 70 (1.43%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    1 / 30 (3.33%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    1
    0
    0
    0
    1
    3
    Pharyngitis
         subjects affected / exposed
    3 / 63 (4.76%)
    1 / 58 (1.72%)
    2 / 70 (2.86%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    1 / 25 (4.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    2 / 39 (5.13%)
    1 / 24 (4.17%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    4
    1
    2
    0
    1
    1
    0
    0
    2
    1
    0
    0
    Pyoderma
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    1 / 70 (1.43%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 58 (1.72%)
    0 / 70 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    1 / 70 (1.43%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    2 / 25 (8.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    1
    2
    1
    2
    0
    1
    0
    0
    0
    1
    Skin infection
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 25 (4.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 63 (6.35%)
    2 / 58 (3.45%)
    1 / 70 (1.43%)
    0 / 12 (0.00%)
    3 / 59 (5.08%)
    1 / 25 (4.00%)
    2 / 20 (10.00%)
    0 / 22 (0.00%)
    2 / 39 (5.13%)
    1 / 24 (4.17%)
    0 / 30 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    4
    2
    1
    0
    3
    1
    2
    0
    2
    1
    0
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 58 (1.72%)
    1 / 70 (1.43%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    1 / 25 (4.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    1
    1
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 58 (0.00%)
    0 / 70 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 25 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 39 (0.00%)
    0 / 24 (0.00%)
    0 / 30 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Nov 2018
    * Extended the safety follow-up period from 12 weeks to 20 weeks after the final dose of investigational product (18 weeks after the EOT visit). * Added additional descriptive statistics for continuous endpoints. * Added PPD or Quantiferon GOLD testing at screening and EOT/ET visits. * Updated inclusion criterion #107 to remove moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin. * Updated exclusion criterion #215 to include within 5 elimination half-lives for receipt of any approved biologic agent. * Removed language regarding receiving treatment with systemic corticosteroids or nonsteroidal systemic immunosuppressive drugs after week 16. * Updated interim analysis guidelines. * Changed week 64 pregnancy testing to week 70. * Updated contraception guidance to specify female partners of male participants will be required to use a highly effective method of contraception.
    04 Sep 2019
    * Addressed Amgen-mandated updates to the collection and reporting of disease-related events. * Aligned male contraception language in the protocol with the updated contraception guidance in the tezepelumab investigator’s brochure.
    25 Aug 2020
    * Updated safety language to specify female participants and female partners of male participants were required to refrain from becoming pregnant or breastfeeding, and to report pregnancies, for an additional 16 weeks, instead of 14 weeks, after the last dose of tezepelumab.

    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.
    Enrollment of Part A of this study was completed as of 27 July 2020. The study was terminated prior to the enrollment of any participants into Part B.
    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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