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    Clinical Trial Results:
    A Phase 2a, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects with Moderate-to-Severe Atopic Dermatitis

    Summary
    EudraCT number
    2015-000595-10
    Trial protocol
    DE   HU  
    Global end of trial date
    15 Jul 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Nov 2017
    First version publication date
    01 Nov 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5240C00001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02525094
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MedImmune Ltd
    Sponsor organisation address
    Milstein Building, Granta Park, Cambridge, United Kingdom, CB21 6GH
    Public contact
    AstraZeneca, AstraZeneca Clinical Study Information Center, +1 1-877-240-9479, information.center@astrazeneca.com
    Scientific contact
    AstraZeneca, AstraZeneca Clinical Study Information Center, +1 1-877-240-9479, 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
    15 Jul 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of trial was to evaluate the effect of MEDI9929 compared with placebo in adult participants with moderate to-severe Atopic Dermatitis (AD), assessed using the change from baseline in Eczema Area and Severity Index (EASI) at Week 12.
    Protection of trial subjects
    The conduct of this clinical study met all local and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Conference on Harmonization guideline: Good Clinical Practice and applicable regulatory requirements. Subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    All participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Aug 2015
    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
    Australia: 13
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    Germany: 36
    Country: Number of subjects enrolled
    Hungary: 15
    Country: Number of subjects enrolled
    New Zealand: 1
    Country: Number of subjects enrolled
    United States: 34
    Worldwide total number of subjects
    111
    EEA total number of subjects
    51
    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)
    105
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted from 29Aug2015 to 15Jul2016.

    Pre-assignment
    Screening details
    A total of 155 participants were screened, of which 113 were randomized. Out of 113 participants, 111 were treated in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.
    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
    Placebo administered as 6 subcutaneous doses for every 2 weeks for 12 weeks, with the last dose at Week 10.

    Arm title
    MEDI9929 280 mg
    Arm description
    Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI9929
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MEDI9929 was administered at the dose of 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.

    Number of subjects in period 1
    Placebo MEDI9929 280 mg
    Started
    56
    55
    Completed
    49
    48
    Not completed
    7
    7
         Consent withdrawn by subject
    5
    6
         Lost to follow-up
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.

    Reporting group title
    MEDI9929 280 mg
    Reporting group description
    Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.

    Reporting group values
    Placebo MEDI9929 280 mg Total
    Number of subjects
    56 55 111
    Age Categorical
    Units: Subjects
        18-35 years
    28 27 55
        36-75 years
    28 28 56
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    38.8 ± 15.3 38.5 ± 14.9 -
    Gender, Male/Female
    Units: Subjects
        Female
    26 23 49
        Male
    30 32 62
    Eczema Area and Severity Index Score
    The eczema area and severity index (EASI) evaluates 4 natural anatomical regions for severity (0 [none] to 3 [severe]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease.
    Units: Subjects
        <= 25 points
    36 33 69
        > 25 points
    20 22 42
    Investigator's Global Assessment
    The investigator’s global assessment (IGA) allows investigators to assess overall disease severity at one 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, and 4 = severe disease).
    Units: Subjects
        Category 2
    0 1 1
        Category 3
    46 44 90
        Category 4
    10 10 20
    Atopic Dermatitis Status
    Units: Subjects
        IgE >= 150 kU/L and Positive Serum Specific IgEa
    50 47 97
        IgE >= 150 kU/L and Negative Serum Specific IgE
    2 0 2
        IgE < 150 kU/L and Positive Serum Specific IgE
    3 3 6
        IgE < 150 kU/L and Negative Serum Specific IgEb
    1 3 4
        Missing
    0 2 2
    Subject analysis sets

    Subject analysis set title
    MEDI9929 280mg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10. Participants who received at least one dose of MEDI9929 during the study, regardless of randomized treatment assignment, were analyzed under MEDI9929 group. One participant who randomized to placebo group but received an incorrect first dose of MEDI9929 was included in the "MEDI9929" group. An arbitrary value of '99999' indicates value was not estimable.

    Subject analysis sets values
    MEDI9929 280mg
    Number of subjects
    56
    Age Categorical
    Units: Subjects
        18-35 years
        36-75 years
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    38.5 ± 14.9
    Gender, Male/Female
    Units: Subjects
        Female
        Male
    Eczema Area and Severity Index Score
    The eczema area and severity index (EASI) evaluates 4 natural anatomical regions for severity (0 [none] to 3 [severe]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease.
    Units: Subjects
        <= 25 points
    99999
        > 25 points
    Investigator's Global Assessment
    The investigator’s global assessment (IGA) allows investigators to assess overall disease severity at one 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, and 4 = severe disease).
    Units: Subjects
        Category 2
        Category 3
        Category 4
    Atopic Dermatitis Status
    Units: Subjects
        IgE >= 150 kU/L and Positive Serum Specific IgEa
        IgE >= 150 kU/L and Negative Serum Specific IgE
        IgE < 150 kU/L and Positive Serum Specific IgE
        IgE < 150 kU/L and Negative Serum Specific IgEb
        Missing

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.

    Reporting group title
    MEDI9929 280 mg
    Reporting group description
    Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.

    Subject analysis set title
    MEDI9929 280mg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10. Participants who received at least one dose of MEDI9929 during the study, regardless of randomized treatment assignment, were analyzed under MEDI9929 group. One participant who randomized to placebo group but received an incorrect first dose of MEDI9929 was included in the "MEDI9929" group. An arbitrary value of '99999' indicates value was not estimable.

    Primary: Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12

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    End point title
    Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12
    End point description
    The eczema area and severity index (EASI) evaluates 4 natural anatomical regions for severity (0 [none] to 3 [severe]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI50 responder defined as a participant who achieved at least 50% reduction in EASI score from baseline. Intent-To-Treat (ITT) population included all participants who were randomized and received any study investigational product.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    Placebo MEDI9929 280 mg
    Number of subjects analysed
    56
    55
    Units: Percentage of particpants
        number (not applicable)
    48.2
    64.7
    Statistical analysis title
    Placebo vs MEDI9929 280mg
    Comparison groups
    MEDI9929 280 mg v Placebo
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.97
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.9
         upper limit
    4.33

    Secondary: Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12

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    End point title
    Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12
    End point description
    The EASI evaluates 4 natural anatomical regions for severity (0 [none] to 3 [severe]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI75 responder defined as a participant who achieves at least a 75% reduction in EASI score from baseline. ITT population included all participants who were randomized and received any study investigational product.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo MEDI9929 280 mg
    Number of subjects analysed
    56
    55
    Units: Percentage of particpants
        number (not applicable)
    19.8
    24.4
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in EASI Total Score at Week 12

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    End point title
    Mean Change From Baseline in EASI Total Score at Week 12
    End point description
    The EASI evaluates 4 natural anatomical regions for severity (0 [none] to 3 [severe]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. ITT population included all participants who were randomized and received any study investigational product. Here, "n" is number of participants analysed for this time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 12
    End point values
    Placebo MEDI9929 280 mg
    Number of subjects analysed
    56
    55
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=56, 55)
    24.48 ± 11.21
    24.05 ± 12.38
        Week 12 (n=50, 49)
    -11.23 ± 8.73
    -12.16 ± 9.96
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline

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    End point title
    Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline
    End point description
    The investigator’s global assessment (IGA) allows investigators to assess overall disease severity at one 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, and 4 = severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline. ITT population included all participants who were randomized and received any study investigational product.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo MEDI9929 280 mg
    Number of subjects analysed
    56
    55
    Units: Percentage of particpants
        number (not applicable)
    12.8
    19.3
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12

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    End point title
    Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12
    End point description
    The scoring of atopic dermatitis (SCORAD) is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. ITT population included all participants who were randomized and received any study investigational product. Here, "n" is number of participants analysed for this time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 12
    End point values
    Placebo MEDI9929 280 mg
    Number of subjects analysed
    56
    55
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=56, 55)
    58.66 ± 13.32
    57.68 ± 14.80
        Week 12 (n=50, 49)
    -19.35 ± 17.49
    -24.24 ± 16.94
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50

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    End point title
    Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50
    End point description
    The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. The SCORAD 50 responder defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline. ITT population included all participants who were randomized and received any study investigational product.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo MEDI9929 280 mg
    Number of subjects analysed
    56
    55
    Units: Percentage of particpants
        number (not applicable)
    29.4
    41.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75

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    End point title
    Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75
    End point description
    The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. The SCORAD 75 responder is defined as a participant who achieves at least a 75% reduction in SCORAD score from baseline. ITT population included all participants who were randomized and received any study investigational product.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo MEDI9929 280 mg
    Number of subjects analysed
    56
    55
    Units: Percentage of particpants
        number (not applicable)
    7.4
    9.8
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12

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    End point title
    Mean Change from Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12
    End point description
    Pruritus is assessed using an Numeric Rating Scale (NRS) (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated. ITT population included all participants who were randomized and received any study investigational product. Here, "n" is number of participants analysed for this time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 12
    End point values
    Placebo MEDI9929 280 mg
    Number of subjects analysed
    56
    55
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=55, 55)
    5.15 ± 2.10
    5.26 ± 2.02
        Week 12 (n=48, 47)
    -1.39 ± 1.93
    -1.90 ± 1.99
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in 5-D Pruritus Score at Week 12

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    End point title
    Mean Change from Baseline in 5-D Pruritus Score at Week 12
    End point description
    The 5-D pruritus scale is a brief questionnaire designed to assess itch. This scale takes into account the multidimensional nature of pruritus, its impact on quality of life, and is capable of detecting change over time. The 5-D pruritus scale included 5 domains (duration, degree, direction, disability, and distribution of pruritus). The total 5-D score was obtained by scoring each of the domains separately and then summing them together. 5-D total scores ranged between 5 (no pruritus) and 25 (most severe pruritus). The higher values indicating more severe pruritus. ITT population included all participants who were randomized and received any study investigational product. Here, "n" is number of participants analysed for this time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 12
    End point values
    Placebo MEDI9929 280 mg
    Number of subjects analysed
    56
    55
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=52, 50)
    16.7 ± 3.7
    16.0 ± 3.7
        Week 12 (n=47, 46)
    -3.9 ± 4.5
    -3.6 ± 4.4
    No statistical analyses for this end point

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

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    End point title
    Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [1]
    End point description
    An AE is any unfavourable and unintended signs, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. SAE is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, life-threatening , a congenital anomaly/birth defect, or an important medical event. TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug until Week 22. As-treated population included all participants who received any study drug. Participants who received at least one dose of MEDI9929 during the study, regardless of randomized treatment assignment, were analyzed under MEDI9929 group. One participant who randomized to placebo group but received an incorrect first dose of MEDI9929 was included in the "MEDI9929" group.
    End point type
    Secondary
    End point timeframe
    From treatment administration (Day1) to 22 weeks
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed.
    End point values
    Placebo MEDI9929 280mg
    Number of subjects analysed
    55
    56
    Units: Number of particpants
        TEAEs
    40
    38
        TESAEs
    3
    2
    No statistical analyses for this end point

    Secondary: Mean Trough Serum Concentration of MEDI9929

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    End point title
    Mean Trough Serum Concentration of MEDI9929 [2]
    End point description
    The mean serum concentrations of MEDI9929 was observed. PK population included all participants who received MEDI9929 and had a sufficient number of serum concentration measurements for computing PK parameters. Here, "N" is number of participants analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Week 0 (Pre dose) and Week 12 (post dose)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic parameters were not analysed for placebo arm.
    End point values
    MEDI9929 280 mg
    Number of subjects analysed
    50
    Units: mcg/mL
        arithmetic mean (standard deviation)
    54.9 ± 21.5
    No statistical analyses for this end point

    Secondary: Number of Participants who Developed Detectable MEDI9929 Anti-drug Antibodies at Week 22

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    End point title
    Number of Participants who Developed Detectable MEDI9929 Anti-drug Antibodies at Week 22
    End point description
    A participant was considered ADA-positive across the study if they had a positive reading (titer of 50 or higher) at any time point during the study period. ITT population included all participants who were randomized and received any study investigational product. Here, "N" is the number of participants analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Week 22
    End point values
    Placebo MEDI9929 280 mg
    Number of subjects analysed
    47
    48
    Units: Number of particpants
    2
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From treatment administration (Day1) to 22 weeks
    Adverse event reporting additional description
    AEs were reported for As-treated population, which included all participants who received any study drug. Participants who received at least one dose of MEDI9929, regardless of randomized treatment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    MEDI9929 280 mg
    Reporting group description
    Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.

    Reporting group title
    Placebo
    Reporting group description
    Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.

    Serious adverse events
    MEDI9929 280 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 56 (3.57%)
    3 / 55 (5.45%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (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: 1%
    Non-serious adverse events
    MEDI9929 280 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 56 (51.79%)
    33 / 55 (60.00%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 55 (1.82%)
         occurrences all number
    4
    1
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    Injection site erythema
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 55 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    5 / 56 (8.93%)
    3 / 55 (5.45%)
         occurrences all number
    6
    3
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    5 / 56 (8.93%)
    7 / 55 (12.73%)
         occurrences all number
    6
    9
    Rash
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    4
    Pruritus
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1
    Arthralgia
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 55 (3.64%)
         occurrences all number
    1
    2
    Musculoskeletal pain
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    Myalgia
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    2
    Conjunctivitis
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1
    Herpes simplex
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1
    Folliculitis
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    13 / 56 (23.21%)
    11 / 55 (20.00%)
         occurrences all number
    15
    14
    Sinusitis
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 55 (3.64%)
         occurrences all number
    2
    2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 56 (1.79%)
    7 / 55 (12.73%)
         occurrences all number
    1
    8
    Urinary tract infection
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Sep 2015
    The Protocol was amended to modify the wording for the primary endpoint, secondary endpoints (1, 3, 5, and 6) and exploratory endpoints (1 and 2); Measurement of EASI50 was also added under the secondary endpoints as this endpoint were measured beyond Week 12; Removed “IgE” from the list of biomarkers; A positive QFT-G test for TB does not require an investigator’s opinion; Added creatine kinase (CK) and lactate dehydrogenase (LDH) to the list of serum chemistry tests; Added the correct pruritus NRS instead of the incorrectly added eczema-related sleep NRS. Updated the text wherever applicable for more clarification.

    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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