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    Clinical Trial Results:
    A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects with Moderate-to-severe Atopic Dermatitis

    Summary
    EudraCT number
    2019-003304-12
    Trial protocol
    DE   GB  
    Global end of trial date
    26 Jul 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Oct 2023
    First version publication date
    04 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D9182C00001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04212169
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    1 Francis Crick Avenue, Cambridge, United Kingdom, CB2 0AA
    Public contact
    Global Clinical Lead, AstraZeneca, +1 18772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 18772409479, 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
    18 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD.
    Protection of trial subjects
    The study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Council for Harmonisation (ICH)/Good Clinical Practice (GCP), and applicable regulatory requirements. All participant must meet all inclusion criteria and not meet any exclusion criteria before receiving investigational product. IDMC was formed to monitor potential risk in the study.
    Background therapy
    Participants who meet the eligibility (inclusion/exclusion) criteria will discontinue use of topical corticosteroids and topical calcineurin inhibitorss at Visit 2. Subjects will be required to apply moisturizers twice daily for at least 7 days before randomization at Visit 3 (Day 1) with a minimum of 85% compliance
    Evidence for comparator
    Not applicable as there was no comparator arm in the study
    Actual start date of recruitment
    09 Dec 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Poland: 16
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    United Kingdom: 91
    Country: Number of subjects enrolled
    United States: 16
    Worldwide total number of subjects
    148
    EEA total number of subjects
    39
    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)
    148
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted in 6 countries between 19 Dec 2019 and 20 Sep 2022. A total of 329 participants were screened in the study.

    Pre-assignment
    Screening details
    Out of 329 participants, 148 were randomised and treated in the study with 3:1:1:3 overall ratio to receive either placebo (56 subjects), MEDI3506 dose 1 (19 subjects), MEDI3506 dose 2 (18 subjects), or MEDI3506 dose 3 (55 subjects).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    Subject was randomised using an interactive web response system to receive either of 3 doses of MEDI3506 or placebo. Participants, investigators and the sponsors are blinded with regard to the actual dose information.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Pooled Placebo
    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
    Given subcutaneously on Day 1, Day 29, Day 57 and Day 85

    Arm title
    MEDI3506 Dose 1
    Arm description
    MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI3506 Dose 1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Given subcutaneously on Day 1, Day 29, Day 57 and Day 85.

    Arm title
    MEDI3506 Dose 2
    Arm description
    MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI3506 Dose 2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Given subcutaneously on Day 1, Day 29, Day 57 and Day 85

    Arm title
    MEDI3506 Dose 3
    Arm description
    MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI3506 Dose 3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Given subcutaneously on Day 1, Day 29, Day 57 and Day 85

    Number of subjects in period 1
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Started
    56
    19
    18
    55
    Completed
    42
    16
    13
    42
    Not completed
    14
    3
    5
    13
         Consent withdrawn by subject
    10
    2
    5
    7
         Adverse event, non-fatal
    -
    -
    -
    2
         Lost to follow-up
    1
    -
    -
    2
         Other reason, unspecified
    3
    1
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Pooled Placebo

    Reporting group title
    MEDI3506 Dose 1
    Reporting group description
    MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks

    Reporting group title
    MEDI3506 Dose 2
    Reporting group description
    MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks

    Reporting group title
    MEDI3506 Dose 3
    Reporting group description
    MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

    Reporting group values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3 Total
    Number of subjects
    56 19 18 55 148
    Age categorical
    Units: Subjects
        Adults (18-35 years)
    39 16 9 32 96
        From 36-75 years
    17 3 9 23 52
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    32.3 ( 11.4 ) 28.7 ( 8.9 ) 37.9 ( 14.3 ) 34.6 ( 11.8 ) -
    Sex: Female, Male
    Units: Participants
        Female
    27 8 7 25 67
        Male
    29 11 11 30 81
    Race (NIH/OMB)
    Units: Subjects
        AMERICAN INDIAN OR ALASKA NATIVE
    0 0 0 0 0
        ASIAN
    8 5 3 6 22
        BLACK OR AFRICAN AMERICAN
    1 1 2 2 6
        MULTIPLE CATEGORIES CHECKED
    1 0 1 0 2
        NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
    0 0 0 0 0
        OTHER
    0 0 1 2 3
        WHITE
    46 13 11 45 115
    Region of Enrollment
    Units: Subjects
        USA
    6 0 3 7 16
        Australia
    0 0 1 1 2
        Germany
    5 1 3 2 11
        Spain
    7 0 0 5 12
        United Kingdom
    34 13 9 35 91
        Poland
    4 5 2 5 16
    Eczema Area and Severity Index (EASI) score
    Eczema Area and Severity Index (EASI) score is a composite score of area of involvement and severity score of 4 different body areas. The severity score is based on erythema, oedema/papulation, excoriation and lichenification of 4 body areas which are head, trunk, upper limbs and lower limbs. The score ranges between 0 to 72 points. Higher EASI score indicates more severe disease.
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    28.81 ( 8.9 ) 28.94 ( 11.66 ) 28.36 ( 11.87 ) 32.3 ( 10.86 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Pooled Placebo

    Reporting group title
    MEDI3506 Dose 1
    Reporting group description
    MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks

    Reporting group title
    MEDI3506 Dose 2
    Reporting group description
    MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks

    Reporting group title
    MEDI3506 Dose 3
    Reporting group description
    MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

    Primary: Percent Change from Baseline to Week 16 in EASI score

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    End point title
    Percent Change from Baseline to Week 16 in EASI score
    End point description
    The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    55
    19
    17
    54
    Units: Percentage of change from baseline
    least squares mean (standard error)
        Repeated measures mixed model
    -51.31 ( 5.214 )
    -50.03 ( 7.419 )
    -45.43 ( 8.402 )
    -53.02 ( 4.858 )
        MCP-mod dose response model
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
    Statistical analysis title
    Difference in % change in EASI score
    Comparison groups
    MEDI3506 Dose 1 v Placebo
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.888
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    1.27
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -13.67
         upper limit
    16.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    8.981
    Statistical analysis title
    Difference in % change in EASI score
    Comparison groups
    MEDI3506 Dose 3 v Placebo
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.807
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.72
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -13.38
         upper limit
    9.95
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.014
    Statistical analysis title
    Difference in % change in EASI score
    Comparison groups
    MEDI3506 Dose 2 v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.549
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    5.87
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -10.36
         upper limit
    22.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.756

    Secondary: Percentage of Subjects achieving a 90% reduction from baseline in EASI Score at week 16

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    End point title
    Percentage of Subjects achieving a 90% reduction from baseline in EASI Score at week 16
    End point description
    To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 90% reduction from baseline in EASI score.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: Participants
        Number of participants achieving reduction
    0
    0
    1
    3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects achieving a 75% reduction from baseline in EASI Score at week 16

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    End point title
    Percentage of Subjects achieving a 75% reduction from baseline in EASI Score at week 16
    End point description
    To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 75% reduction from baseline in EASI score.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: Participants
        Number of participants achieving reduction
    4
    2
    1
    10
    Statistical analysis title
    Odds ratio
    Comparison groups
    MEDI3506 Dose 1 v Placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6396
    Method
    Fisher exact
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.53
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.19
         upper limit
    9.94
    Statistical analysis title
    Odds ratio
    Comparison groups
    MEDI3506 Dose 3 v Placebo
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0935
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.89
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.91
         upper limit
    10.49
    Statistical analysis title
    Odds ratio
    Comparison groups
    MEDI3506 Dose 2 v Placebo
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.9999
    Method
    Fisher exact
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.76
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.03
         upper limit
    6.38

    Secondary: Percentage of Subjects achieving a 50% reduction from baseline in EASI Score at week 16

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    End point title
    Percentage of Subjects achieving a 50% reduction from baseline in EASI Score at week 16
    End point description
    To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 50% reduction from baseline in EASI score.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: Participants
        Number of participants achieving reduction
    12
    5
    5
    16
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving an IGA of 0 (clear) or 1 (almost clear) with at least a 2 grade reduction from baseline score at Week 16

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    End point title
    Percentage of subjects achieving an IGA of 0 (clear) or 1 (almost clear) with at least a 2 grade reduction from baseline score at Week 16
    End point description
    The IGA allows investigators to assess overall AD disease severity at 1 given time point and consists of a 5-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease).
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: Participants
        IGA response
    1
    1
    0
    5
        IGA response using MCP-Mod dose-response analysis
    0
    0
    0
    0
    Statistical analysis title
    Odds ratio
    Comparison groups
    MEDI3506 Dose 1 v Placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.445
    Method
    Fisher exact
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.06
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.08
         upper limit
    119.65
    Statistical analysis title
    Odds ratio
    Comparison groups
    MEDI3506 Dose 3 v Placebo
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1132
    Method
    Fisher exact
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.5
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.75
         upper limit
    130.35
    Statistical analysis title
    Odds ratio
    Comparison groups
    MEDI3506 Dose 2 v Placebo
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9999
    Method
    Fisher exact
    Parameter type
    Odds ratio (OR)
    Point estimate
    0
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0
         upper limit
    28

    Secondary: Percentage of subjects achieving a reduction of ≥ 3 from baseline to Week 16 in weekly mean of daily peak pruritus NRS

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    End point title
    Percentage of subjects achieving a reduction of ≥ 3 from baseline to Week 16 in weekly mean of daily peak pruritus NRS
    End point description
    Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: Participants
    9
    3
    3
    12
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 16 in weekly mean of daily peak pruritus NRS

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    End point title
    Change from baseline to Week 16 in weekly mean of daily peak pruritus NRS
    End point description
    Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    28
    14
    10
    29
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -1.98 ( 2.38 )
    -1.18 ( 2.72 )
    -2.12 ( 1.61 )
    -2.49 ( 2.01 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 16 in weekly mean of daily peak skin pain NRS

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    End point title
    Change from baseline to Week 16 in weekly mean of daily peak skin pain NRS
    End point description
    Skin pain (ie, worst skin pain experienced in the previous 24 hours) assessed using an NRS (0 to 10) with 0 = no pain and 10 = worst imaginable pain. The daily assessments were summarised as a weekly mean.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    41
    16
    12
    40
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -1.44 ( 2.39 )
    -1.66 ( 2.62 )
    -1.52 ( 1.61 )
    -1.63 ( 2.30 )
    No statistical analyses for this end point

    Secondary: SCORAD: Percent change from baseline to Week 16

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    End point title
    SCORAD: Percent change from baseline to Week 16
    End point description
    SCORAD is a clinical tool for assessing the severity of AD that evaluates the extent and intensity of AD lesions, in addition to subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    35
    15
    12
    40
    Units: Percentage of change from baseline
        arithmetic mean (standard deviation)
    -31.79 ( 25.09 )
    -29.88 ( 23.14 )
    -36.22 ( 25.34 )
    -39.42 ( 25.44 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 16 in percentage body surface area (BSA) affected by AD

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    End point title
    Change from baseline to Week 16 in percentage body surface area (BSA) affected by AD
    End point description
    Change in percentage of body surface area (BSA) affected by AD from baseline at week 16.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    37
    15
    13
    40
    Units: Percentage of body surface area
        arithmetic mean (standard deviation)
    -17.81 ( 17.09 )
    -11.07 ( 10.92 )
    -9.46 ( 13.23 )
    -23.13 ( 19.35 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 16 in DLQI

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    End point title
    Change from baseline to Week 16 in DLQI
    End point description
    The Dermatology Life Quality Index (DLQI) is a 10-item, patient- completed, health-related quality of life assessment of dermatology conditions with a recall period of 1 week. Each item is scored on a 4-point Likert scale with 0 = not at all ⁄not relevant, 1 = a little, 2 = a lot, and 3 = very much. The score from each item is summed, and the maximum total score is 30 while the minimum score is 0. Higher score means highest (adverse) effect on participant's life.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    38
    15
    12
    40
    Units: Scores on scale
        arithmetic mean (standard deviation)
    -2.9 ( 5.3 )
    -2.1 ( 6.5 )
    -2.4 ( 4.9 )
    -2.7 ( 4.9 )
    No statistical analyses for this end point

    Secondary: Patient description of Atopic Dermatitis or eczema from Patient Global Impression of Severity at Week 16

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    End point title
    Patient description of Atopic Dermatitis or eczema from Patient Global Impression of Severity at Week 16
    End point description
    The Patient Global Impression of Severity (PGI-S) is a tool that allows patients to rate the severity of a condition over the past 7 days with response options of “No symptoms”, “Very mild”, “Mild”, “Moderate”, “Severe” and "Very severe".
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: Participants
        No symptoms|No in category at week 16
    1
    0
    1
    1
        Very mild|No in category at week 16
    5
    0
    5
    10
        Mild|No in category at week 16
    9
    4
    2
    8
        Moderate|No in category at week 16
    11
    5
    1
    14
        Severe|No in category at week 16
    11
    4
    2
    6
        Very severe|No in category at week 16
    1
    2
    1
    1
        Missing data|No in category at week 16
    18
    4
    6
    15
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 16 in POEM

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    End point title
    Change from baseline to Week 16 in POEM
    End point description
    The Patient-Oriented Eczema Measure (POEM) is a 7-item questionnaire for assessing disease symptoms including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping occurring in the past week. Each item is scored on a 5-point scale with 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = every day. The total POEM score is calculated by summing the score of each item resulting in a maximum of 28 and a minimum of 0, with higher values indicating severe disease
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    38
    15
    12
    40
    Units: Scores on scale
        arithmetic mean (standard deviation)
    -5.4 ( 7.9 )
    -2.5 ( 4.8 )
    -3.7 ( 8.7 )
    -6.3 ( 6.9 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 16 in 5-D itch

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    End point title
    Change from baseline to Week 16 in 5-D itch
    End point description
    The 5-D Itch Scale is a questionnaire consisting of 5 items used specifically to measure the course of itch by asking for the degree, duration, disability and distribution of the pruritus within the last 2 weeks. The scores from each item are summed, with maximum score of 25 and minimum score of 5. Higher score represent worse outcome
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    38
    15
    12
    40
    Units: Scores on scale
        arithmetic mean (standard deviation)
    -3.0 ( 4.9 )
    -3.0 ( 2.6 )
    -3.8 ( 3.4 )
    -4.0 ( 5.1 )
    No statistical analyses for this end point

    Secondary: Occurrence of Adverse Events

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    End point title
    Occurrence of Adverse Events
    End point description
    To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
    End point type
    Secondary
    End point timeframe
    up to 24 weeks
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: Participant
        At least one adverse event
    37
    9
    14
    32
        At least one investigational product related event
    7
    3
    7
    8
        At least one event of ≥ grade 3 severity
    7
    2
    2
    5
        At least one serious event
    2
    0
    2
    1
        At least one IP related serious event
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Oral or tympanic temperature taken during vital signs assessment

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    End point title
    Oral or tympanic temperature taken during vital signs assessment
    End point description
    Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
    End point type
    Secondary
    End point timeframe
    Baseline, week 16 and week 24
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: degrees C
    arithmetic mean (standard deviation)
        Baseline
    36.46 ( 0.35 )
    36.43 ( 0.52 )
    36.41 ( 0.43 )
    36.52 ( 0.39 )
        Week 16
    36.49 ( 0.36 )
    36.71 ( 0.41 )
    36.50 ( 0.32 )
    36.47 ( 0.39 )
        Week 24
    36.44 ( 0.43 )
    36.63 ( 0.50 )
    36.55 ( 0.42 )
    36.51 ( 0.37 )
    No statistical analyses for this end point

    Secondary: Systolic blood pressure taken during vital signs assessment

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    End point title
    Systolic blood pressure taken during vital signs assessment
    End point description
    Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
    End point type
    Secondary
    End point timeframe
    Baseline, week 16 and week 24
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline
    117.7 ( 12.9 )
    119.3 ( 9.2 )
    123.8 ( 9.9 )
    121.5 ( 12.5 )
        Week 16
    117.8 ( 9.6 )
    117.3 ( 7.2 )
    120.7 ( 13.6 )
    119.8 ( 10.6 )
        Week 24
    118.9 ( 11.1 )
    117.6 ( 11.4 )
    120.1 ( 15.1 )
    120.6 ( 12.1 )
    No statistical analyses for this end point

    Secondary: Heart rate taken during vital signs assessment

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    End point title
    Heart rate taken during vital signs assessment
    End point description
    Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
    End point type
    Secondary
    End point timeframe
    Baseline, week 16 and week 24
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: Pulse Rate (beats/min)
    arithmetic mean (standard deviation)
        Baseline
    68.1 ( 9.8 )
    66.6 ( 8.7 )
    71.3 ( 9.3 )
    68.2 ( 11.1 )
        Week 16
    69.4 ( 10.1 )
    66.9 ( 10.6 )
    65.9 ( 8.6 )
    66.4 ( 11.0 )
        Week 24
    72.0 ( 13.5 )
    67.0 ( 10.4 )
    74.1 ( 8.7 )
    67.6 ( 10.1 )
    No statistical analyses for this end point

    Secondary: Respiratory rate collected during vital signs assessment

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    End point title
    Respiratory rate collected during vital signs assessment
    End point description
    Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
    End point type
    Secondary
    End point timeframe
    Baseline, week 16 and week 24
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: breaths/min
    arithmetic mean (standard deviation)
        Baseline
    15.4 ( 2.2 )
    16.0 ( 1.5 )
    16.2 ( 1.8 )
    15.5 ( 1.8 )
        Week 16
    16.0 ( 2.3 )
    15.7 ( 1.8 )
    16.3 ( 1.9 )
    15.9 ( 1.4 )
        Week 24
    15.8 ( 2.4 )
    16.1 ( 1.5 )
    17.1 ( 2.4 )
    15.6 ( 1.6 )
    No statistical analyses for this end point

    Secondary: Number of Participants with Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology

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    End point title
    Number of Participants with Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
    End point description
    To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
    End point type
    Secondary
    End point timeframe
    up to 24 weeks
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: Participants
        Basophil|AtLeastOne PostBaseline Value BelowLLN
    0
    0
    0
    0
        Eosinophil|AtLeastOne PostBaseline Value BelowLLN
    0
    0
    0
    0
        Hematocrit|AtLeastOne PostBaseline Value BelowLLN
    4
    3
    2
    7
        Hb|AtLeastOne PostBaseline Value BelowLLN
    5
    1
    3
    8
        Lymphocyte|AtLeastOne PostBaseline Value BelowLLN
    6
    0
    3
    10
        Monocyte|AtLeastOne PostBaseline Value BelowLLN
    1
    0
    1
    3
        Platelet|AtLeastOne PostBaseline Value BelowLLN
    1
    1
    0
    0
        Erythrocyte|AtLeastOne PostBaseline Value BelowLLN
    10
    3
    4
    17
        WCC|AtLeastOne PostBaseline Value BelowLLN
    7
    1
    2
    6
        Basophil|AtLeastOne PostBaseline Value AboveULN
    3
    0
    0
    0
        Eosinophil|AtLeastOne PostBaseline Value AboveULN
    22
    4
    5
    14
        Hematocrit|AtLeastOne PostBaseline Value AboveULN
    0
    0
    1
    0
        Hb|AtLeastOne PostBaseline Value AboveULN
    0
    0
    1
    0
        Lymphocyte|AtLeastOne PostBaseline Value AboveULN
    0
    0
    0
    0
        Monocyte|AtLeastOne PostBaseline Value AboveULN
    2
    0
    2
    3
        Platelet|AtLeastOne PostBaseline Value AboveULN
    3
    0
    2
    5
        Erythrocyte|AtLeastOne PostBaseline Value AboveULN
    0
    0
    0
    0
        WCCt|AtLeastOne PostBaseline Value AboveULN
    5
    2
    0
    2
        Basophil|Values within normal range
    53
    19
    18
    55
        Eosinophil|Values within normal range
    34
    15
    13
    41
        Hematocrit|Values within normal range
    52
    16
    15
    48
        Hb|Values within normal range
    51
    18
    14
    47
        Lymphocyte|Values within normal range
    50
    19
    15
    45
        Monocyte|Values within normal range
    53
    19
    15
    49
        Platelet|Values within normal range
    52
    18
    16
    50
        Erythrocyte|Values within normal range
    46
    16
    14
    38
        WCC|Values within normal range
    44
    16
    16
    47
    No statistical analyses for this end point

    Secondary: Number of Participants with Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry

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    End point title
    Number of Participants with Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
    End point description
    To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
    End point type
    Secondary
    End point timeframe
    up to 24 weeks
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: Participants
        Albumin|AtLeastOne PostBaseline Value BelowLLN
    0
    0
    0
    0
        ALP|AtLeastOne PostBaseline Value BelowLLN
    3
    0
    0
    2
        ALT|AtLeastOne PostBaseline Value BelowLLN
    0
    0
    0
    0
        AST|AtLeastOne PostBaseline Value BelowLLN
    0
    0
    0
    0
        Bilirubin|AtLeastOne PostBaseline Value BelowLLN
    0
    0
    0
    0
        Urea|AtLeastOne PostBaseline Value BelowLLN
    0
    0
    0
    0
        Creatinine|AtLeastOne PostBaseline Value BelowLLN
    0
    0
    0
    0
        GGT|AtLeastOne PostBaseline Value BelowLLN
    4
    2
    0
    5
        Potassium|AtLeastOne PostBaseline Value BelowLLN
    1
    1
    0
    1
        Sodium|A LeastOne PostBaseline Value BelowLLN
    0
    0
    0
    0
        Albumin|AtLeastOne PostBaseline Value AboveULN
    21
    5
    6
    15
        ALP|AtLeastOne PostBaseline Value AboveULN
    3
    2
    2
    4
        ALT|AtLeastOne PostBaseline Value AboveULN
    7
    4
    4
    5
        AST|AtLeastOne PostBaseline Value AboveULN
    6
    3
    3
    8
        Bilirubin|AtLeastOne PostBaseline Value AboveULN
    3
    0
    1
    1
        Urea|AtLeastOne PostBaseline Value AboveULN
    0
    0
    0
    2
        Creatinine|AtLeastOne PostBaseline Value AboveULN
    0
    0
    1
    3
        GGT|AtLeastOne PostBaseline Value AboveULN
    2
    3
    2
    1
        Potassium|AtLeastOne PostBaseline Value AboveULN
    1
    0
    1
    1
        Sodium|AtLeastOne PostBaseline Value AboveULN
    2
    0
    0
    2
        Albumin|Values within normal range
    35
    14
    12
    40
        ALP|Values within normal range
    50
    17
    16
    49
        ALT|Values within normal range
    49
    15
    14
    50
        AST|Values within normal range
    50
    16
    15
    47
        Bilirubin|Values within normal range
    53
    19
    17
    54
        Urea|Values within normal range
    56
    19
    18
    53
        Creatinine|Values within normal range
    56
    19
    17
    52
        GGT|Values within normal range
    50
    14
    16
    49
        Potassium|Values within normal range
    54
    18
    17
    53
        Sodium|Values within normal range
    54
    19
    18
    53
    No statistical analyses for this end point

    Secondary: Number of Participants with Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis

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    End point title
    Number of Participants with Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
    End point description
    To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
    End point type
    Secondary
    End point timeframe
    up to 24 weeks
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: Participants
        pH|AtLeastOne PostBaseline Value BelowLLN
    0
    0
    0
    0
        Erythrocyte|AtLeastOne PostBaseline Value BelowLLN
    0
    0
    0
    0
        Sp gravity|AtLeastOne PostBaseline Value BelowLLN
    0
    0
    0
    0
        Leukocyte|AtLeastOne PostBaseline Value BelowLLN
    0
    0
    0
    0
        pH|AtLeastOne PostBaseline Value AboveULN
    0
    0
    0
    1
        Erythrocyte|AtLeastOne PostBaseline Value AboveULN
    8
    2
    1
    6
        Sp gravity|AtLeastOne PostBaseline Value AboveULN
    4
    0
    3
    7
        Leukocyte|AtLeas One PostBaseline Value AboveULN
    4
    2
    1
    5
        pH|Values within normal range
    56
    19
    18
    54
        Erythrocyte|Values within normal range
    48
    17
    17
    49
        Sp gravity|Values within normal range
    52
    19
    15
    48
        Leukocyte|Values within normal range
    52
    17
    17
    50
    No statistical analyses for this end point

    Secondary: Heart rate (beats/min) recorded on ECGs

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    End point title
    Heart rate (beats/min) recorded on ECGs
    End point description
    Collectively with other ECG parameters are used t assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
    End point type
    Secondary
    End point timeframe
    Baseline, week 16 and week 24
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: beats per minute
    arithmetic mean (standard deviation)
        Baseline
    67.59 ( 9.82 )
    65.61 ( 6.87 )
    72.63 ( 9.82 )
    65.18 ( 9.43 )
        Week 16
    66.02 ( 9.97 )
    63.80 ( 8.56 )
    65.42 ( 9.08 )
    63.05 ( 10.61 )
        Week 24
    68.17 ( 13.94 )
    63.88 ( 10.41 )
    72.46 ( 9.12 )
    64.58 ( 9.43 )
    No statistical analyses for this end point

    Secondary: QT (miliseconds) recorded on ECGs

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    End point title
    QT (miliseconds) recorded on ECGs
    End point description
    Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
    End point type
    Secondary
    End point timeframe
    Baseline, week 16 and week 24
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: milliseconds
    arithmetic mean (standard deviation)
        Baseline
    385.43 ( 27.75 )
    390.67 ( 20.57 )
    380.04 ( 26.38 )
    390.27 ( 22.69 )
        Week 16
    387.05 ( 26.14 )
    390.40 ( 24.24 )
    395.75 ( 20.36 )
    391.95 ( 29.22 )
        Week 24
    385.88 ( 34.31 )
    398.69 ( 28.52 )
    383.15 ( 19.05 )
    393.40 ( 26.54 )
    No statistical analyses for this end point

    Secondary: Number of Participants with Investigator's overall ECGs evaluations, e.g. normal/abnormal and their clinical significance

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    End point title
    Number of Participants with Investigator's overall ECGs evaluations, e.g. normal/abnormal and their clinical significance
    End point description
    Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
    End point type
    Secondary
    End point timeframe
    Week 16 and week 24
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: participants
        Week 16|Abnormal ECG: Clinically significant
    0
    0
    0
    0
        Week 24|Abnormal ECG: Clinically significant
    0
    0
    0
    0
        Week 16|Abnormal ECG: Not Clinically significant
    3
    2
    2
    10
        Week 24|Abnormal ECG: Not Clinically significant
    4
    4
    2
    11
        Week 16|Normal ECG
    38
    13
    10
    32
        Week 24|Normal ECG
    38
    12
    11
    29
        Week 16|Missing
    15
    4
    6
    13
        Week 24|Missing
    14
    3
    5
    15
    No statistical analyses for this end point

    Secondary: Left Ventricular Ejection Fraction measured by Echocardiogram

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    End point title
    Left Ventricular Ejection Fraction measured by Echocardiogram
    End point description
    To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
    End point type
    Secondary
    End point timeframe
    Baseline and week 16
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: % LVEF
    arithmetic mean (standard deviation)
        Baseline
    64.3 ( 6.3 )
    64.7 ( 6.2 )
    62.8 ( 5.2 )
    63.6 ( 4.7 )
        Week 16
    64.3 ( 5.9 )
    63.0 ( 4.4 )
    61.0 ( 3.6 )
    65.2 ( 5.1 )
    No statistical analyses for this end point

    Secondary: Serum MEDI3506 concentration profiles

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    End point title
    Serum MEDI3506 concentration profiles [1]
    End point description
    To evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.
    End point type
    Secondary
    End point timeframe
    Week 16 and week 24
    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: Placebo arm not included since this is PK
    End point values
    MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    18
    17
    48
    Units: μg/mL
    geometric mean (geometric coefficient of variation)
        Week 16
    0.377 ( 242 )
    2.158 ( 193 )
    5.979 ( 118 )
        Week 24
    0.018 ( 184 )
    0.118 ( 298 )
    0.188 ( 234 )
    No statistical analyses for this end point

    Secondary: Occurence of Anti-drug antibody during the treatment and follow-up periods

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    End point title
    Occurence of Anti-drug antibody during the treatment and follow-up periods
    End point description
    To evaluate the immunogenicity of MEDI3506 in adult subjects with moderate-to-severe AD.
    End point type
    Secondary
    End point timeframe
    up to 24 weeks
    End point values
    Placebo MEDI3506 Dose 1 MEDI3506 Dose 2 MEDI3506 Dose 3
    Number of subjects analysed
    56
    19
    18
    55
    Units: participants
        Number of ADA positive participants at baseline
    1
    0
    0
    0
        Number of ADA positive participants post baseline
    1
    1
    0
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Pooled Placebo

    Reporting group title
    MEDI3506 Dose 3
    Reporting group description
    MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

    Reporting group title
    MEDI3506 Dose 2
    Reporting group description
    MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks

    Reporting group title
    MEDI3506 Dose 1
    Reporting group description
    MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks

    Serious adverse events
    Placebo MEDI3506 Dose 3 MEDI3506 Dose 2 MEDI3506 Dose 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 55 (1.82%)
    2 / 18 (11.11%)
    0 / 19 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Venous thrombosis limb
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Medical device removal
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis exfoliative generalised
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Covid-19 pneumonia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo MEDI3506 Dose 3 MEDI3506 Dose 2 MEDI3506 Dose 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 56 (51.79%)
    25 / 55 (45.45%)
    14 / 18 (77.78%)
    11 / 19 (57.89%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Injection site swelling
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Injection site reaction
         subjects affected / exposed
    0 / 56 (0.00%)
    4 / 55 (7.27%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    6
    1
    0
    Injection site bruising
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Influenza like illness
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Investigations
    Liver function test increased
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 55 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    2
    0
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Urine analysis abnormal
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fall
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 55 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    3
    0
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 55 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    0
    1
    Dry mouth
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Diarrhoea
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    12 / 56 (21.43%)
    14 / 55 (25.45%)
    0 / 18 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    14
    17
    0
    2
    Pruritus
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 55 (1.82%)
    2 / 18 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    3
    1
    2
    1
    Eczema
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 55 (3.64%)
    2 / 18 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    3
    3
    2
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    2 / 18 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Bronchitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Acarodermatitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Otitis externa
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Oral herpes
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 55 (5.45%)
    2 / 18 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    3
    2
    1
    Influenza
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eczema infected
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dermatitis infected
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Folliculitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Covid-19
         subjects affected / exposed
    7 / 56 (12.50%)
    2 / 55 (3.64%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    7
    2
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Oct 2019
    Amendment 1
    24 Oct 2019
    Amendment 2
    13 Jan 2020
    Amendment 3
    27 Mar 2020
    Amendment 4
    03 Jun 2020
    Amendment 5
    07 Sep 2020
    Amendment 6
    29 Oct 2020
    Amendment 7
    23 Feb 2021
    Amendment 8
    15 Jun 2022
    Amendment 9

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    26 Mar 2020
    Subject recruitment was temporarily placed on hold on 26 March 2020 due to COVID-19 pandemic. Subject recruitment was restarted on a site-by-site basis after gaining regulatory and ethical approval of Protocol Amendment 5 and reviewing the local epidemiological situation and the ability of each site to safely conduct the study in the new circumstances
    03 Jun 2020

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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