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

    Summary
    EudraCT number
    2014-003725-17
    Trial protocol
    DE   PL  
    Global end of trial date
    05 Feb 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    12 May 2018
    First version publication date
    25 May 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D2213C00001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02347176
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    Milstein Building, Granta Park, Cambridge, United Kingdom,
    Public contact
    Rene van der Merwe, Senior Director, Clinical Development, Respiratory and Inflammation, MedImmune, LLC, +44 3013984095, information.center@astrazeneca.com
    Scientific contact
    Rene van der Merwe, Senior Director, Clinical Development, Respiratory and Inflammation, MedImmune, LLC, +44 3013984095, 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
    05 Feb 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of study was to evaluate the efficacy of Tralokinumab Dose 1, 2 and 3, tested hierarchically, compared with placebo in adults with moderate to severe AD, assessed using the absolute change in Eczema Area and Severity Index (EASI) from baseline at Week 12, and using the 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 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. Participants 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
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Jan 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: 33
    Country: Number of subjects enrolled
    Canada: 11
    Country: Number of subjects enrolled
    Germany: 40
    Country: Number of subjects enrolled
    Japan: 25
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    United States: 80
    Worldwide total number of subjects
    204
    EEA total number of subjects
    55
    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)
    197
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 299 participants participated in the study at 55 sites worldwide, including 24 sites in the USA, 8 sites in Germany, 6 sites each in Japan, Poland, and Canada, and 5 sites in Australia.

    Pre-assignment
    Screening details
    95 participants were considered screen failures and 204 participants were randomized and 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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo was administered subcutaneously to participants.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo was administered subcutaneously to participants.

    Arm title
    Tralokinumab Dose 1
    Arm description
    Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Tralokinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

    Arm title
    Tralokinumab Dose 2
    Arm description
    Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Tralokinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

    Arm title
    Tralokinumab Dose 3
    Arm description
    Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Tralokinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

    Number of subjects in period 1
    Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
    Started
    51
    50
    51
    52
    Completed
    39
    40
    43
    48
    Not completed
    12
    10
    8
    4
         Unspecified
             1
             2
             2
             -
         Consent withdrawn by subject
             9
             5
             5
             3
         Lost to follow-up
             2
             3
             1
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo was administered subcutaneously to participants.

    Reporting group title
    Tralokinumab Dose 1
    Reporting group description
    Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

    Reporting group title
    Tralokinumab Dose 2
    Reporting group description
    Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

    Reporting group title
    Tralokinumab Dose 3
    Reporting group description
    Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

    Reporting group values
    Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3 Total
    Number of subjects
    51 50 51 52 204
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    48 48 51 50 197
        From 65-84 years
    3 2 0 2 7
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    39.4 ± 14.5 39.1 ± 15.1 37.1 ± 14.0 35.7 ± 14.6 -
    Gender, Male/Female
    Units: Participants
        Male
    22 29 26 33 110
        Female
    29 21 25 19 94

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo was administered subcutaneously to participants.

    Reporting group title
    Tralokinumab Dose 1
    Reporting group description
    Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

    Reporting group title
    Tralokinumab Dose 2
    Reporting group description
    Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

    Reporting group title
    Tralokinumab Dose 3
    Reporting group description
    Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

    Primary: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12

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    End point title
    Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12
    End point description
    EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications. The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, "N" is number of participants analysed for this outcome measure.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
    Number of subjects analysed
    40
    43
    44
    48
    Units: units on a scale
        arithmetic mean (standard error)
    -10.78 ± 1.398
    -13.67 ± 1.386
    -15.14 ± 1.361
    -15.72 ± 1.334
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Tralokinumab Dose 1
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.143
    Method
    ANCOVA
    Parameter type
    Adj Mean Difference
    Point estimate
    -2.89
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.78
         upper limit
    0.99
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.968
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Tralokinumab Dose 2
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.027
    Method
    ANCOVA
    Parameter type
    Adj Mean Difference
    Point estimate
    -4.36
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.22
         upper limit
    -0.51
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.951
    Statistical analysis title
    Statistical Analysis 3
    Comparison groups
    Placebo v Tralokinumab Dose 3
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.011
    Method
    ANCOVA
    Parameter type
    Adj Mean Difference
    Point estimate
    -4.94
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.76
         upper limit
    -1.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.932

    Primary: 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 at Week 12

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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 at Week 12
    End point description
    The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very 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. The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, "N" is number of participants analysed for this outcome measure.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
    Number of subjects analysed
    50
    50
    51
    51
    Units: Percentage of participant
        number (not applicable)
    11.8
    11.6
    19.4
    26.4
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v Tralokinumab Dose 1
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.976
    Method
    ANCOVA
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.29
         upper limit
    3.32
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Tralokinumab Dose 2
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.283
    Method
    ANCOVA
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.84
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.6
         upper limit
    5.6
    Statistical analysis title
    Statistical Analysis 3
    Comparison groups
    Placebo v Tralokinumab Dose 3
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.063
    Method
    ANCOVA
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.79
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.95
         upper limit
    8.2

    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)
    End point description
    An adverse event (AE) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug until Week 22. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state. As-treated population included all treated participants, grouped according to actual treatment received.
    End point type
    Secondary
    End point timeframe
    From Study Drug Administration to Week 22
    End point values
    Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
    Number of subjects analysed
    51
    50
    51
    52
    Units: Participant
        TEAEs
    31
    36
    35
    30
        TESAEs
    1
    3
    2
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events

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    End point title
    Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
    End point description
    Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. TEAEs were 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 treated participants, grouped according to actual treatment received.
    End point type
    Secondary
    End point timeframe
    From Study Drug Administration to Week 22
    End point values
    Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
    Number of subjects analysed
    51
    50
    51
    52
    Units: Participant
        Blood pressure increased
    0
    1
    1
    0
        Pyrexia
    1
    0
    1
    0
        Acute coronary syndrome
    0
    1
    0
    0
        Angina pectoris
    1
    0
    0
    0
        Hypertension
    0
    0
    1
    0
        Pallor
    0
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events

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    End point title
    Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
    End point description
    An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between first dose of study drug and 10 weeks after the last dose that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed. As-treated population included all treated participants, grouped according to actual treatment received.
    End point type
    Secondary
    End point timeframe
    From Study Drug Administration to Week 22
    End point values
    Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
    Number of subjects analysed
    51
    50
    51
    52
    Units: Participant
        Anaemia
    0
    1
    0
    0
        Lymphopenia
    1
    0
    0
    0
        Alanine aminotransferase increased
    0
    1
    0
    0
        Aspartate aminotransferase increased
    0
    1
    0
    0
        Blood alkaline phosphatase increased
    0
    0
    1
    0
        Blood creatinine increased
    0
    1
    0
    0
        Blood immunoglobulin E increased
    0
    0
    1
    0
        Gamma-glutamyltransferase increased
    0
    1
    0
    0
        Hepatic function abnormal
    0
    1
    0
    0
        Hyperbilirubinaemia
    1
    0
    0
    0
        Liver function test abnormal
    0
    0
    1
    0
        Glycosuria
    0
    1
    0
    0
        Leukocyturia
    1
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events

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    End point title
    Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events
    End point description
    AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS and QT intervals. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state. As-treated population included all treated participants, grouped according to actual treatment received.
    End point type
    Secondary
    End point timeframe
    From Study Drug Administration to Week 22
    End point values
    Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
    Number of subjects analysed
    51
    50
    51
    52
    Units: Participant
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving 50 percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12

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    End point title
    Percentage of Participants Achieving 50 percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12
    End point description
    EASI50 responder is defined as a participant who achieves at least a 50% reduction in EASI score from baseline. The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, "N" is number of participants analyzed for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
    Number of subjects analysed
    41
    45
    47
    48
    Units: Percentage of participant
        number (not applicable)
    61.0
    64.4
    72.3
    75.0
    No statistical analyses for this end point

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

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    End point title
    Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12
    End point description
    The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of AD. The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The maximum total score is 103, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from subjects who took prohibited medications. The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, "N" is number of participants analyzed for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
    Number of subjects analysed
    40
    43
    44
    48
    Units: units on a scale
        arithmetic mean (standard error)
    -16.67 ± 2.224
    -21.97 ± 2.204
    -26.09 ± 2.168
    -26.50 ± 2.123
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving 50 percent (%) Reduction From Baseline in SCORAD at Week 12

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    End point title
    Percentage of Participants Achieving 50 percent (%) Reduction From Baseline in SCORAD at Week 12
    End point description
    SCORAD50 responder is defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline. The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, "N" is number of participants analyzed for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
    Number of subjects analysed
    41
    45
    47
    48
    Units: Percentage of participant
        number (not applicable)
    26.8
    35.6
    46.8
    43.8
    No statistical analyses for this end point

    Secondary: Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day mean score) at Week 12

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    End point title
    Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day mean score) at Week 12
    End point description
    Pruritus assessed using an 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. The data presented here is Adjusted mean change after excluding the data from subjects who took prohibited medications. The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, "N" is number of participants analyzed for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
    Number of subjects analysed
    38
    38
    42
    42
    Units: units on a scale
        arithmetic mean (standard error)
    -1.03 ± 0.270
    -1.80 ± 0.266
    -1.59 ± 0.260
    -2.17 ± 0.256
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Study Drug Administration to Week 22
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo was administered subcutaneously to participants.

    Reporting group title
    Tralokinumab Dose 1
    Reporting group description
    Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

    Reporting group title
    Tralokinumab Dose 2
    Reporting group description
    Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

    Reporting group title
    Tralokinumab Dose 3
    Reporting group description
    Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

    Serious adverse events
    Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 51 (3.92%)
    3 / 50 (6.00%)
    2 / 51 (3.92%)
    0 / 52 (0.00%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 52 (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
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 52 (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 / 1
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 52 (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
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 52 (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
    Uterine polyp
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 52 (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
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 52 (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
    Hepatic function abnormal
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 52 (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
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 51 (29.41%)
    20 / 50 (40.00%)
    21 / 51 (41.18%)
    22 / 52 (42.31%)
    Investigations
    Blood immunoglobuline increased
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 50 (4.00%)
    3 / 51 (5.88%)
    1 / 52 (1.92%)
         occurrences all number
    1
    2
    3
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 51 (3.92%)
    3 / 50 (6.00%)
    4 / 51 (7.84%)
    4 / 52 (7.69%)
         occurrences all number
    3
    6
    4
    4
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    4 / 51 (7.84%)
    3 / 50 (6.00%)
    3 / 51 (5.88%)
    3 / 52 (5.77%)
         occurrences all number
    5
    3
    4
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 51 (11.76%)
    11 / 50 (22.00%)
    8 / 51 (15.69%)
    13 / 52 (25.00%)
         occurrences all number
    9
    12
    9
    20
    Sinusitis
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    2 / 51 (3.92%)
    3 / 52 (5.77%)
         occurrences all number
    1
    1
    2
    3
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 51 (9.80%)
    5 / 50 (10.00%)
    6 / 51 (11.76%)
    4 / 52 (7.69%)
         occurrences all number
    6
    7
    9
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Mar 2015
    Protocol Amendment 1: The major changes were made as per Food and Drug Administration (FDA) suggestion to establish the efficacy based on the primary endpoint of Investigator's Global Assessment (IGA) severity scale, clarification on usage of lower potency steroids, and eligibility criteria updated. Minor editing and correction of typographical errors were also addressed.

    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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