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    Clinical Trial Results:
    A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects with Inadequately Controlled, Severe Asthma

    Summary
    EudraCT number
    2013-003269-33
    Trial protocol
    HU   CZ   LT   LV   SK   BG  
    Global end of trial date
    01 Mar 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Jun 2018
    First version publication date
    17 Jun 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CD-RI-MEDI9929-1146
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02054130
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, Maryland, United States, 20878
    Public contact
    Fred Reid, MBChB, MedImmune, LLC, +44 0 203 749 6512, information.center@astrazeneca.com
    Scientific contact
    Fred Reid, MBChB, MedImmune, LLC, +44 0 203 749 6512, 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
    01 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of 3 dose levels of MEDI9929 on asthma exacerbations in adult subjects with inadequately controlled, severe asthma
    Protection of trial subjects
    The conduct of this study met all the local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and was consistent with the ICH guidelines on GCP. Participating participants signed the 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
    In this study, all participants received stable background asthma therapy of medium- or high-dose inhaled corticosteroids (ICS) and long acting β2 agonist (LABA), with or without additional asthma controller medications that is consistent with Global Initiative for Asthma (GINA).
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Dec 2013
    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
    Slovakia: 75
    Country: Number of subjects enrolled
    South Africa: 7
    Country: Number of subjects enrolled
    Ukraine: 135
    Country: Number of subjects enrolled
    United States: 36
    Country: Number of subjects enrolled
    Bulgaria: 57
    Country: Number of subjects enrolled
    Czech Republic: 44
    Country: Number of subjects enrolled
    Hungary: 95
    Country: Number of subjects enrolled
    Israel: 29
    Country: Number of subjects enrolled
    Japan: 19
    Country: Number of subjects enrolled
    Latvia: 36
    Country: Number of subjects enrolled
    Lithuania: 13
    Country: Number of subjects enrolled
    Serbia: 4
    Worldwide total number of subjects
    550
    EEA total number of subjects
    320
    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)
    471
    From 65 to 84 years
    79
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted from 19Dec2013 to 01Mar2017 across 12 countries (United States, Slovakia, Bulgaria, Czech Republic, Hungary, Israel, Japan, Latvia, Lithuania, Serbia, South Africa, and Ukraine). A total of 918 participants were recruited in the study.

    Pre-assignment
    Screening details
    Of 918 participants, 334 were considered screen failures and 584 participants were randomized. Of which, all populations excluded 34 participants from one site due to non-compliance of the principles of Good Clinical Practice.

    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
    Carer, Subject, Investigator, Monitor
    Blinding implementation details
    This was a double-blind study. Neither the participant/legal representative nor any of the investigator or sponsor staff who are involved in the treatment or clinical evaluation of the participant were aware of the treatment received.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received 3 subcutaneous (SC) injections (1 × 1 mL and 2 × 1.5 mL) of placebo matched to MEDI9929 once every 2 weeks from Week 0, Day 1 to Week 50.
    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
    Participants received 3 subcutaneous (SC) injections (1 × 1 mL and 2 × 1.5 mL) of placebo matched to MEDI9929 once every 2 weeks from Week 0, Day 1 to Week 50.

    Arm title
    MEDI9929 70 mg
    Arm description
    Participants received 3 SC injections (1 × 1 mL MEDI9929 and 2 × 1.5 mL placebo) once every 4 weeks from Week 0, Day 1 to Week 48 alternating with 3 SC injections (1 × 1 mL and 2 × 1.5 mL of placebo) once every 4 weeks from Week 2 to Week 50 equivalent to MEDI9929 70 milligram (mg) dose.
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI9929 70 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 3 SC injections (1 × 1 mL MEDI9929 and 2 × 1.5 mL placebo) once every 4 weeks from Week 0, Day 1 to Week 48 alternating with 3 SC injections (1 × 1 mL and 2 × 1.5 mL of placebo) once every 4 weeks from Week 2 to Week 50 equivalent to MEDI9929 70 milligram (mg) dose.

    Arm title
    MEDI9929 210 mg
    Arm description
    Participants received 3 SC injections (1 × 1 mL MEDI9929 and 2 × 1.5 mL [combining 1 mL MEDI9929 and 0.5 mL placebo in each syringe]) once every 4 weeks from Week 0, Day 1 to Week 48 alternating with 3 SC injections (1 × 1 mL and 2 × 1.5 mL of placebo) once every 4 weeks from Week 2 to Week 50 equivalent to MEDI9929 210 mg dose.
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI9929 210 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 3 SC injections (1 × 1 mL MEDI9929 and 2 × 1.5 mL [combining 1 mL MEDI9929 and 0.5 mL placebo in each syringe]) once every 4 weeks from Week 0, Day 1 to Week 48 alternating with 3 SC injections (1 × 1 mL and 2 × 1.5 mL of placebo) once every 4 weeks from Week 2 to Week 50 equivalent to MEDI9929 210 mg dose.

    Arm title
    MEDI9929 280 mg
    Arm description
    Participants received 3 SC injections (1 × 1 mL and 2 × 1.5 mL) of MEDI9929 280 mg dose once every 2 weeks from Week 0, Day 1 to Week 50.
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI9929 280 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 3 SC injections (1 × 1 mL and 2 × 1.5 mL) of MEDI9929 280 mg dose once every 2 weeks from Week 0, Day 1 to Week 50.

    Number of subjects in period 1
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Started
    138
    138
    137
    137
    Completed
    130
    127
    122
    115
    Not completed
    8
    11
    15
    22
         Missed dose
    4
    6
    7
    10
         Adverse event, serious fatal
    -
    1
    -
    -
         Consent withdrawn by subject
    4
    4
    7
    10
         Lost to follow-up
    -
    -
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received 3 subcutaneous (SC) injections (1 × 1 mL and 2 × 1.5 mL) of placebo matched to MEDI9929 once every 2 weeks from Week 0, Day 1 to Week 50.

    Reporting group title
    MEDI9929 70 mg
    Reporting group description
    Participants received 3 SC injections (1 × 1 mL MEDI9929 and 2 × 1.5 mL placebo) once every 4 weeks from Week 0, Day 1 to Week 48 alternating with 3 SC injections (1 × 1 mL and 2 × 1.5 mL of placebo) once every 4 weeks from Week 2 to Week 50 equivalent to MEDI9929 70 milligram (mg) dose.

    Reporting group title
    MEDI9929 210 mg
    Reporting group description
    Participants received 3 SC injections (1 × 1 mL MEDI9929 and 2 × 1.5 mL [combining 1 mL MEDI9929 and 0.5 mL placebo in each syringe]) once every 4 weeks from Week 0, Day 1 to Week 48 alternating with 3 SC injections (1 × 1 mL and 2 × 1.5 mL of placebo) once every 4 weeks from Week 2 to Week 50 equivalent to MEDI9929 210 mg dose.

    Reporting group title
    MEDI9929 280 mg
    Reporting group description
    Participants received 3 SC injections (1 × 1 mL and 2 × 1.5 mL) of MEDI9929 280 mg dose once every 2 weeks from Week 0, Day 1 to Week 50.

    Reporting group values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg Total
    Number of subjects
    138 138 137 137 550
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    118 117 114 122 471
        From 65-84 years
    20 21 23 15 79
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    52.32 ± 11.71 50.80 ± 12.36 52.66 ± 12.67 50.43 ± 12.25 -
    Sex: Female, Male
    Units: Subjects
        Male
    44 49 50 46 189
        Female
    94 89 87 91 361
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    1 0 1 2 4
        Not Hispanic or Latino
    137 138 136 135 546
        Unknown or Not Reported
    0 0 0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        Asian|
    6 3 5 5 19
        Black or African American|
    6 4 3 6 19
        White|
    123 131 128 122 504
        Other|
    2 0 0 2 4
        Multiple Categories Checked|
    1 0 1 2 4

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received 3 subcutaneous (SC) injections (1 × 1 mL and 2 × 1.5 mL) of placebo matched to MEDI9929 once every 2 weeks from Week 0, Day 1 to Week 50.

    Reporting group title
    MEDI9929 70 mg
    Reporting group description
    Participants received 3 SC injections (1 × 1 mL MEDI9929 and 2 × 1.5 mL placebo) once every 4 weeks from Week 0, Day 1 to Week 48 alternating with 3 SC injections (1 × 1 mL and 2 × 1.5 mL of placebo) once every 4 weeks from Week 2 to Week 50 equivalent to MEDI9929 70 milligram (mg) dose.

    Reporting group title
    MEDI9929 210 mg
    Reporting group description
    Participants received 3 SC injections (1 × 1 mL MEDI9929 and 2 × 1.5 mL [combining 1 mL MEDI9929 and 0.5 mL placebo in each syringe]) once every 4 weeks from Week 0, Day 1 to Week 48 alternating with 3 SC injections (1 × 1 mL and 2 × 1.5 mL of placebo) once every 4 weeks from Week 2 to Week 50 equivalent to MEDI9929 210 mg dose.

    Reporting group title
    MEDI9929 280 mg
    Reporting group description
    Participants received 3 SC injections (1 × 1 mL and 2 × 1.5 mL) of MEDI9929 280 mg dose once every 2 weeks from Week 0, Day 1 to Week 50.

    Primary: Annualized asthma exacerbation rate (AER) through Week 52

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    End point title
    Annualized asthma exacerbation rate (AER) through Week 52
    End point description
    Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up. Intent-to-treat (ITT) population was considered for this endpoint, which included all participants who are randomized and received any study drug.
    End point type
    Primary
    End point timeframe
    Week 0 (Day 1) up to Week 52
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: events per person-year
        number (confidence interval 95%)
    0.72 (0.59 to 0.88)
    0.27 (0.19 to 0.38)
    0.20 (0.13 to 0.30)
    0.23 (0.16 to 0.34)
    Statistical analysis title
    Comparison between Placebo and MEDI9929 70 mg
    Comparison groups
    MEDI9929 70 mg v Placebo
    Number of subjects included in analysis
    276
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Negative binomial regression
    Parameter type
    Rate ratio
    Point estimate
    0.38
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.23
         upper limit
    0.63
    Statistical analysis title
    Comparison between Placebo and MEDI9929 210 mg
    Comparison groups
    Placebo v MEDI9929 210 mg
    Number of subjects included in analysis
    275
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Negative binomial regression
    Parameter type
    Rate ratio
    Point estimate
    0.29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.16
         upper limit
    0.51
    Statistical analysis title
    Comparison between Placebo and MEDI9929 280 mg
    Comparison groups
    Placebo v MEDI9929 280 mg
    Number of subjects included in analysis
    275
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Negative bnomial regression
    Parameter type
    Rate ratio
    Point estimate
    0.34
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.2
         upper limit
    0.58

    Secondary: Reduction in AER on Subpopulations at Week 52

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    End point title
    Reduction in AER on Subpopulations at Week 52
    End point description
    Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Reduction in AER was evaluated in pre-specified subpopulations of asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up. Also, the high or low was determined using median value. ITT population was considered for this endpoint, which included all participants who are randomized and received any study drug. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: events per person-year
    number (confidence interval 95%)
        Eosinophilic->= 250 cells/µL (n=78,80,76,76)
    0.78 (0.59 to 1.00)
    0.29 (0.18 to 0.43)
    0.26 (0.16 to 0.42)
    0.21 (0.12 to 0.35)
        Non-Eosinophilic- < 250 cells/µL(n=60,58,61,61)
    0.65 (0.46 to 0.89)
    0.25 (0.14 to 0.42)
    0.14 (0.06 to 0.27)
    0.26 (0.14 to 0.43)
        Th2 Status - High (n=75,62,65,62)
    0.62 (0.45 to 0.83)
    0.33 (0.20 to 0.50)
    0.25 (0.14 to 0.41)
    0.21 (0.11 to 0.36)
        Th2 Status - Low (n=62,75,70,74)
    0.86 (0.64 to 1.13)
    0.23 (0.14 to 0.37)
    0.15 (0.07 to 0.28)
    0.26 (0.15 to 0.41)
        FENO - High (n=70,72,68,64)
    0.94 (0.72 to 1.20)
    0.32 (0.20 to 0.48)
    0.20 (0.11 to 0.35)
    0.20 (0.10 to 0.35)
        FENO - Low (n=67,65,67,69)
    0.51 (0.36 to 0.72)
    0.23 (0.13 to 0.38)
    0.21 (0.11 to 0.36)
    0.28 (0.16 to 0.44)
        Serum Periostin - High (n=69,63,73,68)
    0.78 (0.59 to 1.02)
    0.29 (0.17 to 0.45)
    0.19 (0.10 to 0.33)
    0.19 (0.10 to 0.32)
        Serum Periostin - Low (n=69,74,63,66)
    0.66 (0.48 to 0.89)
    0.27 (0.16 to 0.42)
    0.22 (0.12 to 0.38)
    0.30 (0.18 to 0.47)
        Post-BD FEV1 Reversibility-Yes (n=126,123,114,125)
    0.60 (0.47 to 0.75)
    0.26 (0.18 to 0.37)
    0.17 (0.10 to 0.27)
    0.21 (0.14 to 0.32)
        Allergic (n=80,68,77,71)
    0.75 (0.57 to 0.97)
    0.25 (0.15 to 0.40)
    0.14 (0.07 to 0.26)
    0.23 (0.13 to 0.38)
        Non-Allergic (n=50,60,50,58)
    0.65 (0.44 to 0.91)
    0.23 (0.12 to 0.39)
    0.26 (0.13 to 0.45)
    0.22 (0.11 to 0.38)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Pre-bronchodilator (pre-BD) Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC) at Week 52

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    End point title
    Change From Baseline in Pre-bronchodilator (pre-BD) Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC) at Week 52
    End point description
    Forced expiratory volume in 1 second and forced vital capacity measures taken before bronchodilator use were reported. ITT population was considered for this endpoint, which included all participants who are randomized and received any study drug. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 [Day 1]) to Week 52
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: Liter
    arithmetic mean (standard deviation)
        Pre-BD FEV1(n=131,130,121,116)
    0.071 ± 0.405
    0.200 ± 0.432
    0.210 ± 0.433
    0.245 ± 0.411
        Pre-BD FVC (n=131,130,121,116)
    0.068 ± 0.477
    0.244 ± 0.560
    0.202 ± 0.616
    0.197 ± 0.484
    No statistical analyses for this end point

    Secondary: Change From Baseline in FEV1 on Subpopulations at Week 52

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    End point title
    Change From Baseline in FEV1 on Subpopulations at Week 52
    End point description
    Forced expiratory volume in one second (FEV1) was evaluated in pre-specified subpopulations of asthma. The data presented in the below table for this OM is for Pre-BD FEV1. ITT population was considered for this endpoint, which included all participants who are randomized and received any study drug. The 'n' denotes the number of participants analysed for specified time points. The dispersion measure (standard deviation) was only generated for the outcome measures relative to placebo. Therefore, reported by an arbitrary value (99999).
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 52
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: Liters
    least squares mean (standard deviation)
        Eosinophilic- >= 250 cells/µL (n=76,77,66,63)
    -0.045 ± 99999
    0.118 ± 99999
    0.125 ± 99999
    0.160 ± 99999
        Non-Eosinophilic- < 250 cells/µL (n=55,53,55,53)
    -0.072 ± 99999
    -0.030 ± 99999
    0.008 ± 99999
    0.011 ± 99999
        Th2 Status – High |(n=73,59,57,53)
    -0.058 ± 99999
    0.037 ± 99999
    0.052 ± 99999
    0.182 ± 99999
        Th2 Status – Low |(n=57,70,62,62)
    -0.052 ± 99999
    0.103 ± 99999
    0.103 ± 99999
    0.062 ± 99999
        FENO – High (n=65,66,60,54)
    -0.054 ± 99999
    0.093 ± 99999
    0.137 ± 99999
    0.155 ± 99999
        FENO – Low |(n=65,63,59,59)
    0.027 ± 99999
    0.115 ± 99999
    0.095 ± 99999
    0.133 ± 99999
        Serum Periostin – High (n=67,61,65,61)
    -0.017 ± 99999
    0.147 ± 99999
    0.207 ± 99999
    0.185 ± 99999
        Serum Periostin – Low (n=64,68,55,52)
    -0.040 ± 99999
    0.060 ± 99999
    -0.013 ± 99999
    0.064 ± 99999
        Post-BD FEV1 Reversibility-Yes (n=120,117,102,105)
    -0.081 ± 99999
    0.052 ± 99999
    0.049 ± 99999
    0.066 ± 99999
        Allergic (n=75,65,70,57)
    -0.047 ± 99999
    0.131 ± 99999
    0.084 ± 99999
    0.065 ± 99999
        Non-Allergic (n=48,56,42,52)
    -0.037 ± 99999
    0.050 ± 99999
    0.148 ± 99999
    0.164 ± 99999
    No statistical analyses for this end point

    Secondary: Change From Baseline in Post-bronchodilator (post-BD) FEV1 and FVC at Week 52

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    End point title
    Change From Baseline in Post-bronchodilator (post-BD) FEV1 and FVC at Week 52
    End point description
    Forced expiratory volume in 1 second and forced vital capacity measures taken after bronchodilator use were reported. ITT population was considered for this endpoint, which included all participants who are randomized and received any study drug. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 [Day 1]) to Week 52
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: Liter
    arithmetic mean (standard deviation)
        Post-BD FEV1 (n=130,130,121,115)
    -0.064 ± 0.352
    0.117 ± 0.389
    0.099 ± 0.449
    0.128 ± 0.415
        Post-BD FVC (n=130,130,121,115)
    -0.092 ± 0.353
    0.088 ± 0.439
    0.092 ± 0.515
    0.083 ± 0.435
    No statistical analyses for this end point

    Secondary: Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52

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    End point title
    Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52
    End point description
    The overall asthma symptom score is the average of scores of day time severity, day time frequency, and night time severity. Overall asthma symptom score was evaluated in pre-specified subpopulations of asthma. ITT population was considered for this endpoint, which included all participants who are randomized and received any study drug. The 'n' denotes the number of participants analysed for specified time points. The dispersion measure was only generated for the outcome measures relative to placebo. Therefore, reported by an arbitrary value (99999).
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 52
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: Units on a scale
    least squares mean (standard deviation)
        Eosinophilic- >= 250 cells/µL (n=70,72,58,64)
    -0.57 ± 99999
    -0.62 ± 99999
    -0.78 ± 99999
    -0.72 ± 99999
        Non-Eosinophilic- < 250 cells/µL (n=48,47,47,49)
    -0.49 ± 99999
    -0.60 ± 99999
    -0.56 ± 99999
    -0.72 ± 99999
        Th2 Status - High (n=65,54,51,48)
    -0.54 ± 99999
    -0.65 ± 99999
    -0.62 ± 99999
    -0.75 ± 99999
        Th2 Status - Low (n=52,64,52,54)
    -0.50 ± 99999
    -0.57 ± 99999
    -0.72 ± 99999
    -0.71 ± 99999
        FENO - High (n=59,60,49,44)
    -0.52 ± 99999
    -0.68 ± 99999
    -0.75 ± 99999
    -0.72 ± 99999
        FENO - Low (n=59,58,54,56)
    -0.54 ± 99999
    -0.55 ± 99999
    -0.59 ± 99999
    -0.71 ± 99999
        Serum Periostin - High (n=63,57,56,54)
    -0.48 ± 99999
    -0.54 ± 99999
    -0.84 ± 99999
    -0.74 ± 99999
        Serum Periostin - Low (n=55,61,48,46)
    -0.58 ± 99999
    -0.63 ± 99999
    -0.47 ± 99999
    -0.69 ± 99999
        Post-BD FEV1 Reversibility-Yes(n=108,106,87,92)
    -0.55 ± 99999
    -0.60 ± 99999
    -0.64 ± 99999
    -0.71 ± 99999
        Allergic (n=66,56,60,48)
    -0.53 ± 99999
    -0.59 ± 99999
    -0.63 ± 99999
    -0.67 ± 99999
        Non-Allergic (n=46,55,36,47)
    -0.50 ± 99999
    -0.60 ± 99999
    -0.72 ± 99999
    -0.85 ± 99999
    No statistical analyses for this end point

    Secondary: Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52

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    End point title
    Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52
    End point description
    The asthma daily diary includes the following daily assessments: asthma symptoms; inhalations of rescue medication; night time awakening due to asthma requiring rescue medication use, asthma-related activity limitations, asthma-related stress, and background medication compliance. It was measured as daytime severity, daytime frequency, and nightime severity. ITT population was considered for this endpoint, which included all participants who are randomized and received any study drug.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 [Day 1]) and Week 52
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    118
    119
    105
    103
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Daytime Severity
    -0.483 ± 0.700
    -0.657 ± 0.726
    -0.669 ± 0.640
    -0.680 ± 0.688
        Daytime Frequency
    -0.493 ± 0.792
    -0.598 ± 0.837
    -0.727 ± 0.753
    -0.754 ± 0.752
        Nighttime Severity
    -0.643 ± 0.799
    -0.616 ± 0.687
    -0.807 ± 0.699
    -0.662 ± 0.730
    No statistical analyses for this end point

    Secondary: Change From Baseline in Asthma symptoms measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52

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    End point title
    Change From Baseline in Asthma symptoms measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52
    End point description
    The ACQ is a patient-reported questionnaire assessing asthma symptoms (ie, night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use and FEV1. The ACQ-6 is a shortened version of the ACQ that omits the FEV1 measurement from the original ACQ score. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). ITT population was considered for this endpoint, which included all participants who are randomized and received any study drug.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 [Day 1]) and Week 52
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    53
    52
    44
    49
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -0.89 ± 0.91
    -1.24 ± 0.94
    -1.17 ± 1.00
    -1.19 ± 1.00
    No statistical analyses for this end point

    Secondary: Rate of Severe Asthma Exacerbation Through Week 52

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    End point title
    Rate of Severe Asthma Exacerbation Through Week 52
    End point description
    A severe asthma exacerbation is defined as an event that resulted in hospitalization. The severe AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up. ITT population was considered for this endpoint, which included all participants who are randomized and received any study drug.
    End point type
    Secondary
    End point timeframe
    Week 0 (Day 1) up to Week 52
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: events per person-year
        number (confidence interval 95%)
    0.14 (0.08 to 0.22)
    0.04 (0.01 to 0.09)
    0.02 (0.00 to 0.07)
    0.03 (0.01 to 0.08)
    No statistical analyses for this end point

    Secondary: Time to First Asthma Exacerbation Through Week 52

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    End point title
    Time to First Asthma Exacerbation Through Week 52
    End point description
    Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first asthma exacerbation was reported. ITT population was considered for this endpoint, which included all participants who are randomized and received any study drug. Median time was not estimable due to less than 50% participants had exacerbations occurred. Therefore, reported with arbitrary values (99999).
    End point type
    Secondary
    End point timeframe
    Week 0 (Day 1) through Week 52
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: Days
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Statistical analysis title
    Comparison between Placebo and MEDI9929 70 mg
    Comparison groups
    Placebo v MEDI9929 70 mg
    Number of subjects included in analysis
    276
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.044
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.62
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.39
         upper limit
    0.99
    Statistical analysis title
    Comparison between Placebo and MEDI9929 210 mg
    Comparison groups
    Placebo v MEDI9929 210 mg
    Number of subjects included in analysis
    275
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.002
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.45
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.26
         upper limit
    0.75
    Statistical analysis title
    Comparison between Placebo and MEDI9929 280 mg
    Comparison groups
    Placebo v MEDI9929 280 mg
    Number of subjects included in analysis
    275
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.013
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.54
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.33
         upper limit
    0.88

    Secondary: Time to First Severe Asthma Exacerbation Through Week 52

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    End point title
    Time to First Severe Asthma Exacerbation Through Week 52
    End point description
    Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first severe asthma exacerbations (hospitalization) were reported. ITT population was considered for this endpoint, which included all participants who are randomized and received any study drug. Median time was not estimable due to less than 50% participants had exacerbations occurred. Therefore, reported with arbitrary values (99999).
    End point type
    Secondary
    End point timeframe
    Week 0 (Day 1) through Week 52
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: Days
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Statistical analysis title
    Comparison between Placebo and MEDI9929 70 mg
    Comparison groups
    Placebo v MEDI9929 70 mg
    Number of subjects included in analysis
    276
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.231
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.17
         upper limit
    1.52
    Statistical analysis title
    Comparison between Placebo and MEDI9929 210 mg
    Comparison groups
    Placebo v MEDI9929 210 mg
    Number of subjects included in analysis
    275
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.077
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.09
         upper limit
    1.21
    Statistical analysis title
    Comparison between Placebo and MEDI9929 280 mg
    Comparison groups
    Placebo v MEDI9929 280 mg
    Number of subjects included in analysis
    275
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.151
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.14
         upper limit
    1.43

    Secondary: Number of Participants With at least one Asthma Exacerbations Through Week 52

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    End point title
    Number of Participants With at least one Asthma Exacerbations Through Week 52
    End point description
    Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. ITT population was considered for this endpoint, which included all participants who are randomized and received any study drug.
    End point type
    Secondary
    End point timeframe
    Week 0 (Day 1) through Week 52
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: Participants
    43
    30
    21
    25
    No statistical analyses for this end point

    Secondary: Number of Participants With at least one Severe Asthma Exacerbations Through Week 52

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    End point title
    Number of Participants With at least one Severe Asthma Exacerbations Through Week 52
    End point description
    Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Participants with severe asthma exacerbations (hospitalization) were reported. ITT population was considered for this endpoint, which included all participants who are randomized and received any study drug.
    End point type
    Secondary
    End point timeframe
    Week 0 (Day 1) through Week 52
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: Participants
    9
    5
    3
    4
    No statistical analyses for this end point

    Secondary: Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52

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    End point title
    Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52
    End point description
    The AQLQ(S) +12 is a 32-item questionnaire that measures the health-related quality of life experienced by asthma participants. The questionnaire comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli) scaled on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). ITT population was considered for this endpoint, which included all participants who are randomized and received any study drug.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 [Day 1]) and Week 52
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    47
    51
    41
    48
    Units: Units on a scale
        arithmetic mean (standard deviation)
    1.04 ± 1.11
    1.19 ± 0.90
    0.93 ± 1.03
    1.13 ± 1.13
    No statistical analyses for this end point

    Secondary: Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52

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    End point title
    Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52
    End point description
    The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems, and extreme problems) that reflect increasing levels of difficulty. The questionnaire also includes a visual analogue scale, where the participant will be asked to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state. The health state valuation (an index-based value) and the visual analog scale were summarized. ITT population was considered for this endpoint, which included all participants who are randomized and received any study drug. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 [Day 1]) and Week 52
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Health State Valuation (n=38,41,33,40)
    0.1051 ± 0.1511
    0.0752 ± 0.2179
    0.0729 ± 0.1624
    0.0395 ± 0.1935
        Visual Analog Scale (n=138,138,137,137)
    13.8 ± 17.6
    14.0 ± 16.4
    12.0 ± 18.0
    12.3 ± 18.0
    No statistical analyses for this end point

    Secondary: Total amount of Study Drug Exposure

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    End point title
    Total amount of Study Drug Exposure [1]
    End point description
    The total amount of study drug exposure (in mg) for the entire study period was summarized. As-treated population was considered for this endpoint, which included all participants who received any study drug.
    End point type
    Secondary
    End point timeframe
    Week 0 (Day 1) through Week 52
    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: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    137
    137
    Units: Milligram
        arithmetic mean (standard deviation)
    877.0 ± 116.9
    2493.9 ± 640.4
    6574.9 ± 1630.2
    No statistical analyses for this end point

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

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    End point title
    Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
    End point description
    An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any AE that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period until and including the follow-up period (Week 64). As-treated population was considered for this endpoint, which included all participants who received any study drug.
    End point type
    Secondary
    End point timeframe
    Day 1 upto Week 64
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: Participants
        TEAEs|
    91
    93
    90
    89
        TESAEs|
    18
    17
    13
    18
    No statistical analyses for this end point

    Secondary: Number of Participants With TEAEs Related to Vital Sign Parameters

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    End point title
    Number of Participants With TEAEs Related to Vital Sign Parameters
    End point description
    AEs observed in participants with clinically significant vital signs abnormalities were assessed. As-treated population was considered for this endpoint, which included all participants who received any study drug.
    End point type
    Secondary
    End point timeframe
    Day 1 upto Week 64
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: Participants
        Blood pressure diastolic increased|
    0
    1
    0
    0
        Blood pressure increased|
    1
    2
    1
    0
        Heart rate increased|
    0
    0
    0
    1
        Hypertension|
    7
    7
    5
    6
        Hypertensive crisis|
    0
    0
    0
    1
        Hypotension|
    0
    0
    0
    2
        Pyrexia|
    0
    2
    2
    0
        Respiratory rate increased|
    0
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Participants With TEAEs Related to Clinical Laboratory Evaluation

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    End point title
    Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
    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. Laboratory evaluations of blood and urine samples were performed. As-treated population was considered for this endpoint, which included all participants who received any study drug.
    End point type
    Secondary
    End point timeframe
    Day 1 upto Week 64
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: Participants
        Anaemia|
    0
    0
    0
    1
        Leukopenia|
    0
    1
    0
    0
        Lymphopenia|
    0
    1
    0
    0
        Neutropenia|
    0
    1
    0
    0
        Thrombocytopenia|
    0
    1
    0
    0
        Dyslipidaemia|
    0
    1
    0
    0
        Hepatic enzyme increased|
    0
    0
    1
    0
        Hypercholesterolaemia|
    0
    0
    1
    0
        Hyperuricaemia|
    0
    0
    1
    0
        Hypokalaemia|
    0
    0
    1
    0
        Vitamin D deficiency|
    0
    0
    1
    0
        Hematuria|
    1
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With TEAEs Related to Electrocardiogram Evaluations

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    End point title
    Number of Participants With TEAEs Related to Electrocardiogram Evaluations
    End point description
    AEs observed in participants with clinically significant ECG abnormalities were assessed. As-treated population was considered for this endpoint, which included all participants who received any study drug.
    End point type
    Secondary
    End point timeframe
    From the start of study drug administration upto Week 64
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: Participants
        Atrial fibrillation|
    1
    0
    2
    0
        Atrial flutter|
    0
    1
    0
    0
        Bundle branch block left|
    0
    0
    1
    0
        Supraventricular extrasystoles|
    1
    0
    0
    0
        Tachycardia|
    1
    1
    1
    2
    No statistical analyses for this end point

    Secondary: Mean Serum Concentrations of MEDI9929

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    End point title
    Mean Serum Concentrations of MEDI9929 [2]
    End point description
    The mean serum concentrations of MEDI9929 was observed at specified timepoints. Pharmacokinetic population was considered for this endpoint, which included all participants who received MEDI9929 and have a sufficient number of serum concentration measurements. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 12, 20, 28, 40, 52, and 64
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    133
    128
    132
    Units: ng/mL
    arithmetic mean (standard deviation)
        Week 4 (n=129,126,130)
    3933.6 ± 3022.7
    10733.1 ± 4649.4
    39722.7 ± 15140.7
        Week 12 (n=129,121,126)
    6215.8 ± 3779.2
    16625.4 ± 7751.6
    63223.7 ± 60627.6
        Week 20 (n=126,113,116)
    6028.3 ± 2897.9
    18237.1 ± 8721.9
    64442.9 ± 22558.3
        Week 28 (n=127,117,120)
    6084.1 ± 2885.5
    19373.4 ± 9191.4
    64659.9 ± 24121.6
        Week 40 (n=127,117,118)
    6050.4 ± 3296.4
    18926.1 ± 10252.7
    64404.0 ± 26473.0
        Week 52 (n=128,118,116)
    6027.2 ± 3024.8
    18821.9 ± 10435.2
    68899.1 ± 71137.2
        Week 64 (n=123,116,113)
    632.8 ± 519.5
    1991.2 ± 1882.4
    6986.0 ± 5289.0
    No statistical analyses for this end point

    Secondary: Number of Participants With Positive Antibodies to MEDI9929

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    End point title
    Number of Participants With Positive Antibodies to MEDI9929
    End point description
    Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9929. The number of participants with positive serum antibodies to MEDI9929 were presented. As-treated population was considered for this endpoint, which included all participants who received any study drug. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Week 0 (Day 1) to Week 64
    End point values
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Number of subjects analysed
    138
    138
    137
    137
    Units: Participants
        ADA Positive at Baseline (n=138,137,136,135)
    7
    1
    2
    2
        ADA prevalence (n=138,136,131,131)
    13
    6
    2
    4
        ADA incidence (n=138,136,131,131)
    13
    5
    1
    3
        NeutralizingAntibodyADAPositive(n=138,136,131,131)
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 upto Week 64
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received 3 subcutaneous (SC) injections (1 × 1 mL and 2 × 1.5 mL) of placebo matched to MEDI9929 once every 2 weeks from Week 0, Day 1 to Week 50.

    Reporting group title
    MEDI9929 70 mg
    Reporting group description
    Participants received 3 SC injections (1 × 1 mL MEDI9929 and 2 × 1.5 mL placebo) once every 4 weeks from Week 0, Day 1 to Week 48 alternating with 3 SC injections (1 × 1 mL and 2 × 1.5 mL of placebo) once every 4 weeks from Week 2 to Week 50 equivalent to MEDI9929 70 milligram (mg) dose.

    Reporting group title
    MEDI9929 210 mg
    Reporting group description
    Participants received 3 SC injections (1 × 1 mL MEDI9929 and 2 × 1.5 mL [combining 1 mL MEDI9929 and 0.5 mL placebo in each syringe]) once every 4 weeks from Week 0, Day 1 to Week 48 alternating with 3 SC injections (1 × 1 mL and 2 × 1.5 mL of placebo) once every 4 weeks from Week 2 to Week 50 equivalent to MEDI9929 210 mg dose.

    Reporting group title
    MEDI9929 280 mg
    Reporting group description
    Participants received 3 SC injections (1 × 1 mL and 2 × 1.5 mL) of MEDI9929 280 mg dose once every 2 weeks from Week 0, Day 1 to Week 50.

    Serious adverse events
    Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 138 (13.04%)
    17 / 138 (12.32%)
    13 / 137 (9.49%)
    18 / 137 (13.14%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    1
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    1 / 137 (0.73%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (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
    Lipoma
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (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
    Prostate cancer
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (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
    Prostate cancer stage i
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    0 / 137 (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
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion threatened
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperemesis gravidarum
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (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
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (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
    Reproductive system and breast disorders
    Cervical leukoplakia
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Testicular pain
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (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
    Injury, poisoning and procedural complications
    Cartilage injury
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (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
    Concussion
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body aspiration
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (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
    Ligament sprain
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (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
    Lower limb fracture
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (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
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (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
    Upper limb fracture
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (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
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    0 / 137 (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
    Atrial flutter
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (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
    Cardiac failure
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (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
    Myocardial infarction
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (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
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    10 / 138 (7.25%)
    5 / 138 (3.62%)
    4 / 137 (2.92%)
    6 / 137 (4.38%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 5
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (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
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (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
    Guillain-barre syndrome
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (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
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    0 / 137 (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
    Hiatus hernia
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (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
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    0 / 137 (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
    Dermatitis contact
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (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
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (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
    Osteoarthritis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (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
    Osteochondrosis
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (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
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (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
    Cellulitis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    0 / 137 (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
    Chronic sinusitis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Genitourinary tract infection
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (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
    Pneumonia
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 138 (2.17%)
    0 / 137 (0.00%)
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (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
    Sinusitis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    0 / 137 (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
    Staphylococcal infection
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (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
    Tooth abscess
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 138 (0.00%)
    0 / 137 (0.00%)
    0 / 137 (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
    Urinary tract infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 138 (0.72%)
    0 / 137 (0.00%)
    0 / 137 (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
    Viral infection
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    1 / 137 (0.73%)
    0 / 137 (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 MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    56 / 138 (40.58%)
    49 / 138 (35.51%)
    44 / 137 (32.12%)
    50 / 137 (36.50%)
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    47 / 138 (34.06%)
    31 / 138 (22.46%)
    23 / 137 (16.79%)
    35 / 137 (25.55%)
         occurrences all number
    111
    50
    37
    47
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 138 (4.35%)
    6 / 138 (4.35%)
    11 / 137 (8.03%)
    5 / 137 (3.65%)
         occurrences all number
    11
    10
    21
    11
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    16 / 138 (11.59%)
    19 / 138 (13.77%)
    19 / 137 (13.87%)
    15 / 137 (10.95%)
         occurrences all number
    26
    24
    25
    30
    Bronchitis
         subjects affected / exposed
    7 / 138 (5.07%)
    7 / 138 (5.07%)
    5 / 137 (3.65%)
    9 / 137 (6.57%)
         occurrences all number
    11
    7
    6
    11

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Oct 2014
    The original protocol was amended to modify several inclusion and exclusion criteria for ease of enrollment, to provide further clarification, and to correct typographical errors.
    10 Feb 2016
    The purpose of this amendment was to change the Medical Monitor of the study.
    01 Aug 2016
    The purpose of this amendment was to change the Medical Monitor of the study.

    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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