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    Clinical Trial Results:
    A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to Medium-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients with Uncontrolled Asthma (PAMPERO)

    Summary
    EudraCT number
    		 2013-002352-32
    Trial protocol
    		 DE   PL   SE   BG  
    Global end of trial date
    22 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2017
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D3250C00016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AZ-PPD
    Sponsor organisation address
    Granta Park, Great Ablington, Cambridge, United Kingdom, CB21 6GQ
    Public contact
    Peggy Snowden, Astrazeneca, 1 3013980466, Peggy.snoden@astrazeneca.com
    Scientific contact
    Steven Fox, AZ-PPD, 44 1480716682, steven.fox@ppdi.com
    Sponsor organisation name
    Astrazeneca
    Sponsor organisation address
    1 MedImmune Way, Gaithersburg, MD, United States, 20878
    Public contact
    Peggy Snowden, Astrazeneca, 1 3013980466, peggy.snowden@astrazeneca.com
    Scientific contact
    Curt Johnson, Astrazeneca, 1 3013980466, Curt.johnson@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
    12 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jul 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect of two dosing regimens of benralizumab on asthma exacerbations in adult patients with uncontrolled asthma.
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Conference on Harmonisation/Good Clinical Practice (GCP) and applicable regulatory requirements and the AstraZeneca policy on Bioethics and Human Biological Samples. The investigator at each center ensured that the patient, parent, guardian, or legal representative (as appropriate) was given full and adequate oral and written information about the nature, purpose, possible risk, and benefit of the study. The patient, parent, guardian, or legal representative (as appropriate) were notified that they were free to discontinue from the study at any time and were given the opportunity to ask questions and allowed time to consider the information provided.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Nov 2013
    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
    United States: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    0
    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)
    11
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was stopped with 13 patients randomised

    Pre-assignment
    Screening details
    		 13 patients were enrolled and 13 were randomised

    Pre-assignment period milestones
    Number of subjects started
    		 130 [1]
    Number of subjects completed
    		 13

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Sponsor decision to terminate study: 117
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects enrolled is smaller because the study was terminated.
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Benra 30 mg q.4 weeks
    Arm description
    		 Fixed 30 mg dose of benralizumab (every 4 weeks)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benralizumab
    Investigational medicinal product code
    MEDI-563
    Other name
    aa
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30 mg q.4

    Arm title
    		 Benra 30 mg-Placebo q.8 weeks
    Arm description
    		 Fixed 30 mg dose of belralizumab (every 4 weeks for the first 3 doses and then every 8 weeks thereafter)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benralizumab
    Investigational medicinal product code
    MEDI-563
    Other name
    aa
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30 mg q.8

    Arm title
    		 Placebo
    Arm description
    		 A (Dummy) injection
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30 mg

    Number of subjects in period 1
    		Benra 30 mg q.4 weeks Benra 30 mg-Placebo q.8 weeks Placebo
    Started
    3
    5
    5
    Completed
    3
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Benra 30 mg q.4 weeks
    Reporting group description
    		 Fixed 30 mg dose of benralizumab (every 4 weeks)

    Reporting group title
    Benra 30 mg-Placebo q.8 weeks
    Reporting group description
    		 Fixed 30 mg dose of belralizumab (every 4 weeks for the first 3 doses and then every 8 weeks thereafter)

    Reporting group title
    Placebo
    Reporting group description
    		 A (Dummy) injection

    Reporting group values
    		 Benra 30 mg q.4 weeks Benra 30 mg-Placebo q.8 weeks Placebo Total
    Number of subjects
    		 3 5 5 13
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 2 4 5 11
        From 65-84 years
    		 1 1 0 2
        85 years and over
    		 0 0 0 0
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 58.7 ( 15.7 ) 57.8 ( 6.38 ) 49.6 ( 6.35 ) -
    Gender, Male/Female
    Units: Male/Female
        Female
    		 2 4 5 11
        Male
    		 1 1 0 2

    End points

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    End points reporting groups
    Reporting group title
    Benra 30 mg q.4 weeks
    Reporting group description
    		 Fixed 30 mg dose of benralizumab (every 4 weeks)

    Reporting group title
    Benra 30 mg-Placebo q.8 weeks
    Reporting group description
    		 Fixed 30 mg dose of belralizumab (every 4 weeks for the first 3 doses and then every 8 weeks thereafter)

    Reporting group title
    Placebo
    Reporting group description
    		 A (Dummy) injection

    Primary: Asthma exacerbations over 48 weeks treatment

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    End point title
    		 Asthma exacerbations over 48 weeks treatment [1]
    End point description
    End point type
    Primary
    End point timeframe
    48 weeks treatment
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Owing to the insufficient sample size no statistical analyses were performed .
    End point values
    		 Benra 30 mg q.4 weeks Benra 30 mg-Placebo q.8 weeks Placebo
    Number of subjects analysed
    3
    5
    5
    Units: Number of events
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    57 days was the maximum duration experienced by a patient, since the study was stopped early.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Benra 30 mg q.4 weeks
    Reporting group description
    		 Fixed 30 mg dose of benralizumab (every 4 weeks)

    Reporting group title
    Placebo
    Reporting group description
    		 A (Dummy) injection

    Reporting group title
    Benra 30 mg-Placebo q.8 weeks
    Reporting group description
    		 Fixed 30 mg dose of belralizumab (every 4 weeks for the first 3 doses and then every 8 weeks thereafter)

    Serious adverse events
    		 Benra 30 mg q.4 weeks Placebo Benra 30 mg-Placebo q.8 weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Benra 30 mg q.4 weeks Placebo Benra 30 mg-Placebo q.8 weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    Respiratory, thoracic and mediastinal disorders
    Prolonged expiration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    22 Jul 2014
    Sponsor decision to terminate
    -

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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