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    Clinical Trial Results:
    An open-label, single arm, repeat dose, multi-center study to evaluate the use of an autoinjector for the subcutaneous administration of mepolizumab in subjects with severe eosinophilic asthma (Study 204959)

    Summary
    EudraCT number
    2016-001832-36
    Trial protocol
    GB   DE   SE   Outside EU/EEA  
    Global end of trial date
    30 Nov 2017

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

    Trial information

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    Trial identification
    Sponsor protocol code
    204959
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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
    19 Mar 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the use of the combination product, mepolizumab liquid drug product in autoinjector for the subcutaneous self-administration of mepolizumab by participants with severe eosinophilic asthma
    Protection of trial subjects
    The participants were educated by site staff prior to self-administration and their first scheduled dose was supervised in the clinic by site staff. Additionally, the IFU instructed the participants on the safe use of the device. A plastic needle guard shields the needle before and after injection to minimise the potential for needle stick injuries. Following injection, the needle guard re-extends and locks in place to cover the needle. The risk of systemic reactions associated with a mAb therapy was mitigated with AE monitoring, participant monitoring for 1 h following in clinic injections, and participant instructions to call the investigator and/or go to an Emergency Department for any unusual symptoms.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 May 2017
    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: 17
    Country: Number of subjects enrolled
    Canada: 15
    Country: Number of subjects enrolled
    Germany: 26
    Country: Number of subjects enrolled
    Russian Federation: 9
    Country: Number of subjects enrolled
    Sweden: 5
    Country: Number of subjects enrolled
    United Kingdom: 19
    Country: Number of subjects enrolled
    United States: 68
    Worldwide total number of subjects
    159
    EEA total number of subjects
    50
    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)
    11
    Adults (18-64 years)
    122
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants with severe eosinophilic asthma, were enrolled at 16 sites in the United States of America, 6 sites in Germany, 5 sites in the United Kingdom, 4 sites in Canada, 3 sites in Australia, 2 sites in Russia and 2 sites in Sweden. The study duration lasted from 04 May 2017 to 30 November 2017.

    Pre-assignment
    Screening details
    Of the total 181 participants screened, 22 were screen failures and 159 were enrolled in this open-label, single arm, repeat dose study of mepolizumab and attempted to self-administer at least one dose of study treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Mepolizumab Liquid Autoinjector
    Arm description
    Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, in the thigh, abdomen or upper arm (caregiver only) for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Mepolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants self-administered mepolizumab liquid drug product using an autoinjector (100 milligrams) in the thigh, abdomen or administered in the upper arm (caregiver only) subcutaneously every 4 weeks for 12 weeks.

    Number of subjects in period 1
    Mepolizumab Liquid Autoinjector
    Started
    159
    Completed
    157
    Not completed
    2
         Physician decision
    1
         Adverse event, non-fatal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mepolizumab Liquid Autoinjector
    Reporting group description
    Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, in the thigh, abdomen or upper arm (caregiver only) for 12 weeks.

    Reporting group values
    Mepolizumab Liquid Autoinjector Total
    Number of subjects
    159
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    49.3 ± 16.18 -
    Gender categorical
    Units: Subjects
        Female
    98 98
        Male
    61 61
    Race/Ethnicity, Customized
    Units: Subjects
        African American/African Heritage
    25 25
        Asian - Central/South Asian Heritage
    2 2
        Asian - East Asian Heritage
    1 1
        Asian - South East Asian Heritage
    3 3
        White - Arabic/North African Heritage
    1 1
        White - White/Caucasian/European Heritage
    126 126
        Other
    1 1

    End points

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    End points reporting groups
    Reporting group title
    Mepolizumab Liquid Autoinjector
    Reporting group description
    Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, in the thigh, abdomen or upper arm (caregiver only) for 12 weeks.

    Primary: Percentage of participants with successful self-administration of their observed third dose at Week 8 – Autoinjector with Standard Label + Pictogram

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    End point title
    Percentage of participants with successful self-administration of their observed third dose at Week 8 – Autoinjector with Standard Label + Pictogram [1]
    End point description
    Due to differences in the labelling requirements among regulatory authorities around the world, two different labelling approaches were included in this global study: labelling that includes a pictogram plus standard labelling elements, or a standard labelling without the pictogram. Participants (and/or their caregiver) attended three on treatment visits at Week 0, 4, 8, and End of Study Visit. Training on the study treatment, device handling and administration technique was provided by the investigator or qualified site staff at Week 0 and then first dose was self-administered under observation of investigator/site staff in clinic. Second dose self-administered unobserved, at home (Week 4) and third dose was self-administered under the observation of investigator/site staff in clinic (Week 8). All Subjects (Safety) Population included all enrolled participants attempting at least one self-administration of mepolizumab. Only participants with data available at Week 8 were analyzed.
    End point type
    Primary
    End point timeframe
    Week 8
    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: No statistical analysis was performed
    End point values
    Mepolizumab Liquid Autoinjector
    Number of subjects analysed
    103 [2]
    Units: Percentage of participants
        Percentage of participants
    99
    Notes
    [2] - All Subjects (Safety) Population
    No statistical analyses for this end point

    Primary: Percentage of participants with successful self-administration of their observed third dose at Week 8 – Autoinjector with Standard Label only

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    End point title
    Percentage of participants with successful self-administration of their observed third dose at Week 8 – Autoinjector with Standard Label only [3]
    End point description
    Due to differences in the labeling requirements among regulatory authorities around the world, two different labeling approaches were included in this global study: labeling that includes a pictogram plus standard labeling elements, or a standard labeling without the pictogram. Participants (and/or their caregiver) attended three on treatment visits at Week 0, Week 4, Week 8, and the End of Study Visit. Training on the study treatment, device handling and administration techniques was provided by the investigator or qualified site staff at Week 0 and then first dose was self-administered under observation of investigator/site staff in clinic. Second dose self-administered unobserved, at home (Week 4) and third dose was self-administered under the observation of investigator/site staff in clinic (Week 8). Only participants with data available at Week 8 were analyzed
    End point type
    Primary
    End point timeframe
    Week 8
    Notes
    [3] - 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: No statistical analysis was performed
    End point values
    Mepolizumab Liquid Autoinjector
    Number of subjects analysed
    54 [4]
    Units: Percentage of participants
        Participants
    98
    Notes
    [4] - All Subjects (Safety) Population
    No statistical analyses for this end point

    Secondary: Percentage of participants with successful self-administration of their unobserved dose at Week 4 – Autoinjector with Standard Label + Pictogram

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    End point title
    Percentage of participants with successful self-administration of their unobserved dose at Week 4 – Autoinjector with Standard Label + Pictogram
    End point description
    Due to differences in the labeling requirements among regulatory authorities around the world, two different labeling approaches were included in this global study: labeling that includes a pictogram plus standard labeling elements, or a standard labeling without the pictogram. Data for participants (and/or their caregiver) self-administering the second dose unobserved, at home (Week 4) using Autoinjector with Standard Label + Pictogram has been presented. Only participants with data available at Week 4 were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Mepolizumab Liquid Autoinjector
    Number of subjects analysed
    103 [5]
    Units: Percentage of participants
        Percentage of participants
    98
    Notes
    [5] - All Subjects (Safety) Population
    No statistical analyses for this end point

    Secondary: Percentage of participants with successful self-administration of their unobserved dose at Week 4 – Autoinjector with Standard label only

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    End point title
    Percentage of participants with successful self-administration of their unobserved dose at Week 4 – Autoinjector with Standard label only
    End point description
    Due to differences in the labeling requirements among regulatory authorities around the world, two different labeling approaches were included in this global study: labeling that includes a pictogram plus standard labeling elements, or a standard labeling without the pictogram. Data for participants (and/or their caregiver) self-administering the second dose unobserved, at home (Week 4) using Autoinjector with Standard Label has been presented. Only participants with data available at Week 4 were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Mepolizumab Liquid Autoinjector
    Number of subjects analysed
    54 [6]
    Units: Percentage of participants
        Percentage of participants
    96
    Notes
    [6] - All Subjects (Safety) Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of Study Treatment (Week 0) until the End of Study/Early Withdrawal Visit (Week 12)
    Adverse event reporting additional description
    On-treatment SAEs and non-serious AEs are reported for All Subjects (Safety) Population
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Mepolizumab Liquid Autoinjector
    Reporting group description
    Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, in the thigh, abdomen or upper arm (caregiver only) for 12 weeks.

    Serious adverse events
    Mepolizumab Liquid Autoinjector
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 159 (2.52%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skull fractured base
         subjects affected / exposed
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Alveolitis allergic
         subjects affected / exposed
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Mepolizumab Liquid Autoinjector
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 159 (16.98%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 159 (5.03%)
         occurrences all number
    11
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 159 (5.66%)
         occurrences all number
    11
    Lower respiratory tract infection
         subjects affected / exposed
    5 / 159 (3.14%)
         occurrences all number
    5
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 159 (3.77%)
         occurrences all number
    6
    Urinary tract infection
         subjects affected / exposed
    5 / 159 (3.14%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Oct 2016
    Amendment 01: • To refine the criteria for a successful injection following a use-related risk review • To amend Exclusion Criterion 7 to allow either Fridericia’s or Bazett’s to be used as the correction formula for heart rate when measuring the QT interval • To remove Exclusion Criterion 15 as the exclusion of pregnant or lactating females is covered in Inclusion Criterion 9 • To correct minor typographical errors
    15 Feb 2017
    Amendment 02: • To include information regarding a change to the labelling of the autoinjector so that two different labelling formats will be used, depending on geographical region • To increase the participant numbers as a result of the introduction of two different label formats and to indicate that the results will be presented separately according to the label format • To amend inclusion criterion 5 to allow participants to be enrolled who require high dose inhaled corticosteroids to prevent exacerbations but who may not have received continuous high dose inhaled corticosteroids due to financial or tolerance issues • To remove ‘incidence of asthma exacerbations’ as safety endpoint and reclassify as an other endpoint • To change the wording to indicate that all used autoinjectors should to be returned to GSK rather than just faulty devices • To remove reference to a practice injection into a foam pad prior the first injection at Visit 2 • To add the assessment of asthma exacerbations during the study to the Time and Events table and under Section 7.7.8 • To correct minor typographical errors

    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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