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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of mepolizumab in the treatment of adolescent and adult subjects with severe hypereosinophilic syndrome

    Summary
    EudraCT number
    		 2014-001232-11
    Trial protocol
    		 GB   ES   DE   FR   BE   PL   IT  
    Global end of trial date
    08 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Feb 2020
    First version publication date
    23 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    200622
    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, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.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
    13 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy of mepolizumab compared with placebo based on maintenance of control of hypereosinophilic syndrome (HES) symptoms during the treatment period.
    Protection of trial subjects
    As this was a double-blind trial the participants’ eosinophil (EOS) levels were monitored by an unblinded Medical Monitor. According to a pre-defined process, if a EOS level was met then oral corticosteroids were issued and administered to the participant. This was managed by the unblinded team to ensure the blind was maintained.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Mar 2017
    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
    Argentina: 7
    Country: Number of subjects enrolled
    Belgium: 11
    Country: Number of subjects enrolled
    Brazil: 4
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Mexico: 5
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    Romania: 3
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 15
    Worldwide total number of subjects
    108
    EEA total number of subjects
    70
    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)
    4
    Adults (18-64 years)
    90
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This 32-week, randomized, double-blind, placebo-controlled study assessed the efficacy and safety of mepolizumab 300 milligrams (mg) subcutaneous (SC) every 4 weeks compared with placebo in adolescent and adult participants with severe hypereosinophilic syndrome (HES) receiving standard of care (SoC) therapy.

    Pre-assignment
    Screening details
    		 A total of 108 participants were enrolled in the study and randomized. The study was conducted in 13 countries.

    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
    		 Investigator, Monitor, Carer, Data analyst, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants were randomized to receive matching placebo SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received matching placebo as 0.9 percent (%) sodium chloride solution every 4 weeks. Participants were dosed with three separate placebo SC injections every 4 weeks.

    Arm title
    		 Mepolizumab 300 mg SC
    Arm description
    		 Participants were randomized to receive 300 mg mepolizumab SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mepolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 300 milligrams (mg) mepolizumab lyophilized powder for injection reconstituted with sterile water subcutaneously (SC) every 4 weeks. Participants were dosed with three separate 100 mg SC injections every 4 weeks.

    Number of subjects in period 1
    		Placebo Mepolizumab 300 mg SC
    Started
    54
    54
    Completed
    52
    52
    Not completed
    2
    2
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive matching placebo SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.

    Reporting group title
    Mepolizumab 300 mg SC
    Reporting group description
    		 Participants were randomized to receive 300 mg mepolizumab SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.

    Reporting group values
    		 Placebo Mepolizumab 300 mg SC Total
    Number of subjects
    		 54 54 108
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 3 1 4
        Adults (18-64 years)
    		 41 49 90
        From 65-84 years
    		 10 4 14
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 45.4 ( 18.25 ) 46.6 ( 12.99 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 27 30 57
        Male
    		 27 24 51
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 2 1 3
        Asian-Central/South Asian Heritage
    		 0 1 1
        Asian-East Asian Heritage
    		 1 0 1
        Asian-South East Asian Heritage
    		 1 0 1
        Black or African American
    		 2 0 2
        White-Arabic/North African Heritage
    		 1 0 1
        White-White/Caucasian/European Heritage
    		 47 52 99

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive matching placebo SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.

    Reporting group title
    Mepolizumab 300 mg SC
    Reporting group description
    		 Participants were randomized to receive 300 mg mepolizumab SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.

    Primary: Percentage of participants who experienced an HES flare or who withdrew from the study during the 32-Week study treatment period

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    End point title
    		 Percentage of participants who experienced an HES flare or who withdrew from the study during the 32-Week study treatment period
    End point description
    Percentage of participants who experienced >=1 HES flare during the 32-Week treatment period or who withdrew from the study has been presented. A HES flare is defined as a HES related clinical manifestation based on a physician-documented change in clinical signs or symptoms which resulted in need for an increase in the maintenance Oral Corticosteroid (OCS) dose by at least 10 mg per day for 5 days or an increase in or addition of any cytotoxic or immunosuppressive HES therapy. HES flare is also defined as receipt of two or more courses of blinded active OCS during the treatment period. Intent-to-treat (ITT) Population comprises of all randomized participants. This population was based on the treatment to which the participants were randomized. Any participant who received a treatment randomization number were considered to be randomized.
    End point type
    Primary
    End point timeframe
    Up to Week 32
    End point values
    		 Placebo Mepolizumab 300 mg SC
    Number of subjects analysed
    54 [1]
    54 [2]
    Units: Percentage of participants
    56
    28
    Notes
    [1] - ITT Population.
    [2] - ITT Population.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Mepolizumab 300 mg SC
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [3] - Cochran-Mantel-Haenszel test stratified by Baseline oral corticosteroid (OCS) (0-<=20 mg per day and >20mg perday prednisone or equivalent) and region
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v Mepolizumab 300 mg SC
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.003 [5]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.12
         upper limit
    		 0.64
    Notes
    [4] - Treatment comparison between placebo and mepolizumab 300 mg using odds ratio and 95% confidence interval (CI) has been presented. Odds ratio <1 indicated lower odds of HES flare with Mepolizumab compared with placebo.
    [5] - Logistic regression analysis adjusted for Baseline OCS dose and region.

    Secondary: Percentage of participants who experienced a HES Flare or who withdrew from the study during Week 20 Through Week 32

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    End point title
    		 Percentage of participants who experienced a HES Flare or who withdrew from the study during Week 20 Through Week 32
    End point description
    HES flare during Week 20 through Week 32 was defined as a HES flare starting or ongoing on or after the date of the Week 20 visit up to and including the date of the Week 32 visit. Percentage of participants who experienced >=1 HES flare during Week 20 through Week 32 or who withdrew from the study has been presented.
    End point type
    Secondary
    End point timeframe
    Week 20 to Week 32
    End point values
    		 Placebo Mepolizumab 300 mg SC
    Number of subjects analysed
    54 [6]
    54 [7]
    Units: Percentage of participants
    35
    17
    Notes
    [6] - ITT Population.
    [7] - ITT Population.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Mepolizumab 300 mg SC
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [8] - Cochran-Mantel-Haenszel test stratified by Baseline OCS (0-<=20 mg per day and >20mg perday prednisone or equivalent) and region.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v Mepolizumab 300 mg SC
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.022 [10]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 0.85
    Notes
    [9] - Treatment comparison between placebo and mepolizumab 300 mg using odds ratio and 95% CI has been presented. Odds ratio <1 indicated lower odds of HES flare with Mepolizumab compared with placebo.
    [10] - Logistic regression analysis adjusted for Baseline OCS dose and region

    Secondary: Time to first HES flare

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    End point title
    		 Time to first HES flare
    End point description
    The time to first HES flare was calculated as (onset date of first HES flare minus date of first dose of study treatment) plus 1. Probability of first flare (by week 4, 8, 12, 16, 20, 24, 28, and 32) and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20, 24, 28 and 32
    End point values
    		 Placebo Mepolizumab 300 mg SC
    Number of subjects analysed
    54 [11]
    54 [12]
    Units: Probability expressed as percentage
    number (confidence interval 95%)
        Flares by Week 4
    7.4 (2.8 to 18.5)
    5.6 (1.8 to 16.2)
        Flares by Week 8
    14.9 (7.7 to 27.5)
    7.4 (2.8 to 18.5)
        Flares by Week 12
    26.2 (16.4 to 40.2)
    9.3 (4.0 to 20.8)
        Flares by Week 16
    33.8 (22.8 to 48.1)
    13.0 (6.4 to 25.3)
        Flares by Week 20
    41.3 (29.5 to 55.7)
    13.0 (6.4 to 25.3)
        Flares by Week 24
    48.9 (36.5 to 63.0)
    14.8 (7.7 to 27.4)
        Flares by Week 28
    50.8 (38.3 to 64.8)
    20.5 (11.9 to 34.0)
        Flares by Week 32
    52.7 (40.1 to 66.5)
    26.3 (16.5 to 40.3)
    Notes
    [11] - ITT Population.
    [12] - ITT Population.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Mepolizumab 300 mg SC
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 = 0.002 [14]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.18
         upper limit
    		 0.67
    Notes
    [13] - Treatment comparison between placebo and mepolizumab 300 mg using hazards ratio and its corresponding 95% CI has been presented. Hazard ratio <1 indicated a lower risk of HES flare with Mepolizumab compared with Placebo.
    [14] - Cox proportional hazards regression analysis adjusted for Baseline OCS dose and region.

    Secondary: Number of HES flares per participant per year

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    End point title
    		 Number of HES flares per participant per year
    End point description
    The rate of HES flares for each participant was calculated as the number of observed HES flares divided by the time (expressed in years) between randomization and either the week 32 visit date if available, or the study withdrawal date. Negative binomial generalized linear model including Baseline OCS dose, region, treatment and observed time (offset variable). Wilcoxon test stratified by Baseline OCS (0-<=20mg/day, >20mg/day prednisone or equivalent) and region. Adjusted mean and 95% CI rate/year has been presented.
    End point type
    Secondary
    End point timeframe
    Up to Week 32
    End point values
    		 Placebo Mepolizumab 300 mg SC
    Number of subjects analysed
    54 [15]
    54 [16]
    Units: Flares per participant per year
        arithmetic mean (confidence interval 95%)
    1.46 (1.05 to 2.02)
    0.50 (0.30 to 0.84)
    Notes
    [15] - ITT Population.
    [16] - ITT Population.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Mepolizumab 300 mg SC
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 = 0.002 [18]
    Method
    		 Wilcoxon Rank Sum Test
    Parameter type
    		 Rate Ratio
    Point estimate
    0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.19
         upper limit
    		 0.63
    Notes
    [17] - Treatment comparison between placebo and mepolizumab 300 mg using rate ratio and 95% CI has been presented. Rate ratio <1 indicates a lower flare rate with Mepolizumab compared with Placebo.
    [18] - Wilcoxon test stratified by Baseline OCS (0-<=20 mg/day, >20 mg/day prednisone or equivalent) and region.

    Secondary: Number of participants with change from Baseline in fatigue severity based on Brief Fatigue Inventory (BFI) in item 3 (worst level of fatigue during past 24 hours) at Week 32 by category

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    End point title
    		 Number of participants with change from Baseline in fatigue severity based on Brief Fatigue Inventory (BFI) in item 3 (worst level of fatigue during past 24 hours) at Week 32 by category
    End point description
    The change from Baseline in fatigue severity (worst level of fatigue during past 24 hours) at Week 32 was calculated using the mean of the 7 daily assessments of BFI item 3 up to and including the date of the Week 32 visit as the Week 32 assessment, and the mean of the 7 daily assessments of BFI item 3 up to but not including the date of first dose of study treatment as the Baseline assessment. Wilcoxon Rank Sum test stratified by Baseline fatigue severity ("severe" defined as BFI item 3>=7 and "not severe" defined as BFI item 3<7), Baseline OCS (0-<=20mg/day and >20mg/day prednisone or equivalent) and region. Participants with missing change from Baseline at Week 32 were included in the worst category (>=4 point increase).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and at Week 32
    End point values
    		 Placebo Mepolizumab 300 mg SC
    Number of subjects analysed
    54 [19]
    54 [20]
    Units: Participants
        >=4 point increase (>=3.5)
    7
    5
        3 point increase (>=2.5 to <3.5)
    4
    0
        2 point increase (>=1.5 to <2.5)
    4
    5
        1 point increase (>=0.5 to <1.5)
    9
    6
        No change (>-0.5 to <0.5)
    14
    9
        1 point reduction (>-1.5 to <=-0.5)
    5
    11
        2 point reduction (>-2.5 to <=-1.5)
    3
    7
        3 point reduction (>-3.5 to <=-2.5)
    5
    2
        >=4 point reduction (<=-3.5)
    3
    9
    Notes
    [19] - ITT Population.
    [20] - ITT Population.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Mepolizumab 300 mg SC
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.036 [21]
    Method
    		 Wilcoxon Rank Sum Test
    Confidence interval
    Notes
    [21] - P-value was calculated using Wilcoxon Rank Sum Test

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious adverse events (non-SAEs) from start of study treatment until 28 days after last dose (Up to 32 weeks) are reported. SAEs were collected from the day of randomization (Week 0) up to end of study (Up to Week 40).
    Adverse event reporting additional description
    Non-SAEs and SAEs were collected for Safety Population. The Safety Population comprises of all participants who were randomized and who received at least one dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Mepolizumab 300 mg SC
    Reporting group description
    		 Participants were randomized to receive 300 mg mepolizumab SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive matching placebo SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.

    Serious adverse events
    		 Mepolizumab 300 mg SC Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 54 (18.52%)
    9 / 54 (16.67%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    T-cell lymphoma
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Restrictive cardiomyopathy
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Hypereosinophilic syndrome
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Musculoskeletal and connective tissue disorders
    Costochondritis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis infective
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tooth infection
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Mepolizumab 300 mg SC Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 54 (75.93%)
    43 / 54 (79.63%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 54 (3.70%)
         occurrences all number
    1
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 54 (5.56%)
    5 / 54 (9.26%)
         occurrences all number
    3
    9
    Pyrexia
         subjects affected / exposed
    4 / 54 (7.41%)
    2 / 54 (3.70%)
         occurrences all number
    5
    2
    Asthenia
         subjects affected / exposed
    0 / 54 (0.00%)
    5 / 54 (9.26%)
         occurrences all number
    0
    6
    Influenza like illness
         subjects affected / exposed
    3 / 54 (5.56%)
    2 / 54 (3.70%)
         occurrences all number
    3
    2
    Injection site reaction
         subjects affected / exposed
    3 / 54 (5.56%)
    2 / 54 (3.70%)
         occurrences all number
    5
    10
    Peripheral swelling
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 54 (3.70%)
         occurrences all number
    1
    2
    Malaise
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Vaginal haemorrhage
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 54 (3.70%)
    5 / 54 (9.26%)
         occurrences all number
    2
    7
    Dyspnoea
         subjects affected / exposed
    3 / 54 (5.56%)
    2 / 54 (3.70%)
         occurrences all number
    5
    3
    Nasal obstruction
         subjects affected / exposed
    3 / 54 (5.56%)
    2 / 54 (3.70%)
         occurrences all number
    3
    2
    Rhinorrhoea
         subjects affected / exposed
    1 / 54 (1.85%)
    4 / 54 (7.41%)
         occurrences all number
    1
    4
    Cough
         subjects affected / exposed
    0 / 54 (0.00%)
    4 / 54 (7.41%)
         occurrences all number
    0
    4
    Epistaxis
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 54 (3.70%)
         occurrences all number
    1
    2
    Oropharyngeal pain
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 54 (3.70%)
         occurrences all number
    2
    2
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 54 (1.85%)
         occurrences all number
    3
    2
    Skin abrasion
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 54 (0.00%)
         occurrences all number
    3
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 54 (12.96%)
    7 / 54 (12.96%)
         occurrences all number
    11
    15
    Dizziness
         subjects affected / exposed
    4 / 54 (7.41%)
    3 / 54 (5.56%)
         occurrences all number
    4
    3
    Hypoaesthesia
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 54 (1.85%)
         occurrences all number
    3
    1
    Paraesthesia
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 54 (0.00%)
         occurrences all number
    3
    0
    Presyncope
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    0
    3
    Somnolence
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 54 (9.26%)
    7 / 54 (12.96%)
         occurrences all number
    7
    7
    Vomiting
         subjects affected / exposed
    3 / 54 (5.56%)
    3 / 54 (5.56%)
         occurrences all number
    3
    3
    Nausea
         subjects affected / exposed
    3 / 54 (5.56%)
    2 / 54 (3.70%)
         occurrences all number
    4
    3
    Constipation
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 54 (1.85%)
         occurrences all number
    6
    2
    Abdominal pain
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 54 (3.70%)
         occurrences all number
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 54 (3.70%)
         occurrences all number
    1
    2
    Stomatitis
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 54 (1.85%)
         occurrences all number
    2
    1
    Toothache
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 54 (1.85%)
         occurrences all number
    3
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 54 (7.41%)
    7 / 54 (12.96%)
         occurrences all number
    4
    8
    Urticaria
         subjects affected / exposed
    0 / 54 (0.00%)
    5 / 54 (9.26%)
         occurrences all number
    0
    7
    Alopecia
         subjects affected / exposed
    4 / 54 (7.41%)
    0 / 54 (0.00%)
         occurrences all number
    4
    0
    Rash
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 54 (3.70%)
         occurrences all number
    2
    2
    Eczema
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Erythema
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Hyperhidrosis
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 54 (7.41%)
    4 / 54 (7.41%)
         occurrences all number
    10
    4
    Pain in extremity
         subjects affected / exposed
    6 / 54 (11.11%)
    2 / 54 (3.70%)
         occurrences all number
    7
    2
    Myalgia
         subjects affected / exposed
    4 / 54 (7.41%)
    3 / 54 (5.56%)
         occurrences all number
    7
    3
    Back pain
         subjects affected / exposed
    3 / 54 (5.56%)
    3 / 54 (5.56%)
         occurrences all number
    4
    4
    Musculoskeletal chest pain
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 54 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    7 / 54 (12.96%)
    10 / 54 (18.52%)
         occurrences all number
    7
    12
    Nasopharyngitis
         subjects affected / exposed
    7 / 54 (12.96%)
    7 / 54 (12.96%)
         occurrences all number
    7
    9
    Rhinitis
         subjects affected / exposed
    5 / 54 (9.26%)
    6 / 54 (11.11%)
         occurrences all number
    6
    6
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 54 (14.81%)
    2 / 54 (3.70%)
         occurrences all number
    10
    2
    Sinusitis
         subjects affected / exposed
    2 / 54 (3.70%)
    4 / 54 (7.41%)
         occurrences all number
    2
    5
    Urinary tract infection
         subjects affected / exposed
    5 / 54 (9.26%)
    0 / 54 (0.00%)
         occurrences all number
    6
    0
    Influenza
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 54 (1.85%)
         occurrences all number
    3
    1
    Oral herpes
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 54 (3.70%)
         occurrences all number
    3
    2
    Cystitis
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 54 (3.70%)
         occurrences all number
    1
    2
    Gastroenteritis
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 54 (3.70%)
         occurrences all number
    1
    2
    Arthritis infective
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Gastroenteritis viral
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    3
    Onychomycosis
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Respiratory tract infection
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    0
    3

    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? 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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    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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