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    Clinical Trial Results:
    A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard of Care Therapy.

    Summary
    EudraCT number
    2012-004385-17
    Trial protocol
    BE   DE   GB   IT   ES  
    Global end of trial date
    05 Sep 2016

    Results information
    Results version number
    v4(current)
    This version publication date
    10 Feb 2018
    First version publication date
    14 Sep 2017
    Other versions
    v1 , v2 , v3
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    115921
    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)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000069-PIP04-13
    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
    09 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of mepolizumab plus standard of care compared with placebo plus standard of care on duration of clinical remission, defined as accrued duration in weeks where a subject achieves a BVAS=0 and corticosteroid dose ≤4 mg/day prednisolone/prednisone, in subjects with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA) receiving standard of care therapy including corticosteroid therapy reduction/withdrawal. To investigate the durability of response to treatment with mepolizumab plus standard of care compared with placebo plus standard of care, assessed by the proportion of subjects in remission at both Weeks 36 and 48.
    Protection of trial subjects
    Not applicable
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Feb 2014
    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
    Spain: 4
    Country: Number of subjects enrolled
    United Kingdom: 13
    Country: Number of subjects enrolled
    United States: 59
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Canada: 6
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Germany: 19
    Country: Number of subjects enrolled
    Italy: 13
    Country: Number of subjects enrolled
    Japan: 6
    Worldwide total number of subjects
    136
    EEA total number of subjects
    65
    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)
    119
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Eligible participants at screening and run-in visit, entered a 52 week study treatment phase followed by 8-week follow-up phase. The total duration for the study participation was approximately 64 weeks.

    Pre-assignment
    Screening details
    A total of 151 participants with a history of relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) were screened, out of which 4 were screen failures and 11 were run-in failures. 136 participants completed run-in period and received Mepolizumab 300 milligram (mg) or placebo in a randomized manner in the treatment phase.

    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, Assessor, Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
    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
    Randomized participants received placebo (0.9 percent sodium chloride) injection via subcutaneous route once every 4 weeks along with standard of care treatment.

    Arm title
    Mepolizumab 300mg
    Arm description
    Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
    Arm type
    Experimental

    Investigational medicinal product name
    Mepolizumab 300 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Randomized participants received Mepolizumab 300 mg injection via subcutaneous route once every 4 weeks along with standard of care treatment.

    Number of subjects in period 1
    Placebo Mepolizumab 300mg
    Started
    68
    68
    Completed
    61
    65
    Not completed
    7
    3
         Physician decision
    2
    -
         Lack of efficacy
    1
    -
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    3
    2
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.

    Reporting group title
    Mepolizumab 300mg
    Reporting group description
    Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.

    Reporting group values
    Placebo Mepolizumab 300mg Total
    Number of subjects
    68 68
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    48.2 ± 14.32 48.7 ± 12.39 -
    Gender categorical
    Units: Subjects
        Female
    38 42 80
        Male
    30 26 56
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaskan Native
    0 1 1
        Asian - Japanese Heritage
    3 3 6
        Asian - South East Asian Heritage
    2 0 2
        White - Arabic/North African Heritage
    0 2 2
        White - White/Caucasian/European Heritage
    61 62 123
        Mixed Race
    2 0 2

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.

    Reporting group title
    Mepolizumab 300mg
    Reporting group description
    Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.

    Primary: Number of Participants in Each Category of Accrued Duration of Remission

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    End point title
    Number of Participants in Each Category of Accrued Duration of Remission
    End point description
    Total accrued duration of remission is the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose <=4 mg/day over the 52 week study treatment period was reported. The accrued duration was categorized into zero, >0 to <12 weeks, 12 to <24 weeks, 24 to <36 weeks and >=36 weeks. Statistical analysis was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. Intent-to-Treat (ITT) Population was used for the analysis and was defined as all participants who were randomized and received at least one dose of trial medication. Randomized participants were assumed to have received study treatment unless definitive evidence to the contrary exists. The odds ratio for treatment difference and associated probability (p)-value and 95 percent confidence interval (CI) were calculated.
    End point type
    Primary
    End point timeframe
    Up to Week 52
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [1]
    68 [2]
    Units: Participants
        Zero
    55
    32
        >0 to <12 weeks
    8
    8
        12 to <24 weeks
    3
    9
        24 to <36 weeks
    0
    10
        >=36 weeks
    2
    9
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Mepolizumab 300mg v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [3]
    Method
    Proportional odds regression model
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.91
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.68
         upper limit
    13.03
    Notes
    [3] - P- value was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region.

    Primary: Number of participants who are in remission at 36 and 48 weeks

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    End point title
    Number of participants who are in remission at 36 and 48 weeks
    End point description
    The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone <=4 mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
    End point type
    Primary
    End point timeframe
    Week 36 and Week 48
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [4]
    68 [5]
    Units: Participants
        Participants
    2
    22
    Notes
    [4] - ITT Population
    [5] - ITT Population
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Mepolizumab 300mg v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    16.74
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.61
         upper limit
    77.56

    Secondary: Time to First EGPA Relapse

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    End point title
    Time to First EGPA Relapse
    End point description
    EGPA relapse was defined as worsening or persistence of active disease since the last visit characterized by active vasculitis or active asthma symptoms and/or signs with a corresponding worsening in Asthma Control Questionnaire-6 (ACQ-6) score or active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions warranting: i) an increased dose of OCS therapy (or other systemic corticosteroid therapy) to >4 mg/day prednisolone total daily dose or equivalent; OR ii) an increased dose or addition of immunosuppressive therapy; OR iii) hospitalization related to EGPA worsening. Participants who completed study, or withdrawn prematurely from the study without experiencing the event were censored. The number of participants with at least one EGPA relapse during the planned study treatment period are presented.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [6]
    68 [7]
    Units: Participants
        Category title 1
    56
    38
    Notes
    [6] - ITT Population
    [7] - ITT Population
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Mepolizumab 300mg v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    other [8]
    P-value
    < 0.001 [9]
    Method
    Cox Proportional Hazard regression
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.322
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.206
         upper limit
    0.502
    Notes
    [8] - Hazard ratio (Mepolizumab 300mg/Placebo)
    [9] - p-value was based on a cox proportional hazards model with covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region.

    Secondary: Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period

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    End point title
    Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period
    End point description
    The number of participants with an average daily prednisolone/prednisone dose during the last 4 weeks of the Study Treatment Period (48 through 52) was calculated. The average dose was categorized into zero, >0 to <=4.0mg, >4.0 to <=7.5mg and >7.5mg. The statistical analysis was performed using a proportional odds regression model with Baseline covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region and the comparison between treatment groups was presented as an odds ratio, p-value and 95 percent CI.
    End point type
    Secondary
    End point timeframe
    Week 48 and Week52
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [10]
    68 [11]
    Units: Participants
        Zero
    2
    12
        >0 to <=4.0mg
    3
    18
        >4.0 to <=7.5mg
    18
    10
        >7.5mg
    45
    28
    Notes
    [10] - ITT Population
    [11] - ITT Population
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Mepolizumab 300mg v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    other [12]
    P-value
    < 0.001 [13]
    Method
    Proportional odds regression model
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.09
         upper limit
    0.41
    Notes
    [12] - Odds ratio (Mepolizumab 300mg/Placebo)
    [13] - p-value was based on a proportional odds regression model with Baseline covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region.

    Secondary: Number of participants who achieved remission within the first 24 weeks and remained in remission for the remainder of the treatment period

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    End point title
    Number of participants who achieved remission within the first 24 weeks and remained in remission for the remainder of the treatment period
    End point description
    The number of participants who achieved remission (i.e., BVAS=0 and prednisolone/prednisone<=4 mg/day) within the first 24 weeks and remain in remission for the remainder of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [14]
    68 [15]
    Units: Participants
        Participants
    1
    13
    Notes
    [14] - ITT Population
    [15] - ITT Population
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mepolizumab 300mg
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.007
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    19.65
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.3
         upper limit
    167.93

    Secondary: Number of Participants in Each Category of Accrued Duration of Remission

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    End point title
    Number of Participants in Each Category of Accrued Duration of Remission
    End point description
    Total accrued duration of remission, i.e., the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose <=7.5mg/day over the 52 week study treatment period was reported. BVAS is a validated, clinician-completed tool used for the comprehensive multisystem clinical assessment of disease activity in systemic vasculitis. The duration was categorized into zero, >0 to <12 weeks, 12 to <24 weeks, 24 to <36 weeks and >=36 weeks. Statistical analysis was performed on ITT Population and was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [16]
    68 [17]
    Units: Participants
        Zero
    36
    15
        >0 to <12 weeks
    19
    15
        12 to <24 weeks
    0
    7
        24 to <36 weeks
    7
    9
        >=36 weeks
    6
    22
    Notes
    [16] - ITT Population
    [17] - ITT Population
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mepolizumab 300mg
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [18]
    Method
    Proportional odds regression model
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.31
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.63
         upper limit
    10.74
    Notes
    [18] - P- value was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region.

    Secondary: Number of participants who are in remission at 36 and 48 weeks

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    End point title
    Number of participants who are in remission at 36 and 48 weeks
    End point description
    The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone <=7.5 mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
    End point type
    Secondary
    End point timeframe
    Week 36 and Week 48
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [19]
    68 [20]
    Units: Participants
        Participants
    7
    28
    Notes
    [19] - ITT Population
    [20] - ITT Population
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mepolizumab 300mg
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [21]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    7.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.6
         upper limit
    19.87
    Notes
    [21] - P- value was based on logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region.

    Secondary: Number of participants who achieved remission (BVAS=0 and prednisolone/prednisone <=7.5 mg/day) within the first 24 weeks and remained in remission for the remainder of the treatment period

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    End point title
    Number of participants who achieved remission (BVAS=0 and prednisolone/prednisone <=7.5 mg/day) within the first 24 weeks and remained in remission for the remainder of the treatment period
    End point description
    The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone <=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [22]
    68 [23]
    Units: Participants
        Participants
    2
    16
    Notes
    [22] - ITT Population
    [23] - ITT Population
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mepolizumab 300mg
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.003
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    11.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.35
         upper limit
    55.24

    Secondary: Number of participants with local and systemic Adverse Events (AEs)

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    End point title
    Number of participants with local and systemic Adverse Events (AEs)
    End point description
    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs including systemic allergic and non-allergic reactions as well as local site injection-related reactions were counted throughout treatment phase and follow up phase. Systemic allergic reactions included Facial paralysis, flushing, hypersensitivity and rash pruritic. Injection related reactions were considered as systemic non-allergic reactions. Local site reactions included injection site bruising, erythema, pain and reaction. The analysis was performed on Safety Population which comprised of all participants who receive at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [24]
    68 [25]
    Units: Participants
        Facial paralysis
    1
    0
        Flushing
    0
    1
        Hypersensitivity
    0
    1
        Rash pruritic
    0
    1
        Injection related reactions
    0
    1
        Injection site bruising
    0
    1
        Injection site erythema
    1
    1
        Injection site pain
    1
    0
        Injection site reaction
    7
    9
    Notes
    [24] - Safety Population
    [25] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in clinical chemistry parameters of alanine aminotransferase (ALT), alkaline phosphatase (Alk.phosph.), aspartate aminotransferase (AST), creatinine kinase, gamma glutamyl transaminase (GGT) and lactate dehydrogenase (dehydro) levels

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    End point title
    Change from Baseline in clinical chemistry parameters of alanine aminotransferase (ALT), alkaline phosphatase (Alk.phosph.), aspartate aminotransferase (AST), creatinine kinase, gamma glutamyl transaminase (GGT) and lactate dehydrogenase (dehydro) levels
    End point description
    Blood samples were collected to evaluate change from Baseline in ALT, Alk.phosph., AST, creatinine kinase, GGT and lactate dehydro values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [26]
    68 [27]
    Units: International Unit per Liter (IU/L)
    arithmetic mean (standard deviation)
        Absolute ALT; Baseline; n= 68, 68
    19.9 ± 8.91
    21.3 ± 14.22
        ALT; Week 4; n= 68, 68
    0.2 ± 6.17
    -2.2 ± 8.59
        ALT; Week 8; n= 67, 66
    -0.9 ± 5.66
    -1.7 ± 10.14
        ALT; Week 12; n= 65, 68
    -0.9 ± 4.53
    -0.7 ± 12.65
        ALT; Week 16; n= 65, 68
    -0.4 ± 6.56
    -2.2 ± 9.73
        ALT; Week 20; n= 63, 68
    -0.3 ± 6.25
    -1.2 ± 12.30
        ALT; Week 24; n= 63, 66
    -1.3 ± 5.38
    -0.2 ± 15.77
        ALT; Week 28; n= 62, 66
    -0.9 ± 6.73
    -0.4 ± 13.62
        ALT; Week 32; n= 61, 67
    -0.7 ± 6.79
    -2.4 ± 11.30
        ALT; Week 36; n= 60, 67
    -0.1 ± 6.21
    -3.0 ± 11.66
        ALT; Week 40; n= 61, 66
    0.3 ± 9.01
    -2.3 ± 11.70
        ALT; Week 44; n= 61, 66
    0.9 ± 9.68
    -2.7 ± 9.51
        ALT; Week 48; n= 61, 64
    1.7 ± 9.04
    -1.6 ± 15.47
        ALT; Week 52; n= 60, 65
    1.5 ± 10.42
    -2.8 ± 12.87
        ALT; Week 56; n= 61, 63
    -0.1 ± 7.35
    -3.6 ± 12.79
        ALT; Week 60; n= 60, 65
    -0.3 ± 7.33
    -4.7 ± 14.11
        Absolute Alk.phosph.; Baseline; n= 68, 68
    61.2 ± 17.83
    60.4 ± 20.90
        Alk.phosph.; Week 4; n= 68, 68
    -0.9 ± 6.65
    -3.2 ± 10.01
        Alk.phosph.; Week 8; n= 67, 66
    -1.7 ± 9.95
    -1.7 ± 11.56
        Alk. phosph.; Week 12; n= 65, 68
    -1.9 ± 8.36
    -1.1 ± 12.99
        Alk. phosph.; Week 16; n= 65, 68
    -1.3 ± 9.35
    -1.1 ± 14.61
        Alk. phosph.; Week 20; n= 63, 68
    0.0 ± 11.24
    4.4 ± 21.90
        Alk. phosph.; Week 24; n= 63, 66
    -1.1 ± 10.65
    2.8 ± 17.64
        Alk. phosph.; Week 28; n= 62, 66
    0.2 ± 10.95
    4.9 ± 17.17
        Alk. phosph.; Week 32; n= 61, 67
    0.2 ± 11.14
    4.4 ± 15.83
        Alk. phosph.; Week 36; n= 60, 67
    0.2 ± 10.42
    4.8 ± 14.71
        Alk. phosph.; Week 40; n= 61, 66
    1.0 ± 10.08
    6.2 ± 18.43
        Alk. phosph.; Week 44; n= 61, 66
    1.1 ± 12.55
    5.1 ± 16.53
        Alk. phosph.; Week 48; n= 61, 64
    1.2 ± 11.66
    5.1 ± 17.56
        Alk. phosph.; Week 52; n= 60, 65
    0.3 ± 12.30
    2.3 ± 14.47
        Alk. phosph.; Week 56; n= 61, 63
    -0.9 ± 12.04
    1.7 ± 16.42
        Alk. phosph.; Week 60; n= 60, 65
    -1.5 ± 13.16
    1.0 ± 15.08
        Absolute AST; Baseline; n= 68, 68
    19.3 ± 6.11
    21.8 ± 10.73
        AST; Week 4; n= 68, 68
    0.0 ± 4.41
    -1.7 ± 8.61
        AST; Week 8; n= 67, 66
    -0.4 ± 4.77
    -1.0 ± 8.21
        AST; Week 12; n= 65, 68
    0.5 ± 4.41
    -0.7 ± 9.62
        AST; Week 16; n= 65, 68
    0.4 ± 5.48
    -0.6 ± 7.90
        AST; Week 20; n= 63, 68
    0.8 ± 4.66
    -0.6 ± 8.49
        AST; Week 24; n= 63, 66
    0.0 ± 4.46
    -0.4 ± 10.44
        AST; Week 28; n= 61, 66
    -0.9 ± 5.34
    -0.4 ± 10.59
        AST; Week 32; n= 61, 67
    -0.2 ± 4.91
    -1.3 ± 10.67
        AST; Week 36; n= 60, 67
    0.2 ± 4.68
    -2.2 ± 9.61
        AST; Week 40; n= 61, 66
    0.5 ± 5.51
    -1.6 ± 8.97
        AST; Week 44; n= 61, 66
    0.4 ± 5.77
    -2.4 ± 9.02
        AST; Week 48; n= 61, 64
    1.1 ± 6.86
    -2.3 ± 10.14
        AST; Week 52; n= 60, 65
    0.9 ± 6.84
    -3.0 ± 10.49
        AST; Week 56; n= 61, 63
    -0.2 ± 4.92
    -2.8 ± 10.64
        AST; Week 60; n= 60, 65
    -0.4 ± 5.24
    -3.7 ± 10.92
        Absolute Creatinine kinase; Baseline; n= 68, 68
    99.0 ± 75.99
    88.8 ± 75.18
        Creatinine kinase; Week 4; n= 68, 68
    -2.4 ± 83.23
    2.0 ± 60.92
        Creatinine kinase; Week 8; n= 67, 66
    -5.0 ± 62.41
    3.5 ± 50.48
        Creatinine kinase; Week 12; n= 65, 68
    5.4 ± 93.24
    6.1 ± 40.86
        Creatinine kinase; Week 16; n= 65, 68
    15.8 ± 125.84
    0.5 ± 49.65
        Creatinine kinase; Week 20; n= 63, 68
    1.3 ± 78.35
    6.5 ± 54.83
        Creatinine kinase; Week 24; n= 63, 66
    -0.6 ± 56.55
    6.0 ± 66.69
        Creatinine kinase; Week 28; n= 62, 66
    -15.9 ± 59.38
    6.3 ± 55.84
        Creatinine kinase; Week 32; n= 61, 67
    -13.1 ± 59.29
    0.2 ± 49.68
        Creatinine kinase; Week 36; n= 60, 67
    -12.0 ± 65.11
    4.9 ± 52.71
        Creatinine kinase; Week 40; n= 61, 66
    2.6 ± 91.89
    2.8 ± 62.74
        Creatinine kinase; Week 44; n= 61, 66
    5.8 ± 86.76
    -2.4 ± 62.13
        Creatinine kinase; Week 48; n= 61, 64
    -8.1 ± 70.09
    -2.6 ± 90.09
        Creatinine kinase; Week 52; n= 60, 65
    0.9 ± 67.51
    0.2 ± 53.45
        Creatinine kinase; Week 56; n= 61, 63
    -8.7 ± 60.58
    -0.2 ± 62.08
        Creatinine kinase; Week 60; n= 60, 65
    -10.3 ± 65.83
    0.4 ± 61.45
        Absolute GGT; Baseline; n= 68, 68
    30.8 ± 25.49
    30.1 ± 27.24
        GGT; Week 4; n= 68, 68
    0.2 ± 11.70
    -2.0 ± 9.68
        GGT; Week 8; n= 67, 66
    -1.0 ± 8.59
    -0.6 ± 17.99
        GGT; Week 12; n= 65, 68
    -2.9 ± 6.68
    -1.9 ± 18.70
        GGT; Week 16; n= 65, 68
    -2.1 ± 10.18
    -1.5 ± 21.36
        GGT; Week 20; n= 63, 68
    1.7 ± 19.02
    -1.1 ± 24.50
        GGT; Week 24; n= 63, 66
    -1.7 ± 11.83
    -3.3 ± 22.52
        GGT; Week 28; n= 62, 66
    -1.9 ± 11.71
    -3.1 ± 16.86
        GGT; Week 32; n= 61, 67
    -1.5 ± 15.77
    -3.6 ± 17.87
        GGT; Week 36; n= 60, 67
    -2.1 ± 10.64
    -4.7 ± 14.96
        GGT; Week 40; n= 61, 66
    -0.2 ± 16.05
    -0.3 ± 19.75
        GGT; Week 44; n= 61, 66
    -2.9 ± 8.26
    -2.7 ± 15.25
        GGT; Week 48; n= 61, 64
    0.9 ± 18.91
    -3.0 ± 16.51
        GGT; Week 52; n= 60, 65
    -1.6 ± 16.44
    -4.2 ± 13.53
        GGT; Week 56; n= 61, 63
    -5.0 ± 16.77
    -3.6 ± 17.02
        GGT; Week 60; n= 60, 65
    -4.8 ± 16.45
    -5.6 ± 15.37
        Absolute Lactate dehydro; Baseline; n= 68, 68
    186.5 ± 47.82
    179.6 ± 38.88
        Lactate dehydro; Week 4; n= 68, 68
    -3.6 ± 19.73
    -2.3 ± 27.80
        Lactate dehydro; Week 8; n= 67, 66
    -8.2 ± 29.91
    -5.3 ± 24.46
        Lactate dehydro; Week 12; n= 65, 68
    -2.2 ± 27.17
    -7.7 ± 25.56
        Lactate dehydro; Week 16; n= 65, 68
    -2.6 ± 32.13
    -10.6 ± 26.12
        Lactate dehydro; Week 20; n= 63, 68
    2.2 ± 26.80
    -13.7 ± 25.79
        Lactate dehydro; Week 24; n= 63, 66
    -4.3 ± 26.22
    -13.5 ± 26.99
        Lactate dehydro; Week 28; n= 61, 66
    -8.5 ± 27.77
    -15.9 ± 30.44
        Lactate dehydro; Week 32; n= 61, 67
    -8.3 ± 25.49
    -17.1 ± 24.88
        Lactate dehydro; Week 36; n= 60, 67
    -3.6 ± 36.45
    -16.2 ± 30.54
        Lactate dehydro; Week 40; n= 61, 66
    -4.5 ± 35.81
    -13.5 ± 36.31
        Lactate dehydro; Week 44; n= 61, 66
    -2.7 ± 33.40
    -17.0 ± 31.37
        Lactate dehydro; Week 48; n= 61, 64
    0.8 ± 43.82
    -19.0 ± 30.66
        Lactate dehydro; Week 52; n= 60, 65
    -0.1 ± 34.99
    -17.8 ± 33.45
        Lactate dehydro; Week 56; n= 61, 63
    -5.2 ± 32.69
    -16.0 ± 30.87
        Lactate dehydro; Week 60; n= 60, 65
    -3.5 ± 34.15
    -12.4 ± 33.23
    Notes
    [26] - Safety Population
    [27] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in clinical chemistry parameters of albumin and protein levels

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    End point title
    Change from Baseline in clinical chemistry parameters of albumin and protein levels
    End point description
    Blood samples were collected to evaluate change from Baseline in albumin and protein levels values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [28]
    68 [29]
    Units: gram per liter (g/L)
    arithmetic mean (standard deviation)
        Absolute Albumin; Baseline; n= 68, 68
    43.4 ± 2.45
    43.5 ± 3.01
        Albumin; Week 4; n= 68, 68
    -0.6 ± 2.25
    -0.1 ± 2.16
        Albumin; Week 8; n= 67, 66
    -0.8 ± 2.16
    -0.6 ± 2.72
        Albumin; Week 12; n= 65, 68
    -0.2 ± 2.47
    -0.4 ± 2.64
        Albumin; Week 16; n= 65, 68
    -0.6 ± 2.57
    -0.6 ± 2.54
        Albumin; Week 20; n= 63, 68
    -0.1 ± 2.35
    -0.2 ± 2.92
        Albumin; Week 24; n= 63, 66
    0.0 ± 2.80
    0.1 ± 2.72
        Albumin; Week 28; n= 62, 66
    -0.2 ± 2.67
    0.1 ± 2.67
        Albumin; Week 32; n= 61, 67
    -0.4 ± 2.71
    -0.1 ± 2.69
        Albumin; Week 36; n= 60, 67
    -0.1 ± 2.58
    0.3 ± 3.01
        Albumin; Week 40; n= 61, 66
    -0.2 ± 2.98
    0.2 ± 2.82
        Albumin; Week 44; n= 61, 66
    0.3 ± 2.95
    -0.3 ± 2.87
        Albumin; Week 48; n= 61, 64
    -0.4 ± 2.74
    -0.3 ± 2.77
        Albumin; Week 52; n= 60, 65
    -0.5 ± 2.45
    -0.3 ± 3.10
        Albumin; Week 56; n= 61, 63
    -0.7 ± 2.84
    -0.5 ± 2.88
        Albumin; Week 60; n= 60, 65
    -0.9 ± 2.55
    -0.7 ± 3.04
        Absolute Protein; Baseline; n= 68, 68
    67.7 ± 4.26
    67.3 ± 4.46
        Protein; Week 4; n= 68, 68
    -0.8 ± 3.00
    -0.5 ± 3.19
        Protein; Week 8; n= 67, 66
    -1.5 ± 2.97
    -0.9 ± 3.60
        Protein; Week 12; n= 65, 68
    -0.6 ± 3.57
    -0.6 ± 3.30
        Protein; Week 16; n= 65, 68
    -0.3 ± 3.56
    -0.8 ± 3.93
        Protein; Week 20; n= 63, 68
    0.0 ± 3.21
    0.1 ± 4.28
        Protein; Week 24; n= 63, 66
    0.2 ± 3.99
    0.0 ± 3.96
        Protein; Week 28; n= 62, 66
    -0.2 ± 4.13
    -0.1 ± 3.59
        Protein; Week 32; n= 61, 67
    -0.5 ± 4.09
    -0.4 ± 3.91
        Protein; Week 36; n= 60, 67
    -0.2 ± 3.82
    0.2 ± 4.45
        Protein; Week 40; n= 61, 66
    -0.4 ± 3.48
    0.1 ± 3.98
        Protein; Week 44; n= 61, 66
    0.4 ± 4.43
    -0.6 ± 4.19
        Protein; Week 48; n= 61, 64
    -0.5 ± 3.94
    -0.5 ± 4.29
        Protein; Week 52; n= 60, 65
    -0.3 ± 3.75
    -0.4 ± 4.08
        Protein; week 56; n= 61, 63
    -0.1 ± 4.77
    -0.5 ± 4.21
        Protein; Week 60; n= 60, 65
    -0.4 ± 5.88
    -0.7 ± 4.17
    Notes
    [28] - Safety Population
    [29] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in clinical chemistry parameters of direct, indirect and total bilirubin and creatinine levels

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    End point title
    Change from Baseline in clinical chemistry parameters of direct, indirect and total bilirubin and creatinine levels
    End point description
    Blood samples were collected to evaluate change from Baseline in direct, indirect and total bilirubin and creatinine values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [30]
    68 [31]
    Units: micromole per liter (µmol/L)
    arithmetic mean (standard deviation)
        Absolute Total bilirubin; Baseline; n= 68, 68
    9.8 ± 6.14
    8.8 ± 4.10
        Total bilirubin; week 4; n= 68, 68
    -0.9 ± 4.02
    0.1 ± 3.48
        Total bilirubin; Week 8; n= 67, 66
    -1.2 ± 4.38
    0.0 ± 3.50
        Total bilirubin; Week 12; n= 65, 68
    -0.3 ± 3.01
    0.1 ± 3.27
        Total bilirubin; Week 16; n= 65, 68
    -1.1 ± 4.15
    0.0 ± 4.14
        Total bilirubin; Week 20; n= 63, 68
    -0.5 ± 2.90
    0.3 ± 3.57
        Total bilirubin; Week 24; n= 63, 66
    -0.3 ± 3.36
    0.0 ± 2.71
        Total bilirubin; Week 28; n= 62, 66
    -0.8 ± 3.13
    0.3 ± 4.43
        Total bilirubin; Week 32; n= 61, 67
    -1.1 ± 3.07
    -0.1 ± 3.63
        Total bilirubin; Week 36; n= 60, 67
    -0.7 ± 3.39
    0.1 ± 4.09
        Total bilirubin; Week 40; n= 61, 66
    -0.2 ± 3.22
    -0.3 ± 3.78
        Total bilirubin; Week 44; n= 61, 66
    0.0 ± 2.50
    0.1 ± 3.64
        Total bilirubin; Week 48; n= 61, 64
    -0.2 ± 2.59
    -0.1 ± 3.77
        Total bilirubin; Week 52; n= 60, 65
    -0.1 ± 3.41
    0.7 ± 3.92
        Total bilirubin; Week 56; n= 61, 63
    -0.8 ± 3.17
    0.5 ± 3.24
        Total bilirubin; Week 60; n= 60, 65
    -0.5 ± 3.21
    0.0 ± 3.42
        Absolute Creatinine; Baseline; n= 68, 68
    75.49 ± 12.878
    73.00 ± 12.289
        Creatinine; Week 4; n= 68, 68
    0.69 ± 7.195
    2.09 ± 5.533
        Creatinine; Week 8; n= 67, 66
    1.87 ± 7.505
    1.15 ± 6.737
        Creatinine; Week 12; n= 65, 68
    1.50 ± 9.029
    0.34 ± 7.006
        Creatinine; Week 16; n= 65, 68
    1.53 ± 10.012
    2.72 ± 6.702
        Creatinine; Week 20; n= 63, 68
    1.73 ± 6.916
    2.60 ± 7.739
        Creatinine; Week 24; n= 63, 66
    0.74 ± 7.775
    0.06 ± 6.538
        Creatinine; Week 28; n= 62, 66
    0.96 ± 7.504
    1.02 ± 7.764
        Creatinine; Week 32; n= 61, 67
    1.89 ± 9.809
    1.85 ± 8.589
        Creatinine; Week 36; n= 60, 67
    1.42 ± 6.957
    0.40 ± 7.839
        Creatinine; Week 40; n= 61, 66
    1.16 ± 8.253
    0.34 ± 8.119
        Creatinine; Week 44; n= 61, 66
    2.14 ± 8.991
    0.04 ± 9.070
        Creatinine; Week 48; n= 61, 64
    1.53 ± 7.972
    -2.25 ± 7.398
        Creatinine; Week 52; n= 60, 65
    0.52 ± 7.719
    -1.35 ± 7.182
        Creatinine; Week 56; n= 61, 63
    1.39 ± 7.367
    -0.30 ± 8.695
        Creatinine; Week 60; n= 60, 65
    0.34 ± 7.014
    -1.22 ± 10.896
        Absolute Direct bilirubin; Baseline; n= 68, 68
    2.1 ± 1.33
    1.9 ± 0.98
        Direct bilirubin; Week 4; n= 68, 68
    0.0 ± 1.06
    0.0 ± 0.84
        Direct bilirubin; Week 8; n= 67, 66
    0.0 ± 1.01
    0.1 ± 0.96
        Direct bilirubin; Week 12; n= 65, 68
    0.0 ± 0.97
    0.0 ± 1.04
        Direct bilirubin; Week 16; n= 65, 68
    -0.2 ± 0.96
    -0.1 ± 1.20
        Direct bilirubin; Week 20; n= 63, 68
    0.0 ± 0.86
    0.1 ± 1.03
        Direct bilirubin; Week 24; n= 63, 66
    0.1 ± 0.90
    0.0 ± 0.88
        Direct bilirubin; Week 28; n= 62, 66
    -0.1 ± 1.20
    0.2 ± 1.15
        Direct bilirubin; Week 32; n= 61, 67
    -0.2 ± 0.99
    0.1 ± 0.99
        Direct bilirubin; Week 36; n= 60, 67
    -0.1 ± 1.11
    0.1 ± 1.17
        Direct bilirubin; Week 40; n= 61, 66
    0.0 ± 1.11
    0.0 ± 0.94
        Direct bilirubin; Week 44; n= 61, 66
    0.1 ± 0.93
    0.0 ± 1.12
        Direct bilirubin; Week 48; n= 61, 64
    0.1 ± 0.99
    0.0 ± 1.17
        Direct bilirubin; Week 52; n= 60, 65
    0.1 ± 1.05
    0.2 ± 1.06
        Direct bilirubin; Week 56; n= 61, 63
    0.1 ± 1.08
    0.1 ± 1.06
        Direct bilirubin; Week 60; n= 60, 65
    0.1 ± 1.10
    0.1 ± 1.07
        Absolute Indirect bilirubin; Baseline; n= 68, 68
    7.7 ± 5.09
    6.9 ± 3.38
        Indirect bilirubin; Week 4; n= 68, 68
    -0.8 ± 3.68
    0.0 ± 3.06
        Indirect bilirubin; Week 8; n= 67, 66
    -1.2 ± 3.86
    -0.1 ± 2.94
        Indirect bilirubin; Week 12; n= 65, 68
    -0.3 ± 2.61
    0.1 ± 2.79
        Indirect bilirubin; Week 16; n= 65, 68
    -0.9 ± 3.67
    0.1 ± 3.37
        Indirect bilirubin; Week 20; n= 63, 68
    -0.5 ± 2.37
    0.2 ± 3.00
        Indirect bilirubin; Week 24; n= 63, 66
    -0.4 ± 2.94
    0.0 ± 2.37
        Indirect bilirubin; Week 28; n= 62, 66
    -0.7 ± 2.60
    0.1 ± 3.71
        Indirect bilirubin; Week 32; n= 61, 66
    -0.9 ± 2.48
    -0.2 ± 3.02
        Indirect bilirubin; Week 36; n= 60, 67
    -0.6 ± 2.77
    0.0 ± 3.30
        Indirect bilirubin; Week 40; n= 61, 66
    -0.1 ± 2.56
    -0.2 ± 3.16
        Indirect bilirubin; Week 44; n= 61, 66
    -0.1 ± 2.19
    0.1 ± 2.99
        Indirect bilirubin; Week 48; n= 61, 64
    -0.3 ± 2.19
    -0.1 ± 3.13
        Indirect bilirubin; Week 52; n= 60, 65
    -0.2 ± 2.84
    0.5 ± 3.32
        Indirect bilirubin; Week 56; n= 61, 63
    -0.9 ± 2.72
    0.4 ± 2.64
        Indirect bilirubin; Week 60; n= 60, 65
    -0.6 ± 2.64
    -0.1 ± 2.81
    Notes
    [30] - Safety Population
    [31] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in calcium, chloride, cholesterol, glucose, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, phosphorus, potassium, sodium, urea nitrogen and very low density lipoprotein (VLDL) cholesterol levels

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    End point title
    Change from Baseline in calcium, chloride, cholesterol, glucose, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, phosphorus, potassium, sodium, urea nitrogen and very low density lipoprotein (VLDL) cholesterol levels
    End point description
    Blood samples were collected to evaluate change from Baseline in calcium, chloride, cholesterol, glucose, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, phosphorus, potassium, sodium, urea nitrogen and very low density lipoprotein (VLDL) cholesterol values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured. 99999 indicates that data were not available.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [32]
    68 [33]
    Units: millimoles per liter (mmol/L)
    arithmetic mean (standard deviation)
        Absolute Calcium; Baseline; n= 68, 68
    2.365 ± 0.0864
    2.382 ± 0.1189
        Calcium; Week 4; n= 68, 68
    -0.011 ± 0.0836
    -0.012 ± 0.1200
        Calcium; Week 8; n= 67, 66
    -0.013 ± 0.0877
    -0.010 ± 0.1003
        Calcium; Week 12; n= 65, 68
    -0.013 ± 0.0844
    -0.026 ± 0.0889
        Calcium; Week 16; n= 65, 68
    0.000 ± 0.1091
    -0.029 ± 0.1018
        Calcium; Week 20; n= 63, 68
    0.002 ± 0.0882
    -0.016 ± 0.1032
        Calcium; Week 24; n= 63, 66
    0.001 ± 0.0901
    -0.013 ± 0.1111
        Calcium; Week 28; n= 61, 66
    0.001 ± 0.0962
    -0.001 ± 0.1039
        Calcium; Week 32; n= 61, 67
    0.000 ± 0.0911
    -0.006 ± 0.0977
        Calcium; Week 36; n= 60, 67
    -0.006 ± 0.0931
    -0.006 ± 0.1133
        Calcium; Week 40; n= 61, 66
    0.014 ± 0.1126
    0.005 ± 0.1115
        Calcium; Week 44; n= 61, 66
    0.016 ± 0.1144
    -0.020 ± 0.1115
        Calcium; Week 48; n= 61, 64
    -0.007 ± 0.1007
    -0.018 ± 0.1002
        Calcium; Week 52; n= 60, 65
    -0.008 ± 0.1001
    -0.027 ± 0.1110
        Calcium; Week 56; n= 61, 63
    -0.008 ± 0.0931
    -0.015 ± 0.0994
        Calcium; Week 60; n= 60, 65
    -0.025 ± 0.0946
    -0.019 ± 0.1058
        Absolute Chloride; Baseline; n= 68, 68
    103.4 ± 2.05
    104.0 ± 2.21
        Chloride; Week 4; n= 68, 68
    0.6 ± 1.97
    0.2 ± 2.00
        Chloride; Week 8; n= 67, 66
    0.9 ± 2.05
    0.5 ± 2.06
        Chloride; Week 12; n= 65, 68
    0.7 ± 2.32
    0.7 ± 2.20
        Chloride; Week 16; n= 65, 68
    0.5 ± 2.08
    0.8 ± 1.95
        Chloride; Week 20; n= 63, 68
    0.3 ± 2.38
    0.7 ± 2.04
        Chloride; Week 24; n= 63, 66
    0.6 ± 2.51
    0.8 ± 2.20
        Chloride; Week 28; n= 62, 66
    0.7 ± 2.17
    0.8 ± 2.59
        Chloride; Week 32; n= 61, 67
    0.4 ± 2.24
    0.5 ± 2.32
        Chloride; Week 36; n= 60, 67
    0.8 ± 2.53
    0.6 ± 2.08
        Chloride; Week 40; n= 61, 66
    0.9 ± 2.22
    0.7 ± 2.13
        Chloride; Week 44; n= 61, 66
    0.5 ± 2.13
    0.6 ± 2.55
        Chloride; Week 48; n= 61, 64
    0.5 ± 2.38
    0.5 ± 2.34
        Chloride; Week 52; n= 60, 65
    0.3 ± 2.26
    0.4 ± 2.24
        Chloride; Week 56; n= 61, 63
    0.7 ± 2.27
    0.2 ± 2.06
        Chloride; Week 60; n= 60, 65
    0.4 ± 2.01
    0.4 ± 2.20
        Absolute Cholesterol; Baseline; n= 68, 68
    5.771 ± 1.2033
    5.788 ± 1.2386
        Cholesterol; Week 8; n= 2, 0
    -0.250 ± 0.1414
    99999 ± 99999
        Cholesterol; Week 12; n= 1, 0
    0.050 ± 99999
    99999 ± 99999
        Cholesterol; Week 16; n= 1, 1
    -0.400 ± 99999
    -0.300 ± 99999
        Cholesterol; Week 20; n= 1, 1
    0.050 ± 99999
    -0.300 ± 99999
        Cholesterol; Week 24; n= 0, 1
    99999 ± 99999
    -0.560 ± 99999
        Cholesterol; Week 36; n= 0, 1
    99999 ± 99999
    0.420 ± 99999
        Cholesterol; Week 52; n= 60, 65
    -0.006 ± 0.9364
    -0.384 ± 0.8798
        Cholesterol; Week 56; n= 1, 0
    -0.220 ± 99999
    99999 ± 99999
        Absolute Glucose; Baseline; n= 68, 68
    5.76 ± 2.000
    5.35 ± 1.195
        Glucose; Week 4; n= 68, 68
    0.27 ± 1.619
    -0.01 ± 1.050
        Glucose; Week 8; n= 67, 66
    0.09 ± 1.695
    0.07 ± 0.986
        Glucose; Week 12; n= 65, 68
    0.27 ± 1.961
    0.26 ± 1.079
        Glucose; Week 16; n= 65, 68
    0.03 ± 1.454
    0.04 ± 1.077
        Glucose; Week 20; n= 63, 68
    0.25 ± 1.644
    -0.03 ± 1.351
        Glucose; Week 24; n= 63, 66
    0.02 ± 1.588
    0.16 ± 1.211
        Glucose; Week 28; n= 62, 66
    0.14 ± 1.613
    0.21 ± 1.551
        Glucose; Week 32; n= 61, 67
    -0.03 ± 1.808
    -0.14 ± 1.162
        Glucose; Week 36; n= 60, 67
    0.11 ± 1.525
    0.03 ± 1.003
        Glucose; Week 40; n= 61, 66
    0.34 ± 1.831
    -0.03 ± 1.305
        Glucose; Week 44; n= 61, 66
    0.21 ± 1.766
    -0.05 ± 0.891
        Glucose; Week 48; n= 61, 64
    0.32 ± 2.065
    0.21 ± 1.740
        Glucose; Week 52; n= 60, 65
    -0.17 ± 1.650
    0.02 ± 1.258
        Glucose; Week 56; n= 61, 63
    0.01 ± 1.718
    0.13 ± 1.852
        Glucose; Week 60; n= 60, 65
    0.20 ± 1.664
    0.11 ± 1.483
        Absolute HDL cholesterol; Baseline; n= 68, 68
    1.837 ± 0.4540
    1.937 ± 0.5606
        HDL cholesterol; Week 8; n= 2, 0
    -0.075 ± 0.0354
    99999 ± 99999
        HDL cholesterol; Week 12; n= 1, 0
    -0.100 ± 99999
    99999 ± 99999
        HDL cholesterol; Week 16; n= 1, 1
    0.400 ± 99999
    -0.150 ± 99999
        HDL cholesterol; Week 20; n= 1, 1
    0.000 ± 99999
    -0.250 ± 99999
        HDL cholesterol; Week 24; n= 0, 1
    99999 ± 99999
    -0.390 ± 99999
        HDL cholesterol; Week 36; n= 0, 1
    99999 ± 99999
    0.400 ± 99999
        HDL cholesterol; Week 52; n= 60, 65
    -0.045 ± 0.2832
    -0.150 ± 0.3146
        HDL cholesterol; Week 56; n= 1, 0
    -0.060 ± 99999
    99999 ± 99999
        Absolute LDL cholesterol; Baseline; n= 67, 68
    3.261 ± 1.0808
    3.205 ± 1.0992
        LDL cholesterol; Week 8; n= 1, 0
    -0.350 ± 99999
    99999 ± 99999
        LDL cholesterol; Week 12; n= 1, 0
    0.190 ± 99999
    99999 ± 99999
        LDL cholesterol; Week 16; n= 1, 1
    -0.730 ± 99999
    -0.790 ± 99999
        LDL cholesterol; Week 20; n= 1, 1
    -0.150 ± 99999
    -0.540 ± 99999
        LDL cholesterol; Week 24; n= 0, 1
    99999 ± 99999
    0.040 ± 99999
        LDL cholesterol; Week 36; n= 0, 1
    99999 ± 99999
    0.250 ± 99999
        LDL cholesterol; Week 52; n= 58, 64
    0.016 ± 0.7717
    -0.215 ± 0.8079
        LDL cholesterol; Week 56; n= 1, 0
    0.100 ± 99999
    99999 ± 99999
        Absolute Phosphate; Baseline; n= 68, 68
    1.068 ± 0.1797
    1.066 ± 0.1939
        Phosphate; Week 4; n= 68, 68
    -0.027 ± 0.2183
    0.014 ± 0.1833
        Phosphate; Week 8; n= 67, 66
    -0.004 ± 0.1577
    0.024 ± 0.2239
        Phosphate; Week 12; n= 65, 68
    0.003 ± 0.1821
    0.019 ± 0.2181
        Phosphate; Week 16; n= 65, 68
    0.016 ± 0.1819
    0.016 ± 0.2205
        Phosphate; Week 20; n= 63, 68
    -0.001 ± 0.1611
    0.019 ± 0.2087
        Phosphate; Week 24; n= 63, 66
    -0.042 ± 0.1565
    0.007 ± 0.2142
        Phosphate; Week 28; n= 62, 66
    -0.025 ± 0.1819
    0.003 ± 0.2539
        Phosphate; Week 32; n= 61, 67
    -0.018 ± 0.1975
    0.040 ± 0.2172
        Phosphate; Week 36; n= 60, 67
    -0.038 ± 0.2159
    0.023 ± 0.2260
        Phosphate; Week 40; n= 61, 66
    -0.029 ± 0.1822
    0.026 ± 0.2213
        Phosphate; Week 44; n= 61, 66
    -0.018 ± 0.2104
    0.041 ± 0.2240
        Phosphate; Week 48; n= 61, 64
    -0.053 ± 0.1931
    -0.020 ± 0.2443
        Phosphate; Week 52; n= 60, 65
    0.005 ± 0.1939
    0.053 ± 0.2988
        Phosphate; Week 56; n= 61, 63
    0.019 ± 0.2962
    0.043 ± 0.3066
        Phosphate; Week 60; n= 60, 65
    -0.035 ± 0.2125
    -0.007 ± 0.2322
        Absolute Potassium; Baseline; n= 68, 68
    4.11 ± 0.348
    4.10 ± 0.359
        Potassium; Week 4; n= 68, 68
    0.05 ± 0.378
    -0.02 ± 0.345
        Potassium; Week 8; n= 67, 66
    0.01 ± 0.309
    0.02 ± 0.323
        Potassium; Week 12; n= 65, 68
    -0.04 ± 0.318
    0.01 ± 0.296
        Potassium; Week 16; n= 65, 68
    0.06 ± 0.340
    0.05 ± 0.317
        Potassium; Week 20; n= 63, 68
    0.08 ± 0.382
    0.01 ± 0.372
        Potassium; Week 24; n= 63, 66
    -0.02 ± 0.298
    0.04 ± 0.350
        Potassium; Week 28; n= 61, 66
    0.07 ± 0.338
    0.10 ± 0.382
        Potassium; Week 32; n= 61, 67
    0.04 ± 0.340
    0.11 ± 0.305
        Potassium; Week 36; n= 60, 67
    0.02 ± 0.291
    0.01 ± 0.351
        Potassium; Week 40; n= 61, 66
    0.08 ± 0.419
    0.14 ± 0.313
        Potassium; Week 44; n= 61, 66
    0.08 ± 0.383
    0.09 ± 0.341
        Potassium; Week 48; n= 61, 64
    0.09 ± 0.367
    0.05 ± 0.349
        Potassium; Week 52; n= 60, 65
    0.05 ± 0.344
    0.01 ± 0.329
        Potassium; Week 56; n= 61, 63
    0.08 ± 0.379
    0.08 ± 0.378
        Potassium; Week 60; n= 60, 65
    0.00 ± 0.358
    0.10 ± 0.390
        Absolute Sodium; Baseline; n= 68, 68
    139.8 ± 2.03
    140.3 ± 1.83
        Sodium; Week 4; n= 68, 68
    0.2 ± 1.86
    0.3 ± 2.03
        Sodium; Week 8; n= 67, 66
    0.4 ± 2.06
    0.2 ± 1.89
        Sodium; Week 12; n= 65, 68
    0.1 ± 1.99
    -0.1 ± 2.28
        Sodium; Week 16; n= 65, 68
    0.0 ± 1.46
    -0.1 ± 1.91
        Sodium; Week 20; n= 63, 68
    0.0 ± 1.88
    0.1 ± 2.09
        Sodium; Week 24; n= 63, 66
    0.2 ± 1.94
    0.0 ± 1.95
        Sodium; Week 28; n= 62, 66
    0.5 ± 1.71
    0.0 ± 2.23
        Sodium; Week 32; n= 61, 67
    0.3 ± 1.92
    0.1 ± 2.13
        Sodium; Week 36; n= 60, 67
    0.4 ± 2.10
    0.0 ± 1.95
        Sodium; Week 40; n= 61, 66
    0.2 ± 2.42
    0.0 ± 2.18
        Sodium; Week 44; n= 61, 66
    0.1 ± 1.77
    -0.2 ± 2.02
        Sodium; Week 48; n= 61, 64
    0.1 ± 2.03
    -0.4 ± 1.97
        Sodium; Week 52; n= 60, 65
    0.4 ± 1.79
    -0.2 ± 2.17
        Sodium; Week 56; n= 61, 63
    0.4 ± 2.15
    -0.5 ± 2.08
        Sodium; Week 60; n= 60, 65
    -0.1 ± 2.04
    -0.3 ± 2.36
        Absolute Urea; Baseline; n= 68, 68
    5.94 ± 1.451
    5.79 ± 1.629
        Urea; Week 4; n= 68, 68
    -0.08 ± 1.412
    0.09 ± 1.241
        Urea; Week 8; n= 67, 66
    -0.23 ± 1.564
    0.20 ± 1.206
        Urea; Week 12; n= 65, 68
    -0.15 ± 1.414
    -0.10 ± 1.217
        Urea; Week 16; n= 65, 68
    -0.07 ± 1.569
    0.00 ± 1.317
        Urea; Week 20; n= 63, 68
    -0.21 ± 1.465
    -0.23 ± 1.286
        Urea; Week 24; n= 63, 66
    -0.28 ± 1.513
    -0.12 ± 1.172
        Urea; Week 28; n= 62, 66
    -0.21 ± 1.525
    -0.22 ± 1.350
        Urea; Week 32; n= 61, 67
    -0.11 ± 1.320
    -0.23 ± 1.359
        Urea; Week 36; n= 60, 67
    -0.27 ± 1.407
    -0.32 ± 1.391
        Urea; Week 40; n= 61, 66
    -0.44 ± 1.377
    -0.23 ± 1.375
        Urea; Week 44; n= 61, 66
    -0.32 ± 1.731
    -0.19 ± 1.698
        Urea; Week 48; n= 61, 64
    -0.36 ± 1.422
    -0.09 ± 1.429
        Urea; Week 52; n= 60, 65
    -0.19 ± 1.737
    -0.18 ± 1.128
        Urea; Week 56; n= 61, 63
    -0.11 ± 1.495
    -0.13 ± 1.539
        Urea; Week 60; n= 60, 65
    -0.09 ± 1.546
    -0.10 ± 1.170
        Absolute VLDL cholesterol; Baseline; n= 67, 68
    0.680 ± 0.2846
    0.646 ± 0.2841
        VLDL cholesterol; Week 8; n= 1, 0
    0.100 ± 99999
    99999 ± 99999
        VLDL cholesterol; Week 12; n= 1, 0
    -0.040 ± 99999
    99999 ± 99999
        VLDL cholesterol; Week 16; n= 1, 1
    -0.070 ± 99999
    0.640 ± 99999
        VLDL cholesterol; Week 20; n= 1, 1
    0.200 ± 99999
    0.490 ± 99999
        VLDL cholesterol; Week 24; n= 0, 1
    99999 ± 99999
    -0.210 ± 99999
        VLDL cholesterol; Week 36; n= 0, 1
    99999 ± 99999
    -0.230 ± 99999
        VLDL cholesterol; Week 52; n= 58, 64
    -0.019 ± 0.3229
    -0.051 ± 0.1927
        VLDL cholesterol; Week 56; n= 1, 0
    -0.260 ± 99999
    99999 ± 99999
    Notes
    [32] - Safety Population
    [33] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in clinical chemistry parameter of troponin levels

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    End point title
    Change from Baseline in clinical chemistry parameter of troponin levels
    End point description
    Blood samples were collected to evaluate change from Baseline in troponin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [34]
    68 [35]
    Units: µg/L
    arithmetic mean (standard deviation)
        Absolute Troponin; Baseline; n= 68, 68
    0.013 ± 0.0110
    0.013 ± 0.0092
        Troponin; Week 4; n= 68, 66
    -0.001 ± 0.0106
    0.008 ± 0.0717
        Troponin; Week 8; n= 67, 67
    -0.002 ± 0.0111
    0.001 ± 0.0089
        Troponin; Week 12; n= 64, 67
    -0.002 ± 0.0108
    -0.001 ± 0.0053
        Troponin; Week 16; n= 65, 68
    -0.002 ± 0.0104
    0.002 ± 0.0272
        Troponin; Week 20; n= 61, 68
    -0.002 ± 0.0105
    -0.001 ± 0.0089
        Troponin; Week 24; n= 62, 67
    -0.002 ± 0.0098
    0.004 ± 0.0535
        Troponin; Week 28; n= 63, 66
    -0.003 ± 0.0102
    -0.002 ± 0.0090
        Troponin; Week 32; n= 61, 67
    -0.003 ± 0.0100
    -0.002 ± 0.0092
        Troponin; Week 36; n= 61, 67
    -0.002 ± 0.0107
    0.000 ± 0.0185
        Troponin; Week 40; n= 61, 66
    -0.001 ± 0.0117
    -0.002 ± 0.0090
        Troponin; Week 44; n= 61, 65
    0.000 ± 0.0068
    -0.001 ± 0.0095
        Troponin; Week 48; n= 60, 65
    0.017 ± 0.1479
    -0.001 ± 0.0101
        Troponin; Week 52; n= 60, 65
    -0.002 ± 0.0114
    -0.001 ± 0.0111
        Troponin; Week 56; n= 61, 63
    -0.003 ± 0.0112
    -0.002 ± 0.0086
        Troponin; Week 60; n= 59, 65
    -0.003 ± 0.0109
    -0.001 ± 0.0093
    Notes
    [34] - Safety Population
    [35] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in hematology parameters of basophils, eosinophil, leukocytes, lymphocytes, monocytes, neutrophils, platelets levels

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    End point title
    Change from Baseline in hematology parameters of basophils, eosinophil, leukocytes, lymphocytes, monocytes, neutrophils, platelets levels
    End point description
    Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelet values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [36]
    68 [37]
    Units: 10^9 cells/L
    arithmetic mean (standard deviation)
        Absolute Basophils; Baselin; n= 68, 68
    0.030 ± 0.0253
    0.028 ± 0.0236
        Basophils; Week 4; n= 66, 66
    -0.002 ± 0.0302
    -0.007 ± 0.0282
        Basophils; Week 8; n= 65, 66
    0.005 ± 0.0285
    -0.002 ± 0.0261
        Basophils; Week 12; n= 63, 65
    0.007 ± 0.0351
    -0.007 ± 0.0222
        Basophils; Week 16; n= 64, 68
    0.005 ± 0.0333
    -0.004 ± 0.0295
        Basophils; Week 20; n= 61, 66
    0.005 ± 0.0338
    -0.002 ± 0.0287
        Basophils; Week 24; n= 61, 66
    0.004 ± 0.0341
    -0.002 ± 0.0328
        Basophils; Week 28; n= 62, 65
    0.006 ± 0.0411
    -0.005 ± 0.0297
        Basophils; Week 32; n= 61, 66
    0.010 ± 0.0467
    0.002 ± 0.0355
        Basophils; Week 36; n= 60, 66
    0.009 ± 0.0321
    0.005 ± 0.0424
        Basophils; Week 40; n= 61, 65
    0.005 ± 0.0357
    -0.002 ± 0.0356
        Basophils; Week 44; n= 59, 61
    0.008 ± 0.0328
    0.000 ± 0.0296
        Basophils; Week 48; n= 59, 64
    0.003 ± 0.0408
    -0.004 ± 0.0300
        Basophils; Week 52; n= 60, 64
    0.004 ± 0.0289
    -0.003 ± 0.0284
        Basophils; Week 56; n= 59, 61
    0.009 ± 0.0381
    -0.003 ± 0.0286
        Basophils; Week 60; n= 58, 64
    0.002 ± 0.0316
    -0.006 ± 0.0248
        Absolute Eosinophils; Baseline; n= 68, 68
    0.362 ± 0.5835
    0.398 ± 0.8415
        Eosinophils; Week 4; n= 66, 66
    -0.054 ± 0.3309
    -0.339 ± 0.6794
        Eosinophils; Week 8; n= 65, 66
    0.103 ± 0.2921
    -0.370 ± 0.8092
        Eosinophils; Week 12; n= 63, 65
    0.027 ± 0.3515
    -0.364 ± 0.8407
        Eosinophils; Week 16; n= 64, 68
    0.058 ± 0.4092
    -0.355 ± 0.8280
        Eosinophils; Week 20; n= 61, 66
    0.162 ± 0.5900
    -0.347 ± 0.8266
        Eosinophils; Week 24; n= 61, 66
    0.136 ± 0.4044
    -0.364 ± 0.8211
        Eosinophils; Week 28; n= 62, 65
    0.172 ± 0.4365
    -0.360 ± 0.8258
        Eosinophils; Week 32; n= 61, 66
    0.079 ± 0.3759
    -0.347 ± 0.8310
        Eosinophils; Week 36; n= 60, 66
    0.086 ± 0.3758
    -0.347 ± 0.8388
        Eosinophils; Week 40; n= 61, 65
    0.022 ± 0.4448
    -0.358 ± 0.8396
        Eosinophils; Week 44; n= 59, 61
    0.051 ± 0.4472
    -0.365 ± 0.8604
        Eosinophils; Week 48; n= 59, 64
    0.109 ± 0.3873
    -0.364 ± 0.8540
        Eosinophils; Week 52; n= 60, 64
    0.055 ± 0.3764
    -0.341 ± 0.8456
        Eosinophils; Week 56; n= 59, 61
    0.071 ± 0.4137
    -0.351 ± 0.8624
        Eosinophils; Week 60; n= 58, 64
    0.111 ± 0.4666
    -0.302 ± 0.8352
        Absolute Leukocytes; Baseline; n= 68, 68
    9.91 ± 2.714
    9.54 ± 3.130
        Leukocytes; Week 4; 66, 66
    -0.11 ± 2.109
    -0.77 ± 2.356
        Leukocytes; Week 8; n= 65, 66
    -0.18 ± 2.562
    -0.83 ± 2.511
        Leukocytes; Week 12; n= 63, 65
    -0.53 ± 1.765
    -1.24 ± 2.716
        Leukocytes; ; Week 16; n= 64, 68
    0.01 ± 2.567
    -1.16 ± 2.827
        Leukocytes; Week 20; n= 61, 66
    -0.13 ± 2.269
    -1.43 ± 2.649
        Leukocytes; Week 24; n= 61, 66
    -0.73 ± 2.110
    -1.47 ± 2.738
        Leukocytes; Week 28; n= 62, 65
    -0.01 ± 2.297
    -1.66 ± 2.804
        Leukocytes; week 32; n= 61, 66
    -0.33 ± 2.218
    -1.54 ± 2.725
        Leukocytes; Week 36; n= 60, 66
    -0.17 ± 2.501
    -1.37 ± 2.578
        Leukocytes; Week 40; n= 61, 65
    0.17 ± 2.912
    -1.28 ± 3.284
        Leukocytes; Week 44; n= 59, 61
    0.25 ± 3.166
    -1.57 ± 2.198
        Leukocytes; Week 48; n= 59, 64
    -0.10 ± 3.092
    -1.46 ± 2.546
        Leukocytes; Week 52; n= 60, 64
    -0.12 ± 3.114
    -1.50 ± 2.521
        Leukocytes; Week 56; n= 59, 61
    -0.05 ± 3.357
    -1.50 ± 2.840
        Leukocytes; Week 60; n= 58, 64
    0.19 ± 3.533
    -1.20 ± 2.396
        Absolute Lymphocytes; Baseline; n= 68, 68
    1.638 ± 0.9375
    1.508 ± 0.8230
        Lymphocytes; Week 4; n= 66, 66
    0.031 ± 0.8990
    0.145 ± 0.7485
        Lymphocytes; Week 8; n= 65, 66
    0.245 ± 0.8804
    -0.048 ± 0.6388
        Lymphocytes; Week 12; n= 63, 65
    0.160 ± 0.9043
    -0.071 ± 0.7665
        Lymphocytes; Week 16; n= 64, 68
    0.078 ± 1.0337
    0.079 ± 0.7254
        Lymphocytes; Week 20; n= 61, 66
    0.137 ± 0.7984
    0.127 ± 0.7096
        Lymphocytes; Week 24; n= 61, 66
    0.056 ± 0.8778
    0.011 ± 0.8077
        Lymphocytes; Week 28; n= 62, 65
    0.261 ± 1.0966
    0.004 ± 0.7328
        Lymphocytes; Week 32; n= 61, 66
    0.244 ± 0.9633
    0.031 ± 0.7986
        Lymphocytes; Week 36; n= 60, 66
    0.156 ± 1.0399
    0.031 ± 0.5939
        Lymphocytes; Week 40; n= 61, 65
    0.064 ± 1.0537
    0.037 ± 0.6391
        Lymphocytes; Week 44; n= 59, 61
    0.130 ± 0.8773
    0.059 ± 0.6471
        Lymphocytes; Week 48; n=59, 64
    0.106 ± 0.8396
    0.035 ± 0.7368
        Lymphocytes; Week 52; n= 60, 64
    0.144 ± 0.9262
    0.031 ± 0.6244
        Lymphocytes; Week 56; n= 59, 61
    0.200 ± 0.8356
    0.128 ± 0.7824
        Lymphocytes; Week 60; n= 58, 64
    0.076 ± 0.8821
    -0.101 ± 0.6848
        Absolute Monocytes; Baseline; n= 68, 68
    0.377 ± 0.2126
    0.405 ± 0.2376
        Monocytes; week 4; n= 66, 66
    0.038 ± 0.2444
    0.014 ± 0.2127
        Monocytes; Week 8; n= 65, 66
    0.052 ± 0.2271
    0.039 ± 0.1988
        Monocytes; Week 12; n= 63, 65
    0.077 ± 0.2468
    -0.004 ± 0.1985
        Monocytes; Week 16; n= 64, 68
    0.086 ± 0.2790
    0.031 ± 0.2157
        Monocytes; Week 20; n= 61, 66
    0.132 ± 0.2684
    0.030 ± 0.1967
        Monocytes; Week 24; n= 61, 66
    0.061 ± 0.2290
    0.013 ± 0.2412
        Monocytes; Week 28; n= 62, 65
    0.107 ± 0.2363
    0.035 ± 0.2350
        Monocytes; Week 32; n= 61, 66
    0.108 ± 0.2839
    0.057 ± 0.2069
        Monocytes; Week 36; n= 60, 66
    0.089 ± 0.2992
    0.072 ± 0.2416
        Monocytes; Week 40; n= 61, 65
    0.084 ± 0.2495
    0.050 ± 0.2096
        Monocytes; Week 44; n= 59, 61
    0.090 ± 0.2494
    0.077 ± 0.2176
        Monocytes; Week 48; n= 59, 64
    0.078 ± 0.2261
    0.025 ± 0.2235
        Monocytes; Week 52; n= 60, 64
    0.075 ± 0.2407
    0.024 ± 0.2098
        Monocytes; Week 56; n= 59, 61
    0.051 ± 0.2104
    0.037 ± 0.2303
        Monocytes; Week 60; n= 58, 64
    0.052 ± 0.2600
    0.001 ± 0.2165
        Absolute Neutrophils; Baseline; n= 68, 68
    7.500 ± 2.7424
    7.198 ± 2.9732
        Neutrophils; Week 4; n= 66, 66
    -0.124 ± 2.6170
    -0.583 ± 2.2703
        Neutrophils; Week 8; n= 65, 66
    -0.572 ± 2.6791
    -0.443 ± 2.56476
        Neutrophils; Week 12; n= 63, 65
    -0.797 ± 2.2948
    -0.799 ± 2.6278
        Neutrophils; Week 16; n= 64, 68
    -0.222 ± 2.7666
    -0.914 ± 2.6034
        Neutrophils; Week 20; n= 61, 66
    -0.560 ± 2.3679
    -1.243 ± 2.6857
        Neutrophils; Week 24; n= 61, 66
    -0.980 ± 2.3151
    -1.120 ± 2.8349
        Neutrophils; Week 28; n= 62, 65
    -0.555 ± 2.3719
    -1.335 ± 2.9428
        Neutrophils; Week 32; n= 61, 66
    -0.762 ± 2.4952
    -1.286 ± 2.6995
        Neutrophils; Week 36; n= 60, 66
    -0.509 ± 2.8231
    -1.131 ± 2.4261
        Neutrophils; Week 40; n= 61, 65
    -0.009 ± 3.0467
    -1.010 ± 3.3999
        Neutrophils; Week 44; n= 59, 61
    -0.020 ± 3.3497
    -1.344 ± 2.1031
        Neutrophils; Week 48; n= 59, 64
    -0.403 ± 3.2656
    -1.151 ± 2.5806
        Neutrophils; Week 52; n= 60, 64
    -0.391 ± 3.4463
    -1.211 ± 2.2815
        Neutrophils; Week 56; n= 59, 61
    -0.381 ± 3.4297
    -1.311 ± 3.0024
        Neutrophils; Week 60; n= 58, 64
    -0.048 ± 3.5724
    -0.795 ± 2.6501
        Absolute Platelets; Baseline; n= 68, 68
    259.8 ± 61.16
    270.3 ± 60.86
        Platelets; Week 4; n= 66, 67
    4.5 ± 38.14
    -1.4 ± 33.79
        Platelets; Week 8; n= 66, 66
    5.0 ± 43.97
    4.1 ± 26.48
        Platelets; Week 12; n= 63, 65
    3.1 ± 50.60
    -4.3 ± 37.89
        Platelets; Week 16; n= 64, 68
    15.4 ± 71.20
    1.8 ± 40.25
        Platelets; Week 20; n= 61, 68
    12.3 ± 49.92
    6.1 ± 52.76
        Platelets; Week 24; n= 62, 65
    10.9 ± 50.38
    -4.2 ± 40.07
        Platelets; Week 28; n= 62, 66
    13.3 ± 55.12
    5.4 ± 41.57
        Platelets; Week 32; n= 61, 67
    12.1 ± 45.36
    0.7 ± 43.85
        Platelets; Week 36; n= 60, 66
    9.3 ± 42.64
    0.6 ± 37.87
        Platelets; Week 40; n= 61, 65
    14.7 ± 45.63
    2.0 ± 42.12
        Platelets; Week 44; n= 60, 63
    19.3 ± 48.88
    4.9 ± 40.27
        Platelets; Week 48; n= 59, 64
    14.2 ± 53.93
    5.4 ± 44.80
        Platelets; Week 52; n= 60, 64
    14.7 ± 48.19
    -3.7 ± 46.34
        Platelets; Week 56; n= 59, 61
    20.3 ± 47.35
    -1.0 ± 48.51
        Platelets; Week 60; n= 59, 64
    13.0 ± 50.07
    -2.0 ± 41.32
    Notes
    [36] - Safety Population
    [37] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in hematology parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and hemoglobin levels

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    End point title
    Change from Baseline in hematology parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and hemoglobin levels
    End point description
    Blood samples were collected to evaluate change from Baseline in MCHC and hemoglobin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [38]
    68 [39]
    Units: g/L
    arithmetic mean (standard deviation)
        Absolute MCHC; Baseline; n= 68, 68
    324.9 ± 7.53
    324.4 ± 7.37
        MCHC; Week 4; n= 66, 67
    -1.2 ± 6.02
    -1.1 ± 5.92
        MCHC; Week 8; n= 66, 66
    -1.5 ± 6.69
    -1.5 ± 6.86
        MCHC; Week 12; n= 63, 65
    -1.3 ± 7.73
    0.3 ± 6.60
        MCHC; Week 16; n= 64, 68
    -2.3 ± 7.11
    -2.1 ± 7.88
        MCHC; Week 20; n= 61, 68
    -2.2 ± 6.65
    -1.2 ± 7.88
        MCHC; Week 24; n= 62, 66
    -3.2 ± 10.19
    -2.6 ± 7.39
        MCHC; Week 28; n= 62, 66
    -4.3 ± 7.07
    -2.6 ± 7.33
        MCHC; Week 32; n= 61, 67
    -6.6 ± 8.19
    -3.6 ± 7.56
        MCHC; Week 36; n= 60, 66
    -4.7 ± 8.05
    -3.3 ± 8.37
        MCHC; Week 40; n= 61, 65
    -4.5 ± 8.04
    -3.2 ± 8.96
        MCHC; Week 44; n= 60, 64
    -4.7 ± 8.51
    -4.5 ± 9.40
        MCHC; Week 48; n= 59, 64
    -6.0 ± 8.03
    -4.8 ± 10.56
        MCHC; Week 52; n= 60, 64
    -5.2 ± 7.79
    -5.3 ± 7.72
        MCHC; Week 56; n= 59, 61
    -6.9 ± 7.74
    -5.3 ± 7.47
        MCHC; Week 60; n= 59, 64
    -7.5 ± 7.41
    -4.7 ± 9.90
        Absolute Hemoglobin; Baseline; n= 68, 68
    141.6 ± 12.67
    140.6 ± 12.99
        Hemoglobin; Week 4; n= 66, 67
    -2.3 ± 6.86
    -1.8 ± 6.43
        Hemoglobin; Week 8; n= 66, 66
    -2.5 ± 7.56
    -1.1 ± 6.28
        Hemoglobin; Week 12; n= 63, 65
    -1.6 ± 8.28
    -2.2 ± 7.17
        Hemoglobin; Week 16; n= 64, 68
    -1.6 ± 8.24
    -1.9 ± 7.64
        Hemoglobin; Week 20; n= 61, 68
    -0.3 ± 6.85
    -1.4 ± 7.64
        Hemoglobin; Week 24; n= 62, 66
    -1.1 ± 8.06
    -1.6 ± 8.51
        Hemoglobin; Week 28; n= 62, 66
    -1.3 ± 7.48
    -1.3 ± 8.94
        Hemoglobin; Week 32; n= 61, 67
    -1.3 ± 8.03
    -1.6 ± 9.22
        Hemoglobin; Week 36; n= 60, 66
    -0.2 ± 8.50
    -0.4 ± 10.23
        Hemoglobin; Week 40; n= 61, 65
    0.1 ± 8.35
    -0.9 ± 9.74
        Hemoglobin; Week 44; n= 60, 64
    0.7 ± 9.59
    -1.9 ± 10.47
        Hemoglobin; Week 48; n= 59, 64
    0.5 ± 8.20
    -1.9 ± 11.07
        Hemoglobin; Week 52; n= 60, 64
    0.1 ± 8.57
    -1.9 ± 10.36
        Hemoglobin; Week 56; n= 59, 61
    -1.5 ± 9.92
    -1.9 ± 11.48
        Hemoglobin; Week 60; n= 59, 64
    -1.8 ± 9.86
    -2.4 ± 11.36
    Notes
    [38] - Safety Population
    [39] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in hematology parameters of Mean Corpuscle Volume (MCV) levels

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    End point title
    Change from Baseline in hematology parameters of Mean Corpuscle Volume (MCV) levels
    End point description
    Blood samples were collected to evaluate change from Baseline in MCV values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [40]
    68 [41]
    Units: femtoliter (fL)
    arithmetic mean (standard deviation)
        Absolute, Baseline; n= 68, 68
    94.8 ± 9.02
    94.8 ± 6.14
        Week 4; n= 66, 67
    0.4 ± 1.67
    0.0 ± 2.33
        Week 8; n= 66, 66
    0.3 ± 2.50
    0.0 ± 2.58
        Week 12; n= 63, 65
    0.2 ± 2.00
    -0.7 ± 2.30
        Week 16; n= 64, 68
    0.0 ± 2.22
    -0.4 ± 2.94
        Week 20; n= 61, 68
    -0.3 ± 1.87
    -0.9 ± 2.66
        Week 24; n= 62, 66
    -0.5 ± 2.21
    -1.0 ± 2.92
        Week 28; n= 62, 66
    -0.4 ± 2.86
    -1.4 ± 3.48
        Week 32; n= 61, 67
    -0.2 ± 3.01
    -1.7 ± 3.56
        Week 36; n= 60, 66
    -0.5 ± 3.55
    -1.9 ± 3.74
        Week 40; n= 61, 65
    -0.9 ± 4.09
    -1.4 ± 3.73
        Week 44; n= 60, 64
    -1.2 ± 5.06
    -1.5 ± 3.91
        Week 48; n= 59, 64
    -1.1 ± 5.96
    -1.5 ± 4.04
        Week 52; n= 60, 64
    -0.8 ± 6.52
    -1.3 ± 4.29
        Week 56; n= 59, 61
    -0.5 ± 6.47
    -1.0 ± 4.15
        Week 60; n= 59, 64
    -0.6 ± 6.57
    -1.0 ± 4.49
    Notes
    [40] - Safety Population
    [41] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in hematology parameters of Mean Corpuscle Hemoglobin (MCH) levels

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    End point title
    Change from Baseline in hematology parameters of Mean Corpuscle Hemoglobin (MCH) levels
    End point description
    Blood samples were collected to evaluate change from Baseline in MCH values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [42]
    68 [43]
    Units: Picogram (pg)
    arithmetic mean (standard deviation)
        Absolute, Baseline; n= 68, 68
    30.77 ± 2.902
    30.77 ± 2.255
        Week 4; n= 66, 67
    0.04 ± 0.331
    -0.12 ± 0.785
        Week 8; n= 66, 66
    -0.02 ± 0.950
    -0.16 ± 0.653
        Week 12; n= 63, 65
    -0.04 ± 0.550
    -0.17 ± 0.769
        Week 16; n= 64, 68
    -0.21 ± 0.845
    -0.34 ± 0.769
        Week 20; n= 61, 68
    -0.28 ± 0.665
    -0.41 ± 0.851
        Week 24; n= 62, 66
    -0.45 ± 1.270
    -0.59 ± 0.959
        Week 28; n= 62, 66
    -0.51 ± 0.618
    -0.70 ± 1.184
        Week 32; n= 61, 67
    -0.66 ± 0.764
    -0.88 ± 1.368
        Week 36; n= 60, 66
    -0.60 ± 0.910
    -0.90 ± 1.395
        Week 40; n= 61, 65
    -0.67 ± 1.171
    -0.79 ± 1.390
        Week 44; n= 60, 64
    -0.78 ± 1.566
    -0.95 ± 1.484
        Week 48; n= 59, 64
    -0.87 ± 1.745
    -0.96 ± 1.654
        Week 52; n= 60, 64
    -0.69 ± 1.908
    -0.95 ± 1.585
        Week 56; n= 59, 61
    -0.79 ± 2.056
    -0.83 ± 1.713
        Week 60; n= 59, 64
    -0.86 ± 2.094
    -0.80 ± 1.818
    Notes
    [42] - Safety Population
    [43] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in hematology parameters of erythrocytes levels

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    End point title
    Change from Baseline in hematology parameters of erythrocytes levels
    End point description
    Blood samples were collected to evaluate change from Baseline in erythrocytes values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [44]
    68 [45]
    Units: 10^12 cells/L
    arithmetic mean (standard deviation)
        Absolute, Baseline; n= 68, 68
    4.64 ± 0.511
    4.58 ± 0.456
        Week 4; n= 66, 67
    -0.07 ± 0.228
    -0.03 ± 0.226
        Week 8; n= 66, 66
    -0.07 ± 0.278
    -0.01 ± 0.211
        Week 12; n= 63, 65
    -0.04 ± 0.273
    -0.04 ± 0.252
        Week 16; n= 64, 68
    -0.02 ± 0.266
    -0.01 ± 0.243
        Week 20; n= 61, 68
    0.03 ± 0.243
    0.03 ± 0.252
        Week 24; n= 62, 66
    0.02 ± 0.252
    0.05 ± 0.265
        Week 28; n= 62, 66
    0.03 ± 0.286
    0.08 ± 0.264
        Week 32; n= 61, 67
    0.06 ± 0.300
    0.09 ± 0.273
        Week 36; n= 60, 66
    0.08 ± 0.314
    0.14 ± 0.299
        Week 40; n= 61, 65
    0.09 ± 0.274
    0.09 ± 0.270
        Week 44; n= 60, 64
    0.13 ± 0.332
    0.08 ± 0.260
        Week 48; n= 59, 64
    0.14 ± 0.293
    0.10 ± 0.271
        Week 52; n= 60, 64
    0.10 ± 0.309
    0.09 ± 0.251
        Week 56; n= 59, 61
    0.06 ± 0.365
    0.07 ± 0.284
        Week 60; n= 59, 64
    0.07 ± 0.384
    0.05 ± 0.318
    Notes
    [44] - Safety Population
    [45] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with anti-Mepolizumab antibodies

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    End point title
    Number of participants with anti-Mepolizumab antibodies
    End point description
    Blood samples were collected for the determination of anti-Mepolizumab antibodies. Participants who showed presence of anti-Mepolizumab antibody were termed as 'positive' and those who did not have anti-Mepolizumab antibody in blood sample were termed as 'negative'. Participants who did not have a positive ADA assay prior to the first dose of investigational product were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    67 [46]
    66 [47]
    Units: Participants
        Negative
    66
    65
        Positive
    1
    1
    Notes
    [46] - Safety Population
    [47] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) levels

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    End point title
    Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) levels
    End point description
    SBP and DBP were measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [48]
    68 [49]
    Units: millimeter of mercury (mm of Hg)
    arithmetic mean (standard deviation)
        Absolute SBP; Baseline; n= 68, 68
    127.46 ± 17.794
    122.46 ± 14.134
        SBP; Week 4; n= 68, 68
    0.47 ± 15.865
    0.93 ± 12.370
        SBP; Week 8; n= 67, 68
    0.07 ± 14.192
    1.29 ± 11.066
        SBP; Week 12; n= 66, 68
    -1.12 ± 14.380
    -1.41 ± 12.071
        SBP; Week 16; n= 64, 68
    -0.97 ± 16.630
    -0.41 ± 11.579
        SBP; Week 20; n= 63, 68
    -0.97 ± 15.028
    -0.85 ± 12.019
        SBP; Week 24; n= 63, 67
    -1.54 ± 15.449
    -1.57 ± 12.824
        SBP; Week 28; n= 63, 67
    -0.06 ± 14.337
    -0.15 ± 13.240
        SBP; Week 32; n= 62, 67
    -2.35 ± 14.027
    0.04 ± 11.181
        SBP; Week 36; n= 62, 67
    1.02 ± 14.663
    0.48 ± 14.397
        SBP; Week 40; n= 62, 66
    0.90 ± 14.202
    1.27 ± 12.075
        SBP; Week 44; n= 61, 66
    1.41 ± 16.143
    -0.36 ± 13.694
        SBP; Week 48; n= 61, 65
    -0.41 ± 17.140
    -0.22 ± 12.351
        SBP: Week 52; n= 61, 65
    -1.03 ± 13.200
    -0.32 ± 13.091
        SBP; Week 56; n= 62, 63
    0.06 ± 15.216
    1.02 ± 13.559
        SBP; Week 60; n= 61, 65
    0.61 ± 15.627
    -0.63 ± 11.656
        Absolute DBP; Baseline; n= 68, 68
    80.21 ± 10.127
    76.22 ± 9.646
        DBP; Week 4; n= 68, 68
    -2.26 ± 10.046
    1.01 ± 10.130
        DBP; Week 8; n= 67, 68
    -2.04 ± 8.461
    -0.34 ± 10.078
        DBP; Week 12; n= 66, 68
    -1.92 ± 10.115
    -0.37 ± 9.167
        DBP; Week 16; n= 64, 68
    -1.36 ± 10.237
    0.46 ± 9.824
        DBP; Week 20; n= 63, 68
    -1.25 ± 8.092
    -1.19 ± 9.214
        DBP; Week 24; n= 63, 67
    -2.24 ± 8.751
    -1.16 ± 9.629
        DBP; Week 28; n= 63, 67
    -2.02 ± 9.939
    0.36 ± 10.071
        DBP; Week 32; n= 62, 67
    -4.27 ± 9.313
    -0.49 ± 10.652
        DBP; Week 36; n= 62, 67
    -1.97 ± 10.995
    0.16 ± 10.988
        DBP; Week 40; n= 62, 66
    -0.48 ± 9.625
    -0.03 ± 8.868
        DBP; Week 44; n= 61, 66
    -0.79 ± 9.930
    -1.03 ± 9.595
        DBP; Week 48; n= 61, 65
    -3.26 ± 10.466
    -1.71 ± 9.239
        DBP; Week 52; n= 61, 65
    -3.66 ± 10.628
    -0.06 ± 9.236
        DBP; Week 56; n= 62, 63
    -3.48 ± 10.570
    0.11 ± 8.899
        DBP; Week 60; n= 61, 65
    -2.54 ± 11.278
    -0.45 ± 9.836
    Notes
    [48] - Safety Population
    [49] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in pulse rate

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    End point title
    Change from Baseline in pulse rate
    End point description
    Pulse rate was measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [50]
    68 [51]
    Units: beats per minute (bpm)
    arithmetic mean (standard deviation)
        Absolute Baseline; n= 68, 68
    77.38 ± 13.763
    75.75 ± 10.404
        Week 4; n= 68, 68
    2.01 ± 12.294
    1.87 ± 10.543
        Week 8; n= 67, 68
    0.97 ± 10.718
    -1.01 ± 10.304
        Week 12; n= 66, 68
    1.52 ± 12.393
    -0.12 ± 10.855
        Week 16; n= 64, 68
    0.59 ± 11.287
    0.44 ± 11.411
        Week 20; n= 63, 68
    1.03 ± 11.521
    -0.56 ± 9.687
        Week 24; n= 63, 67
    0.79 ± 12.134
    0.37 ± 10.057
        Week 28; n= 62, 67
    1.29 ± 10.439
    0.16 ± 10.093
        Week 32; n= 62, 67
    1.60 ± 11.703
    -0.31 ± 10.530
        Week 36; n= 62, 67
    3.47 ± 12.538
    -0.57 ± 11.422
        Week 40; n= 62, 66
    2.65 ± 12.297
    0.74 ± 11.669
        Week 44; n= 61, 66
    3.10 ± 12.195
    0.15 ± 12.763
        Week 48; n= 61, 65
    3.85 ± 12.383
    -1.12 ± 10.315
        Week 52; n= 61, 65
    1.85 ± 11.987
    -2.17 ± 9.596
        Week 56; n= 62, 63
    2.60 ± 14.041
    -0.35 ± 9.986
        Week 60; n= 61, 65
    1.51 ± 12.793
    0.09 ± 10.280
    Notes
    [50] - Safety Population
    [51] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in body temperature

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    End point title
    Change from Baseline in body temperature
    End point description
    Body temperature was measured from Baseline throughout follow-up (till Week 60). The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. The analysis was performed on Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [52]
    68 [53]
    Units: Degree celsius
    arithmetic mean (standard deviation)
        Absolute Baseline; n= 68, 68
    36.52 ± 0.385
    36.51 ± 0.462
        Week 4; n= 68, 68
    0.05 ± 0.439
    -0.04 ± 0.411
        Week 8; n= 67,68
    -0.01 ± 0.379
    -0.02 ± 0.425
        Week 12; n= 66, 68
    0.05 ± 0.410
    -0.03 ± 0.447
        Week 16; n= 64, 68
    -0.01 ± 0.421
    -0.03 ± 0.432
        Week 20; n= 63, 68
    -0.08 ± 0.351
    -0.13 ± 0.376
        Week 24; n= 62, 67
    -0.06 ± 0.449
    -0.06 ± 0.389
        Week 28; n= 63, 67
    -0.06 ± 0.499
    -0.14 ± 0.411
        Week 32; n= 62, 67
    -0.09 ± 0.392
    -0.07 ± 0.355
        Week 36; n= 62, 67
    -0.05 ± 0.431
    0.03 ± 0.468
        Week 40; n= 62, 66
    -0.03 ± 0.530
    -0.13 ± 0.406
        Week 44; n= 61, 65
    -0.03 ± 0.550
    -0.08 ± 0.396
        Week 48; n= 61, 64
    -0.04 ± 0.452
    -0.09 ± 0.414
        Week 52; n= 60, 65
    -0.04 ± 0.423
    -0.12 ± 0.541
        Week 56; n= 61, 63
    -0.08 ± 0.530
    0.00 ± 0.402
        Week 60; n= 61, 64
    0.03 ± 0.467
    -0.02 ± 0.479
    Notes
    [52] - Safety Population
    [53] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in QT interval corrected by Fridericia's method (QTcF) and QT interval corrected by Bazett's method (QTcB) values

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    End point title
    Mean change from Baseline in QT interval corrected by Fridericia's method (QTcF) and QT interval corrected by Bazett's method (QTcB) values
    End point description
    Single measurements of 12-lead electrocardiogram (ECGs) were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Mean change from Baseline in QTcF and QTcB values were measured. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [54]
    68 [55]
    Units: milliseconds (msec)
    arithmetic mean (standard deviation)
        QTcF; Week 8; n= 66, 66
    0.1 ± 17.90
    1.0 ± 15.03
        QTcF; Week 16; n= 64, 66
    0.8 ± 15.26
    0.2 ± 14.05
        QTcF; Week 24; n= 60, 66
    2.8 ± 14.43
    1.9 ± 16.66
        QTcF; Week 32; n= 61, 66
    6.2 ± 25.19
    1.5 ± 17.16
        QTcF; Week 40; n= 61, 65
    -0.5 ± 15.25
    -0.3 ± 17.53
        QTcF; Week 52; n= 58, 64
    2.0 ± 15.96
    3.0 ± 16.04
        QTcF; Week 60; n= 58, 63
    3.0 ± 14.30
    2.9 ± 14.97
        QTcF; Any time post Baseline; n= 68, 68
    16.9 ± 23.74
    15.4 ± 13.79
        QTcB; Week 8; n= 66, 66
    -0.8 ± 19.05
    0.9 ± 17.31
        QTcB; Week 16; n= 64, 66
    -0.1 ± 18.33
    -0.9 ± 14.76
        QTcB; Week 24; n= 60, 66
    1.4 ± 17.89
    1.0 ± 18.10
        QTcB; Week 32; n= 61, 66
    5.2 ± 29.63
    0.0 ± 19.63
        QTcB; Week 40; n= 61, 65
    -0.6 ± 17.83
    -1.4 ± 18.88
        QTcB; Week 52; n= 58, 64
    1.8 ± 17.64
    0.7 ± 18.27
        QTcB; Week 60; n= 58, 63
    1.2 ± 16.56
    2.7 ± 17.27
        QTcB; Any time post Baseline; n= 68, 68
    18.8 ± 26.46
    18.1 ± 15.28
    Notes
    [54] - Safety Population
    [55] - Safety Population
    No statistical analyses for this end point

    Secondary: Maximum change from Baseline in QTcF and QTcB values

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    End point title
    Maximum change from Baseline in QTcF and QTcB values
    End point description
    Single measurements of 12-lead ECGs were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Maximum change from Baseline in QTcF and QTcB values were measured.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 60
    End point values
    Placebo Mepolizumab 300mg
    Number of subjects analysed
    68 [56]
    68 [57]
    Units: msec
    arithmetic mean (standard deviation)
        QTcB interval
    18.8 ± 26.46
    18.1 ± 15.28
        QTcF interval
    16.9 ± 23.74
    15.4 ± 13.79
    Notes
    [56] - Safety Population
    [57] - 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 Adverse Events (AEs) were collected from the start of the study treatment until week 52.
    Adverse event reporting additional description
    AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.

    Reporting group title
    Mepolizumab 300mg
    Reporting group description
    Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.

    Serious adverse events
    Placebo Mepolizumab 300mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 68 (26.47%)
    12 / 68 (17.65%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Testis cancer
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergic granulomatous angiitis
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    4 / 68 (5.88%)
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    2 / 68 (2.94%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebellar ischaemia
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paresis
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nystagmus
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pachymeningitis
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hernia
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Influenza
         subjects affected / exposed
    2 / 68 (2.94%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 68 (2.94%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corona virus infection
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal infection
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory infection
         subjects affected / exposed
    2 / 68 (2.94%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Placebo Mepolizumab 300mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    61 / 68 (89.71%)
    65 / 68 (95.59%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 68 (0.00%)
    3 / 68 (4.41%)
         occurrences all number
    0
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    10 / 68 (14.71%)
    10 / 68 (14.71%)
         occurrences all number
    14
    13
    Injection site reaction
         subjects affected / exposed
    7 / 68 (10.29%)
    9 / 68 (13.24%)
         occurrences all number
    11
    38
    Pyrexia
         subjects affected / exposed
    7 / 68 (10.29%)
    7 / 68 (10.29%)
         occurrences all number
    12
    12
    Asthenia
         subjects affected / exposed
    3 / 68 (4.41%)
    5 / 68 (7.35%)
         occurrences all number
    18
    43
    Chest pain
         subjects affected / exposed
    5 / 68 (7.35%)
    1 / 68 (1.47%)
         occurrences all number
    5
    3
    Injection site pain
         subjects affected / exposed
    3 / 68 (4.41%)
    2 / 68 (2.94%)
         occurrences all number
    15
    3
    Oedema peripheral
         subjects affected / exposed
    1 / 68 (1.47%)
    3 / 68 (4.41%)
         occurrences all number
    1
    4
    Influenza like illness
         subjects affected / exposed
    0 / 68 (0.00%)
    3 / 68 (4.41%)
         occurrences all number
    0
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 68 (5.88%)
    2 / 68 (2.94%)
         occurrences all number
    5
    3
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    2 / 68 (2.94%)
    3 / 68 (4.41%)
         occurrences all number
    4
    3
    Ligament sprain
         subjects affected / exposed
    1 / 68 (1.47%)
    4 / 68 (5.88%)
         occurrences all number
    1
    4
    Contusion
         subjects affected / exposed
    1 / 68 (1.47%)
    3 / 68 (4.41%)
         occurrences all number
    1
    3
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 68 (0.00%)
    5 / 68 (7.35%)
         occurrences all number
    0
    5
    Weight increased
         subjects affected / exposed
    1 / 68 (1.47%)
    4 / 68 (5.88%)
         occurrences all number
    1
    5
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 68 (0.00%)
    3 / 68 (4.41%)
         occurrences all number
    0
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 68 (0.00%)
    3 / 68 (4.41%)
         occurrences all number
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    7 / 68 (10.29%)
    10 / 68 (14.71%)
         occurrences all number
    11
    14
    Cough
         subjects affected / exposed
    8 / 68 (11.76%)
    5 / 68 (7.35%)
         occurrences all number
    12
    5
    Oropharyngeal pain
         subjects affected / exposed
    5 / 68 (7.35%)
    8 / 68 (11.76%)
         occurrences all number
    5
    8
    Productive cough
         subjects affected / exposed
    7 / 68 (10.29%)
    6 / 68 (8.82%)
         occurrences all number
    15
    8
    Sinus congestion
         subjects affected / exposed
    6 / 68 (8.82%)
    6 / 68 (8.82%)
         occurrences all number
    9
    9
    Wheezing
         subjects affected / exposed
    6 / 68 (8.82%)
    5 / 68 (7.35%)
         occurrences all number
    7
    9
    Nasal congestion
         subjects affected / exposed
    5 / 68 (7.35%)
    4 / 68 (5.88%)
         occurrences all number
    6
    4
    Upper-airway cough syndrome
         subjects affected / exposed
    6 / 68 (8.82%)
    2 / 68 (2.94%)
         occurrences all number
    6
    2
    Dyspnoea
         subjects affected / exposed
    4 / 68 (5.88%)
    1 / 68 (1.47%)
         occurrences all number
    4
    1
    Epistaxis
         subjects affected / exposed
    2 / 68 (2.94%)
    3 / 68 (4.41%)
         occurrences all number
    8
    3
    Sneezing
         subjects affected / exposed
    1 / 68 (1.47%)
    3 / 68 (4.41%)
         occurrences all number
    1
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 68 (17.65%)
    22 / 68 (32.35%)
         occurrences all number
    20
    50
    Dizziness
         subjects affected / exposed
    5 / 68 (7.35%)
    3 / 68 (4.41%)
         occurrences all number
    8
    6
    Paraesthesia
         subjects affected / exposed
    3 / 68 (4.41%)
    4 / 68 (5.88%)
         occurrences all number
    4
    4
    Sinus headache
         subjects affected / exposed
    3 / 68 (4.41%)
    2 / 68 (2.94%)
         occurrences all number
    4
    4
    Migraine
         subjects affected / exposed
    1 / 68 (1.47%)
    3 / 68 (4.41%)
         occurrences all number
    1
    3
    Eye disorders
    Vision blurred
         subjects affected / exposed
    2 / 68 (2.94%)
    4 / 68 (5.88%)
         occurrences all number
    2
    4
    Cataract
         subjects affected / exposed
    2 / 68 (2.94%)
    3 / 68 (4.41%)
         occurrences all number
    2
    3
    Eye pruritus
         subjects affected / exposed
    0 / 68 (0.00%)
    3 / 68 (4.41%)
         occurrences all number
    0
    3
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 68 (1.47%)
    5 / 68 (7.35%)
         occurrences all number
    1
    5
    Ear discomfort
         subjects affected / exposed
    4 / 68 (5.88%)
    1 / 68 (1.47%)
         occurrences all number
    5
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    13 / 68 (19.12%)
    11 / 68 (16.18%)
         occurrences all number
    14
    16
    Diarrhoea
         subjects affected / exposed
    8 / 68 (11.76%)
    12 / 68 (17.65%)
         occurrences all number
    9
    16
    Vomiting
         subjects affected / exposed
    4 / 68 (5.88%)
    11 / 68 (16.18%)
         occurrences all number
    4
    12
    Abdominal pain upper
         subjects affected / exposed
    5 / 68 (7.35%)
    5 / 68 (7.35%)
         occurrences all number
    5
    11
    Abdominal pain
         subjects affected / exposed
    4 / 68 (5.88%)
    2 / 68 (2.94%)
         occurrences all number
    4
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 68 (5.88%)
    1 / 68 (1.47%)
         occurrences all number
    5
    1
    Dyspepsia
         subjects affected / exposed
    3 / 68 (4.41%)
    1 / 68 (1.47%)
         occurrences all number
    3
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    6 / 68 (8.82%)
    9 / 68 (13.24%)
         occurrences all number
    7
    10
    Pruritus
         subjects affected / exposed
    1 / 68 (1.47%)
    6 / 68 (8.82%)
         occurrences all number
    1
    7
    Urticaria
         subjects affected / exposed
    1 / 68 (1.47%)
    4 / 68 (5.88%)
         occurrences all number
    1
    7
    Skin lesion
         subjects affected / exposed
    0 / 68 (0.00%)
    3 / 68 (4.41%)
         occurrences all number
    0
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    12 / 68 (17.65%)
    15 / 68 (22.06%)
         occurrences all number
    22
    17
    Myalgia
         subjects affected / exposed
    9 / 68 (13.24%)
    6 / 68 (8.82%)
         occurrences all number
    12
    8
    Back pain
         subjects affected / exposed
    6 / 68 (8.82%)
    8 / 68 (11.76%)
         occurrences all number
    10
    10
    Pain in extremity
         subjects affected / exposed
    6 / 68 (8.82%)
    5 / 68 (7.35%)
         occurrences all number
    7
    5
    Neck pain
         subjects affected / exposed
    2 / 68 (2.94%)
    8 / 68 (11.76%)
         occurrences all number
    2
    9
    Musculoskeletal pain
         subjects affected / exposed
    2 / 68 (2.94%)
    6 / 68 (8.82%)
         occurrences all number
    2
    7
    Joint swelling
         subjects affected / exposed
    3 / 68 (4.41%)
    2 / 68 (2.94%)
         occurrences all number
    3
    2
    Muscle spasms
         subjects affected / exposed
    2 / 68 (2.94%)
    3 / 68 (4.41%)
         occurrences all number
    4
    3
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 68 (0.00%)
    3 / 68 (4.41%)
         occurrences all number
    0
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    16 / 68 (23.53%)
    12 / 68 (17.65%)
         occurrences all number
    25
    19
    Sinusitis
         subjects affected / exposed
    11 / 68 (16.18%)
    14 / 68 (20.59%)
         occurrences all number
    19
    15
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 68 (16.18%)
    14 / 68 (20.59%)
         occurrences all number
    14
    21
    Bronchitis
         subjects affected / exposed
    8 / 68 (11.76%)
    7 / 68 (10.29%)
         occurrences all number
    9
    9
    Influenza
         subjects affected / exposed
    6 / 68 (8.82%)
    7 / 68 (10.29%)
         occurrences all number
    6
    9
    Respiratory tract infection
         subjects affected / exposed
    8 / 68 (11.76%)
    5 / 68 (7.35%)
         occurrences all number
    15
    7
    Urinary tract infection
         subjects affected / exposed
    4 / 68 (5.88%)
    5 / 68 (7.35%)
         occurrences all number
    6
    5
    Acute sinusitis
         subjects affected / exposed
    2 / 68 (2.94%)
    6 / 68 (8.82%)
         occurrences all number
    3
    6
    Conjunctivitis
         subjects affected / exposed
    4 / 68 (5.88%)
    4 / 68 (5.88%)
         occurrences all number
    4
    4
    Rhinitis
         subjects affected / exposed
    3 / 68 (4.41%)
    5 / 68 (7.35%)
         occurrences all number
    3
    5
    Ear infection
         subjects affected / exposed
    6 / 68 (8.82%)
    1 / 68 (1.47%)
         occurrences all number
    8
    1
    Fungal skin infection
         subjects affected / exposed
    3 / 68 (4.41%)
    4 / 68 (5.88%)
         occurrences all number
    3
    4
    Oral herpes
         subjects affected / exposed
    3 / 68 (4.41%)
    4 / 68 (5.88%)
         occurrences all number
    5
    6
    Gastroenteritis
         subjects affected / exposed
    1 / 68 (1.47%)
    5 / 68 (7.35%)
         occurrences all number
    1
    5
    Otitis media
         subjects affected / exposed
    1 / 68 (1.47%)
    3 / 68 (4.41%)
         occurrences all number
    1
    3
    Viral infection
         subjects affected / exposed
    1 / 68 (1.47%)
    3 / 68 (4.41%)
         occurrences all number
    1
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Oct 2013
    Generated to remove evaluation of ACQ-6 and sino-nasal symptoms at the time of relapse and to clarify the definition of time of onset of relapse; countryspecific requirements for Japan regarding hepatitis B screening added as well as clarification to text as needed and administrative changes
    27 Aug 2014
    Generated to clarify investigators can taper oral corticosteroids downward when BVAS≠0; to include additional statement in risk assessment table; to clarify that participants who become pregnant must be withdrawn from study treatment; to clarify requirements for collection of a fasting blood sample in diabetic participants; to clarify that collection of PK samples at Weeks 1 and 29 is optional; to delete requirement for measurement of eosinophil count as a liver event follow-up assessment; to amend the schedule for sputum sampling in the biomarker sub-study; to add country-specific change for Japan regarding definition of relapsing disease in inclusion criteria; to include SAMAs and LAMAs as bronchodilator to be withheld prior to reversibility testing; to clarify requirements for participant follow-up in the event study treatment is discontinued; to include reference to the Supplement to Version 12 of the Investigator’s Brochure and other administrative changes.
    24 Jun 2016
    Generated to add secondary endpoints including the remission definition as per the EULAR recommendations for conducting clinical trials in systemic vasculitis, i.e., BVAS=0 and prednisolone/prednisone dose ≤7.5 mg/day, to clarify relapse definition, to amend the statistical analysis plan in accordance with the addition of the new secondary endpoints, to clarify specific aspects of the Data Analysis and Statistical Considerations section and to include some administrative updates.

    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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