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    Clinical Trial Results:
    A randomised, double-blind, parallel group PhIII study to assess the clinical efficacy and safety of 100 mg SC Mepolizumab as an add on to maintenance treatment in adults with severe bilateral nasal polyps

    Summary
    EudraCT number
    		 2016-004255-70
    Trial protocol
    		 DE   GB   SE   NL   RO  
    Global end of trial date
    11 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Dec 2020
    First version publication date
    06 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    205687
    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 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Apr 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of 100 mg mepolizumab compared to placebo
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 May 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 71
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Romania: 58
    Country: Number of subjects enrolled
    Sweden: 26
    Country: Number of subjects enrolled
    United Kingdom: 18
    Country: Number of subjects enrolled
    United States: 56
    Country: Number of subjects enrolled
    Argentina: 55
    Country: Number of subjects enrolled
    Australia: 20
    Country: Number of subjects enrolled
    Canada: 34
    Country: Number of subjects enrolled
    Korea, Republic of: 11
    Country: Number of subjects enrolled
    Russian Federation: 64
    Worldwide total number of subjects
    414
    EEA total number of subjects
    174
    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)
    355
    From 65 to 84 years
    59
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants (par.) were enrolled across 11 countries (Germany, Netherlands, Romania, Sweden, United Kingdom, United States, Argentina, Australia, Canada, Republic of Korea and Russian Federation).

    Pre-assignment
    Screening details
    		 A total of 414 participants were enrolled and randomized in the study, of which only 407 participants received study treatment and were included in the Intent-to-Treat Population (defined as all randomized participants who took at least 1 dose of study treatment). Seven participants did not receive study treatment as they were randomized in error.

    Period 1
    Period 1 title
    Treatment Period (TP) (52 Weeks)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants were randomized to receive up to 13 subcutaneous (SC) doses of mepolizumab matching placebo every 4 weeks to Week 52 (Wk 52) on top of standard of care (SoC) for nasal polyps (NP) which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received subcutaneous (SC) doses of mepolizumab matching placebo every 4 weeks until 52 Weeks.

    Investigational medicinal product name
    Mometasone furorate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Inhalation use
    Dosage and administration details
    Participants received Mometasone furorate nasal spray as a Standard of care (SoC) for nasal polyps (NP).

    Arm title
    		 Mepolizumab 100 mg SC
    Arm description
    		 Participants were randomized to receive up to 13 SC doses of mepolizumab 100 milligrams per milliliter (mg/mL) every 4 weeks to Week 52 on top of SoC for nasal polyps which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mepolizumab 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 100 mg SC doses of Mepolizumab every 4 weeks until 52 Weeks.

    Investigational medicinal product name
    Mometasone furorate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Inhalation use
    Dosage and administration details
    Participants received Mometasone furorate nasal spray as a Standard of care (SoC) for nasal polyps (NP).

    Number of subjects in period 1 [1]
    		Placebo Mepolizumab 100 mg SC
    Started
    201
    206
    Completed Investigational Product (IP)
    167 [2]
    183 [3]
    Not Completed IP
    34 [4]
    23 [5]
    Withdrew IP Due to: Adverse Event
    4 [6]
    4 [7]
    Withdrew IP Due to: Lack of Efficacy
    11 [8]
    5 [9]
    Withdrew IP Due to: Protocol Deviation
    1 [10]
    0 [11]
    Withdrew IP Due to: Stopping Criteria
    1 [12]
    1 [13]
    Withdrew IP Due to: Physician Decision
    2 [14]
    1 [15]
    Withdrew IP Due to: Withdrawal by par.
    15 [16]
    12 [17]
    Completed
    184
    189
    Not completed
    17
    17
         Consent withdrawn by subject
    16
    17
         Lost to follow-up
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 414 participants were enrolled and randomized in the study, of which only 407 participants received study treatment and were included in the Intent-to-Treat Population (defined as all randomized participants who took at least 1 dose of study treatment). Seven participants did not receive study treatment as they were randomized in error.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    [10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    [11] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    [12] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    [13] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    [14] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    [15] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    [16] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    [17] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participants with withdrawal from investigational product only.
    Period 2
    Period 2 title
    No-treatment Follow-up Period (6 months)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants were randomized to receive up to 13 subcutaneous (SC) doses of mepolizumab matching placebo every 4 weeks to Week 52 (Wk 52) on top of standard of care (SoC) for nasal polyps (NP) which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received subcutaneous (SC) doses of mepolizumab matching placebo every 4 weeks until 52 Weeks.

    Investigational medicinal product name
    Mometasone furorate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Inhalation use
    Dosage and administration details
    Participants received Mometasone furorate nasal spray as a Standard of care (SoC) for nasal polyps (NP).

    Arm title
    		 Mepolizumab 100 mg SC
    Arm description
    		 Participants were randomized to receive up to 13 SC doses of mepolizumab 100 milligrams per milliliter (mg/mL) every 4 weeks to Week 52 on top of SoC for nasal polyps which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mepolizumab 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 100 mg SC doses of Mepolizumab every 4 weeks until 52 Weeks.

    Investigational medicinal product name
    Mometasone furorate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Inhalation use
    Dosage and administration details
    Participants received Mometasone furorate nasal spray as a Standard of care (SoC) for nasal polyps (NP).

    Number of subjects in period 2 [18]
    		Placebo Mepolizumab 100 mg SC
    Started
    65
    69
    Completed
    65
    68
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1
    Notes
    [18] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only 134 participants (65 + 69) continued in No-treatment Follow-up period to check maintenance of response after stopping treatment per protocol.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive up to 13 subcutaneous (SC) doses of mepolizumab matching placebo every 4 weeks to Week 52 (Wk 52) on top of standard of care (SoC) for nasal polyps (NP) which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.

    Reporting group title
    Mepolizumab 100 mg SC
    Reporting group description
    		 Participants were randomized to receive up to 13 SC doses of mepolizumab 100 milligrams per milliliter (mg/mL) every 4 weeks to Week 52 on top of SoC for nasal polyps which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.

    Reporting group values
    		 Placebo Mepolizumab 100 mg SC Total
    Number of subjects
    		 201 206 407
    Age categorical
    Units: Subjects
        All participants
    		 201 206 407
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 48.9 ± 12.46 48.6 ± 13.55 -
    Sex: Female, Male
    Units: Participants
        Female
    		 76 67 143
        Male
    		 125 139 264
    Race/Ethnicity, Customized
    Units: Subjects
        Asian-Central/South Asian Heritage (H.)
    		 1 2 3
        Asian-Japanese H./East Asian H./SouthEast Asian H.
    		 8 7 15
        Black or African American (AA)
    		 4 5 9
        White
    		 187 192 379
        AA/African H. and American Indian or Alaska Native
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive up to 13 subcutaneous (SC) doses of mepolizumab matching placebo every 4 weeks to Week 52 (Wk 52) on top of standard of care (SoC) for nasal polyps (NP) which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.

    Reporting group title
    Mepolizumab 100 mg SC
    Reporting group description
    		 Participants were randomized to receive up to 13 SC doses of mepolizumab 100 milligrams per milliliter (mg/mL) every 4 weeks to Week 52 on top of SoC for nasal polyps which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive up to 13 subcutaneous (SC) doses of mepolizumab matching placebo every 4 weeks to Week 52 (Wk 52) on top of standard of care (SoC) for nasal polyps (NP) which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.

    Reporting group title
    Mepolizumab 100 mg SC
    Reporting group description
    		 Participants were randomized to receive up to 13 SC doses of mepolizumab 100 milligrams per milliliter (mg/mL) every 4 weeks to Week 52 on top of SoC for nasal polyps which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.

    Primary: Change from Baseline in total endoscopic nasal polyps score at Week 52

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    End point title
    		 Change from Baseline in total endoscopic nasal polyps score at Week 52
    End point description
    Independent reviewers, blinded to treatment, reviewed image recordings of nasal endoscopies to determine total endoscopic NP score based on NP size. The right and left nostrils were scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction/congestion of the inferior meatus). The total score is the sum of the right and left nostril scores and ranges from 0 to 8, higher scores indicate greater disease severity. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and Week 52
    End point values
    		 Placebo Mepolizumab 100 mg SC
    Number of subjects analysed
    201 [1]
    206 [2]
    Units: Scores on a scale
        median (full range (min-max))
    0.0 (-5 to 3)
    -1.0 (-6 to 3)
    Notes
    [1] - ITT Population included all randomized participants who took at least 1 dose of study treatment.
    [2] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Quantile regression with covariates: treatment,region,Baseline score,Baseline eosinophilcount(BEC). Par. with nasal surgery prior to Wk52/withdrew early with no nasal surgery assigned their worst observed score prior to nasal surgery/study withdrawal
    Comparison groups
    Placebo v Mepolizumab 100 mg SC
    Number of subjects included in analysis
    407
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 Wilcoxon rank-sum test
    Parameter type
    		 Difference in Medians
    Point estimate
    -0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.11
         upper limit
    		 -0.34
    Notes
    [3] - p-Value was based on Wilcoxon rank-sum test.

    Primary: Change from Baseline in nasal obstruction visual analog scale (VAS) score during the 4 weeks prior to Week 52

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    End point title
    		 Change from Baseline in nasal obstruction visual analog scale (VAS) score during the 4 weeks prior to Week 52
    End point description
    Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale (VAS) using an electronic diary (eDiary). Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final nasal obstruction VAS score ranged between 0 and 10, with higher scores indicating greater disease severity. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
    End point type
    Primary
    End point timeframe
    Baseline and Weeks 49 to 52
    End point values
    		 Placebo Mepolizumab 100 mg SC
    Number of subjects analysed
    201 [4]
    206 [5]
    Units: Scores on a scale
        median (full range (min-max))
    -0.82 (-9.23 to 2.58)
    -4.41 (-9.90 to 1.54)
    Notes
    [4] - ITT Population
    [5] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.
    Comparison groups
    Placebo v Mepolizumab 100 mg SC
    Number of subjects included in analysis
    407
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [6]
    Method
    		 Wilcoxon rank-sum test
    Parameter type
    		 Difference in Medians
    Point estimate
    -3.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.09
         upper limit
    		 -2.18
    Notes
    [6] - p-Value was based on Wilcoxon rank-sum test.

    Secondary: Percentage of participants with nasal surgery over time

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    End point title
    		 Percentage of participants with nasal surgery over time
    End point description
    The percentage of participants with nasal surgery over time (by Weeks 8, 16, 24, 32, 40, 48 and 52) was derived from Kaplan-Meier time-to-event analyses for the event ‘first nasal surgery’. Nasal surgery was defined as any procedure involving instruments resulting in incision and removal of tissue (polypectomy) in the nasal cavity. Time to first nasal surgery was defined as (Date of first nasal surgery – Date of first dose of study treatment) + 1. Percentage of participants with nasal surgery over time (by Weeks 8, 16, 24, 32, 40, 48 and 52) and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method. Analysis included surgeries occurring up to Week 52, reported on-treatment and those reported after early discontinuation from IP by participants who remained in the study.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 16, 24, 32, 40, 48 and 52
    End point values
    		 Placebo Mepolizumab 100 mg SC
    Number of subjects analysed
    201 [7]
    206 [8]
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 8
    1.0 (0.3 to 3.9)
    0.5 (0.1 to 3.4)
        Week 16
    3.5 (1.7 to 7.2)
    1.0 (0.2 to 3.8)
        Week 24
    9.1 (5.8 to 14.0)
    4.0 (2.0 to 7.8)
        Week 32
    14.2 (10.0 to 19.9)
    6.0 (3.5 to 10.4)
        Week 40
    18.9 (14.0 to 25.1)
    7.6 (4.6 to 12.3)
        Week 48
    22.0 (16.8 to 28.5)
    9.2 (5.9 to 14.2)
        Week 52
    23.6 (18.3 to 30.3)
    9.2 (5.9 to 14.2)
    Notes
    [7] - ITT Population
    [8] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis using a Cox Proportional Hazards Model with covariates of treatment, geographic region, Baseline total endoscopic score (centrally read), Baseline nasal obstruction VAS, Baseline BEC, number of previous surgeries (1, 2, >2 as ordinal).
    Comparison groups
    Placebo v Mepolizumab 100 mg SC
    Number of subjects included in analysis
    407
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003 [9]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard Ratio (Mepolizumab/Placebo)
    Point estimate
    0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 0.76
    Notes
    [9] - p-Value was based on Cox Proportional Hazards Model.

    Secondary: Change from Baseline in overall VAS score during the 4 weeks prior to Week 52

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    End point title
    		 Change from Baseline in overall VAS score during the 4 weeks prior to Week 52
    End point description
    Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final overall VAS score ranged between 0 and 10, with higher scores indicating greater disease severity. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 49 to 52
    End point values
    		 Placebo Mepolizumab 100 mg SC
    Number of subjects analysed
    201 [10]
    206 [11]
    Units: Scores on a scale
        median (full range (min-max))
    -0.90 (-9.11 to 1.19)
    -4.48 (-10.00 to 1.62)
    Notes
    [10] - ITT Population
    [11] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.
    Comparison groups
    Placebo v Mepolizumab 100 mg SC
    Number of subjects included in analysis
    407
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003 [12]
    Method
    		 Wilcoxon rank-sum test
    Parameter type
    		 Difference in Medians
    Point estimate
    -3.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 -2.26
    Notes
    [12] - p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.

    Secondary: Change from Baseline in sino-nasal outcome test (SNOT)-22 total score at Week 52

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    End point title
    		 Change from Baseline in sino-nasal outcome test (SNOT)-22 total score at Week 52
    End point description
    The SNOT-22 is a 22-item self-reported questionnaire developed to measure symptoms and impacts related to chronic rhinosinusitis. The 22 questions are self-completed by participants based on their recall of their symptoms over the previous 2 weeks using a 6-point rating scale (0 = Not present/no problem; 1 = Very mild problem; 2 = Mild or slight problem; 3 = Moderate problem; 4 = Severe problem; 5 = Problem as “bad as it can be”). Scores for each question are summed to derive the total score. The SNOT-22 total score ranges from 0 to 110, with higher scores representing worse quality of life. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value. Only those participants with data available at the specified data point were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 52
    End point values
    		 Placebo Mepolizumab 100 mg SC
    Number of subjects analysed
    198 [13]
    205 [14]
    Units: Scores on a scale
        median (full range (min-max))
    -14.0 (-86 to 38)
    -30.0 (-93 to 42)
    Notes
    [13] - ITT Population
    [14] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wk 52/withdrew early with no nasal surgery assigned their worst observed score prior to nasal surgery/study withdrawal.
    Comparison groups
    Placebo v Mepolizumab 100 mg SC
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003 [15]
    Method
    		 Wilcoxon rank-sum test
    Parameter type
    		 Difference in Medians
    Point estimate
    -16.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.57
         upper limit
    		 -9.42
    Notes
    [15] - p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.

    Secondary: Percentage of participants requiring at least one course of systemic steroids for nasal polyps up to Week 52

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    End point title
    		 Percentage of participants requiring at least one course of systemic steroids for nasal polyps up to Week 52
    End point description
    The number of courses of systemic steroids received by participants were recorded. For the purpose of this study, a course of systemic corticosteroid separated by less than 7 days was considered as a continuation of the same course. Percentage of participants requiring at least one course of systemic steroids for nasal polyps up to Week 52 is presented. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Placebo Mepolizumab 100 mg SC
    Number of subjects analysed
    201 [16]
    206 [17]
    Units: Percentage of participants
    37
    25
    Notes
    [16] - ITT Population
    [17] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Covariates: treatment group, geographic region, number of oral corticosteroids courses for NP in last 12 months(0,1,>1 as ordinal), Baseline total endoscopic score(centrally read),Baseline nasal obstruction VAS score,log(e) Baseline eosinophil count.
    Comparison groups
    Placebo v Mepolizumab 100 mg SC
    Number of subjects included in analysis
    407
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.02 [18]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 0.92
    Notes
    [18] - p-Value was based on logistic regression model and is adjusted for multiplicity.

    Secondary: Change from Baseline in the composite VAS score (combining VAS scores for nasal obstruction, nasal discharge, mucus in the throat and loss of smell) during the 4 weeks prior to Week 52

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    End point title
    		 Change from Baseline in the composite VAS score (combining VAS scores for nasal obstruction, nasal discharge, mucus in the throat and loss of smell) during the 4 weeks prior to Week 52
    End point description
    Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from electronically captured scores by dividing by 10. The composite VAS score was calculated as average of individual scores of nasal obstruction, nasal discharge, mucus in the throat and loss of smell and ranged between 0 and 10, with higher scores indicating greater disease severity. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 49 to 52
    End point values
    		 Placebo Mepolizumab 100 mg SC
    Number of subjects analysed
    201 [19]
    206 [20]
    Units: Scores on a scale
        median (full range (min-max))
    -0.89 (-9.29 to 2.90)
    -3.96 (-9.93 to 1.37)
    Notes
    [19] - ITT Population
    [20] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.
    Comparison groups
    Placebo v Mepolizumab 100 mg SC
    Number of subjects included in analysis
    407
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.02 [21]
    Method
    		 Wilcoxon rank-sum test
    Parameter type
    		 Difference in Medians
    Point estimate
    -2.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.44
         upper limit
    		 -1.91
    Notes
    [21] - p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.

    Secondary: Change from Baseline in individual VAS symptom score: loss of smell during the 4 weeks prior to Week 52

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    End point title
    		 Change from Baseline in individual VAS symptom score: loss of smell during the 4 weeks prior to Week 52
    End point description
    Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final loss of smell VAS score ranged between 0 and 10, with higher scores indicating greater disease severity. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 49 to 52
    End point values
    		 Placebo Mepolizumab 100 mg SC
    Number of subjects analysed
    201 [22]
    206 [23]
    Units: Scores on a scale
        median (full range (min-max))
    0.00 (-9.97 to 1.94)
    -0.53 (-10.00 to 1.27)
    Notes
    [22] - ITT Population
    [23] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.
    Comparison groups
    Placebo v Mepolizumab 100 mg SC
    Number of subjects included in analysis
    407
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.02 [24]
    Method
    		 Wilcoxon rank-sum test
    Parameter type
    		 Difference in Medians
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.65
         upper limit
    		 -0.08
    Notes
    [24] - p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 52 for treatment period and up to 6 months during no-treatment follow-up period after Week 52 visit
    Adverse event reporting additional description
    Non-serious AEs and serious AEs were collected for Safety Population which consisted of all randomized participants who took at least one dose of study treatment. Adverse events are presented treatment-wise and period-wise.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Placebo (Treatment period)
    Reporting group description
    		 Participants were randomized to receive up to 13 SC doses of mepolizumab matching placebo every 4 weeks to Week 52 on top of SoC for nasal polyps which included daily mometasone furorate nasal spray.

    Reporting group title
    Mepolizumab 100 mg SC (Treatment period)
    Reporting group description
    		 Participants were randomized to receive up to 13 SC doses of mepolizumab 100 mg/mL every 4 weeks to Week 52 on top of SoC for nasal polyps which included daily mometasone furorate nasal spray.

    Reporting group title
    Placebo (Follow-up)
    Reporting group description
    		 Participants entered in a 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment. Participants received mepolizumab matching placebo during treatment period.

    Reporting group title
    Mepolizumab 100 mg SC (Follow-up)
    Reporting group description
    		 Participants entered in a 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment. Participants received mepolizumab 100 mg/mL during treatment period.

    Serious adverse events
    		 Placebo (Treatment period) Mepolizumab 100 mg SC (Treatment period) Placebo (Follow-up) Mepolizumab 100 mg SC (Follow-up)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 201 (6.97%)
    12 / 206 (5.83%)
    4 / 65 (6.15%)
    2 / 69 (2.90%)
         number of deaths (all causes)
    0
    0
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign vulval neoplasm
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal adenoma
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 206 (0.00%)
    1 / 65 (1.54%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion missed
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    1 / 65 (1.54%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 206 (0.00%)
    1 / 65 (1.54%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 201 (0.00%)
    2 / 206 (0.97%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural complication
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    1 / 65 (1.54%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Facial paralysis
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine with aura
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 201 (0.00%)
    2 / 206 (0.97%)
    1 / 65 (1.54%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal polyp
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 206 (0.00%)
    1 / 65 (1.54%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 206 (0.00%)
    1 / 65 (1.54%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Focal segmental glomerulosclerosis
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Foot deformity
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 201 (0.50%)
    1 / 206 (0.49%)
    0 / 65 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 201 (0.00%)
    2 / 206 (0.97%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Placebo (Treatment period) Mepolizumab 100 mg SC (Treatment period) Placebo (Follow-up) Mepolizumab 100 mg SC (Follow-up)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    141 / 201 (70.15%)
    139 / 206 (67.48%)
    13 / 65 (20.00%)
    14 / 69 (20.29%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    9 / 201 (4.48%)
    8 / 206 (3.88%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    11
    11
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    44 / 201 (21.89%)
    37 / 206 (17.96%)
    5 / 65 (7.69%)
    5 / 69 (7.25%)
         occurrences all number
    141
    114
    14
    8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 206 (0.00%)
    2 / 65 (3.08%)
    0 / 69 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    8 / 201 (3.98%)
    4 / 206 (1.94%)
    2 / 65 (3.08%)
    0 / 69 (0.00%)
         occurrences all number
    14
    5
    2
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    5 / 201 (2.49%)
    7 / 206 (3.40%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    5
    11
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    18 / 201 (8.96%)
    17 / 206 (8.25%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    20
    24
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    10 / 201 (4.98%)
    16 / 206 (7.77%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    11
    19
    0
    0
    Nasal polyps
         subjects affected / exposed
    16 / 201 (7.96%)
    8 / 206 (3.88%)
    1 / 65 (1.54%)
    3 / 69 (4.35%)
         occurrences all number
    28
    11
    1
    3
    Asthma
         subjects affected / exposed
    17 / 201 (8.46%)
    4 / 206 (1.94%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    20
    31
    0
    0
    Cough
         subjects affected / exposed
    13 / 201 (6.47%)
    7 / 206 (3.40%)
    2 / 65 (3.08%)
    2 / 69 (2.90%)
         occurrences all number
    15
    9
    3
    2
    Nasal congestion
         subjects affected / exposed
    6 / 201 (2.99%)
    7 / 206 (3.40%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    9
    12
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 206 (0.00%)
    2 / 65 (3.08%)
    2 / 69 (2.90%)
         occurrences all number
    0
    0
    3
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    14 / 201 (6.97%)
    15 / 206 (7.28%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    16
    24
    0
    0
    Arthralgia
         subjects affected / exposed
    5 / 201 (2.49%)
    13 / 206 (6.31%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    6
    14
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    46 / 201 (22.89%)
    52 / 206 (25.24%)
    4 / 65 (6.15%)
    6 / 69 (8.70%)
         occurrences all number
    64
    83
    6
    8
    Sinusitis
         subjects affected / exposed
    22 / 201 (10.95%)
    10 / 206 (4.85%)
    0 / 65 (0.00%)
    3 / 69 (4.35%)
         occurrences all number
    29
    12
    0
    3
    Acute sinusitis
         subjects affected / exposed
    13 / 201 (6.47%)
    13 / 206 (6.31%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    18
    17
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 201 (6.97%)
    12 / 206 (5.83%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    18
    20
    0
    0
    Bronchitis
         subjects affected / exposed
    13 / 201 (6.47%)
    10 / 206 (4.85%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    16
    10
    0
    0
    Influenza
         subjects affected / exposed
    8 / 201 (3.98%)
    7 / 206 (3.40%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    10
    7
    0
    0
    Otitis media
         subjects affected / exposed
    10 / 201 (4.98%)
    5 / 206 (2.43%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    12
    5
    0
    0
    Rhinitis
         subjects affected / exposed
    8 / 201 (3.98%)
    5 / 206 (2.43%)
    0 / 65 (0.00%)
    0 / 69 (0.00%)
         occurrences all number
    10
    5
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 May 2017
    Amendment 1: The amendment was made to support country-specific requirements and amendments for South Korea. The changes included the Investigational Product (IP) label, provided additional clarification about the inclusion criteria age as per local regulations and provided details of oral corticosteroids (OCS) supplied for South Korea.
    14 Jul 2017
    Amendment 2: The main purpose of this amendment was to reflect comments from investigators to clarify points in the protocol that might be confusing or inconsistent. In addition, it also reflected the removal of computerized tomography (CT) scans and exit interviews as well as simplifying some of the endpoints such as reduction of endoscopic NP endpoints.
    20 Feb 2018
    Amendment 3: The purpose of this amendment was to clarify that screen failures could also be re-screened (not just run-in failures) and that the electrocardiogram (ECG) machine did not need to be automated.

    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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