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    Clinical Trial Results:
    A double blind (sponsor open) placebo-controlled, stratified, parallel group study to evaluate the efficacy and safety of repeat doses of GSK3772847 in participants with moderate to severe asthma with allergic fungal airway disease (AFAD)

    Summary
    EudraCT number
    		 2017-003544-20
    Trial protocol
    		 GB   FR   NL  
    Global end of trial date
    06 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Oct 2020
    First version publication date
    15 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    207972
    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
    28 Apr 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of 3 doses of GSK3772847 (administered every 4 weeks) compared with placebo in moderate to severe asthma participants with allergic fungal airway disease (AFAD) who are currently on Standard of Care (SoC)
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Apr 2018
    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
    Netherlands: 3
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    Russian Federation: 64
    Country: Number of subjects enrolled
    United Kingdom: 38
    Worldwide total number of subjects
    115
    EEA total number of subjects
    51
    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)
    89
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a double-blind, placebo-controlled, parallel group study conducted in participants with moderate to severe asthma with allergic fungal airway disease (AFAD). The study was conducted across 4 countries-France, Netherlands, Russian Federation and the United Kingdom.

    Pre-assignment
    Screening details
    		 A total of 17 participants were randomized in a ratio of 1:1 to receive either GSK3772847 10 milligrams per kilogram (mg/kg) or placebo. Recruitment in the study was terminated early due to the feasibility of completing the study in a timely manner.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received three doses of placebo administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo was sterile normal saline. Participants were administered three doses of placebo via the intravenous route every 4 weeks (Weeks 0, 4 and 8)

    Arm title
    		 GSK3772847
    Arm description
    		 Participants received three doses of GSK3772847 10 mg/kg administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK3772847
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    GSK3772847 was available as white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial to be reconstituted and diluted with sterile normal saline. Participants were administered three doses of GSK3772847 10 mg/kg via the intravenous route every 4 weeks (Weeks 0, 4 and 8)

    Number of subjects in period 1 [1]
    		Placebo GSK3772847
    Started
    9
    8
    Completed
    8
    8
    Not completed
    1
    0
         Physician decision
    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 115 participants were screened of which 17 participants were randomized in the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received three doses of placebo administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.

    Reporting group title
    GSK3772847
    Reporting group description
    		 Participants received three doses of GSK3772847 10 mg/kg administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.

    Reporting group values
    		 Placebo GSK3772847 Total
    Number of subjects
    		 9 8 17
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 6 6 12
        From 65-84 years
    		 3 2 5
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 59.9 ( 9.57 ) 53.6 ( 12.59 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 3 2 5
        Male
    		 6 6 12
    Race/Ethnicity, Customized
    Units: Subjects
        Asian-Japanese/East Asian (EA)/South EA Heritage
    		 0 2 2
        White
    		 9 6 15

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received three doses of placebo administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.

    Reporting group title
    GSK3772847
    Reporting group description
    		 Participants received three doses of GSK3772847 10 mg/kg administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.

    Primary: Percent change from Baseline in blood eosinophils over time

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    End point title
    		 Percent change from Baseline in blood eosinophils over time [1]
    End point description
    Blood samples were collected at the indicated time points for assessment of blood eosinophil cell count. Baseline is the most recent recorded value before dosing on Day 1. Percent change from Baseline is calculated as (Ratio to Baseline minus 1)*100, where ratio to Baseline is the value at specified time point divided by Baseline value. Modified Intent-to-Treat (mITT) Population comprised of all randomized participants who took at least 1 dose of study treatment. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
    End point type
    Primary
    End point timeframe
    Baseline (Day 1, pre-dose), Weeks 2, 4, 8 and 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was performed
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [2]
    8 [3]
    Units: Percent change
    median (full range (min-max))
        Week 2; n=9, 8
    30.8 (4 to 61)
    28.1 (-46 to 550)
        Week 4; n=8, 8
    16.0 (-17 to 77)
    2.1 (-71 to 469)
        Week 8; n=8, 8
    14.4 (-98 to 262)
    -31.4 (-59 to 10)
        Week 12; n=5, 7
    9.7 (-88 to 67)
    -10.9 (-76 to 469)
    Notes
    [2] - mITT Population
    [3] - mITT Population
    No statistical analyses for this end point

    Primary: Percent change from Baseline in fractional exhaled nitric oxide (FeNO) over time

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    End point title
    		 Percent change from Baseline in fractional exhaled nitric oxide (FeNO) over time [4]
    End point description
    FeNO was assessed using a handheld electronic device. The measurements were obtained in accordance with the American Thoracic Society and the European Respiratory Society Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide. Participants did not use their rescue medication for at least 6 hours before each FeNO assessment, unless essential for clinical need. Baseline is the most recent recorded value before dosing on Day 1. Percent change from Baseline is calculated as (Ratio to Baseline minus 1)*100, where ratio to Baseline is the value at specified time point divided by Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
    End point type
    Primary
    End point timeframe
    Baseline (Day 1, pre-dose), Weeks 2, 4, 8 and 12
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was performed
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [5]
    8 [6]
    Units: Percent change
    median (full range (min-max))
        Week 2; n=9, 6
    33.4 (-39 to 51)
    -18.6 (-37 to 12)
        Week 4; n=8, 8
    13.7 (-29 to 205)
    -12.5 (-48 to 36)
        Week 8; n=8, 7
    11.7 (-80 to 75)
    -42.8 (-67 to 5)
        Week 12; n=5, 6
    -37.2 (-65 to -16)
    -45.6 (-68 to -34)
    Notes
    [5] - mITT Population
    [6] - mITT Population
    No statistical analyses for this end point

    Secondary: Serum concentrations of GSK3772847

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    End point title
    		 Serum concentrations of GSK3772847 [7]
    End point description
    Whole blood samples were collected at indicated time points for measurement of serum concentrations of GSK3772847. Pharmacokinetic (PK) Population comprised of all randomized participants who received at least one dose of study medication, and for whom at least one pharmacokinetic sample was obtained, analyzed and was measurable.
    End point type
    Secondary
    End point timeframe
    Week 0 (post-dose), Week 2, Week 4 (pre-dose), Week 8 (pre-dose and post-dose), Week 12 and Week 24
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is specific to GSK3772847 arm.
    End point values
    		 GSK3772847
    Number of subjects analysed
    8 [8]
    Units: Micrograms per milliliter
    arithmetic mean (standard deviation)
        Week 0, post-dose
    156.50 ( 74.102 )
        Week 2
    65.35 ( 10.900 )
        Week 4, pre-dose
    39.13 ( 10.777 )
        Week 8, pre-dose
    56.24 ( 9.658 )
        Week 8, post-dose
    209.61 ( 93.217 )
        Week 12
    68.59 ( 15.570 )
        Week 24
    1.67 ( 1.276 )
    Notes
    [8] - PK Population
    No statistical analyses for this end point

    Secondary: Serum levels of free suppressor of tumorigenicity 2 (ST2)

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    End point title
    		 Serum levels of free suppressor of tumorigenicity 2 (ST2)
    End point description
    Serum samples were collected at indicated time points for assessment of free ST2 levels. Baseline is the most recent recorded value before dosing on Day 1 (Week 0). Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 0 (post-dose), Week 2, Week 4 (pre-dose), Week 8 (pre-dose and post-dose) and Week 12
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [9]
    8 [10]
    Units: Micrograms per liter
    geometric mean (geometric coefficient of variation)
        Baseline; n=9, 8
    2.365 ( 54.3 )
    2.418 ( 50.0 )
        Week 0 (post-dose); n=9, 8
    2.301 ( 46.9 )
    0.025 ( 668.2 )
        Week 2; n=9, 8
    2.286 ( 50.2 )
    0.156 ( 43.4 )
        Week 4 (pre-dose); n=8, 8
    2.382 ( 32.1 )
    0.197 ( 44.0 )
        Week 8 (pre-dose); n=8, 8
    2.563 ( 30.8 )
    0.181 ( 25.8 )
        Week 8 (post-dose); n=8, 8
    2.568 ( 33.7 )
    0.126 ( 38.2 )
        Week 12; n=5, 6
    2.194 ( 46.5 )
    0.144 ( 67.3 )
    Notes
    [9] - mITT Population
    [10] - mITT Population
    No statistical analyses for this end point

    Secondary: Serum levels of total soluble ST2

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    End point title
    		 Serum levels of total soluble ST2
    End point description
    Serum samples were collected at indicated time points for assessment of total soluble ST2 levels. Baseline is the most recent recorded value before dosing on Day 1 (Week 0). Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 0 (post-dose), Week 2, Week 4 (pre-dose), Week 8 (pre-dose and post-dose) and Week 12
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [11]
    8 [12]
    Units: Micrograms per liter
    geometric mean (geometric coefficient of variation)
        Baseline; n=9, 8
    1.905 ( 71.4 )
    2.382 ( 51.1 )
        Week 0 (post-dose); n=9, 8
    1.884 ( 60.4 )
    3.258 ( 39.6 )
        Week 2; n=9, 8
    1.777 ( 65.5 )
    63.353 ( 44.7 )
        Week 4 (pre-dose); n=8, 8
    1.950 ( 35.6 )
    65.833 ( 47.3 )
        Week 8 (pre-dose); n=8, 8
    2.141 ( 39.9 )
    79.286 ( 31.6 )
        Week 8 (post-dose); n=8, 8
    2.201 ( 40.7 )
    74.046 ( 44.7 )
        Week 12; n=5, 6
    1.900 ( 61.3 )
    75.703 ( 54.1 )
    Notes
    [11] - mITT Population
    [12] - mITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with positive anti-GSK3772847 antibodies post-dosing

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    End point title
    		 Number of participants with positive anti-GSK3772847 antibodies post-dosing
    End point description
    Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3772847. The presence of anti-GSK3772847 antibodies was assessed using a tiered approach including a screening assay, a confirmation assay and calculation of titre. Data for participants who showed positive results for confirmation assay has been presented. Safety Population consisted of all randomized participants who took at least 1 dose of study treatment. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12 and 24
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [13]
    8 [14]
    Units: Participants
        Week 0; n=9, 8
    0
    0
        Week 2; n=9, 8
    0
    0
        Week 4; n=8, 8
    0
    0
        Week 8; n=8, 8
    0
    0
        Week 12; n=8, 8
    0
    0
        Week 24; n=9, 8
    0
    0
    Notes
    [13] - Safety Population
    [14] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants for whom titers of anti-GSK3772847 antibodies was performed

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    End point title
    		 Number of participants for whom titers of anti-GSK3772847 antibodies was performed
    End point description
    Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3772847. The presence of anti-GSK3772847 antibodies was assessed using a tiered approach including a screening assay, a confirmation assay and calculation of titer. Data for number of participants for whom titers of anti-GSK3772847 antibodies was performed is presented. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12 and 24
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [15]
    8 [16]
    Units: Participants
        Week 0; n=9, 8
    0
    0
        Week 2; n=9, 8
    0
    0
        Week 4; n=8, 8
    0
    0
        Week 8; n=8, 8
    0
    0
        Week 12; n=8, 8
    0
    0
        Week 24; n=9, 8
    0
    0
    Notes
    [15] - Safety Population
    [16] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12

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    End point title
    		 Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12
    End point description
    The ACQ-5 is a five-item, self-completed questionnaire, which measures a participant's asthma control. The questions enquire about the frequency and/or severity of symptoms (nocturnal awakening, activity limitation, shortness of breath and wheeze) over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. ACQ-5 score is the mean of the five questions and ranges from 0 (totally controlled) to 6 (severely uncontrolled). Baseline value is defined as the ACQ-5 assessment on Day 1. Change from Baseline is calculated as the post-dose value minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Weeks 2, 4, 8 and 12
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [17]
    8 [18]
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Week 2; n=9, 8
    -0.47 ( 0.616 )
    -0.65 ( 0.739 )
        Week 4; n=8, 8
    -0.23 ( 1.087 )
    -1.03 ( 0.897 )
        Week 8; n=8, 8
    -0.60 ( 0.986 )
    -1.23 ( 1.383 )
        Week 12; n=5, 7
    -0.12 ( 1.262 )
    -1.20 ( 1.095 )
    Notes
    [17] - mITT Population
    [18] - mITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12

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    End point title
    		 Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12
    End point description
    AQLQ is a disease-specific, self-administered quality of life questionnaire to evaluate the impact of asthma treatments on quality of life of asthma sufferers. AQLQ contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (five items), and environmental stimuli (four items). Participants recalled their experience over previous 14 days and responded to each question on a seven-point scale where, 1 indicated ‘total impairment’ and 7 indicated ‘no impairment’. Total score is the mean of responses to all 32 questions and each individual domain score is the mean of items within that domain. Total and domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the AQLQ assessment on Day 1. Change from Baseline=post-dose value minus Baseline value. Only participants with data available at specified time points were analyzed (represented by n=X in category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Weeks 2, 4, 8 and 12
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [19]
    8 [20]
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Total score; Week 2; n=9, 8
    0.31 ( 0.660 )
    0.45 ( 0.623 )
        Total score; Week 4; n=8, 8
    -0.22 ( 0.477 )
    0.56 ( 0.514 )
        Total score; Week 8; n=8, 8
    0.27 ( 0.846 )
    1.09 ( 0.940 )
        Total score; Week 12; n=5, 7
    0.10 ( 1.394 )
    1.13 ( 0.953 )
        Activity limitation; Week 2; n=9, 8
    0.20 ( 0.504 )
    0.31 ( 0.750 )
        Activity limitation; Week 4; n=8, 8
    -0.26 ( 0.499 )
    0.30 ( 0.570 )
        Activity limitation; Week 8; n=8, 8
    0.12 ( 0.603 )
    0.88 ( 0.900 )
        Activity limitation; Week 12; n=5, 7
    -0.07 ( 1.127 )
    0.91 ( 0.993 )
        Symptoms; Week 2; n=9, 8
    0.52 ( 0.924 )
    0.54 ( 0.641 )
        Symptoms; Week 4; n=8, 8
    -0.05 ( 0.774 )
    0.74 ( 0.627 )
        Symptoms; Week 8; n=8, 8
    0.57 ( 1.213 )
    1.24 ( 0.936 )
        Symptoms; Week 12; n=5, 7
    0.52 ( 1.740 )
    1.31 ( 0.810 )
        Environmental stimuli; Week 2; n=9, 8
    -0.14 ( 0.811 )
    0.22 ( 0.891 )
        Environmental stimuli; Week 4; n=8, 8
    -0.44 ( 0.884 )
    0.63 ( 0.886 )
        Environmental stimuli; Week 8; n=8, 8
    -0.44 ( 1.208 )
    1.06 ( 1.132 )
        Environmental stimuli; Week 12; n=5, 7
    -0.65 ( 1.025 )
    0.89 ( 1.257 )
        Emotional function; Week 2; n=9, 8
    0.40 ( 0.860 )
    0.75 ( 0.955 )
        Emotional function; Week 4; n=8, 8
    -0.35 ( 0.833 )
    0.65 ( 0.847 )
        Emotional function; Week 8; n=8, 8
    0.45 ( 1.165 )
    1.22 ( 1.289 )
        Emotional function; Week 12; n=5, 7
    0.08 ( 1.712 )
    1.37 ( 1.246 )
    Notes
    [19] - mITT Population
    [20] - mITT Population
    No statistical analyses for this end point

    Secondary: Percentage of responders to ACQ-5 at Weeks 2, 4, 8 and 12

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    End point title
    		 Percentage of responders to ACQ-5 at Weeks 2, 4, 8 and 12
    End point description
    The ACQ-5 is a five-item, self-completed questionnaire, which measures a participant's asthma control. The questions enquire about the frequency and/or severity of symptoms (nocturnal awakening, activity limitation, shortness of breath and wheeze) over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. ACQ-5 score is the mean of the five questions and ranges from 0 (totally controlled) to 6 (severely uncontrolled). A responder to ACQ-5 is defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more at Weeks 2, 4, 8 and 12. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8 and 12
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [21]
    8 [22]
    Units: Percentage of responders
        Week 2; n=9, 8
    44
    50
        Week 4; n=8, 8
    63
    50
        Week 8; n=8, 8
    50
    50
        Week 12; n=5, 7
    20
    71
    Notes
    [21] - mITT Population
    [22] - mITT Population
    No statistical analyses for this end point

    Secondary: Percentage of responders to AQLQ at Weeks 2, 4, 8 and 12

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    End point title
    		 Percentage of responders to AQLQ at Weeks 2, 4, 8 and 12
    End point description
    AQLQ is a disease-specific, self-administered quality of life questionnaire that was developed to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (five items), and environmental stimuli (four items). Participants were asked to recall their experience over the previous 14 days and respond to each question on a seven-point scale where a value of 1 indicates ‘total impairment’ and 7 indicates ‘no impairment’. The total score is the mean of responses to all 32 questions. The total score was defined on a range from 1 to 7 with higher scores indicating a higher quality of life. A responder to AQLQ is defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more at Weeks 2, 4, 8 and 12. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8 and 12
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [23]
    8 [24]
    Units: Percentage of responders
        Week 2; n=9, 8
    44
    50
        Week 4; n=8, 8
    0
    38
        Week 8; n=8, 8
    25
    63
        Week 12; n=5, 7
    40
    86
    Notes
    [23] - mITT Population
    [24] - mITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in forced expiratory volume in 1 second (FEV1)

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    End point title
    		 Change from Baseline in forced expiratory volume in 1 second (FEV1)
    End point description
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 is measured using spirometry. Baseline is the most recent recorded value before dosing on Day 1. Change from Baseline is calculated as the post-dose value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, pre-dose), Weeks 2, 4, 8 and 12
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [25]
    8 [26]
    Units: Liters
    arithmetic mean (standard deviation)
        Week 2; n=9, 8
    0.076 ( 0.3383 )
    -0.137 ( 0.2640 )
        Week 4; n=7, 8
    -0.049 ( 0.2304 )
    -0.022 ( 0.2703 )
        Week 8; n=7, 7
    0.060 ( 0.4210 )
    0.040 ( 0.2381 )
        Week 12; n=5, 7
    0.102 ( 0.4879 )
    -0.013 ( 0.1923 )
    Notes
    [25] - mITT Population
    [26] - mITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in forced vital capacity (FVC)

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    End point title
    		 Change from Baseline in forced vital capacity (FVC)
    End point description
    FVC is the maximal amount of air that can be forcibly exhaled from lungs after taking the deepest breath possible. FVC is measured by spirometry. Baseline is the most recent recorded value before dosing on Day 1. Change from Baseline is calculated as the post-dose value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, pre-dose), Weeks 2, 4, 8 and 12
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [27]
    8 [28]
    Units: Liters
    arithmetic mean (standard deviation)
        Week 2; n=9, 8
    0.078 ( 0.4201 )
    -0.074 ( 0.3761 )
        Week 4; n=7, 8
    0.091 ( 0.3163 )
    0.090 ( 0.3049 )
        Week 8; n=7, 7
    0.179 ( 0.5145 )
    0.030 ( 0.2291 )
        Week 12; n=5, 7
    0.136 ( 0.5351 )
    0.050 ( 0.2408 )
    Notes
    [27] - mITT Population
    [28] - mITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

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    End point title
    		 Number of participants with adverse events (AEs) and serious adverse events (SAEs)
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.
    End point type
    Secondary
    End point timeframe
    Up to Week 24
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [29]
    8 [30]
    Units: Participants
        AEs
    7
    3
        SAEs
    1
    0
    Notes
    [29] - Safety Population
    [30] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with worst case post-Baseline chemistry results relative to normal range at Baseline

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    End point title
    		 Number of participants with worst case post-Baseline chemistry results relative to normal range at Baseline
    End point description
    Blood samples were collected for the assessment of following clinical chemistry parameters: alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, carbon dioxide, chloride, creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase, glucose, phosphate, potassium, protein, sodium and urea. Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent (%). 'To Low' rows are not presented for tests that have lower limit of normal = 0.
    End point type
    Secondary
    End point timeframe
    Up to Week 24
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [31]
    8 [32]
    Units: Participants
        Alanine aminotransferase; To normal or no change
    9
    8
        Alanine aminotransferase; To high
    0
    0
        Albumin; To low
    0
    0
        Albumin; To normal or no change
    9
    8
        Albumin; To high
    0
    0
        Alkaline Phosphatase; To low
    0
    0
        Alkaline Phosphatase; To normal or no change
    9
    8
        Alkaline Phosphatase; To high
    0
    0
        Aspartate Aminotransferase; To normal or no change
    9
    8
        Aspartate Aminotransferase; To high
    0
    0
        Bilirubin; To normal or no change
    9
    8
        Bilirubin; To high
    0
    0
        Calcium; To low
    0
    1
        Calcium; To normal or no change
    9
    7
        Calcium; To high
    0
    0
        Carbon Dioxide; To low
    2
    1
        Carbon Dioxide; To normal or no change
    7
    7
        Carbon Dioxide; To high
    0
    0
        Chloride; To low
    0
    0
        Chloride; To normal or no change
    9
    7
        Chloride; To high
    0
    1
        Creatine Kinase; To normal or no change
    7
    7
        Creatine Kinase; To high
    2
    1
        Creatinine; To low
    0
    1
        Creatinine; To normal or no change
    9
    7
        Creatinine; To high
    0
    0
        Direct Bilirubin; To normal or no change
    9
    8
        Direct Bilirubin; To high
    0
    0
        Gamma Glutamyl Transferase; To normal or no change
    9
    8
        Gamma Glutamyl Transferase; To high
    0
    0
        Glucose; To low
    0
    0
        Glucose; To normal or no change
    7
    7
        Glucose; To high
    2
    1
        Phosphate; To low
    2
    0
        Phosphate; To normal or no change
    5
    8
        Phosphate; To high
    2
    0
        Potassium; To low
    0
    0
        Potassium; To normal or no change
    9
    7
        Potassium; To high
    0
    1
        Protein; To low
    0
    1
        Protein; To normal or no change
    9
    7
        Protein; To high
    0
    0
        Sodium; To low
    0
    0
        Sodium; To normal or no change
    8
    7
        Sodium; To high
    1
    1
        Urea; To low
    0
    1
        Urea; To normal or no change
    9
    7
        Urea; To high
    0
    0
    Notes
    [31] - Safety Population
    [32] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with worst case post-Baseline hematology results relative to normal range at Baseline

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    End point title
    		 Number of participants with worst case post-Baseline hematology results relative to normal range at Baseline
    End point description
    Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, erythrocyte (Ery. ) mean hemoglobin concentration (MCHC), Ery. mean corpuscular hemoglobin (MCH), Ery mean corpuscular volume (MCV), erythrocytes, erythrocytes distribution width, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. 'To Low' rows are not presented for tests that have lower limit of normal = 0.
    End point type
    Secondary
    End point timeframe
    Up to Week 24
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [33]
    8 [34]
    Units: Participants
        Basophils; To normal or no change
    9
    8
        Basophils; To high
    0
    0
        Eosinophils; To low
    1
    0
        Eosinophils; To normal or no change
    5
    6
        Eosinophils; To high
    3
    2
        Ery. MCHC; To normal or no change
    5
    8
        Ery. MCHC; To high
    0
    0
        Ery. MCH; To low
    0
    0
        Ery. MCH; To normal or no change
    9
    8
        Ery. MCH; To high
    0
    0
        Ery. MCV; To low
    0
    0
        Ery. MCV; To normal or no change
    9
    8
        Ery. MCV; To high
    0
    0
        Erythrocytes; To low
    0
    1
        Erythrocytes; To normal or no change
    9
    7
        Erythrocytes; To high
    0
    0
        EDW; To low
    0
    0
        EDW; To normal or no change
    7
    7
        EDW; To high
    2
    1
        Hematocrit; To low
    1
    1
        Hematocrit; To normal or no change
    8
    6
        Hematocrit; To high
    0
    1
        Hemoglobin; To low
    1
    0
        Hemoglobin; To normal or no change
    8
    8
        Hemoglobin; To high
    0
    0
        Leukocytes; To low
    0
    1
        Leukocytes; To normal or no change
    9
    7
        Leukocytes; To high
    0
    0
        Lymphocytes; To low
    0
    0
        Lymphocytes To normal or no change
    9
    8
        Lymphocytes; To high
    0
    0
        Monocytes; To low
    1
    2
        Monocytes; To normal or no change
    8
    6
        Monocytes; To high
    0
    0
        Neutrophils; To low
    1
    1
        Neutrophils; To normal or no change
    7
    7
        Neutrophils; To high
    1
    0
        Platelets; To low
    0
    0
        Platelets; To normal or no change
    9
    8
        Platelets; To high
    0
    0
        Ery. MCHC; To low
    4
    0
    Notes
    [33] - Safety Population
    [34] - Safety Population
    No statistical analyses for this end point

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

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    End point title
    		 Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
    End point description
    SBP and DBP were measured in the supine position after five minutes of rest for the participant. Baseline is the most recent recorded value before dosing on Day 1 (Week 0). Change from Baseline is calculated as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, pre-dose), Week 0 (post-dose), Weeks 4 and 8 (pre-dose and post-dose) Weeks 12 and 24
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [35]
    8 [36]
    Units: Millimeters of mercury
    arithmetic mean (standard deviation)
        SBP; Week 0 (post-dose); n=9, 8
    3.7 ( 8.77 )
    1.4 ( 9.38 )
        SBP; Week 4 (pre-dose); n=8, 8
    0.1 ( 14.40 )
    -2.5 ( 18.05 )
        SBP; Week 4 (post-dose); n=8, 8
    4.5 ( 14.16 )
    4.5 ( 19.18 )
        SBP; Week 8 (pre-dose); n=8, 8
    0.5 ( 14.42 )
    7.3 ( 17.81 )
        SBP; Week 8 (post-dose); n=8, 8
    0.6 ( 15.27 )
    6.0 ( 18.97 )
        SBP; Week 12; n=8, 8
    4.1 ( 13.17 )
    7.1 ( 18.74 )
        SBP; Week 24; n=9, 8
    2.7 ( 17.00 )
    6.1 ( 14.97 )
        DBP; Week 0 (post-dose); n=9, 8
    0.1 ( 5.40 )
    0.6 ( 7.15 )
        DBP; Week 4 (pre-dose); n=8, 8
    -3.1 ( 3.72 )
    1.0 ( 14.11 )
        DBP; Week 4 (post-dose); n=8, 8
    -4.8 ( 4.92 )
    1.3 ( 12.90 )
        DBP; Week 8 (pre-dose); n=8, 8
    -7.8 ( 8.31 )
    0.6 ( 14.23 )
        DBP; Week 8 (post-dose); n=8, 8
    -11.3 ( 9.92 )
    -1.0 ( 13.63 )
        DBP; Week 12; n=8, 8
    -2.9 ( 4.49 )
    2.6 ( 12.34 )
        DBP; Week 24; n=9, 8
    -5.2 ( 6.98 )
    3.0 ( 14.93 )
    Notes
    [35] - Safety Population
    [36] - 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 in the supine position after five minutes of rest for the participant. Baseline is the most recent recorded value before dosing on Day 1 (Week 0). Change from Baseline is calculated as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, pre-dose), Week 0 (post-dose), Weeks 4 and 8 (pre-dose and post-dose) Weeks 12 and 24
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [37]
    8 [38]
    Units: Beats per minute
    arithmetic mean (standard deviation)
        Week 0 (post-dose); n=9, 8
    -0.8 ( 7.63 )
    -2.5 ( 5.37 )
        Week 4 (pre-dose); n=8, 8
    0.8 ( 9.60 )
    -1.8 ( 8.17 )
        Week 4 (post-dose); n=8, 8
    -6.8 ( 9.04 )
    -1.0 ( 9.80 )
        Week 8 (pre-dose); n=8, 8
    0.0 ( 8.26 )
    -1.5 ( 6.55 )
        Week 8 (post-dose); n=8, 8
    -6.3 ( 6.39 )
    -2.1 ( 6.22 )
        Week 12; n=8, 8
    1.6 ( 3.66 )
    -4.1 ( 6.64 )
        Week 24; n=9, 8
    2.2 ( 6.69 )
    -0.4 ( 6.99 )
    Notes
    [37] - Safety Population
    [38] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with abnormal Electrocardiogram (ECG) findings

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    End point title
    		 Number of participants with abnormal Electrocardiogram (ECG) findings
    End point description
    Twelve lead ECGs were obtained using a standardized ECG machine that measured heart rate, PR, QRS, QT and corrected QT interval (QTc). ECG measurements were done with the participant in a supine position having rested in this position for approximately 5 minutes before each reading. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings at worst-case post-Baseline are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst-case post-Baseline is presented.
    End point type
    Secondary
    End point timeframe
    Up to Week 12
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [39]
    8 [40]
    Units: Participants
        NCS
    6
    6
        CS
    1
    0
    Notes
    [39] - Safety Population
    [40] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with abnormal 24-hour Holter findings

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    End point title
    		 Number of participants with abnormal 24-hour Holter findings
    End point description
    A Holter monitor is a type of continuous ambulatory ECG device used for quantitative assessment of abnormal rhythm events. Number of participants with abnormal 24-hour Holter findings is presented. Data was summarized for participants with at least 16 hours of data.
    End point type
    Secondary
    End point timeframe
    Week 0
    End point values
    		 Placebo GSK3772847
    Number of subjects analysed
    9 [41]
    8 [42]
    Units: Participants
    4
    7
    Notes
    [41] - Safety Population
    [42] - Safety Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs and SAEs were collected from the start of study treatment up to Week 24
    Adverse event reporting additional description
    AEs and SAEs were collected in the Safety Population which comprised of all randomized participants who took at least 1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    GSK3772847
    Reporting group description
    		 Participants received three doses of GSK3772847 10 mg/kg administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received three doses of placebo administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.

    Serious adverse events
    		 GSK3772847 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 GSK3772847 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 8 (37.50%)
    7 / 9 (77.78%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 9 (22.22%)
         occurrences all number
    1
    2
    Lethargy
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Alcoholism
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 9 (22.22%)
         occurrences all number
    1
    2
    Bronchitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Feb 2018
    Amendment 01-To address clarifications regarding the eligibility criteria, the study population, the schedule of activities and the clinical assessments. Also, a few typographical errors were corrected.
    10 Oct 2018
    Amendment 02- To include participants with severe asthma with AFAD treated with low dose oral corticosteroid who still demonstrate a lack of complete control as demonstrated by Asthma Control Questionnaire (ACQ)-5, Fractional exhaled Nitric Oxide (FeNO) and blood eosinophil levels. Also, a few clarifications were included.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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