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    Clinical Trial Results:
    A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants with Severe Uncontrolled Asthma with an Eosinophilic Phenotype

    Summary
    EudraCT number
    		 2020-003611-10
    Trial protocol
    		 FR   CZ   PL   IT   ES   HU  
    Global end of trial date
    11 Apr 2024

    Results information
    Results version number
    		 v2(current)
    This version publication date
    13 Dec 2024
    First version publication date
    24 Oct 2024
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    213744
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04718103
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford,Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of GSK3511294 100 mg (SC) every 26 weeks versus placebo in participants with severe uncontrolled asthma with an eosinophilic phenotype on top of existing asthma therapy.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Feb 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Taiwan: 13
    Country: Number of subjects enrolled
    Japan: 71
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    United States: 139
    Country: Number of subjects enrolled
    Poland: 60
    Country: Number of subjects enrolled
    Spain: 45
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Hungary: 14
    Country: Number of subjects enrolled
    Czechia: 25
    Country: Number of subjects enrolled
    France: 9
    Worldwide total number of subjects
    397
    EEA total number of subjects
    167
    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)
    22
    Adults (18-64 years)
    277
    From 65 to 84 years
    98
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Of 397 participants who were randomized, 380 participants were included in Full analysis set (FAS) population. FAS included all randomized participants received at least 1 dose of study drug excluding 12 participants from 2 sites with Good Clinical Practice (GCP) violation & 5 participants were randomized in error & did not receive any study drug.

    Pre-assignment
    Screening details
    		 In this study, out of 663 participants screened, 397 participants were enrolled/randomized to the study. In total 380 participants received at least one dose of study drug & included in the FAS.

    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
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK3511294
    Arm description
    		 Participants received a 100 milligram (mg) dose of GSK3511294 subcutaneous (SC) injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK3511294
    Investigational medicinal product code
    Other name
    Depemokimab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 milligram (mg) per milligram once every 26 weeks

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching Placebo once every 26 weeks

    Number of subjects in period 1 [1]
    		GSK3511294 Placebo
    Started
    252
    128
    Completed
    233
    117
    Not completed
    19
    11
         Physician decision
    2
    -
         Consent withdrawn by subject
    10
    6
         Adverse event, non-fatal
    1
    1
         Pregnancy
    -
    1
         Lost to follow-up
    2
    2
         Lack of efficacy
    4
    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: Of 17 participants who were randomized, 12 participants from 2 sites were excluded from the full analysis population due to data integrity concerns & GCP violations, and 5 randomized participants did not receive any study intervention, hence not included in the FAS population.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK3511294
    Reporting group description
    		 Participants received a 100 milligram (mg) dose of GSK3511294 subcutaneous (SC) injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.

    Reporting group values
    		 GSK3511294 Placebo Total
    Number of subjects
    		 252 128 380
    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)
    		 12 10 22
        Adults (18-64 years)
    		 169 93 262
        From 65-84 years
    		 71 25 96
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.6 ( 16.00 ) 51.2 ( 16.58 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 160 81 241
        Male
    		 92 47 139
    Race/Ethnicity, Customized
    Race categories (with 0<n<11) are combined into 'Others' category to minimize the possibility of re-identification of participants.
    Units: Subjects
        Asian
    		 52 23 75
        White
    		 181 91 272
        Others
    		 19 14 33

    End points

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    End points reporting groups
    Reporting group title
    GSK3511294
    Reporting group description
    		 Participants received a 100 milligram (mg) dose of GSK3511294 subcutaneous (SC) injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.

    Primary: Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks

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    End point title
    		 Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks
    End point description
    Clinically significant exacerbations recorded were defined as worsening of asthma requiring the use of systemic corticosteroids (CS) [such as intramuscular (IM), intravenous (IV) or oral] and/or hospitalization and/or Emergency Department (ED) visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM corticosteroid dose is required. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Exacerbations recorded in the eCRF were considered as verified clinically significant exacerbations and included in the primary analysis. Exacerbations separated by less than 7 days was treated as a continuation of the same exacerbation. The analysis was performed on the Full Analysis Set population.
    End point type
    Primary
    End point timeframe
    Up to Week 52
    End point values
    		 GSK3511294 Placebo
    Number of subjects analysed
    252
    128
    Units: Exacerbation per participant per year
        least squares mean (confidence interval 95%)
    0.56 (0.44 to 0.70)
    1.08 (0.83 to 1.41)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by the annualized rate of clinically significant exacerbations measured over the study intervention period of 52 weeks.
    Comparison groups
    Placebo v GSK3511294
    Number of subjects included in analysis
    380
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.001
    Method
    		 Negative binomial distribution
    Parameter type
    		 Rate Ratio
    Point estimate
    0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 0.73
    Notes
    [1] - Analysis performed using a generalized linear model assuming a negative binomial distribution and covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region and baseline pre-bronchodilator percent predicted Forced Expiratory Volume in one second (FEV1) and offset of log (total time in the study in years).

    Secondary: Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52

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    End point title
    		 Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
    End point description
    The SGRQ is a 50-item patient-reported outcome tool used to measure Quality of Life in participants with airway obstruction diseases. The questions are designed to be self-completed by the participant. The total score was calculated by the symptom score, activity and impact score; and summarizing the impact of the disease on overall health status. Scores are expressed as a percentage of overall impairment where 100 representing worst possible health status and 0 indicating best possible health status. Higher scores also indicating greater impairment of quality of life. Change from Baseline was defined as value at the indicated time point minus Baseline value. The analysis was performed on the FAS population that included all randomized participants who received at least 1 dose of study intervention excluding participants from 2 sites with GCP violation.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 52 
    End point values
    		 GSK3511294 Placebo
    Number of subjects analysed
    246
    124
    Units: Scores on a scale
        least squares mean (standard error)
    -14.80 ( 1.041 )
    -12.49 ( 1.455 )
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by SGRQ Total Score measured over the study intervention period of 52 weeks.
    Comparison groups
    Placebo v GSK3511294
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.2
    Method
    		 Mixed Models Repeated Measures (MMRM)
    Parameter type
    		 Difference in Least-Square Means
    Point estimate
    -2.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.84
         upper limit
    		 1.23
    Notes
    [2] - Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline SGRQ total score, baseline pre- bronchodilator percent predicted FEV1, visit, visit by baseline SGRQ total score and visit by treatment group.

    Secondary: Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52

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    End point title
    		 Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52
    End point description
    The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma symptom control. The questions are designed to be self-completed by the participant. The 5 questions enquired to recall their how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheezing). The overall ACQ-5 response option is the mean score of all 5 questions representing 0 with no impairment/limitation and 6 as total impairment/ limitation. Higher scores indicated more limitations and lower score with better asthma control. Change from Baseline was defined as value at the indicated time point minus Baseline value. The analysis was performed on the FAS population that included all randomized participants who received at least 1 dose of study intervention excluding participants from 2 GCP violation sites.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 52 
    End point values
    		 GSK3511294 Placebo
    Number of subjects analysed
    246
    124
    Units: Scores on a scale
        least squares mean (standard error)
    -0.81 ( 0.065 )
    -0.70 ( 0.091 )
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ACQ-5 score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ACQ-5 score and visit by treatment group.
    Comparison groups
    GSK3511294 v Placebo
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.333
    Method
    		 Mixed Models Repeated Measures (MMRM)
    Parameter type
    		 Difference in Least-Square Means
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.33
         upper limit
    		 0.11

    Secondary: Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) At Week 52

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    End point title
    		 Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) At Week 52
    End point description
    Forced Expiratory Volume in One Second (FEV1) is defined as the maximum volume of air that can be forced out in one second after taking a deep breath by a person and will be measured by spirometry. Change from Baseline in clinic pre-bronchodilator FEV1 was determined. Change from Baseline was defined as value at the indicated time point minus Baseline value. The analysis was performed on the FAS population that included all randomized participants who received at least 1 dose of study intervention excluding participants from 2 GCP violation sites.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 52 
    End point values
    		 GSK3511294 Placebo
    Number of subjects analysed
    239
    119
    Units: Liters (L)
        least squares mean (standard error)
    0.240 ( 0.0286 )
    0.184 ( 0.0407 )
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline pre-bronchodilator FEV1, visit, visit by baseline pre-bronchodilator FEV1 and visit by treatment group.
    Comparison groups
    GSK3511294 v Placebo
    Number of subjects included in analysis
    358
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.267
    Method
    		 Mixed Models Repeated Measures (MMRM)
    Parameter type
    		 Difference in Least-Square Means
    Point estimate
    0.056
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.043
         upper limit
    		 0.154

    Secondary: Change From Baseline in Asthma Nighttime Symptom Diary (ANSD) Weekly Mean Score at Week 52

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    End point title
    		 Change From Baseline in Asthma Nighttime Symptom Diary (ANSD) Weekly Mean Score at Week 52
    End point description
    The ANSD is a 6-item self-administered patient reported diary developed by Patient Related Outcomes (PRO) Consortium’s Asthma Working Group to facilitate comprehensive and reliable assessment of asthma symptoms from a participant’s perspective. Participants were required to rate the severity of symptoms in 3 categories: breathing symptoms (wheezing, shortness of breath), chest symptoms (chest tightness, chest pain) & cough. The ANSD was to be completed before going to bed & refers to asthma symptoms during the day. Symptoms are rated at their worst using an 11-point numeric rating scale ranging from 0 (None) to 10 (As bad as you can imagine). Higher scores indicate more severe symptoms. Mean daily scores of ANSD was calculated by weekly intervals. The baseline was defined as average score from Days -7 to -1 inclusive (at least 4 days must be non-missing). Change from Baseline as value at each time point minus Baseline value. The FAS included with1 ANSD questionnaire was administered.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52 
    End point values
    		 GSK3511294 Placebo
    Number of subjects analysed
    232
    117
    Units: Scores on a scale
    least squares mean (standard error)
        ANSD Mean Score
    -1.18 ( 0.091 )
    -0.97 ( 0.127 )
    Statistical analysis title
    		 Statistical Analysis for ANSD
    Statistical analysis description
    Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ANSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ANSD weekly mean score and visit by treatment group.
    Comparison groups
    GSK3511294 v Placebo
    Number of subjects included in analysis
    349
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.173
    Method
    		 Mixed Models Repeated Measures (MMRM)
    Parameter type
    		 Difference in Least square means
    Point estimate
    -0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 0.09
    Notes
    [3] - ANSD at Week 52

    Secondary: Change From Baseline in Asthma Daily Symptom Diary (ADSD) Weekly Mean Score at Week 52

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    End point title
    		 Change From Baseline in Asthma Daily Symptom Diary (ADSD) Weekly Mean Score at Week 52
    End point description
    The ADSD is a 6-item self-administered patient reported diary developed by Patient Related Outcomes (PRO) Consortium’s Asthma Working Group to facilitate comprehensive & reliable assessment of asthma symptoms from a participant’s perspective. Participants were required to rate the severity of symptoms in 3 categories: breathing symptoms (wheezing, shortness of breath), chest symptoms (chest tightness, chest pain) & cough. The ADSD was to be completed upon waking & refers to asthma symptoms during the nighttime. Symptoms are rated at their worst using an 11-point numeric rating scale ranging from 0 (None) to 10 (As bad as you can imagine). Higher scores indicate more severe symptoms. Mean daily scores of ADSD was calculated by weekly intervals. The baseline was defined as average score from Days -7 to -1 inclusive (at least 4 days must be non-missing). Change from Baseline as value at each time point minus Baseline value. The FAS included with1 ADSD questionnaire was administered.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 GSK3511294 Placebo
    Number of subjects analysed
    249
    126
    Units: Scores on a Scale
    least squares mean (standard error)
        ADSD Mean Score
    -1.13 ( 0.080 )
    -0.93 ( 0.112 )
    Statistical analysis title
    		 Statistical Analysis for ADSD
    Statistical analysis description
    Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ADSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ADSD weekly mean score and visit by treatment group.
    Comparison groups
    GSK3511294 v Placebo
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.138
    Method
    		 Mixed Models Repeated Measures (MMRM)
    Parameter type
    		 Difference in Least Square Means
    Point estimate
    -0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 0.07
    Notes
    [4] - ADSD at Week 52

    Secondary: Annualized Rate of Exacerbations Requiring Hospitalization and/or Emergency Department (ED) Visit up to 52 Weeks

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    End point title
    		 Annualized Rate of Exacerbations Requiring Hospitalization and/or Emergency Department (ED) Visit up to 52 Weeks
    End point description
    Annualized Rate of exacerbations of asthma were defined as worsening of asthma which required use of systemic corticosteroids (CSs) and/or hospitalization and/or ED visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM CS dose is required. For participants on maintenance systemic CSs, at least double the existing maintenance dose for at least 3 days is required. Exacerbations separated by less than 7 days will be treated as a continuation of the same exacerbation. Exacerbations Requiring Hospitalization and/or ED Visit are reported here. The analysis was performed on the FAS population that included all randomized participants who received at least 1 dose of study intervention excluding participants from 2 sites with GCP violation.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 GSK3511294 Placebo
    Number of subjects analysed
    252
    128
    Units: Exacerbation per participant per year
        least squares mean (confidence interval 95%)
    0.05 (0.02 to 0.09)
    0.11 (0.05 to 0.22)
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    Analysis performed using a generalized linear model assuming a negative binomial distribution and covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region and baseline pre-bronchodilator percent predicted FEV1.
    Comparison groups
    GSK3511294 v Placebo
    Number of subjects included in analysis
    380
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.087
    Method
    		 Negative binomial distribution
    Parameter type
    		 Rate Ratio
    Point estimate
    0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 1.13

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs), deaths and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56.
    Adverse event reporting additional description
    Safety analysis set included all participants who received at least 1 dose of study drug excluding participants from 2 sites with GCP violation. One participant was randomized to receive GSK3511294 but received 1 dose of placebo in error & did not receive 2nd planned dose. This participant was included in actual placebo group for analysis.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.

    Reporting group title
    GSK3511294
    Reporting group description
    		 Participants received a 100 mg dose of GSK3511294 SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.

    Serious adverse events
    		 Placebo GSK3511294
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 129 (10.08%)
    19 / 251 (7.57%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestine adenocarcinoma
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    6 / 129 (4.65%)
    7 / 251 (2.79%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood bilirubin abnormal
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alanine aminotransferase abnormal
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental exposure to product
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Phimosis
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Large intestine polyp
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Ureterolithiasis
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteochondritis
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tenosynovitis stenosans
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 129 (1.55%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Placebo GSK3511294
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    80 / 129 (62.02%)
    138 / 251 (54.98%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    7 / 129 (5.43%)
    7 / 251 (2.79%)
         occurrences all number
    8
    7
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 129 (0.78%)
    8 / 251 (3.19%)
         occurrences all number
    1
    10
    Headache
         subjects affected / exposed
    10 / 129 (7.75%)
    20 / 251 (7.97%)
         occurrences all number
    12
    30
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 129 (2.33%)
    8 / 251 (3.19%)
         occurrences all number
    3
    10
    Nausea
         subjects affected / exposed
    4 / 129 (3.10%)
    1 / 251 (0.40%)
         occurrences all number
    4
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    3 / 129 (2.33%)
    18 / 251 (7.17%)
         occurrences all number
    3
    23
    Oropharyngeal pain
         subjects affected / exposed
    5 / 129 (3.88%)
    3 / 251 (1.20%)
         occurrences all number
    5
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    6 / 129 (4.65%)
    7 / 251 (2.79%)
         occurrences all number
    7
    7
    Arthralgia
         subjects affected / exposed
    5 / 129 (3.88%)
    14 / 251 (5.58%)
         occurrences all number
    5
    16
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 129 (4.65%)
    21 / 251 (8.37%)
         occurrences all number
    6
    29
    Sinusitis
         subjects affected / exposed
    6 / 129 (4.65%)
    11 / 251 (4.38%)
         occurrences all number
    7
    11
    Rhinitis
         subjects affected / exposed
    5 / 129 (3.88%)
    7 / 251 (2.79%)
         occurrences all number
    6
    7
    Respiratory tract infection
         subjects affected / exposed
    8 / 129 (6.20%)
    5 / 251 (1.99%)
         occurrences all number
    4
    5
    Pharyngitis
         subjects affected / exposed
    1 / 129 (0.78%)
    10 / 251 (3.98%)
         occurrences all number
    1
    10
    Nasopharyngitis
         subjects affected / exposed
    27 / 129 (20.93%)
    33 / 251 (13.15%)
         occurrences all number
    44
    45
    Lower respiratory tract infection
         subjects affected / exposed
    5 / 129 (3.88%)
    4 / 251 (1.59%)
         occurrences all number
    8
    5
    Bronchitis
         subjects affected / exposed
    12 / 129 (9.30%)
    10 / 251 (3.98%)
         occurrences all number
    12
    11
    COVID-19
         subjects affected / exposed
    19 / 129 (14.73%)
    36 / 251 (14.34%)
         occurrences all number
    20
    38
    Influenza
         subjects affected / exposed
    9 / 129 (6.98%)
    5 / 251 (1.99%)
         occurrences all number
    9
    5
    Urinary tract infection
         subjects affected / exposed
    4 / 129 (3.10%)
    6 / 251 (2.39%)
         occurrences all number
    5
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Aug 2021
    Amendment 01
    05 Apr 2022
    Amendment 02

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/39248309
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