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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
    		 2020-003632-25
    Trial protocol
    		 DE   FR   CZ   PL   IT   ES   IE  
    Global end of trial date
    21 Nov 2023

    Results information
    Results version number
    		 v3(current)
    This version publication date
    13 Dec 2024
    First version publication date
    06 Jun 2024
    Other versions
    		 v1 , v2
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    206713
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04719832
    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
    15 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Nov 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Nov 2023
    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
    17 Mar 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
    Czechia: 34
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 38
    Country: Number of subjects enrolled
    Ireland: 3
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Poland: 74
    Country: Number of subjects enrolled
    Spain: 74
    Country: Number of subjects enrolled
    United Kingdom: 12
    Country: Number of subjects enrolled
    United States: 62
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    China: 59
    Country: Number of subjects enrolled
    Russian Federation: 21
    Worldwide total number of subjects
    395
    EEA total number of subjects
    232
    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)
    8
    Adults (18-64 years)
    287
    From 65 to 84 years
    100
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Of 395 participants who were randomized, 382 participants were included in Full analysis set (FAS) population. FAS included all randomized participants who received at least 1 dose of study drug excluding 11 participants from 1 site with GCP violation. Two participants were randomized in error & did not receive any study drug.

    Pre-assignment
    Screening details
    		 In this study, out of 622 participants screened, 395 participants were randomized to the study. In total 382 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
    		 Placebo
    Arm description
    		 Participants received placebo 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
    		 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

    Arm title
    		 GSK3511294
    Arm description
    		 Participants received a 100 milligram (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.
    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) once every 26 weeks

    Number of subjects in period 1 [1]
    		Placebo GSK3511294
    Started
    132
    250
    Completed
    122
    237
    Not completed
    10
    13
         Consent withdrawn by subject
    5
    5
         Physician decision
    -
    1
         Adverse event, non-fatal
    2
    -
         Pregnancy
    1
    1
         Lost to follow-up
    -
    2
         Lack of efficacy
    2
    4
    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 395 participants who were randomized, 11 participants from one of the site were excluded from the full analysis population due to data integrity concerns & GCP violations, and two randomized participants did not receive any study treatment. A total of 382 participants received treatment and were included in the Full analysis set population

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo 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
    GSK3511294
    Reporting group description
    		 Participants received a 100 milligram (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.

    Reporting group values
    		 Placebo GSK3511294 Total
    Number of subjects
    		 132 250 382
    Age categorical
    Units: Participants
        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)
    		 5 3 8
        Adults (18-64 years)
    		 91 185 276
        From 65-84 years
    		 36 62 98
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.6 ( 14.91 ) 54.1 ( 13.82 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 79 144 223
        Male
    		 53 106 159
    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
        Others
    		 23 43 66
        White
    		 109 207 316

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo 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
    GSK3511294
    Reporting group description
    		 Participants received a 100 milligram (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.

    Primary: Annualized Rate of Clinically Significant Exacerbations Over 52 Weeks

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    End point title
    		 Annualized Rate of Clinically Significant Exacerbations Over 52 Weeks
    End point description
    Clinically significant exacerbations of asthma were defined as worsening of asthma which required use of systemic corticosteroids (CSs) 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 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 occurring from the start of randomized study treatment up to the Week 52 visit, including exacerbations reported after early discontinuation from study treatment by participants who remained in the study, were included in the analysis. Annualized rate of exacerbations was analyzed using a generalized linear model assuming a negative binomial distribution. The analysis was performed on the Full Analysis Set population.
    End point type
    Primary
    End point timeframe
    Up to Week 52
    End point values
    		 Placebo GSK3511294
    Number of subjects analysed
    132
    249
    Units: Exacerbation per participant per year
        least squares mean (confidence interval 95%)
    1.11 (0.86 to 1.43)
    0.46 (0.36 to 0.58)
    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
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.001
    Method
    		 Negative binomial distribution
    Parameter type
    		 Rate Ratio
    Point estimate
    0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 0.59
    Notes
    [1] - Analysis performed using a negative binomial model with covariates of treatment, exacerbation history (2, 3, 4+), baseline ICS dose (medium, high), geographical region, baseline percent predicted FEV1, and offset of log (total time in the study in years)

    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 how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze). The overall ACQ-5 response option is the mean score of all 5 questions representing 0 with no impairment/limitation & 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 Full Analysis set population.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 52 
    End point values
    		 Placebo GSK3511294
    Number of subjects analysed
    129
    241
    Units: Scores on a Scale
        least squares mean (standard error)
    -0.77 ( 0.091 )
    -0.82 ( 0.066 )
    Statistical analysis title
    		 Statistical Analysis
    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
    Placebo v GSK3511294
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.69
    Method
    		 Mixed Models Repeated Measures (MMRM)
    Parameter type
    		 Difference in Least Square Means
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.27
         upper limit
    		 0.18

    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 Full Analysis set population.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 52 
    End point values
    		 Placebo GSK3511294
    Number of subjects analysed
    128
    240
    Units: Scores on a scale
        least squares mean (standard error)
    -9.67 ( 1.544 )
    -13.03 ( 1.112 )
    Statistical analysis title
    		 Statistical Analysis
    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 SGRQ total score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline SGRQ total score and visit by treatment group
    Comparison groups
    Placebo v GSK3511294
    Number of subjects included in analysis
    368
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.08
    Method
    		 Mixed Models Repeated Measures (MMRM)
    Parameter type
    		 Difference in Least Square Means
    Point estimate
    -3.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.11
         upper limit
    		 0.39

    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. FEV1 was measured using spirometry. Change from Baseline in clinic pre-bronchodilator FEV1 will be determined. Change from Baseline was defined as value at the indicated time point minus Baseline value. The analysis was performed on the Full Analysis set population.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 52 
    End point values
    		 Placebo GSK3511294
    Number of subjects analysed
    126
    236
    Units: Liters (L)
        least squares mean (standard error)
    0.160 ( 0.0364 )
    0.160 ( 0.0263 )
    Statistical analysis title
    		 Statistical Analysis
    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
    Placebo v GSK3511294
    Number of subjects included in analysis
    362
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.991
    Method
    		 Mixed Models Repeated Measures (MMRM)
    Parameter type
    		 Difference in Least Square Means
    Point estimate
    -0.001
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.089
         upper limit
    		 0.088

    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 the patient related outcomes (PRO) Consortium’s Asthma Working Group (in accordance with the Food and Drug Administration’s PRO Guidance) to facilitate comprehensive and reliable assessment of asthma symptoms from a participant’s perspective. ANSD was to be completed before going to bed and refers to asthma symptoms during the day. Participants were required to score based on 6 patient-reported symptoms as difficulty breathing, wheezing, shortness of breath, chest tightness, chest pain, and cough at their worst during the respective timeframes using an 11-point numeric rating scale (NRS) ranging from 0 (None) to 10 (As bad as you can imagine). Higher scores indicate more severe symptoms. Change from Baseline was defined as value at the indicated time point minus Baseline value. The analysis was performed for participants in the FAS population for whom at least one ADSD/ANSD questionnaire were administered.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 52 
    End point values
    		 Placebo GSK3511294
    Number of subjects analysed
    95
    185
    Units: Scores on a Scale
    least squares mean (standard error)
        Asthma Nighttime Symptom Diary (ANSD), n=51,95
    -1.30 ( 0.168 )
    -1.39 ( 0.120 )
    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 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
    Placebo v GSK3511294
    Number of subjects included in analysis
    280
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.65
    Method
    		 Mixed Models Repeated Measures (MMRM)
    Parameter type
    		 Difference in Least Square Means
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.31

    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 the patient related outcomes (PRO) Consortium’s Asthma Working Group (in accordance with the Food and Drug Administration’s PRO Guidance) to facilitate comprehensive and reliable assessment of asthma symptoms from a participant’s perspective. ADSD was to be completed upon waking and refers to asthma symptoms during the night-time. Participants were required to score based on 6 patient-reported symptoms as difficulty breathing, wheezing, shortness of breath, chest tightness, chest pain, and cough at their worst during the respective timeframes using an 11-point numeric rating scale (NRS) ranging from 0 (None) to 10 (As bad as you can imagine). Higher scores indicate more severe symptoms. Change from Baseline was defined as value at the indicated time point minus Baseline value. The analysis was performed for participants in the FAS population for whom at least one ADSD/ANSD questionnaire were administered.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 52
    End point values
    		 Placebo GSK3511294
    Number of subjects analysed
    110
    206
    Units: Scores on a Scale
        least squares mean (standard error)
    -1.25 ( 0.140 )
    -1.33 ( 0.101 )
    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
    Placebo v GSK3511294
    Number of subjects included in analysis
    316
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.647
    Method
    		 Mixed Models Repeated Measures (MMRM)
    Parameter type
    		 Difference in Least Square Means
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 0.26

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

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    End point title
    		 Annualized Rate of Exacerbations Requiring Hospitalization and/or Emergency Department (ED) Visit Over 52 Weeks
    End point description
    The data did not meet the condition (total of 20 or more exacerbations requiring hospitalization and/or ED visit) for conducting the statistical analysis. The number of exacerbations requiring Hospitalization and/or ED Visit are reported here. The assessment was performed on the Full Analysis set population.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Placebo GSK3511294
    Number of subjects analysed
    132
    250
    Units: Number
    13
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs), deaths (all causes) and non-serious adverse events (non-SAEs) were collected from the start of the study intervention till follow up week 56.
    Adverse event reporting additional description
    SAEs, deaths and non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment excluding participants from one study site due to concerns about data integrity and GCP violation.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    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.

    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.

    Serious adverse events
    		 GSK3511294 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 250 (6.00%)
    22 / 132 (16.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Thyroid cancer
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mass
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Genital prolapse
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    3 / 250 (1.20%)
    5 / 132 (3.79%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         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
    Radius fracture
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (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
    Headache
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Rhegmatogenous retinal detachment
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Jaundice cholestatic
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (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
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint range of motion decreased
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 250 (0.40%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 250 (0.00%)
    2 / 132 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 250 (0.40%)
    3 / 132 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (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
    		 GSK3511294 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    145 / 250 (58.00%)
    78 / 132 (59.09%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    9 / 250 (3.60%)
    7 / 132 (5.30%)
         occurrences all number
    10
    7
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 250 (4.80%)
    10 / 132 (7.58%)
         occurrences all number
    17
    13
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 250 (0.80%)
    4 / 132 (3.03%)
         occurrences all number
    3
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    9 / 250 (3.60%)
    6 / 132 (4.55%)
         occurrences all number
    23
    7
    Rhinitis allergic
         subjects affected / exposed
    11 / 250 (4.40%)
    4 / 132 (3.03%)
         occurrences all number
    15
    4
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    6 / 250 (2.40%)
    7 / 132 (5.30%)
         occurrences all number
    6
    11
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    12 / 250 (4.80%)
    5 / 132 (3.79%)
         occurrences all number
    18
    5
    COVID-19
         subjects affected / exposed
    51 / 250 (20.40%)
    27 / 132 (20.45%)
         occurrences all number
    51
    30
    Nasopharyngitis
         subjects affected / exposed
    29 / 250 (11.60%)
    25 / 132 (18.94%)
         occurrences all number
    37
    32
    Pharyngitis
         subjects affected / exposed
    8 / 250 (3.20%)
    2 / 132 (1.52%)
         occurrences all number
    8
    2
    Lower respiratory tract infection
         subjects affected / exposed
    10 / 250 (4.00%)
    5 / 132 (3.79%)
         occurrences all number
    10
    7
    Laryngitis
         subjects affected / exposed
    9 / 250 (3.60%)
    4 / 132 (3.03%)
         occurrences all number
    9
    4
    Influenza
         subjects affected / exposed
    19 / 250 (7.60%)
    2 / 132 (1.52%)
         occurrences all number
    21
    2
    Respiratory tract infection
         subjects affected / exposed
    8 / 250 (3.20%)
    6 / 132 (4.55%)
         occurrences all number
    9
    11
    Upper respiratory tract infection
         subjects affected / exposed
    25 / 250 (10.00%)
    14 / 132 (10.61%)
         occurrences all number
    39
    22
    Sinusitis
         subjects affected / exposed
    11 / 250 (4.40%)
    6 / 132 (4.55%)
         occurrences all number
    14
    6
    Rhinitis
         subjects affected / exposed
    15 / 250 (6.00%)
    10 / 132 (7.58%)
         occurrences all number
    17
    16

    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 1
    08 Apr 2022
    Amendment 2

    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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