Placebo-controlled Efficacy and Safety Study of GSK351129... | NCT04719832

Name	Class
IQVIA Pty Ltd	INDUSTRY

Label	Type	Description	Intervention Names
GSK3511294	Experimental	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.	Biological: GSK3511294 (Depemokimab)
Placebo	Placebo Comparator	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.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
GSK3511294 (Depemokimab)	Biological	GSK3511294 (Depemokimab) will be administered using a pre-filled syringe.	GSK3511294

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks	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 electronic case report form (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.	Up to Week 52

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52	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 on 0-100 rating scale. 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 indicating greater impairment of quality of life. Change from Baseline was defined as value at the indicated time point minus Baseline value.

Eligibility Module

Eligibility Criteria

Key inclusion Criteria:

Adults and adolescents greater than or equal to (>=)12 years of age, at the time of signing the informed consent/assent.
Participants must have a documented physician diagnosis of asthma for >=2 years that meets the National Heart, Lung, and Blood Institute (NHLBI) guidelines or Global Initiative for Asthma (GINA) guidelines and
1. Have, or with high likelihood of having, asthma with an eosinophilic phenotype
2. Have previously confirmed history of >=2 exacerbations requiring treatment with systemic corticosteroid (CS) (intramuscular [IM], intravenous [IV], or oral), in the 12 months prior to Visit 1, despite the use of medium to high-dose ICS. For participants receiving maintenance CS, the CS treatment for the exacerbations must have been a two-fold dose increase or greater.
Persistent airflow obstruction as indicated by:
1. For participants >=18 years of age at Visit 1, a pre-bronchodilator FEV1 less than (<)80% predicted (The Third National Health and Nutrition Examination Survey [NHANES III]) recorded at Visit 1
2. For participants 12-17 years of age at Visit 1:
  - A pre-bronchodilator FEV1 <90% predicted (NHANES III) recorded at Visit 1 OR
  - FEV1:Forced Vital Capacity (FVC) ratio <0.8 recorded at Visit 1.
A well-documented requirement for regular treatment with medium to high dose ICS (in the 12 months prior to Visit 1 with or without maintenance OCS). The maintenance ICS dose must be >=440 micrograms (mcg) Fluticasone propionate (FP) Hydrofluoroalkane (HFA) product daily, or clinically comparable (GINA). Participants who are treated with medium dose ICS will also need to be treated with LABA to qualify for inclusion.
Current treatment with at least one additional controller medication, besides ICS, for at least 3 months (for example [e.g.], LABA, LAMA, leukotriene receptor antagonist [LTRA], or theophylline).

Key randomization inclusion criteria:

For blood eosinophilic count:
1. An elevated peripheral blood eosinophil count of >=300 cells/microliter (mcL) demonstrated in the past 12 months prior to Visit 1 that is related to asthma OR
2. An elevated peripheral blood eosinophil count of >=150 cells/mcL at Screening Visit 1 that is related to asthma.
Evidence of airway reversibility or responsiveness as documented by either:
1. Airway reversibility (FEV1>=12% and 200 milliliters [mL]) demonstrated at Visit 1 or Visit 2 using the Maximum Post Bronchodilator Procedure OR
2. Airway reversibility (FEV1>=12% and 200 mL) documented in the 24 months prior to Visit 2 (randomization visit) OR
3. Airway hyperresponsiveness (methacholine: Provocative concentration causing a 20% fall in FEV1 [PC20] of <8 milligrams (mg)/mL, histamine: PD20 of <7.8 micromoles, mannitol: decrease in FEV1 as per the labelled product instructions) documented in the 24 months prior to Visit 2 (randomization visit).

Key exclusion Criteria:

Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis.
A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Participants that had localized carcinoma of the skin which was resected for cure will not be excluded).
Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis must be excluded prior to enrolment.
Participants who have received mepolizumab (Nucala), reslizumab (Cinqair/Cinqaero), or benralizumab (Fasenra) within 12 months prior to Visit 1 or who have a previous documented failure with anti-IL-5/5 receptor (R) therapy.
Participants who have received omalizumab (Xolair) or dupilumab (Dupixent) within 130 days prior to Visit.
Participants who have received any monoclonal antibody (mAb) within 5 half-lives of Visit 1.
Previously participated in any study with mepolizumab, reslizumab, or benralizumab and received study intervention (including placebo) within 12 months prior to Visit 1.
The QT interval corrected using Fridericia's formula (QTcF) >=450 milliseconds (msec) or QTcF >=480 msec for participants with Bundle Branch Block at screening Visit 1.
Current smokers or former smokers with a smoking history of >=10 pack years (number of pack years = [number of cigarettes per day/20] times number of years smoked). A former smoker is defined as a participant who quit smoking at least 6 months prior to Visit 1.
Participants with allergy/intolerance to the excipients of GSK3511294 or a any mAb or biologic.

Key radomization exclusion criteria:

QTcF >=450 msec or QTcF >=480 msec for participants with Bundle Branch Block, at randomization Visit 2 are excluded. Participants are excluded if an abnormal ECG finding from the 12-lead ECG conducted at Screening Visit 1 is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the Investigator.
Participants with a clinically significant asthma exacerbation in the 7 days prior to randomization should have their randomization visit delayed until the investigator considers the participant's asthma to be stable .
Any changes in the dose or regimen of Baseline ICS and/or additional controller medication (except for treatment of an exacerbation) during the run-in period.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Encinitas	California	92024	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
42159666	Derived	Keeley T, O'Neill D, Dikariyanto V, Dumi G, Fromy P, Markov F, Richards A, Alfonso-Cristancho R. Validity, reliability, and longitudinal measurement properties of the Asthma Daytime and Nighttime Symptom Diaries in patients with moderate-to-severe asthma. J Patient Rep Outcomes. 2026 May 20;10(1):89. doi: 10.1186/s41687-026-01066-5.
41461999

ID	Title	Description
FG000	Placebo	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.
FG001	GSK3511294

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 8, 2022	Nov 21, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks

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 electronic case report form (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 FAS included all randomized participants who received at least one dose of study intervention excluding participants from 1 site with GCP violation. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points.

Posted

Least Squares Mean

95% Confidence Interval

Exacerbation per participant per year

Up to Week 52

ID	Title	Description
OG000	Placebo	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.
OG001	GSK3511294	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.

Units	Counts
Participants	OG000132 OG001249

Title

Denominators

Categories

Title	Measurements
	OG0001.11± 0.86(0.86 to 1.43) OG0010.46± 0.36(0.36 to 0.58)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.	Negative binomial distribution		< 0.001		Rate Ratio	0.42			2-Sided	95	0.30	0.59					Superiority	Analysis performed using a negative binomial model with covariates of treatment, exacerbation history (2, 3, 4+), baseline inhaled CS dose (medium, high), geographical region, baseline 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

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 on 0-100 rating scale. 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 indicating greater impairment of quality of life. Change from Baseline was defined as value at the indicated time point minus Baseline value.

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline (Day 1) and Week 52

ID	Title	Description
OG000	Placebo	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.
OG001

Secondary

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

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, 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.

Posted

Least Squares Mean

Standard Error

Scores on a Scale

Baseline (Day 1) and Week 52

ID	Title	Description
OG000	Placebo	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.

Secondary

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

Forced Expiratory Volume in One Second (FEV1) is defined as the 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 testing. 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.

Posted

Least Squares Mean

Standard Error

Liters (L)

Baseline (Day 1) and Week 52

ID	Title	Description
OG000	Placebo	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.
OG001	GSK3511294	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.

Secondary

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

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 core categories: breathing symptoms (wheezing, shortness of breath), chest symptoms (chest tightness, chest pain) and cough. The ANSD was to be completed before going to bed and 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 values were defined as the average score from Day -7 to Day -1 inclusive (at least 4 days must be non-missing). Change from Baseline was defined as value at each time point minus Baseline value.

All participants in the FAS population (excluding participants from 1 site with GCP violation) for whom at least one ANSD questionnaire was administered. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points.

Posted

Least Squares Mean

Standard Error

Scores on a Scale

Baseline to Week 52

ID	Title	Description
OG000	Placebo	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.

Secondary

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

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 and reliable assessment of asthma symptoms from a participant's perspective. Participants were required to rate the severity of symptoms in 3 core categories: breathing symptoms (wheezing, shortness of breath), chest symptoms (chest tightness, chest pain) and cough. The ADSD was to be completed upon waking and refers to asthma symptoms during the night-time. 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 values were defined as the average score from Day -7 to Day -1 inclusive (at least 4 days must be non-missing). Change from Baseline was defined as value at each time point minus Baseline value.

All participants in the FAS population (excluding participants from 1 site with GCP violation) for whom at least one ADSD questionnaire was administered. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points.

Posted

Least Squares Mean

Standard Error

Scores on a Scale

Baseline to Week 52

ID	Title	Description
OG000	Placebo	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.

Secondary

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

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.

Full analysis set included all randomized participants who received at least 1 dose of study intervention excluding participants from 1 site with GCP violation. Participants were analyzed according to the intervention they were allocated at randomization.

Posted

Number

Exacerbations

Up to Week 52

ID	Title	Description
OG000	Placebo	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.
OG001	GSK3511294	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.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Arrhythmia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Rhegmatogenous retinal detachment	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Colitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
Chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Hernia	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
Mass	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Bronchiolitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected132 at risk EG0010 events0 affected250 at risk
Hepatitis A	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected132 at risk EG0011 events1 affected250 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected250 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected250 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
Genital prolapse	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected132 at risk EG0013 events3 affected250 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected250 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected132 at risk EG0013 events2 affected250 at risk
Bronchitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected132 at risk EG00118 events12 affected250 at risk
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00030 events27 affected132 at risk EG00151 events51 affected250 at risk
Influenza	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected132 at risk EG00121 events19 affected250 at risk
Laryngitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected132 at risk EG0019 events9 affected250 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0007 events5 affected132 at risk EG00110 events10 affected250 at risk
Nasopharyngitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00032 events25 affected132 at risk EG00137 events29 affected250 at risk
Pharyngitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected132 at risk EG0018 events8 affected250 at risk
Respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00011 events6 affected132 at risk EG0019 events8 affected250 at risk
Rhinitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00016 events10 affected132 at risk EG00117 events15 affected250 at risk
Sinusitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected132 at risk EG00114 events11 affected250 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00022 events14 affected132 at risk EG00139 events25 affected250 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00011 events7 affected132 at risk EG0016 events6 affected250 at risk
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00013 events10 affected132 at risk EG00117 events12 affected250 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0007 events6 affected132 at risk EG00123 events9 affected250 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected132 at risk EG00115 events11 affected250 at risk
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0007 events7 affected132 at risk EG00110 events9 affected250 at risk

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Title	Description
BG000	Placebo	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.
BG001	GSK3511294	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	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.	0	132	22	132	78	132
EG001	GSK3511294	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.	0	250	15	250	145	250