A Study of GSK3511294 (Depemokimab) in Participants With... | NCT04718103

Name	Class
IQVIA Pty Ltd	INDUSTRY

Label	Type	Description	Intervention Names
GSK3511294	Experimental	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.	Biological: GSK3511294
Placebo	Placebo Comparator	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.	Biological: Placebo

Name	Type	Description	Arm Group Labels	Other Names
GSK3511294	Biological	GSK3511294 was 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 for study:

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 guidelines (NHLBI) or Global Initiative for Asthma (GINA) guidelines and
1. Eosinophilic phenotype: participants who have, or with high likelihood of having, asthma with an eosinophilic phenotype as per randomization criteria, and
2. Exacerbation history: participants who 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 (i) For participants >=18 years of age at Visit 1, a pre-bronchodilator FEV1 less than (<)80 percent (%) predicted National Health and Nutrition Examination Survey (NHANES III) recorded at Visit 1.

(ii) 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 fluticasone propionate (FP) hydrofluoroalkane product (HFA) daily, or clinically comparable (GINA, 2020). 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 inclusion criteria for randomization:

An elevated peripheral blood eosinophil count of >=300 cells per microliter demonstrated in the past 12 months prior to Visit 1 that is related to asthma or an elevated peripheral blood eosinophil count of >=150 cells per microliter at Screening Visit 1 that is related to asthma.
Evidence of airway reversibility or responsiveness as documented by either:

(i) Airway reversibility (FEV1>=12% and 200 milliliter [mL]) demonstrated at Visit 1 or Visit 2 using the Maximum Post Bronchodilator Procedure or (ii) Airway reversibility (FEV1>=12% and 200 mL) documented in the 24 months prior to Visit 2 (randomization visit) or (iii) Airway hyper-responsiveness (methacholine: Provocative concentration causing a 20% fall in FEV1 [PC20] of <8 milligrams per milliliter (mg/mL), histamine: Provocative dose that decreases FEV1 by 20% [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 for study:

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 who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological or any other system abnormalities that are uncontrolled with standard treatment.
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-Interleukin-5/Anti-Interleukin-5 receptor (anti-IL-5/5R) therapy.
Participants who have received omalizumab (Xolair) or dupilumab (Dupixent) within 130 days prior to Visit 1.
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.
Corrected QT interval 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] multiplied by 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 any mAb or biologic.

Key exclusion criteria for randomization:

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 Electrocardiogram (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		Alabaster	Alabama	35007	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
39248309	Background	Jackson DJ, Wechsler ME, Jackson DJ, Bernstein D, Korn S, Pfeffer PE, Chen R, Saito J, de Luiz Martinez G, Dymek L, Jacques L, Bird N, Schalkwijk S, Smith D, Howarth P, Pavord ID; SWIFT-1 and SWIFT-2 Investigators; SWIFT-1 Investigators; SWIFT-2 Investigators. Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype. N Engl J Med. 2024 Dec 19;391(24):2337-2349. doi: 10.1056/NEJMoa2406673. Epub 2024 Sep 9.
41868651

ID	Title	Description
FG000	GSK3511294	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.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 5, 2022	Oct 8, 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.

Full analysis set population included all randomized participants who received at least one dose of study intervention excluding participants from 2 sites with GCP violation. Participants were analyzed according to the intervention they were allocated at randomization.

Posted

Least Squares Mean

95% Confidence Interval

Exacerbation per participant per year

Up to Week 52

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000252 OG001128

Title

Denominators

Categories

Title	Measurements
	OG0000.56(0.44 to 0.70) OG0011.08(0.83 to 1.41)

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	0.52			2-Sided	95	0.36	0.73					Superiority	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

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.

The FAS included all randomized participants who received at least 1 dose of study intervention excluding participants from 2 sites 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

Standard Error

Scores on a scale

Baseline (Day 1) and Week 52

ID	Title	Description
OG000	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 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	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 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	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.
OG001	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 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 2 sites 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	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 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 2 sites 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	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

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

Annualized Rate of 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 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.

Posted

Least Squares Mean

95% Confidence Interval

Exacerbation per participant per year

Up to Week 52

ID	Title	Description
OG000	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.
OG001

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery disease	Cardiac disorders	MedDRA Version 26.1	Systematic Assessment	EG0000 events0 affected251 at risk EG0011 events1 affected129 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA Version 26.1	Systematic Assessment	EG0000 events0 affected251 at risk EG0011 events1 affected129 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Anaphylactic reaction	Immune system disorders	MedDRA Version 26.1	Systematic Assessment	EG0000 events0 affected251 at risk EG0011 events1 affected129 at risk
COVID-19	Infections and infestations	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Pneumonia	Infections and infestations	MedDRA Version 26.1	Systematic Assessment	EG0000 events0 affected251 at risk EG0014 events2 affected129 at risk
Sepsis	Infections and infestations	MedDRA Version 26.1	Systematic Assessment	EG0000 events0 affected251 at risk EG0011 events1 affected129 at risk
Accidental exposure to product	Injury, poisoning and procedural complications	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Alanine aminotransferase abnormal	Investigations	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Blood bilirubin abnormal	Investigations	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Osteochondritis	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Systematic Assessment	EG0000 events0 affected251 at risk EG0011 events1 affected129 at risk
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Small intestine adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Cerebral infarction	Nervous system disorders	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Epilepsy	Nervous system disorders	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Headache	Nervous system disorders	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Seizure	Nervous system disorders	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0010 events0 affected129 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA Version 26.1	Systematic Assessment	EG0000 events0 affected251 at risk EG0011 events1 affected129 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA Version 26.1	Systematic Assessment	EG0000 events0 affected251 at risk EG0011 events1 affected129 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA Version 26.1	Systematic Assessment	EG0000 events0 affected251 at risk EG0011 events1 affected129 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Systematic Assessment	EG00012 events7 affected251 at risk EG0018 events6 affected129 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA Version 26.1	Systematic Assessment	EG00010 events8 affected251 at risk EG0013 events3 affected129 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 26.1	Systematic Assessment	EG0001 events1 affected251 at risk EG0014 events4 affected129 at risk
Bronchitis	Infections and infestations	MedDRA Version 26.1	Systematic Assessment	EG00012 events12 affected251 at risk EG00111 events10 affected129 at risk
COVID-19	Infections and infestations	MedDRA Version 26.1	Systematic Assessment	EG00038 events36 affected251 at risk EG00120 events19 affected129 at risk
Influenza	Infections and infestations	MedDRA Version 26.1	Systematic Assessment	EG0005 events5 affected251 at risk EG0019 events9 affected129 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA Version 26.1	Systematic Assessment	EG0005 events4 affected251 at risk EG0018 events5 affected129 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 26.1	Systematic Assessment	EG00045 events33 affected251 at risk EG00144 events27 affected129 at risk
Pharyngitis	Infections and infestations	MedDRA Version 26.1	Systematic Assessment	EG00010 events10 affected251 at risk EG0011 events1 affected129 at risk
Respiratory tract infection	Infections and infestations	MedDRA Version 26.1	Systematic Assessment	EG0007 events5 affected251 at risk EG0014 events4 affected129 at risk
Rhinitis	Infections and infestations	MedDRA Version 26.1	Systematic Assessment	EG0007 events7 affected251 at risk EG0016 events5 affected129 at risk
Sinusitis	Infections and infestations	MedDRA Version 26.1	Systematic Assessment	EG00011 events11 affected251 at risk EG0017 events6 affected129 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 26.1	Systematic Assessment	EG00029 events21 affected251 at risk EG0016 events6 affected129 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 26.1	Systematic Assessment	EG0008 events6 affected251 at risk EG0015 events4 affected129 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Systematic Assessment	EG00016 events14 affected251 at risk EG0015 events5 affected129 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Systematic Assessment	EG0007 events7 affected251 at risk EG0017 events6 affected129 at risk
Dizziness	Nervous system disorders	MedDRA Version 26.1	Systematic Assessment	EG00010 events8 affected251 at risk EG0011 events1 affected129 at risk
Headache	Nervous system disorders	MedDRA Version 26.1	Systematic Assessment	EG00030 events20 affected251 at risk EG00112 events10 affected129 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Systematic Assessment	EG0003 events3 affected251 at risk EG0015 events5 affected129 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Systematic Assessment	EG00023 events18 affected251 at risk EG0013 events3 affected129 at risk
Hypertension	Vascular disorders	MedDRA Version 26.1	Systematic Assessment	EG0007 events6 affected251 at risk EG0018 events7 affected129 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	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.
BG001	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.
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	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	251	19	251	138	251
EG001	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	129	13	129	80	129