Trial Outcomes & Findings for A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype (NCT NCT04718103)

NCT ID: NCT04718103

Last Updated: 2024-11-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 397 participants
• Primary outcome timeframe: Up to Week 52
• Results posted on: 2024-11-29

Participant Flow

A total of 397 participants were randomized to the study. Of which 380 participants were included in Full analysis set (FAS) population. FAS included all randomized participants who received at least 1 dose of study intervention excluding 12 participants from 2 sites with Good Clinical Practice (GCP) violation. Five (5) participants were randomized in error and did not receive any study drug.

A total of 397 were randomized in the study.

Participant milestones

Measure	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.	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.
Overall Study STARTED	263	134
Overall Study Full Analysis Population	252	128
Overall Study COMPLETED	233	117
Overall Study NOT COMPLETED	30	17

Reasons for withdrawal

Measure	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.	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.
Overall Study Adverse Event	1	1
Overall Study Lack of Efficacy	4	1
Overall Study Lost to Follow-up	2	2
Overall Study Physician Decision	2	0
Overall Study Pregnancy	0	1
Overall Study Withdrawal by Subject	10	6
Overall Study Randomized, not treated	4	1
Overall Study GCP violations	7	5

Baseline Characteristics

A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype

Baseline characteristics by cohort

Measure	GSK3511294 n=252 Participants 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.	Placebo n=128 Participants 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.	Total n=380 Participants Total of all reporting groups
Age, Continuous	53.6 YEARS STANDARD_DEVIATION 16.00 • n=5 Participants	51.2 YEARS STANDARD_DEVIATION 16.58 • n=7 Participants	52.8 YEARS STANDARD_DEVIATION 16.22 • n=5 Participants
Sex: Female, Male Female	160 Participants n=5 Participants	81 Participants n=7 Participants	241 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	47 Participants n=7 Participants	139 Participants n=5 Participants
Race/Ethnicity, Customized Asian	52 Participants n=5 Participants	23 Participants n=7 Participants	75 Participants n=5 Participants
Race/Ethnicity, Customized White	181 Participants n=5 Participants	91 Participants n=7 Participants	272 Participants n=5 Participants
Race/Ethnicity, Customized Others	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 52

Population: 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.

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.

Outcome measures

Measure	GSK3511294 n=252 Participants 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.	Placebo n=128 Participants 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.
Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks	0.56 Exacerbation per participant per year Interval 0.44 to 0.7	1.08 Exacerbation per participant per year Interval 0.83 to 1.41

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 52

Population: 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.

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.

Outcome measures

Measure	GSK3511294 n=246 Participants 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.	Placebo n=124 Participants 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.
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52	-14.80 Scores on a scale Standard Error 1.041	-12.49 Scores on a scale Standard Error 1.455

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 52

Population: 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.

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.

Outcome measures

Measure	GSK3511294 n=246 Participants 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.	Placebo n=124 Participants 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.
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52	-0.81 Scores on a scale Standard Error 0.065	-0.70 Scores on a scale Standard Error 0.091

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 52

Population: 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.

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.

Outcome measures

Measure	GSK3511294 n=239 Participants 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.	Placebo n=119 Participants 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.
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) At Week 52	0.240 Liters (L) Standard Error 0.0286	0.184 Liters (L) Standard Error 0.0407

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: 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.

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.

Outcome measures

Measure	GSK3511294 n=232 Participants 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.	Placebo n=117 Participants 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.
Change From Baseline in Asthma Nighttime Symptom Diary (ANSD) Weekly Mean Score at Week 52	-1.18 Scores on a scale Standard Error 0.091	-0.97 Scores on a scale Standard Error 0.127

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: 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.

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.

Outcome measures

Measure	GSK3511294 n=249 Participants 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.	Placebo n=126 Participants 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.
Change From Baseline in Asthma Daily Symptom Diary (ADSD) Weekly Mean Score at Week 52	-1.13 Scores on a scale Standard Error 0.080	-0.93 Scores on a scale Standard Error 0.112

SECONDARY outcome

Timeframe: Up to Week 52

Population: 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.

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.

Outcome measures

Measure	GSK3511294 n=252 Participants 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.	Placebo n=128 Participants 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.
Annualized Rate of Exacerbations Requiring Hospitalization and/or Emergency Department (ED) Visit up to 52 Weeks	0.05 Exacerbation per participant per year Interval 0.02 to 0.09	0.11 Exacerbation per participant per year Interval 0.05 to 0.22

Adverse Events

GSK3511294

Serious events: 19 serious events

Other events: 138 other events

Deaths: 0 deaths

Placebo

Serious events: 13 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Measure	GSK3511294 n=251 participants at risk 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.	Placebo n=129 participants at risk 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.
Cardiac disorders Coronary artery disease	0.00% 0/251 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.78% 1/129 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Congenital, familial and genetic disorders Phimosis	0.00% 0/251 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.78% 1/129 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Gastrointestinal disorders Abdominal pain	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Gastrointestinal disorders Large intestine polyp	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Immune system disorders Anaphylactic reaction	0.00% 0/251 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.78% 1/129 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Infections and infestations COVID-19	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Infections and infestations Pneumonia	0.00% 0/251 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	1.6% 2/129 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Infections and infestations Sepsis	0.00% 0/251 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.78% 1/129 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Injury, poisoning and procedural complications Accidental exposure to product	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Investigations Alanine aminotransferase abnormal	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Investigations Blood bilirubin abnormal	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Musculoskeletal and connective tissue disorders Foot deformity	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Musculoskeletal and connective tissue disorders Osteochondritis	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/251 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.78% 1/129 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine adenocarcinoma	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Nervous system disorders Cerebral infarction	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Nervous system disorders Epilepsy	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Nervous system disorders Headache	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Nervous system disorders Seizure	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.00% 0/129 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Renal and urinary disorders Nephrolithiasis	0.00% 0/251 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.78% 1/129 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Renal and urinary disorders Ureterolithiasis	0.00% 0/251 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.78% 1/129 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/251 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.78% 1/129 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Respiratory, thoracic and mediastinal disorders Asthma	2.8% 7/251 • Number of events 12 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	4.7% 6/129 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.

Other adverse events

Measure	GSK3511294 n=251 participants at risk 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.	Placebo n=129 participants at risk 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.
Gastrointestinal disorders Diarrhoea	3.2% 8/251 • Number of events 10 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	2.3% 3/129 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Gastrointestinal disorders Nausea	0.40% 1/251 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	3.1% 4/129 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Infections and infestations Bronchitis	4.8% 12/251 • Number of events 12 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	7.8% 10/129 • Number of events 11 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Infections and infestations COVID-19	14.3% 36/251 • Number of events 38 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	14.7% 19/129 • Number of events 20 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Infections and infestations Influenza	2.0% 5/251 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	7.0% 9/129 • Number of events 9 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Infections and infestations Lower respiratory tract infection	1.6% 4/251 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	3.9% 5/129 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Infections and infestations Nasopharyngitis	13.1% 33/251 • Number of events 45 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	20.9% 27/129 • Number of events 44 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Infections and infestations Pharyngitis	4.0% 10/251 • Number of events 10 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.78% 1/129 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Infections and infestations Respiratory tract infection	2.0% 5/251 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	3.1% 4/129 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Infections and infestations Rhinitis	2.8% 7/251 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	3.9% 5/129 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Infections and infestations Sinusitis	4.4% 11/251 • Number of events 11 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	4.7% 6/129 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Infections and infestations Upper respiratory tract infection	8.4% 21/251 • Number of events 29 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	4.7% 6/129 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Infections and infestations Urinary tract infection	2.4% 6/251 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	3.1% 4/129 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 14/251 • Number of events 16 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	3.9% 5/129 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Musculoskeletal and connective tissue disorders Back pain	2.8% 7/251 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	4.7% 6/129 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Nervous system disorders Dizziness	3.2% 8/251 • Number of events 10 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	0.78% 1/129 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Nervous system disorders Headache	8.0% 20/251 • Number of events 30 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	7.8% 10/129 • Number of events 12 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.2% 3/251 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	3.9% 5/129 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	7.2% 18/251 • Number of events 23 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	2.3% 3/129 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.
Vascular disorders Hypertension	2.4% 6/251 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.	5.4% 7/129 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 site with GCP violation. AEs were reported treatment-wise. One participant was randomized to receive GSK3511294 but received one dose of placebo in error and did not receive the second planned dose. This participant was included in the actual treatment group (placebo) for the safety population.

Additional Information

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GlaxoSmithKline

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