Trial Outcomes & Findings for An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103) (NCT NCT05243680)

Last Updated: 2026-01-15

Results Overview

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

641 participants

Primary outcome timeframe

Up to Week 56

Results posted on

2026-01-15

Participant Flow

Participants who successfully completed treatment in studies 206713 (NCT04719832), and 213744 (NCT04718103) were eligible to continue their treatment in this open-label extension study 212895.

A total of 641 participants were enrolled in this study, however only 629 participants were included in Safety Analysis Set (SAS) (as 12 participants were excluded from the SAS due to data integrity and good clinical practices \[GCP\] violations). SAS included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.

Participant milestones

Participant milestones
Measure	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.	GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study Participants who had previously received GSK3511294 100 mg subcutaneously (SC) in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 mg dose of GSK3511294 as a SC injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma SOC treatment throughout the study.
Overall Study STARTED	214	427
Overall Study Safety Analysis Set	210	419
Overall Study COMPLETED	199	403
Overall Study NOT COMPLETED	15	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.	GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study Participants who had previously received GSK3511294 100 mg subcutaneously (SC) in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 mg dose of GSK3511294 as a SC injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. 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	1	1
Overall Study Lost to Follow-up	5	4
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	3	10
Overall Study Data integrity and GCP violations	4	8

Baseline Characteristics

An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study n=210 Participants Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.	GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study n=419 Participants Participants who had previously received GSK3511294 100 mg subcutaneously (SC) in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 mg dose of GSK3511294 as a SC injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma SOC treatment throughout the study.	Total n=629 Participants Total of all reporting groups
Age, Continuous	53.6 Years STANDARD_DEVIATION 15.84 • n=14 Participants	55.5 Years STANDARD_DEVIATION 14.84 • n=10 Participants	54.8 Years STANDARD_DEVIATION 15.19 • n=24 Participants
Sex: Female, Male Female	128 Participants n=14 Participants	248 Participants n=10 Participants	376 Participants n=24 Participants
Sex: Female, Male Male	82 Participants n=14 Participants	171 Participants n=10 Participants	253 Participants n=24 Participants
Race/Ethnicity, Customized WHITE	169 Participants n=14 Participants	321 Participants n=10 Participants	490 Participants n=24 Participants
Race/Ethnicity, Customized ASIAN	35 Participants n=14 Participants	81 Participants n=10 Participants	116 Participants n=24 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	1 Participants n=14 Participants	2 Participants n=10 Participants	3 Participants n=24 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	5 Participants n=14 Participants	15 Participants n=10 Participants	20 Participants n=24 Participants

PRIMARY outcome

Timeframe: Up to Week 56

Outcome measures

Outcome measures
Measure	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study n=210 Participants Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.	GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study n=419 Participants Participants who had previously received GSK3511294 100 mg subcutaneously (SC) in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 mg dose of GSK3511294 as a SC injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma SOC treatment throughout the study.
Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) Any AEs	147 Participants	301 Participants
Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) Any SAEs	21 Participants	38 Participants

PRIMARY outcome

Timeframe: Up to Week 52

Population: Safety Analysis Set included all participants who received at least one dose of open-label GSK3511294 excluding the participants from the sites with data integrity and GCP violation issues. 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.

Serum samples were collected for the determination of anti-GSK3511294 antibodies (ADA) using a validated electro-chemiluminescent immunoassay. The assay involved screening, confirmation and titration assays. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample and were also further characterized in the Neutralizing antibody (Nab) assay. A participant was considered positive ADA if they had at least one positive worst case post-Baseline ADA result. Number of participants with worst case post-Baseline positive anti-GSK3511294 antibodies are presented.

Outcome measures

Outcome measures
Measure	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study n=206 Participants Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.	GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study n=416 Participants Participants who had previously received GSK3511294 100 mg subcutaneously (SC) in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 mg dose of GSK3511294 as a SC injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma SOC treatment throughout the study.
Number of Participants With Worst Case Post-Baseline Positive Anti-GSK3511294 Antibodies (ADA)	15 Participants	40 Participants

PRIMARY outcome

Timeframe: Up to Week 52

Blood samples were collected for the determination of positive neutralizing antibodies. Neutralizing antibody (NAb) test was only carried out on samples that were positive in the confirmatory binding antibody assay. A participant was considered positive for NAb if they had at least one positive worst case post-Baseline neutralizing antibody result. Number of participants with worst case post-Baseline positive neutralizing antibodies are presented.

Outcome measures

Outcome measures
Measure	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study n=15 Participants Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.	GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study n=40 Participants Participants who had previously received GSK3511294 100 mg subcutaneously (SC) in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 mg dose of GSK3511294 as a SC injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma SOC treatment throughout the study.
Number of Participants With Worst Case Post-Baseline Positive Neutralizing Antibodies	0 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to Week 52

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 analysis. Exacerbations separated by less than 7 days was treated as a continuation of the same exacerbation.

Outcome measures

Outcome measures
Measure	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study n=210 Participants Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.	GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study n=419 Participants Participants who had previously received GSK3511294 100 mg subcutaneously (SC) in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 mg dose of GSK3511294 as a SC injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma SOC treatment throughout the study.
Annualized Rate of Clinically Significant Exacerbations	0.58 Exacerbation per participant per year Interval 0.45 to 0.73	0.55 Exacerbation per participant per year Interval 0.47 to 0.66

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 20, 26, 28, 32, 40 and 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. Baseline was the value at Day 1 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Number of participants with analyzable data for one or more timepoints.

Outcome measures

Outcome measures
Measure	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study n=195 Participants Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.	GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study n=403 Participants Participants who had previously received GSK3511294 100 mg subcutaneously (SC) in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 mg dose of GSK3511294 as a SC injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. 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 Week 4	-0.28 Scores on a Scale Standard Error 0.056	-0.16 Scores on a Scale Standard Error 0.039
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score Week 8	-0.22 Scores on a Scale Standard Error 0.056	-0.19 Scores on a Scale Standard Error 0.039
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score Week 12	-0.28 Scores on a Scale Standard Error 0.055	-0.22 Scores on a Scale Standard Error 0.038
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score Week 20	-0.16 Scores on a Scale Standard Error 0.058	-0.16 Scores on a Scale Standard Error 0.040
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score Week 26	-0.14 Scores on a Scale Standard Error 0.055	-0.12 Scores on a Scale Standard Error 0.038
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score Week 28	-0.23 Scores on a Scale Standard Error 0.057	-0.24 Scores on a Scale Standard Error 0.039
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score Week 32	-0.35 Scores on a Scale Standard Error 0.057	-0.25 Scores on a Scale Standard Error 0.040
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score Week 40	-0.24 Scores on a Scale Standard Error 0.065	-0.16 Scores on a Scale Standard Error 0.045
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score Week 52	-0.15 Scores on a Scale Standard Error 0.059	-0.11 Scores on a Scale Standard Error 0.041

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 26 and 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. Baseline was the value at Day 1 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Number of participants with analyzable data for one or more timepoints.

Outcome measures

Outcome measures
Measure	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study n=188 Participants Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.	GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study n=396 Participants Participants who had previously received GSK3511294 100 mg subcutaneously (SC) in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 mg dose of GSK3511294 as a SC injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. 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 Weeks 26 and 52 Week 26	-5.00 Scores on a Scale Standard Error 0.939	-2.62 Scores on a Scale Standard Error 0.641
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 26 and 52 Week 52	-4.75 Scores on a Scale Standard Error 1.043	-2.33 Scores on a Scale Standard Error 0.713

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 26 and 52

Forced Expiratory Volume in One Second (FEV1) is a measure of lung function and defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline was the value at Day 1 of the study. Change from Baseline in pre-bronchodilator FEV1 was defined as value at the indicated time point minus Baseline value. Number of participants with analyzable data for one or more timepoints.

Outcome measures

Outcome measures
Measure	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study n=195 Participants Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.	GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study n=402 Participants Participants who had previously received GSK3511294 100 mg subcutaneously (SC) in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 mg dose of GSK3511294 as a SC injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. 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 Weeks 26 and 52 Week 26	0.059 Liters (L) Standard Error 0.0207	0.013 Liters (L) Standard Error 0.0144
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at Weeks 26 and 52 Week 52	0.036 Liters (L) Standard Error 0.0217	-0.004 Liters (L) Standard Error 0.0152

Adverse Events

Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study

Serious events: 21 serious events

Other events: 82 other events

Deaths: 0 deaths

GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study

Serious events: 38 serious events

Other events: 178 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study n=210 participants at risk Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.	GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study n=419 participants at risk Participants who had previously received GSK3511294 100 mg subcutaneously (SC) in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 mg dose of GSK3511294 as a SC injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma SOC treatment throughout the study.
Infections and infestations Bronchitis	3.3% 7/210 • Number of events 7 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.	5.3% 22/419 • Number of events 23 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.
Infections and infestations COVID-19	7.1% 15/210 • Number of events 15 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.	6.7% 28/419 • Number of events 29 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.
Infections and infestations Influenza	3.3% 7/210 • Number of events 7 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.	2.1% 9/419 • Number of events 10 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.
Infections and infestations Lower respiratory tract infection	2.9% 6/210 • Number of events 8 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.	3.1% 13/419 • Number of events 16 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.
Infections and infestations Nasopharyngitis	10.0% 21/210 • Number of events 27 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.	13.8% 58/419 • Number of events 73 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.
Infections and infestations Pharyngitis	3.8% 8/210 • Number of events 10 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.	3.6% 15/419 • Number of events 17 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.
Infections and infestations Respiratory tract infection	1.4% 3/210 • Number of events 4 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.	3.8% 16/419 • Number of events 21 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.
Infections and infestations Rhinitis	3.8% 8/210 • Number of events 11 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.	3.1% 13/419 • Number of events 16 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.
Infections and infestations Upper respiratory tract infection	11.9% 25/210 • Number of events 33 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.	10.7% 45/419 • Number of events 60 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.
Nervous system disorders Headache	3.3% 7/210 • Number of events 8 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.	4.3% 18/419 • Number of events 22 • Up to Week 56 All-cause mortality, serious adverse events and common non-serious adverse events were reported for the Safety Analysis Set which included all participants who received at least one dose of open-label GSK3511294 in this extension study, excluding the participants from the sites with data integrity and GCP violation issues.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER