Asthma
Conditions
Keywords
GSK3511294, Depemokimab, Asthma, Long-term safety, Open-label
Brief summary
The purpose of this open-label 12-month extension study is to continue to characterize the long-term safety, efficacy and immunogenic profile of GSK3511294 (Depemokimab) in participants with severe asthma with an eosinophilic phenotype following completion of clinical studies 206713 or 213744.
Interventions
BIOLOGICALGSK3511294 (Depemokimab)
GSK3511294 (Depemokimab) will be administered using a pre-filled safety syringe.
Sponsors
GlaxoSmithKline
Iqvia Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who completed the double-blind study intervention treatment during Study 206713 or Study 213744. * Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion criteria
* Clinically significant change in health status during Study 206713 or Study 213744 which in the opinion of the investigator would make the participant unsuitable for participation in this study. * A current malignancy or a malignancy that developed during Study 206713 or Study 213744 (participants who had localized carcinoma of the skin that was resected for cure will not be excluded). * Participants who have other clinically significant medical conditions uncontrolled with Standard of Care (SoC) therapy not associated with Asthma, for example (e.g.), uncontrolled cardiovascular disease or ongoing active infectious disease which in the opinion of the investigator makes them unsuitable for the study. * Participants with known parasitic (helminth) infections within 6 months prior to Visit 1 will be excluded from the study or required to be adequately treated for helminth infections before initiation of GSK3511294. * Participants who meet the following based on results of Week 48 assessment from Study 206713 or Study 213744 or from a later result: 1. Alanine aminotransferase (ALT) greater than (\>)2 times upper limit of normal (ULN). 2. Total bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than \[\<\] 35 percent \[%\]). 3. Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice. * Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis must be excluded prior to enrolment. * Electrocardiogram (ECG) assessment: QTc corrected by Fridericia's formula (QTcF) greater than or equal to (\>=)450 milliseconds (msec) or QTcF \>=480 msec for participants with Bundle Branch Block at Visit 1. * Current smokers. * Participants with allergy/intolerance to the excipients of GSK3511294, a monoclonal antibody, or biologic. * Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation. * Participants who for any reason permanently discontinued study treatment in the previous study 206713/213744 will be excluded from this study. * Other investigational product/clinical study: 1. Participants who have received treatment with an investigational agent (biologic or non-biologic) within the past 30 days or 5 drug half-lives whichever is longer, prior to the first dose, other than Study 206713/213744 study treatment. The term investigational applies to any drug not approved for sale for the disease/indication to treat in the country in which it is being used or investigational formulations of marketed products. 2. Participants who are currently participating in any other interventional clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) | Up to Week 56 | 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. |
| Number of Participants With Worst Case Post-Baseline Positive Anti-GSK3511294 Antibodies (ADA) | Up to Week 52 | 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. |
| Number of Participants With Worst Case Post-Baseline Positive Neutralizing Antibodies | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Rate of Clinically Significant Exacerbations | 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. |
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at Weeks 26 and 52 | 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. |
| Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | 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. |
| Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 26 and 52 | 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. |
Countries
Australia, Canada, China, Czechia, France, Germany, Hungary, Italy, Japan, Poland, Spain, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 210 |
| 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. | 419 |
| Total | 629 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Data integrity and GCP violations | 4 | 8 |
| 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 |
Baseline characteristics
| Characteristic | GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Total | Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study |
|---|---|---|---|
| Age, Continuous | 55.5 Years STANDARD_DEVIATION 14.84 | 54.8 Years STANDARD_DEVIATION 15.19 | 53.6 Years STANDARD_DEVIATION 15.84 |
| Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized ASIAN | 81 Participants | 116 Participants | 35 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 15 Participants | 20 Participants | 5 Participants |
| Race/Ethnicity, Customized WHITE | 321 Participants | 490 Participants | 169 Participants |
| Sex: Female, Male Female | 248 Participants | 376 Participants | 128 Participants |
| Sex: Female, Male Male | 171 Participants | 253 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 210 | 0 / 419 |
| other Total, other adverse events | 82 / 210 | 178 / 419 |
| serious Total, serious adverse events | 21 / 210 | 38 / 419 |
Outcome results
Primary
Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)
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.
Time frame: Up to Week 56
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) | Any SAEs | 21 Participants |
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) | Any AEs | 147 Participants |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) | Any SAEs | 38 Participants |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) | Any AEs | 301 Participants |
Primary
Number of Participants With Worst Case Post-Baseline Positive Anti-GSK3511294 Antibodies (ADA)
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | Number of Participants With Worst Case Post-Baseline Positive Anti-GSK3511294 Antibodies (ADA) | 15 Participants |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Number of Participants With Worst Case Post-Baseline Positive Anti-GSK3511294 Antibodies (ADA) | 40 Participants |
Primary
Number of Participants With Worst Case Post-Baseline Positive Neutralizing Antibodies
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | Number of Participants With Worst Case Post-Baseline Positive Neutralizing Antibodies | 0 Participants |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Number of Participants With Worst Case Post-Baseline Positive Neutralizing Antibodies | 5 Participants |
Secondary
Annualized Rate of Clinically Significant Exacerbations
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | Annualized Rate of Clinically Significant Exacerbations | 0.58 Exacerbation per participant per year |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Annualized Rate of Clinically Significant Exacerbations | 0.55 Exacerbation per participant per year |
Secondary
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score
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.
Time frame: Baseline (Day 1), Weeks 4, 8, 12, 20, 26, 28, 32, 40 and 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. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 28 | -0.23 Scores on a Scale | Standard Error 0.057 |
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 8 | -0.22 Scores on a Scale | Standard Error 0.056 |
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 4 | -0.28 Scores on a Scale | Standard Error 0.056 |
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 32 | -0.35 Scores on a Scale | Standard Error 0.057 |
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 20 | -0.16 Scores on a Scale | Standard Error 0.058 |
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 40 | -0.24 Scores on a Scale | Standard Error 0.065 |
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 52 | -0.15 Scores on a Scale | Standard Error 0.059 |
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 26 | -0.14 Scores on a Scale | Standard Error 0.055 |
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 12 | -0.28 Scores on a Scale | Standard Error 0.055 |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 32 | -0.25 Scores on a Scale | Standard Error 0.04 |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 20 | -0.16 Scores on a Scale | Standard Error 0.04 |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 40 | -0.16 Scores on a Scale | Standard Error 0.045 |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 28 | -0.24 Scores on a Scale | Standard Error 0.039 |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 26 | -0.12 Scores on a Scale | Standard Error 0.038 |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 4 | -0.16 Scores on a Scale | Standard Error 0.039 |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 8 | -0.19 Scores on a Scale | Standard Error 0.039 |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 12 | -0.22 Scores on a Scale | Standard Error 0.038 |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score | Week 52 | -0.11 Scores on a Scale | Standard Error 0.041 |
Secondary
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at 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.
Time frame: Baseline (Day 1), Weeks 26 and 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. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension 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 |
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | 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 |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at Weeks 26 and 52 | Week 26 | 0.013 Liters (L) | Standard Error 0.0144 |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at Weeks 26 and 52 | Week 52 | -0.004 Liters (L) | Standard Error 0.0152 |
Secondary
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at 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.
Time frame: Baseline (Day 1), Weeks 26 and 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. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension 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 |
| Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study | 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 |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 26 and 52 | Week 52 | -2.33 Scores on a Scale | Standard Error 0.713 |
| GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study | Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 26 and 52 | Week 26 | -2.62 Scores on a Scale | Standard Error 0.641 |