Asthma
Conditions
Keywords
Asthma Control Questionnaire, Allergic fungal airway disease, Asthma Quality of Life Questionnaire, Holter monitoring, Asthma
Brief summary
This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.
Interventions
DRUGGSK3772847
GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.
DRUGPlacebo
Commercially sourced sterile normal saline will be provided as Placebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Participants will be randomized in a 1:1 ratio to receive either 10 mg/kg GSK3772847 or matching placebo intravenously.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must be at least 18 years of age inclusive, at the time of signing the informed consent. * Documented history of physician diagnosed moderate or severe asthma for \>=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (\>=500 micrograms/day \[µg/day\]) fluticasone propionate or equivalent as defined in the guidelines. * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive * FeNO \>= 25 parts per billion (ppb) at Screening * ACQ-5 score \>= 1.5 at Screening * Blood eosinophil \>=300 cells/microliter at Screening * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months. * Body weight within 50-150 kilogram (kg) * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment. * Capable of giving signed informed consent
Exclusion criteria
* Historical diagnosis of cystic fibrosis * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug. * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment. * Cardiovascular disease: Clinically significant organic heart disease * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment. * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1) * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study. * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. * A known immunodeficiency such as human immunodeficiency virus infection. * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis). * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility. * Sinus bradycardia \<45 beats per minute (bpm), sinus tachycardia \>= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate \>100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide \[\>0.04 seconds\] and deep \[\>0.4 millivolts (mV) (4 millimeter \[mm\] with 10mm/mV setting)\] or \>25% of the height of the corresponding R wave, providing the R wave was \>0.5mV \[5mm with 10mm/mV setting\], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) \>= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) \>=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias. * Smoking history: current smokers or former smokers with a smoking history \>= 10 pack years * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1). * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Blood Eosinophils Over Time | Baseline (Day 1, pre-dose), Weeks 2, 4, 8 and 12 | Blood samples were collected at the indicated time points for assessment of blood eosinophil cell count. Baseline is the most recent recorded value before dosing on Day 1. Percent change from Baseline is calculated as (Ratio to Baseline minus 1)\*100, where ratio to Baseline is the value at specified time point divided by Baseline value. |
| Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Over Time | Baseline (Day 1, pre-dose), Weeks 2, 4, 8 and 12 | FeNO was assessed using a handheld electronic device. The measurements were obtained in accordance with the American Thoracic Society and the European Respiratory Society Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide. Participants did not use their rescue medication for at least 6 hours before each FeNO assessment, unless essential for clinical need. Baseline is the most recent recorded value before dosing on Day 1. Percent change from Baseline is calculated as (Ratio to Baseline minus 1)\*100, where ratio to Baseline is the value at specified time point divided by Baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Levels of Total Soluble ST2 | Baseline, Week 0 (post-dose), Week 2, Week 4 (pre-dose), Week 8 (pre-dose and post-dose) and Week 12 | Serum samples were collected at indicated time points for assessment of total soluble ST2 levels. Baseline is the most recent recorded value before dosing on Day 1 (Week 0). |
| Number of Participants With Positive Anti-GSK3772847 Antibodies Post-dosing | Weeks 0, 2, 4, 8, 12 and 24 | Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3772847. The presence of anti-GSK3772847 antibodies was assessed using a tiered approach including a screening assay, a confirmation assay and calculation of titre. Data for participants who showed positive results for confirmation assay has been presented. |
| Number of Participants for Whom Titers of Anti-GSK3772847 Antibodies Was Performed | Weeks 0, 2, 4, 8, 12 and 24 | Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3772847. The presence of anti-GSK3772847 antibodies was assessed using a tiered approach including a screening assay, a confirmation assay and calculation of titer. Data for number of participants for whom titers of anti-GSK3772847 antibodies was performed is presented. |
| Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Absolute Score at Weeks 2, 4, 8 and 12 | Baseline (Day 1), Weeks 2, 4, 8 and 12 | The ACQ-5 is a five-item, self-completed questionnaire, which measures a participant's asthma control. The questions enquire about the frequency and/or severity of symptoms (nocturnal awakening, activity limitation, shortness of breath and wheeze) over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. ACQ-5 score is the mean of the five questions and ranges from 0 (totally controlled) to 6 (severely uncontrolled). Baseline value is defined as the ACQ-5 assessment on Day 1. Change from Baseline is calculated as the post-dose value minus Baseline value. |
| Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Baseline (Day 1), Weeks 2, 4, 8 and 12 | The AQLQ is a disease-specific, self-administered quality of life questionnaire that was developed to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (five items), and environmental stimuli (four items). Participants were asked to recall their experience over the previous 14 days and respond to each question on a seven-point scale where a value of 1 indicates 'total impairment' and 7 indicates 'no impairment'. The total score is the mean of responses to all 32 questions and each individual domain score was calculated as the mean of the items within that domain. Hence, the total and domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is defined as the AQLQ assessment on Day 1. Change from Baseline is calculated as the post-dose value minus Baseline value. |
| Percentage of Responders to ACQ-5 at Weeks 2, 4, 8 and 12 | Weeks 2, 4, 8 and 12 | The ACQ-5 is a five-item, self-completed questionnaire, which measures a participant's asthma control. The questions enquire about the frequency and/or severity of symptoms (nocturnal awakening, activity limitation, shortness of breath and wheeze) over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. ACQ-5 score is the mean of the five questions and ranges from 0 (totally controlled) to 6 (severely uncontrolled). A responder to ACQ-5 is defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more at Weeks 2, 4, 8 and 12. |
| Percentage of Responders to AQLQ at Weeks 2, 4, 8 and 12 | Weeks 2, 4, 8 and 12 | The AQLQ is a disease-specific, self-administered quality of life questionnaire that was developed to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (five items), and environmental stimuli (four items). Participants were asked to recall their experience over the previous 14 days and respond to each question on a seven-point scale where a value of 1 indicates 'total impairment' and 7 indicates 'no impairment'. The total score is the mean of responses to all 32 questions. The total score was defined on a range from 1 to 7 with higher scores indicating a higher quality of life. A responder to AQLQ is defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more at Weeks 2, 4, 8 and 12. |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline (Day 1, pre-dose), Weeks 2, 4, 8 and 12 | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 is measured using spirometry. Baseline is the most recent recorded value before dosing on Day 1. Change from Baseline is calculated as the post-dose value minus the Baseline value. |
| Serum Concentrations of GSK3772847 | Week 0 (post-dose), Week 2, Week 4 (pre-dose), Week 8 (pre-dose and post-dose), Week 12 and Week 24 | Whole blood samples were collected at indicated time points for measurement of serum concentrations of GSK3772847. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 24 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as 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 disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. |
| Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Up to Week 24 | Blood samples were collected for the assessment of following clinical chemistry parameters: alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, carbon dioxide, chloride, creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase, glucose, phosphate, potassium, protein, sodium and urea. Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent (%). 'To Low' rows are not presented for tests that have lower limit of normal = 0. |
| Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Up to Week 24 | Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, erythrocyte (Ery. ) mean hemoglobin concentration (MCHC), Ery. mean corpuscular hemoglobin (MCH), Ery mean corpuscular volume (MCV), erythrocytes, erythrocytes distribution width, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. 'To Low' rows are not presented for tests that have lower limit of normal = 0. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1, pre-dose), Week 0 (post-dose), Weeks 4 and 8 (pre-dose and post-dose) Weeks 12 and 24 | SBP and DBP were measured in the supine position after five minutes of rest for the participant. Baseline is the most recent recorded value before dosing on Day 1 (Week 0). Change from Baseline is calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Pulse Rate | Baseline (Day 1, pre-dose), Week 0 (post-dose), Weeks 4 and 8 (pre-dose and post-dose) Weeks 12 and 24 | Pulse rate was measured in the supine position after five minutes of rest for the participant. Baseline is the most recent recorded value before dosing on Day 1 (Week 0). Change from Baseline is calculated as post-dose visit value minus Baseline value. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Up to Week 12 | Twelve lead ECGs were obtained using a standardized ECG machine that measured heart rate, PR, QRS, QT and corrected QT interval (QTc). ECG measurements were done with the participant in a supine position having rested in this position for approximately 5 minutes before each reading. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings at worst-case post-Baseline are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst-case post-Baseline is presented. |
| Number of Participants With Abnormal 24-hour Holter Findings | Week 0 | A Holter monitor is a type of continuous ambulatory ECG device used for quantitative assessment of abnormal rhythm events. Number of participants with abnormal 24-hour Holter findings is presented. Data was summarized for participants with at least 16 hours of data. |
| Change From Baseline in Forced Vital Capacity (FVC) | Baseline (Day 1, pre-dose), Weeks 2, 4, 8 and 12 | FVC is the maximal amount of air that can be forcibly exhaled from lungs after taking the deepest breath possible. FVC is measured by spirometry. Baseline is the most recent recorded value before dosing on Day 1. Change from Baseline is calculated as the post-dose value minus the Baseline value. |
| Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2) | Baseline, Week 0 (post-dose), Week 2, Week 4 (pre-dose), Week 8 (pre-dose and post-dose) and Week 12 | Serum samples were collected at indicated time points for assessment of free ST2 levels. Baseline is the most recent recorded value before dosing on Day 1 (Week 0). |
Countries
France, Netherlands, Russia, United Kingdom
Participant flow
Recruitment details
This was a double-blind, placebo-controlled, parallel group study conducted in participants with moderate to severe asthma with allergic fungal airway disease (AFAD). The study was conducted across 4 countries-France, Netherlands, Russian Federation and the United Kingdom.
Pre-assignment details
A total of 17 participants were randomized in a ratio of 1:1 to receive either GSK3772847 10 milligrams per kilogram (mg/kg) or placebo. Recruitment in the study was terminated early due to the feasibility of completing the study in a timely manner.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received three doses of placebo administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment. | 9 |
| GSK3772847 Participants received three doses of GSK3772847 10 mg/kg administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment. | 8 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | GSK3772847 | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 53.6 Years STANDARD_DEVIATION 12.59 | 56.9 Years STANDARD_DEVIATION 11.21 | 59.9 Years STANDARD_DEVIATION 9.57 |
| Race/Ethnicity, Customized Asian-Japanese/East Asian (EA)/South EA Heritage | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 15 Participants | 9 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 7 / 9 | 3 / 8 |
| serious Total, serious adverse events | 1 / 9 | 0 / 8 |
Outcome results
Primary
Percent Change From Baseline in Blood Eosinophils Over Time
Blood samples were collected at the indicated time points for assessment of blood eosinophil cell count. Baseline is the most recent recorded value before dosing on Day 1. Percent change from Baseline is calculated as (Ratio to Baseline minus 1)\*100, where ratio to Baseline is the value at specified time point divided by Baseline value.
Time frame: Baseline (Day 1, pre-dose), Weeks 2, 4, 8 and 12
Population: Modified Intent-to-Treat (mITT) Population comprised of all randomized participants who took at least 1 dose of study treatment. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Blood Eosinophils Over Time | Week 2; n=9, 8 | 30.8 Percent change |
| Placebo | Percent Change From Baseline in Blood Eosinophils Over Time | Week 4; n=8, 8 | 16.0 Percent change |
| Placebo | Percent Change From Baseline in Blood Eosinophils Over Time | Week 8; n=8, 8 | 14.4 Percent change |
| Placebo | Percent Change From Baseline in Blood Eosinophils Over Time | Week 12; n=5, 7 | 9.7 Percent change |
| GSK3772847 | Percent Change From Baseline in Blood Eosinophils Over Time | Week 12; n=5, 7 | -10.9 Percent change |
| GSK3772847 | Percent Change From Baseline in Blood Eosinophils Over Time | Week 2; n=9, 8 | 28.1 Percent change |
| GSK3772847 | Percent Change From Baseline in Blood Eosinophils Over Time | Week 8; n=8, 8 | -31.4 Percent change |
| GSK3772847 | Percent Change From Baseline in Blood Eosinophils Over Time | Week 4; n=8, 8 | 2.1 Percent change |
Primary
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Over Time
FeNO was assessed using a handheld electronic device. The measurements were obtained in accordance with the American Thoracic Society and the European Respiratory Society Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide. Participants did not use their rescue medication for at least 6 hours before each FeNO assessment, unless essential for clinical need. Baseline is the most recent recorded value before dosing on Day 1. Percent change from Baseline is calculated as (Ratio to Baseline minus 1)\*100, where ratio to Baseline is the value at specified time point divided by Baseline value.
Time frame: Baseline (Day 1, pre-dose), Weeks 2, 4, 8 and 12
Population: mITT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Over Time | Week 2; n=9, 6 | 33.4 Percent change |
| Placebo | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Over Time | Week 8; n=8, 7 | 11.7 Percent change |
| Placebo | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Over Time | Week 4; n=8, 8 | 13.7 Percent change |
| Placebo | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Over Time | Week 12; n=5, 6 | -37.2 Percent change |
| GSK3772847 | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Over Time | Week 4; n=8, 8 | -12.5 Percent change |
| GSK3772847 | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Over Time | Week 2; n=9, 6 | -18.6 Percent change |
| GSK3772847 | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Over Time | Week 12; n=5, 6 | -45.6 Percent change |
| GSK3772847 | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Over Time | Week 8; n=8, 7 | -42.8 Percent change |
Secondary
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Absolute Score at Weeks 2, 4, 8 and 12
The ACQ-5 is a five-item, self-completed questionnaire, which measures a participant's asthma control. The questions enquire about the frequency and/or severity of symptoms (nocturnal awakening, activity limitation, shortness of breath and wheeze) over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. ACQ-5 score is the mean of the five questions and ranges from 0 (totally controlled) to 6 (severely uncontrolled). Baseline value is defined as the ACQ-5 assessment on Day 1. Change from Baseline is calculated as the post-dose value minus Baseline value.
Time frame: Baseline (Day 1), Weeks 2, 4, 8 and 12
Population: mITT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Absolute Score at Weeks 2, 4, 8 and 12 | Week 2; n=9, 8 | -0.47 Scores on a scale | Standard Deviation 0.616 |
| Placebo | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Absolute Score at Weeks 2, 4, 8 and 12 | Week 4; n=8, 8 | -0.23 Scores on a scale | Standard Deviation 1.087 |
| Placebo | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Absolute Score at Weeks 2, 4, 8 and 12 | Week 8; n=8, 8 | -0.60 Scores on a scale | Standard Deviation 0.986 |
| Placebo | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Absolute Score at Weeks 2, 4, 8 and 12 | Week 12; n=5, 7 | -0.12 Scores on a scale | Standard Deviation 1.262 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Absolute Score at Weeks 2, 4, 8 and 12 | Week 12; n=5, 7 | -1.20 Scores on a scale | Standard Deviation 1.095 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Absolute Score at Weeks 2, 4, 8 and 12 | Week 2; n=9, 8 | -0.65 Scores on a scale | Standard Deviation 0.739 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Absolute Score at Weeks 2, 4, 8 and 12 | Week 8; n=8, 8 | -1.23 Scores on a scale | Standard Deviation 1.383 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Absolute Score at Weeks 2, 4, 8 and 12 | Week 4; n=8, 8 | -1.03 Scores on a scale | Standard Deviation 0.897 |
Secondary
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12
The AQLQ is a disease-specific, self-administered quality of life questionnaire that was developed to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (five items), and environmental stimuli (four items). Participants were asked to recall their experience over the previous 14 days and respond to each question on a seven-point scale where a value of 1 indicates 'total impairment' and 7 indicates 'no impairment'. The total score is the mean of responses to all 32 questions and each individual domain score was calculated as the mean of the items within that domain. Hence, the total and domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is defined as the AQLQ assessment on Day 1. Change from Baseline is calculated as the post-dose value minus Baseline value.
Time frame: Baseline (Day 1), Weeks 2, 4, 8 and 12
Population: mITT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Environmental stimuli; Week 2; n=9, 8 | -0.14 Scores on a scale | Standard Deviation 0.811 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Environmental stimuli; Week 4; n=8, 8 | -0.44 Scores on a scale | Standard Deviation 0.884 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Environmental stimuli; Week 8; n=8, 8 | -0.44 Scores on a scale | Standard Deviation 1.208 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Environmental stimuli; Week 12; n=5, 7 | -0.65 Scores on a scale | Standard Deviation 1.025 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Emotional function; Week 2; n=9, 8 | 0.40 Scores on a scale | Standard Deviation 0.86 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Emotional function; Week 4; n=8, 8 | -0.35 Scores on a scale | Standard Deviation 0.833 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Emotional function; Week 8; n=8, 8 | 0.45 Scores on a scale | Standard Deviation 1.165 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Emotional function; Week 12; n=5, 7 | 0.08 Scores on a scale | Standard Deviation 1.712 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Total score: Week 2; n=9, 8 | 0.31 Scores on a scale | Standard Deviation 0.66 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Total score: Week 4; n=8, 8 | -0.22 Scores on a scale | Standard Deviation 0.477 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Total score: Week 8; n=8, 8 | 0.27 Scores on a scale | Standard Deviation 0.846 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Total score: Week 12; n=5, 7 | 0.10 Scores on a scale | Standard Deviation 1.394 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Activity limitation; Week 2; n=9, 8 | 0.20 Scores on a scale | Standard Deviation 0.504 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Activity limitation; Week 4; n=8, 8 | -0.26 Scores on a scale | Standard Deviation 0.499 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Activity limitation; Week 8; n=8, 8 | 0.12 Scores on a scale | Standard Deviation 0.603 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Activity limitation; Week 12; n=5, 7 | -0.07 Scores on a scale | Standard Deviation 1.127 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Symptoms; Week 2; n=9, 8 | 0.52 Scores on a scale | Standard Deviation 0.924 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Symptoms; Week 4; n=8, 8 | -0.05 Scores on a scale | Standard Deviation 0.774 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Symptoms; Week 8; n=8, 8 | 0.57 Scores on a scale | Standard Deviation 1.213 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Symptoms; Week 12; n=5, 7 | 0.52 Scores on a scale | Standard Deviation 1.74 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Symptoms; Week 12; n=5, 7 | 1.31 Scores on a scale | Standard Deviation 0.81 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Symptoms; Week 4; n=8, 8 | 0.74 Scores on a scale | Standard Deviation 0.627 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Environmental stimuli; Week 2; n=9, 8 | 0.22 Scores on a scale | Standard Deviation 0.891 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Total score: Week 8; n=8, 8 | 1.09 Scores on a scale | Standard Deviation 0.94 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Activity limitation; Week 12; n=5, 7 | 0.91 Scores on a scale | Standard Deviation 0.993 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Environmental stimuli; Week 8; n=8, 8 | 1.06 Scores on a scale | Standard Deviation 1.132 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Total score: Week 12; n=5, 7 | 1.13 Scores on a scale | Standard Deviation 0.953 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Environmental stimuli; Week 12; n=5, 7 | 0.89 Scores on a scale | Standard Deviation 1.257 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Symptoms; Week 8; n=8, 8 | 1.24 Scores on a scale | Standard Deviation 0.936 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Emotional function; Week 2; n=9, 8 | 0.75 Scores on a scale | Standard Deviation 0.955 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Activity limitation; Week 2; n=9, 8 | 0.31 Scores on a scale | Standard Deviation 0.75 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Emotional function; Week 4; n=8, 8 | 0.65 Scores on a scale | Standard Deviation 0.847 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Symptoms; Week 2; n=9, 8 | 0.54 Scores on a scale | Standard Deviation 0.641 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Emotional function; Week 8; n=8, 8 | 1.22 Scores on a scale | Standard Deviation 1.289 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Activity limitation; Week 4; n=8, 8 | 0.30 Scores on a scale | Standard Deviation 0.57 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Emotional function; Week 12; n=5, 7 | 1.37 Scores on a scale | Standard Deviation 1.246 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Environmental stimuli; Week 4; n=8, 8 | 0.63 Scores on a scale | Standard Deviation 0.886 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Total score: Week 2; n=9, 8 | 0.45 Scores on a scale | Standard Deviation 0.623 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Activity limitation; Week 8; n=8, 8 | 0.88 Scores on a scale | Standard Deviation 0.9 |
| GSK3772847 | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total and Domain Scores at Weeks 2, 4, 8 and 12 | Total score: Week 4; n=8, 8 | 0.56 Scores on a scale | Standard Deviation 0.514 |
Secondary
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 is measured using spirometry. Baseline is the most recent recorded value before dosing on Day 1. Change from Baseline is calculated as the post-dose value minus the Baseline value.
Time frame: Baseline (Day 1, pre-dose), Weeks 2, 4, 8 and 12
Population: mITT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Week 2; n=9, 8 | 0.076 Liters | Standard Deviation 0.3383 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Week 4; n=7, 8 | -0.049 Liters | Standard Deviation 0.2304 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Week 8; n=7, 7 | 0.060 Liters | Standard Deviation 0.421 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Week 12; n=5, 7 | 0.102 Liters | Standard Deviation 0.4879 |
| GSK3772847 | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Week 12; n=5, 7 | -0.013 Liters | Standard Deviation 0.1923 |
| GSK3772847 | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Week 2; n=9, 8 | -0.137 Liters | Standard Deviation 0.264 |
| GSK3772847 | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Week 8; n=7, 7 | 0.040 Liters | Standard Deviation 0.2381 |
| GSK3772847 | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Week 4; n=7, 8 | -0.022 Liters | Standard Deviation 0.2703 |
Secondary
Change From Baseline in Forced Vital Capacity (FVC)
FVC is the maximal amount of air that can be forcibly exhaled from lungs after taking the deepest breath possible. FVC is measured by spirometry. Baseline is the most recent recorded value before dosing on Day 1. Change from Baseline is calculated as the post-dose value minus the Baseline value.
Time frame: Baseline (Day 1, pre-dose), Weeks 2, 4, 8 and 12
Population: mITT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Week 2; n=9, 8 | 0.078 Liters | Standard Deviation 0.4201 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Week 4; n=7, 8 | 0.091 Liters | Standard Deviation 0.3163 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Week 8; n=7, 7 | 0.179 Liters | Standard Deviation 0.5145 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Week 12; n=5, 7 | 0.136 Liters | Standard Deviation 0.5351 |
| GSK3772847 | Change From Baseline in Forced Vital Capacity (FVC) | Week 12; n=5, 7 | 0.050 Liters | Standard Deviation 0.2408 |
| GSK3772847 | Change From Baseline in Forced Vital Capacity (FVC) | Week 2; n=9, 8 | -0.074 Liters | Standard Deviation 0.3761 |
| GSK3772847 | Change From Baseline in Forced Vital Capacity (FVC) | Week 8; n=7, 7 | 0.030 Liters | Standard Deviation 0.2291 |
| GSK3772847 | Change From Baseline in Forced Vital Capacity (FVC) | Week 4; n=7, 8 | 0.090 Liters | Standard Deviation 0.3049 |
Secondary
Change From Baseline in Pulse Rate
Pulse rate was measured in the supine position after five minutes of rest for the participant. Baseline is the most recent recorded value before dosing on Day 1 (Week 0). Change from Baseline is calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, pre-dose), Week 0 (post-dose), Weeks 4 and 8 (pre-dose and post-dose) Weeks 12 and 24
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Pulse Rate | Week 0 (post-dose); n=9, 8 | -0.8 Beats per minute | Standard Deviation 7.63 |
| Placebo | Change From Baseline in Pulse Rate | Week 4 (post-dose); n=8, 8 | -6.8 Beats per minute | Standard Deviation 9.04 |
| Placebo | Change From Baseline in Pulse Rate | Week 8 (post-dose); n=8, 8 | -6.3 Beats per minute | Standard Deviation 6.39 |
| Placebo | Change From Baseline in Pulse Rate | Week 12; n=8, 8 | 1.6 Beats per minute | Standard Deviation 3.66 |
| Placebo | Change From Baseline in Pulse Rate | Week 4 (pre-dose); n=8, 8 | 0.8 Beats per minute | Standard Deviation 9.6 |
| Placebo | Change From Baseline in Pulse Rate | Week 24; n=9, 8 | 2.2 Beats per minute | Standard Deviation 6.69 |
| Placebo | Change From Baseline in Pulse Rate | Week 8 (pre-dose); n=8, 8 | 0.0 Beats per minute | Standard Deviation 8.26 |
| GSK3772847 | Change From Baseline in Pulse Rate | Week 24; n=9, 8 | -0.4 Beats per minute | Standard Deviation 6.99 |
| GSK3772847 | Change From Baseline in Pulse Rate | Week 8 (pre-dose); n=8, 8 | -1.5 Beats per minute | Standard Deviation 6.55 |
| GSK3772847 | Change From Baseline in Pulse Rate | Week 8 (post-dose); n=8, 8 | -2.1 Beats per minute | Standard Deviation 6.22 |
| GSK3772847 | Change From Baseline in Pulse Rate | Week 0 (post-dose); n=9, 8 | -2.5 Beats per minute | Standard Deviation 5.37 |
| GSK3772847 | Change From Baseline in Pulse Rate | Week 4 (pre-dose); n=8, 8 | -1.8 Beats per minute | Standard Deviation 8.17 |
| GSK3772847 | Change From Baseline in Pulse Rate | Week 4 (post-dose); n=8, 8 | -1.0 Beats per minute | Standard Deviation 9.8 |
| GSK3772847 | Change From Baseline in Pulse Rate | Week 12; n=8, 8 | -4.1 Beats per minute | Standard Deviation 6.64 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured in the supine position after five minutes of rest for the participant. Baseline is the most recent recorded value before dosing on Day 1 (Week 0). Change from Baseline is calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, pre-dose), Week 0 (post-dose), Weeks 4 and 8 (pre-dose and post-dose) Weeks 12 and 24
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 8 (pre-dose); n=8, 8 | 0.5 Millimeters of mercury | Standard Deviation 14.42 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 0 (post-dose); n=9, 8 | 3.7 Millimeters of mercury | Standard Deviation 8.77 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 4 (pre-dose); n=8, 8 | 0.1 Millimeters of mercury | Standard Deviation 14.4 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 4 (post-dose); n=8, 8 | 4.5 Millimeters of mercury | Standard Deviation 14.16 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 8 (post-dose); n=8, 8 | 0.6 Millimeters of mercury | Standard Deviation 15.27 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 12; n=8, 8 | 4.1 Millimeters of mercury | Standard Deviation 13.17 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 24; n=9, 8 | 2.7 Millimeters of mercury | Standard Deviation 17 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 0 (post-dose); n=9, 8 | 0.1 Millimeters of mercury | Standard Deviation 5.4 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 4 (pre-dose); n=8, 8 | -3.1 Millimeters of mercury | Standard Deviation 3.72 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 4 (post-dose); n=8, 8 | -4.8 Millimeters of mercury | Standard Deviation 4.92 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 8 (pre-dose); n=8, 8 | -7.8 Millimeters of mercury | Standard Deviation 8.31 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 8 (post-dose); n=8, 8 | -11.3 Millimeters of mercury | Standard Deviation 9.92 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 12; n=8, 8 | -2.9 Millimeters of mercury | Standard Deviation 4.49 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 24; n=9, 8 | -5.2 Millimeters of mercury | Standard Deviation 6.98 |
| GSK3772847 | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 8 (pre-dose); n=8, 8 | 0.6 Millimeters of mercury | Standard Deviation 14.23 |
| GSK3772847 | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 0 (post-dose); n=9, 8 | 0.6 Millimeters of mercury | Standard Deviation 7.15 |
| GSK3772847 | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 0 (post-dose); n=9, 8 | 1.4 Millimeters of mercury | Standard Deviation 9.38 |
| GSK3772847 | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 12; n=8, 8 | 2.6 Millimeters of mercury | Standard Deviation 12.34 |
| GSK3772847 | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 4 (pre-dose); n=8, 8 | -2.5 Millimeters of mercury | Standard Deviation 18.05 |
| GSK3772847 | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 4 (pre-dose); n=8, 8 | 1.0 Millimeters of mercury | Standard Deviation 14.11 |
| GSK3772847 | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 4 (post-dose); n=8, 8 | 4.5 Millimeters of mercury | Standard Deviation 19.18 |
| GSK3772847 | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 8 (pre-dose); n=8, 8 | 7.3 Millimeters of mercury | Standard Deviation 17.81 |
| GSK3772847 | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 8 (post-dose); n=8, 8 | -1.0 Millimeters of mercury | Standard Deviation 13.63 |
| GSK3772847 | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 8 (post-dose); n=8, 8 | 6.0 Millimeters of mercury | Standard Deviation 18.97 |
| GSK3772847 | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 4 (post-dose); n=8, 8 | 1.3 Millimeters of mercury | Standard Deviation 12.9 |
| GSK3772847 | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 12; n=8, 8 | 7.1 Millimeters of mercury | Standard Deviation 18.74 |
| GSK3772847 | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 24; n=9, 8 | 3.0 Millimeters of mercury | Standard Deviation 14.93 |
| GSK3772847 | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 24; n=9, 8 | 6.1 Millimeters of mercury | Standard Deviation 14.97 |
Secondary
Number of Participants for Whom Titers of Anti-GSK3772847 Antibodies Was Performed
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3772847. The presence of anti-GSK3772847 antibodies was assessed using a tiered approach including a screening assay, a confirmation assay and calculation of titer. Data for number of participants for whom titers of anti-GSK3772847 antibodies was performed is presented.
Time frame: Weeks 0, 2, 4, 8, 12 and 24
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants for Whom Titers of Anti-GSK3772847 Antibodies Was Performed | Week 0; n=9, 8 | 0 Participants |
| Placebo | Number of Participants for Whom Titers of Anti-GSK3772847 Antibodies Was Performed | Week 2; n=9, 8 | 0 Participants |
| Placebo | Number of Participants for Whom Titers of Anti-GSK3772847 Antibodies Was Performed | Week 4; n=8, 8 | 0 Participants |
| Placebo | Number of Participants for Whom Titers of Anti-GSK3772847 Antibodies Was Performed | Week 8; n=8, 8 | 0 Participants |
| Placebo | Number of Participants for Whom Titers of Anti-GSK3772847 Antibodies Was Performed | Week 12; n=8, 8 | 0 Participants |
| Placebo | Number of Participants for Whom Titers of Anti-GSK3772847 Antibodies Was Performed | Week 24; n=9, 8 | 0 Participants |
| GSK3772847 | Number of Participants for Whom Titers of Anti-GSK3772847 Antibodies Was Performed | Week 12; n=8, 8 | 0 Participants |
| GSK3772847 | Number of Participants for Whom Titers of Anti-GSK3772847 Antibodies Was Performed | Week 0; n=9, 8 | 0 Participants |
| GSK3772847 | Number of Participants for Whom Titers of Anti-GSK3772847 Antibodies Was Performed | Week 8; n=8, 8 | 0 Participants |
| GSK3772847 | Number of Participants for Whom Titers of Anti-GSK3772847 Antibodies Was Performed | Week 2; n=9, 8 | 0 Participants |
| GSK3772847 | Number of Participants for Whom Titers of Anti-GSK3772847 Antibodies Was Performed | Week 24; n=9, 8 | 0 Participants |
| GSK3772847 | Number of Participants for Whom Titers of Anti-GSK3772847 Antibodies Was Performed | Week 4; n=8, 8 | 0 Participants |
Secondary
Number of Participants With Abnormal 24-hour Holter Findings
A Holter monitor is a type of continuous ambulatory ECG device used for quantitative assessment of abnormal rhythm events. Number of participants with abnormal 24-hour Holter findings is presented. Data was summarized for participants with at least 16 hours of data.
Time frame: Week 0
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Abnormal 24-hour Holter Findings | 4 Participants |
| GSK3772847 | Number of Participants With Abnormal 24-hour Holter Findings | 7 Participants |
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Twelve lead ECGs were obtained using a standardized ECG machine that measured heart rate, PR, QRS, QT and corrected QT interval (QTc). ECG measurements were done with the participant in a supine position having rested in this position for approximately 5 minutes before each reading. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings at worst-case post-Baseline are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst-case post-Baseline is presented.
Time frame: Up to Week 12
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS | 6 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS | 1 Participants |
| GSK3772847 | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS | 6 Participants |
| GSK3772847 | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS | 0 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as 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 disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Time frame: Up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 7 Participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| GSK3772847 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 3 Participants |
| GSK3772847 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Secondary
Number of Participants With Positive Anti-GSK3772847 Antibodies Post-dosing
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3772847. The presence of anti-GSK3772847 antibodies was assessed using a tiered approach including a screening assay, a confirmation assay and calculation of titre. Data for participants who showed positive results for confirmation assay has been presented.
Time frame: Weeks 0, 2, 4, 8, 12 and 24
Population: Safety Population consisted of all randomized participants who took at least 1 dose of study treatment. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Positive Anti-GSK3772847 Antibodies Post-dosing | Week 0; n=9, 8 | 0 Participants |
| Placebo | Number of Participants With Positive Anti-GSK3772847 Antibodies Post-dosing | Week 2; n=9, 8 | 0 Participants |
| Placebo | Number of Participants With Positive Anti-GSK3772847 Antibodies Post-dosing | Week 4; n=8, 8 | 0 Participants |
| Placebo | Number of Participants With Positive Anti-GSK3772847 Antibodies Post-dosing | Week 8; n=8, 8 | 0 Participants |
| Placebo | Number of Participants With Positive Anti-GSK3772847 Antibodies Post-dosing | Week 12; n=8, 8 | 0 Participants |
| Placebo | Number of Participants With Positive Anti-GSK3772847 Antibodies Post-dosing | Week 24; n=9, 8 | 0 Participants |
| GSK3772847 | Number of Participants With Positive Anti-GSK3772847 Antibodies Post-dosing | Week 12; n=8, 8 | 0 Participants |
| GSK3772847 | Number of Participants With Positive Anti-GSK3772847 Antibodies Post-dosing | Week 0; n=9, 8 | 0 Participants |
| GSK3772847 | Number of Participants With Positive Anti-GSK3772847 Antibodies Post-dosing | Week 8; n=8, 8 | 0 Participants |
| GSK3772847 | Number of Participants With Positive Anti-GSK3772847 Antibodies Post-dosing | Week 2; n=9, 8 | 0 Participants |
| GSK3772847 | Number of Participants With Positive Anti-GSK3772847 Antibodies Post-dosing | Week 24; n=9, 8 | 0 Participants |
| GSK3772847 | Number of Participants With Positive Anti-GSK3772847 Antibodies Post-dosing | Week 4; n=8, 8 | 0 Participants |
Secondary
Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline
Blood samples were collected for the assessment of following clinical chemistry parameters: alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, carbon dioxide, chloride, creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase, glucose, phosphate, potassium, protein, sodium and urea. Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent (%). 'To Low' rows are not presented for tests that have lower limit of normal = 0.
Time frame: Up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Chloride; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Aspartate Aminotransferase; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Potassium; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Creatine Kinase; To normal or no change | 7 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Albumin; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Creatine Kinase; To high | 2 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Bilirubin; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Creatinine; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Alanine aminotransferase; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Gamma Glutamyl Transferase; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Calcium; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Gamma Glutamyl Transferase; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Calcium; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Glucose; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Albumin; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Glucose; To normal or no change | 7 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Calcium; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Glucose; To high | 2 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Alkaline Phosphatase; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Phosphate; To low | 2 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Carbon Dioxide; To low | 2 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Phosphate; To normal or no change | 5 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Bilirubin; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Phosphate; To high | 2 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Alkaline Phosphatase; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Potassium; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Creatinine; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Alanine aminotransferase; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Potassium; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Direct Bilirubin; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Protein; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Alkaline Phosphatase; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Protein; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Direct Bilirubin; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Protein; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Chloride; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Sodium; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Carbon Dioxide; To normal or no change | 7 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Sodium; To normal or no change | 8 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Aspartate Aminotransferase; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Sodium; To high | 1 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Carbon Dioxide; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Urea; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Albumin; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Urea; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Chloride; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Urea; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Creatinine; To normal or no change | 9 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Urea; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Albumin; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Calcium; To low | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Chloride; To low | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Alanine aminotransferase; To normal or no change | 8 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Alanine aminotransferase; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Albumin; To low | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Albumin; To normal or no change | 8 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Alkaline Phosphatase; To low | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Alkaline Phosphatase; To normal or no change | 8 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Alkaline Phosphatase; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Aspartate Aminotransferase; To normal or no change | 8 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Aspartate Aminotransferase; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Bilirubin; To normal or no change | 8 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Bilirubin; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Calcium; To normal or no change | 7 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Calcium; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Carbon Dioxide; To low | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Creatinine; To normal or no change | 7 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Creatinine; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Direct Bilirubin; To normal or no change | 8 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Direct Bilirubin; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Carbon Dioxide; To normal or no change | 7 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Carbon Dioxide; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Chloride; To normal or no change | 7 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Chloride; To high | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Creatine Kinase; To normal or no change | 7 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Creatine Kinase; To high | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Creatinine; To low | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Gamma Glutamyl Transferase; To normal or no change | 8 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Gamma Glutamyl Transferase; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Glucose; To low | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Glucose; To normal or no change | 7 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Glucose; To high | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Phosphate; To low | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Phosphate; To normal or no change | 8 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Phosphate; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Potassium; To low | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Potassium; To normal or no change | 7 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Potassium; To high | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Protein; To low | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Protein; To normal or no change | 7 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Protein; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Sodium; To low | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Sodium; To normal or no change | 7 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Sodium; To high | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Urea; To low | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Chemistry Results Relative to Normal Range at Baseline | Urea; To normal or no change | 7 Participants |
Secondary
Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline
Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, erythrocyte (Ery. ) mean hemoglobin concentration (MCHC), Ery. mean corpuscular hemoglobin (MCH), Ery mean corpuscular volume (MCV), erythrocytes, erythrocytes distribution width, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. 'To Low' rows are not presented for tests that have lower limit of normal = 0.
Time frame: Up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | EDW; To high | 2 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Eosinophils; To low | 1 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Hematocrit; To low | 1 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCH; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Hematocrit; To normal or no change | 8 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Platelets; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Hematocrit; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCH; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Platelets; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Eosinophils; To normal or no change | 5 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCH; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Hemoglobin; To low | 1 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Basophils; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Hemoglobin; To normal or no change | 8 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCV; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Hemoglobin; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Eosinophils; To high | 3 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Leukocytes; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCV; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Leukocytes; To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Lymphocytes; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Leukocytes; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCV; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCHC; To low | 4 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Lymphocytes To normal or no change | 9 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Erythrocytes; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Lymphocytes; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Basophils; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCHC; To normal or no change | 5 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Monocytes; To normal or no change | 8 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Erythrocytes; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Monocytes; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | EDW; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Neutrophils; To low | 1 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Monocytes; To low | 1 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Neutrophils; To normal or no change | 7 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | EDW; To normal or no change | 7 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Neutrophils; To high | 1 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCHC; To high | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Platelets; To low | 0 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Erythrocytes; To normal or no change | 9 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Platelets; To low | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Erythrocytes; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Basophils; To normal or no change | 8 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Basophils; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Eosinophils; To low | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Eosinophils; To normal or no change | 6 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Eosinophils; To high | 2 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCHC; To low | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCHC; To normal or no change | 8 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCHC; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCH; To low | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCH; To normal or no change | 8 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCH; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCV; To low | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCV; To normal or no change | 8 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Ery. MCV; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Erythrocytes; To low | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Erythrocytes; To normal or no change | 7 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | EDW; To low | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | EDW; To normal or no change | 7 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | EDW; To high | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Hematocrit; To low | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Hematocrit; To normal or no change | 6 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Platelets; To normal or no change | 8 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Platelets; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Hematocrit; To high | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Hemoglobin; To low | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Hemoglobin; To normal or no change | 8 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Hemoglobin; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Leukocytes; To low | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Leukocytes; To normal or no change | 7 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Leukocytes; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Lymphocytes; To low | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Lymphocytes To normal or no change | 8 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Lymphocytes; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Monocytes; To low | 2 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Monocytes; To normal or no change | 6 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Monocytes; To high | 0 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Neutrophils; To low | 1 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Neutrophils; To normal or no change | 7 Participants |
| GSK3772847 | Number of Participants With Worst Case Post-Baseline Hematology Results Relative to Normal Range at Baseline | Neutrophils; To high | 0 Participants |
Secondary
Percentage of Responders to ACQ-5 at Weeks 2, 4, 8 and 12
The ACQ-5 is a five-item, self-completed questionnaire, which measures a participant's asthma control. The questions enquire about the frequency and/or severity of symptoms (nocturnal awakening, activity limitation, shortness of breath and wheeze) over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. ACQ-5 score is the mean of the five questions and ranges from 0 (totally controlled) to 6 (severely uncontrolled). A responder to ACQ-5 is defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more at Weeks 2, 4, 8 and 12.
Time frame: Weeks 2, 4, 8 and 12
Population: mITT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Responders to ACQ-5 at Weeks 2, 4, 8 and 12 | Week 2; n=9, 8 | 44 Percentage of responders |
| Placebo | Percentage of Responders to ACQ-5 at Weeks 2, 4, 8 and 12 | Week 8; n=8, 8 | 50 Percentage of responders |
| Placebo | Percentage of Responders to ACQ-5 at Weeks 2, 4, 8 and 12 | Week 4; n=8, 8 | 63 Percentage of responders |
| Placebo | Percentage of Responders to ACQ-5 at Weeks 2, 4, 8 and 12 | Week 12; n=5, 7 | 20 Percentage of responders |
| GSK3772847 | Percentage of Responders to ACQ-5 at Weeks 2, 4, 8 and 12 | Week 12; n=5, 7 | 71 Percentage of responders |
| GSK3772847 | Percentage of Responders to ACQ-5 at Weeks 2, 4, 8 and 12 | Week 2; n=9, 8 | 50 Percentage of responders |
| GSK3772847 | Percentage of Responders to ACQ-5 at Weeks 2, 4, 8 and 12 | Week 4; n=8, 8 | 50 Percentage of responders |
| GSK3772847 | Percentage of Responders to ACQ-5 at Weeks 2, 4, 8 and 12 | Week 8; n=8, 8 | 50 Percentage of responders |
Secondary
Percentage of Responders to AQLQ at Weeks 2, 4, 8 and 12
The AQLQ is a disease-specific, self-administered quality of life questionnaire that was developed to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (five items), and environmental stimuli (four items). Participants were asked to recall their experience over the previous 14 days and respond to each question on a seven-point scale where a value of 1 indicates 'total impairment' and 7 indicates 'no impairment'. The total score is the mean of responses to all 32 questions. The total score was defined on a range from 1 to 7 with higher scores indicating a higher quality of life. A responder to AQLQ is defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more at Weeks 2, 4, 8 and 12.
Time frame: Weeks 2, 4, 8 and 12
Population: mITT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Responders to AQLQ at Weeks 2, 4, 8 and 12 | Week 2; n=9, 8 | 44 Percentage of responders |
| Placebo | Percentage of Responders to AQLQ at Weeks 2, 4, 8 and 12 | Week 4; n=8, 8 | 0 Percentage of responders |
| Placebo | Percentage of Responders to AQLQ at Weeks 2, 4, 8 and 12 | Week 8; n=8, 8 | 25 Percentage of responders |
| Placebo | Percentage of Responders to AQLQ at Weeks 2, 4, 8 and 12 | Week 12; n=5, 7 | 40 Percentage of responders |
| GSK3772847 | Percentage of Responders to AQLQ at Weeks 2, 4, 8 and 12 | Week 12; n=5, 7 | 86 Percentage of responders |
| GSK3772847 | Percentage of Responders to AQLQ at Weeks 2, 4, 8 and 12 | Week 2; n=9, 8 | 50 Percentage of responders |
| GSK3772847 | Percentage of Responders to AQLQ at Weeks 2, 4, 8 and 12 | Week 8; n=8, 8 | 63 Percentage of responders |
| GSK3772847 | Percentage of Responders to AQLQ at Weeks 2, 4, 8 and 12 | Week 4; n=8, 8 | 38 Percentage of responders |
Secondary
Serum Concentrations of GSK3772847
Whole blood samples were collected at indicated time points for measurement of serum concentrations of GSK3772847.
Time frame: Week 0 (post-dose), Week 2, Week 4 (pre-dose), Week 8 (pre-dose and post-dose), Week 12 and Week 24
Population: Pharmacokinetic (PK) Population comprised of all randomized participants who received at least one dose of study medication, and for whom at least one pharmacokinetic sample was obtained, analyzed and was measurable.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum Concentrations of GSK3772847 | Week 0, post-dose | 156.50 Micrograms per milliliter | Standard Deviation 74.102 |
| Placebo | Serum Concentrations of GSK3772847 | Week 2 | 65.35 Micrograms per milliliter | Standard Deviation 10.9 |
| Placebo | Serum Concentrations of GSK3772847 | Week 4, pre-dose | 39.13 Micrograms per milliliter | Standard Deviation 10.777 |
| Placebo | Serum Concentrations of GSK3772847 | Week 8, pre-dose | 56.24 Micrograms per milliliter | Standard Deviation 9.658 |
| Placebo | Serum Concentrations of GSK3772847 | Week 8, post-dose | 209.61 Micrograms per milliliter | Standard Deviation 93.217 |
| Placebo | Serum Concentrations of GSK3772847 | Week 12 | 68.59 Micrograms per milliliter | Standard Deviation 15.57 |
| Placebo | Serum Concentrations of GSK3772847 | Week 24 | 1.67 Micrograms per milliliter | Standard Deviation 1.276 |
Secondary
Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2)
Serum samples were collected at indicated time points for assessment of free ST2 levels. Baseline is the most recent recorded value before dosing on Day 1 (Week 0).
Time frame: Baseline, Week 0 (post-dose), Week 2, Week 4 (pre-dose), Week 8 (pre-dose and post-dose) and Week 12
Population: mITT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2) | Week 2; n=9, 8 | 2.286 Micrograms per liter | Geometric Coefficient of Variation 50.2 |
| Placebo | Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2) | Week 8 (pre-dose); n=8, 8 | 2.563 Micrograms per liter | Geometric Coefficient of Variation 30.8 |
| Placebo | Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2) | Week 0 (post-dose); n=9, 8 | 2.301 Micrograms per liter | Geometric Coefficient of Variation 46.9 |
| Placebo | Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2) | Week 8 (post-dose); n=8, 8 | 2.568 Micrograms per liter | Geometric Coefficient of Variation 33.7 |
| Placebo | Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2) | Week 4 (pre-dose); n=8, 8 | 2.382 Micrograms per liter | Geometric Coefficient of Variation 32.1 |
| Placebo | Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2) | Week 12; n=5, 6 | 2.194 Micrograms per liter | Geometric Coefficient of Variation 46.5 |
| Placebo | Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2) | Baseline; n=9, 8 | 2.365 Micrograms per liter | Geometric Coefficient of Variation 54.3 |
| GSK3772847 | Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2) | Week 12; n=5, 6 | 0.144 Micrograms per liter | Geometric Coefficient of Variation 67.3 |
| GSK3772847 | Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2) | Baseline; n=9, 8 | 2.418 Micrograms per liter | Geometric Coefficient of Variation 50 |
| GSK3772847 | Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2) | Week 0 (post-dose); n=9, 8 | 0.025 Micrograms per liter | Geometric Coefficient of Variation 668.2 |
| GSK3772847 | Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2) | Week 2; n=9, 8 | 0.156 Micrograms per liter | Geometric Coefficient of Variation 43.4 |
| GSK3772847 | Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2) | Week 4 (pre-dose); n=8, 8 | 0.197 Micrograms per liter | Geometric Coefficient of Variation 44 |
| GSK3772847 | Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2) | Week 8 (pre-dose); n=8, 8 | 0.181 Micrograms per liter | Geometric Coefficient of Variation 25.8 |
| GSK3772847 | Serum Levels of Free Suppressor of Tumorigenicity 2 (ST2) | Week 8 (post-dose); n=8, 8 | 0.126 Micrograms per liter | Geometric Coefficient of Variation 38.2 |
Secondary
Serum Levels of Total Soluble ST2
Serum samples were collected at indicated time points for assessment of total soluble ST2 levels. Baseline is the most recent recorded value before dosing on Day 1 (Week 0).
Time frame: Baseline, Week 0 (post-dose), Week 2, Week 4 (pre-dose), Week 8 (pre-dose and post-dose) and Week 12
Population: mITT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum Levels of Total Soluble ST2 | Week 12; n=5, 6 | 1.900 Micrograms per liter | Geometric Coefficient of Variation 61.3 |
| Placebo | Serum Levels of Total Soluble ST2 | Baseline; n=9, 8 | 1.905 Micrograms per liter | Geometric Coefficient of Variation 71.4 |
| Placebo | Serum Levels of Total Soluble ST2 | Week 0 (post-dose); n=9, 8 | 1.884 Micrograms per liter | Geometric Coefficient of Variation 60.4 |
| Placebo | Serum Levels of Total Soluble ST2 | Week 2; n=9, 8 | 1.777 Micrograms per liter | Geometric Coefficient of Variation 65.5 |
| Placebo | Serum Levels of Total Soluble ST2 | Week 8 (pre-dose); n=8, 8 | 2.141 Micrograms per liter | Geometric Coefficient of Variation 39.9 |
| Placebo | Serum Levels of Total Soluble ST2 | Week 8 (post-dose); n=8, 8 | 2.201 Micrograms per liter | Geometric Coefficient of Variation 40.7 |
| Placebo | Serum Levels of Total Soluble ST2 | Week 4 (pre-dose); n=8, 8 | 1.950 Micrograms per liter | Geometric Coefficient of Variation 35.6 |
| GSK3772847 | Serum Levels of Total Soluble ST2 | Week 8 (pre-dose); n=8, 8 | 79.286 Micrograms per liter | Geometric Coefficient of Variation 31.6 |
| GSK3772847 | Serum Levels of Total Soluble ST2 | Week 4 (pre-dose); n=8, 8 | 65.833 Micrograms per liter | Geometric Coefficient of Variation 47.3 |
| GSK3772847 | Serum Levels of Total Soluble ST2 | Week 12; n=5, 6 | 75.703 Micrograms per liter | Geometric Coefficient of Variation 54.1 |
| GSK3772847 | Serum Levels of Total Soluble ST2 | Week 2; n=9, 8 | 63.353 Micrograms per liter | Geometric Coefficient of Variation 44.7 |
| GSK3772847 | Serum Levels of Total Soluble ST2 | Baseline; n=9, 8 | 2.382 Micrograms per liter | Geometric Coefficient of Variation 51.1 |
| GSK3772847 | Serum Levels of Total Soluble ST2 | Week 8 (post-dose); n=8, 8 | 74.046 Micrograms per liter | Geometric Coefficient of Variation 44.7 |
| GSK3772847 | Serum Levels of Total Soluble ST2 | Week 0 (post-dose); n=9, 8 | 3.258 Micrograms per liter | Geometric Coefficient of Variation 39.6 |