A Phase 2 interventional study of GSK3772847 and Placebo in Asthma, sponsored by GlaxoSmithKline. Terminated at 18 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-23.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
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Among 261 studies in Asthma by GlaxoSmithKline — 7 open to participants now, 12 under way, 7 of them phase 3. Asthma · GlaxoSmithKline.
Among the 261 studies in Asthma by GlaxoSmithKline, this one is the 209th largest by enrollment of the 237 interventional ones that give a count, is one of 9 that started in 2018, is one of 58 in phase 2, and was the 229th registered.
4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.
Browse Asthma studies →7 of the 261 studies in Asthma by GlaxoSmithKline are open now, in 12 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United States, Argentina, Canada and 1 more country
Ages 18+
GlaxoSmithKline · Sites in United States
Ages 12–80
GlaxoSmithKline · Sites in United States, Japan
Ages 12–80
GlaxoSmithKline · Sites in United States
Ages 6–11
GlaxoSmithKline · Sites in United States, United Kingdom
Ages 12+
By country, each count listing its studies:
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
261 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 63 · Phase 2 59 · Phase 3 61 · Phase 4 53
First in 1999; this study’s year is marked. 9 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 17 is below the median of 79 across 3,344 interventional studies indexed under Asthma.
Median enrollment 100 across the 237 interventional studies, 512 across the 24 observational. Of the 239 that completed or were terminated, 131 (55%) have results posted.
This tab as a report to print or save as PDF → With an account.
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
5 of the studies in Asthma by GlaxoSmithKline that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07645248Phase 3GlaxoSmithKlineA Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a) | 2026-12-28 |
| NCT05757102Phase 3GlaxoSmithKlineA Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma | 2027-01-26 |
| NCT07671001Phase 3GlaxoSmithKlineA Study of Depemokimab in Participants of 6 to 11 Years of Age | 2027-03-01 |
| NCT07712393GlaxoSmithKlineA Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283 | 2027-04-13 |
| NCT06433921GlaxoSmithKlineA Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive | 2027-04-16 |
Add all 5 to your calendar (.ics) → With an account.
Among the 261 studies in Asthma by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks
Drug: GSK3772847
Participants will be randomized to receive matching placebo as IV infusion
Drug: Placebo
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.
Commercially sourced sterile normal saline will be provided as Placebo
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
| Milestone | Placebo | GSK3772847 |
|---|---|---|
| Started | 9 | 8 |
| Completed | 8 | 8 |
| Not completed | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
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 | Placebo | GSK3772847 |
|---|---|---|
| Week 2; n=9, 8 | 30.8 (4 to 61) | 28.1 (-46 to 550) |
| Week 4; n=8, 8 | 16.0 (-17 to 77) | 2.1 (-71 to 469) |
| Week 8; n=8, 8 | 14.4 (-98 to 262) | -31.4 (-59 to 10) |
| Week 12; n=5, 7 | 9.7 (-88 to 67) | -10.9 (-76 to 469) |
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.
| Percent change | Placebo | GSK3772847 |
|---|---|---|
| Week 2; n=9, 6 | 33.4 (-39 to 51) | -18.6 (-37 to 12) |
| Week 4; n=8, 8 | 13.7 (-29 to 205) | -12.5 (-48 to 36) |
| Week 8; n=8, 7 | 11.7 (-80 to 75) | -42.8 (-67 to 5) |
| Week 12; n=5, 6 | -37.2 (-65 to -16) | -45.6 (-68 to -34) |
Whole blood samples were collected at indicated time points for measurement of serum concentrations of GSK3772847.
| Micrograms per milliliter | GSK3772847 |
|---|---|
| Week 0, post-dose | 156.50 ± 74.102 |
| Week 2 | 65.35 ± 10.900 |
| Week 4, pre-dose | 39.13 ± 10.777 |
| Week 8, pre-dose | 56.24 ± 9.658 |
| Week 8, post-dose | 209.61 ± 93.217 |
| Week 12 | 68.59 ± 15.570 |
| Week 24 | 1.67 ± 1.276 |
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).
| Micrograms per liter | Placebo | GSK3772847 |
|---|---|---|
| Baseline; n=9, 8 | 2.365 ± 54.3 | 2.418 ± 50.0 |
| Week 0 (post-dose); n=9, 8 | 2.301 ± 46.9 | 0.025 ± 668.2 |
| Week 2; n=9, 8 | 2.286 ± 50.2 | 0.156 ± 43.4 |
| Week 4 (pre-dose); n=8, 8 | 2.382 ± 32.1 | 0.197 ± 44.0 |
| Week 8 (pre-dose); n=8, 8 | 2.563 ± 30.8 | 0.181 ± 25.8 |
| Week 8 (post-dose); n=8, 8 | 2.568 ± 33.7 | 0.126 ± 38.2 |
| Week 12; n=5, 6 | 2.194 ± 46.5 | 0.144 ± 67.3 |
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).
| Micrograms per liter | Placebo | GSK3772847 |
|---|---|---|
| Baseline; n=9, 8 | 1.905 ± 71.4 | 2.382 ± 51.1 |
| Week 0 (post-dose); n=9, 8 | 1.884 ± 60.4 | 3.258 ± 39.6 |
| Week 2; n=9, 8 | 1.777 ± 65.5 | 63.353 ± 44.7 |
| Week 4 (pre-dose); n=8, 8 | 1.950 ± 35.6 | 65.833 ± 47.3 |
| Week 8 (pre-dose); n=8, 8 | 2.141 ± 39.9 | 79.286 ± 31.6 |
| Week 8 (post-dose); n=8, 8 | 2.201 ± 40.7 | 74.046 ± 44.7 |
| Week 12; n=5, 6 | 1.900 ± 61.3 | 75.703 ± 54.1 |
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.
| Participants | Placebo | GSK3772847 |
|---|---|---|
| Week 0; n=9, 8 | 0 | 0 |
| Week 2; n=9, 8 | 0 | 0 |
| Week 4; n=8, 8 | 0 | 0 |
| Week 8; n=8, 8 | 0 | 0 |
| Week 12; n=8, 8 | 0 | 0 |
| Week 24; n=9, 8 | 0 | 0 |
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.
| Participants | Placebo | GSK3772847 |
|---|---|---|
| Week 0; n=9, 8 | 0 | 0 |
| Week 2; n=9, 8 | 0 | 0 |
| Week 4; n=8, 8 | 0 | 0 |
| Week 8; n=8, 8 | 0 | 0 |
| Week 12; n=8, 8 | 0 | 0 |
| Week 24; n=9, 8 | 0 | 0 |
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.
| Scores on a scale | Placebo | GSK3772847 |
|---|---|---|
| Week 2; n=9, 8 | -0.47 ± 0.616 | -0.65 ± 0.739 |
| Week 4; n=8, 8 | -0.23 ± 1.087 | -1.03 ± 0.897 |
| Week 8; n=8, 8 | -0.60 ± 0.986 | -1.23 ± 1.383 |
| Week 12; n=5, 7 | -0.12 ± 1.262 | -1.20 ± 1.095 |
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.
| Scores on a scale | Placebo | GSK3772847 |
|---|---|---|
| Total score: Week 2; n=9, 8 | 0.31 ± 0.660 | 0.45 ± 0.623 |
| Total score: Week 4; n=8, 8 | -0.22 ± 0.477 | 0.56 ± 0.514 |
| Total score: Week 8; n=8, 8 | 0.27 ± 0.846 | 1.09 ± 0.940 |
| Total score: Week 12; n=5, 7 | 0.10 ± 1.394 | 1.13 ± 0.953 |
| Activity limitation; Week 2; n=9, 8 | 0.20 ± 0.504 | 0.31 ± 0.750 |
| Activity limitation; Week 4; n=8, 8 | -0.26 ± 0.499 | 0.30 ± 0.570 |
| Activity limitation; Week 8; n=8, 8 | 0.12 ± 0.603 | 0.88 ± 0.900 |
| Activity limitation; Week 12; n=5, 7 | -0.07 ± 1.127 | 0.91 ± 0.993 |
| Symptoms; Week 2; n=9, 8 | 0.52 ± 0.924 | 0.54 ± 0.641 |
| Symptoms; Week 4; n=8, 8 | -0.05 ± 0.774 | 0.74 ± 0.627 |
| Symptoms; Week 8; n=8, 8 | 0.57 ± 1.213 | 1.24 ± 0.936 |
| Symptoms; Week 12; n=5, 7 | 0.52 ± 1.740 | 1.31 ± 0.810 |
| Environmental stimuli; Week 2; n=9, 8 | -0.14 ± 0.811 | 0.22 ± 0.891 |
| Environmental stimuli; Week 4; n=8, 8 | -0.44 ± 0.884 | 0.63 ± 0.886 |
| Environmental stimuli; Week 8; n=8, 8 | -0.44 ± 1.208 | 1.06 ± 1.132 |
| Environmental stimuli; Week 12; n=5, 7 | -0.65 ± 1.025 | 0.89 ± 1.257 |
| Emotional function; Week 2; n=9, 8 | 0.40 ± 0.860 | 0.75 ± 0.955 |
| Emotional function; Week 4; n=8, 8 | -0.35 ± 0.833 | 0.65 ± 0.847 |
| Emotional function; Week 8; n=8, 8 | 0.45 ± 1.165 | 1.22 ± 1.289 |
| Emotional function; Week 12; n=5, 7 | 0.08 ± 1.712 | 1.37 ± 1.246 |
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 | Placebo | GSK3772847 |
|---|---|---|
| Week 2; n=9, 8 | 44 | 50 |
| Week 4; n=8, 8 | 63 | 50 |
| Week 8; n=8, 8 | 50 | 50 |
| Week 12; n=5, 7 | 20 | 71 |
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.
| Percentage of responders | Placebo | GSK3772847 |
|---|---|---|
| Week 2; n=9, 8 | 44 | 50 |
| Week 4; n=8, 8 | 0 | 38 |
| Week 8; n=8, 8 | 25 | 63 |
| Week 12; n=5, 7 | 40 | 86 |
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.
| Liters | Placebo | GSK3772847 |
|---|---|---|
| Week 2; n=9, 8 | 0.076 ± 0.3383 | -0.137 ± 0.2640 |
| Week 4; n=7, 8 | -0.049 ± 0.2304 | -0.022 ± 0.2703 |
| Week 8; n=7, 7 | 0.060 ± 0.4210 | 0.040 ± 0.2381 |
| Week 12; n=5, 7 | 0.102 ± 0.4879 | -0.013 ± 0.1923 |
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.
| Liters | Placebo | GSK3772847 |
|---|---|---|
| Week 2; n=9, 8 | 0.078 ± 0.4201 | -0.074 ± 0.3761 |
| Week 4; n=7, 8 | 0.091 ± 0.3163 | 0.090 ± 0.3049 |
| Week 8; n=7, 7 | 0.179 ± 0.5145 | 0.030 ± 0.2291 |
| Week 12; n=5, 7 | 0.136 ± 0.5351 | 0.050 ± 0.2408 |
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.
| Participants | Placebo | GSK3772847 |
|---|---|---|
| AEs | 7 | 3 |
| SAEs | 1 | 0 |
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.
| Participants | Placebo | GSK3772847 |
|---|---|---|
| Alanine aminotransferase; To normal or no change | 9 | 8 |
| Alanine aminotransferase; To high | 0 | 0 |
| Albumin; To low | 0 | 0 |
| Albumin; To normal or no change | 9 | 8 |
| Albumin; To high | 0 | 0 |
| Alkaline Phosphatase; To low | 0 | 0 |
| Alkaline Phosphatase; To normal or no change | 9 | 8 |
| Alkaline Phosphatase; To high | 0 | 0 |
| Aspartate Aminotransferase; To normal or no change | 9 | 8 |
| Aspartate Aminotransferase; To high | 0 | 0 |
| Bilirubin; To normal or no change | 9 | 8 |
| Bilirubin; To high | 0 | 0 |
| Calcium; To low | 0 | 1 |
| Calcium; To normal or no change | 9 | 7 |
| Calcium; To high | 0 | 0 |
| Carbon Dioxide; To low | 2 | 1 |
| Carbon Dioxide; To normal or no change | 7 | 7 |
| Carbon Dioxide; To high | 0 | 0 |
| Chloride; To low | 0 | 0 |
| Chloride; To normal or no change | 9 | 7 |
| Chloride; To high | 0 | 1 |
| Creatine Kinase; To normal or no change | 7 | 7 |
| Creatine Kinase; To high | 2 | 1 |
| Creatinine; To low | 0 | 1 |
| Creatinine; To normal or no change | 9 | 7 |
| Creatinine; To high | 0 | 0 |
| Direct Bilirubin; To normal or no change | 9 | 8 |
| Direct Bilirubin; To high | 0 | 0 |
| Gamma Glutamyl Transferase; To normal or no change | 9 | 8 |
| Gamma Glutamyl Transferase; To high | 0 | 0 |
| Glucose; To low | 0 | 0 |
| Glucose; To normal or no change | 7 | 7 |
| Glucose; To high | 2 | 1 |
| Phosphate; To low | 2 | 0 |
| Phosphate; To normal or no change | 5 | 8 |
| Phosphate; To high | 2 | 0 |
| Potassium; To low | 0 | 0 |
| Potassium; To normal or no change | 9 | 7 |
| Potassium; To high | 0 | 1 |
| Protein; To low | 0 | 1 |
| Protein; To normal or no change | 9 | 7 |
| Protein; To high | 0 | 0 |
| Sodium; To low | 0 | 0 |
| Sodium; To normal or no change | 8 | 7 |
| Sodium; To high | 1 | 1 |
| Urea; To low | 0 | 1 |
| Urea; To normal or no change | 9 | 7 |
| Urea; To high | 0 | 0 |
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.
| Participants | Placebo | GSK3772847 |
|---|---|---|
| Basophils; To normal or no change | 9 | 8 |
| Basophils; To high | 0 | 0 |
| Eosinophils; To low | 1 | 0 |
| Eosinophils; To normal or no change | 5 | 6 |
| Eosinophils; To high | 3 | 2 |
| Ery. MCHC; To low | 4 | 0 |
| Ery. MCHC; To normal or no change | 5 | 8 |
| Ery. MCHC; To high | 0 | 0 |
| Ery. MCH; To low | 0 | 0 |
| Ery. MCH; To normal or no change | 9 | 8 |
| Ery. MCH; To high | 0 | 0 |
| Ery. MCV; To low | 0 | 0 |
| Ery. MCV; To normal or no change | 9 | 8 |
| Ery. MCV; To high | 0 | 0 |
| Erythrocytes; To low | 0 | 1 |
| Erythrocytes; To normal or no change | 9 | 7 |
| Erythrocytes; To high | 0 | 0 |
| EDW; To low | 0 | 0 |
| EDW; To normal or no change | 7 | 7 |
| EDW; To high | 2 | 1 |
| Hematocrit; To low | 1 | 1 |
| Hematocrit; To normal or no change | 8 | 6 |
| Hematocrit; To high | 0 | 1 |
| Hemoglobin; To low | 1 | 0 |
| Hemoglobin; To normal or no change | 8 | 8 |
| Hemoglobin; To high | 0 | 0 |
| Leukocytes; To low | 0 | 1 |
| Leukocytes; To normal or no change | 9 | 7 |
| Leukocytes; To high | 0 | 0 |
| Lymphocytes; To low | 0 | 0 |
| Lymphocytes To normal or no change | 9 | 8 |
| Lymphocytes; To high | 0 | 0 |
| Monocytes; To low | 1 | 2 |
| Monocytes; To normal or no change | 8 | 6 |
| Monocytes; To high | 0 | 0 |
| Neutrophils; To low | 1 | 1 |
| Neutrophils; To normal or no change | 7 | 7 |
| Neutrophils; To high | 1 | 0 |
| Platelets; To low | 0 | 0 |
| Platelets; To normal or no change | 9 | 8 |
| Platelets; To high | 0 | 0 |
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.
| Millimeters of mercury | Placebo | GSK3772847 |
|---|---|---|
| SBP; Week 0 (post-dose); n=9, 8 | 3.7 ± 8.77 | 1.4 ± 9.38 |
| SBP; Week 4 (pre-dose); n=8, 8 | 0.1 ± 14.40 | -2.5 ± 18.05 |
| SBP; Week 4 (post-dose); n=8, 8 | 4.5 ± 14.16 | 4.5 ± 19.18 |
| SBP; Week 8 (pre-dose); n=8, 8 | 0.5 ± 14.42 | 7.3 ± 17.81 |
| SBP; Week 8 (post-dose); n=8, 8 | 0.6 ± 15.27 | 6.0 ± 18.97 |
| SBP; Week 12; n=8, 8 | 4.1 ± 13.17 | 7.1 ± 18.74 |
| SBP; Week 24; n=9, 8 | 2.7 ± 17.00 | 6.1 ± 14.97 |
| DBP; Week 0 (post-dose); n=9, 8 | 0.1 ± 5.40 | 0.6 ± 7.15 |
| DBP; Week 4 (pre-dose); n=8, 8 | -3.1 ± 3.72 | 1.0 ± 14.11 |
| DBP; Week 4 (post-dose); n=8, 8 | -4.8 ± 4.92 | 1.3 ± 12.90 |
| DBP; Week 8 (pre-dose); n=8, 8 | -7.8 ± 8.31 | 0.6 ± 14.23 |
| DBP; Week 8 (post-dose); n=8, 8 | -11.3 ± 9.92 | -1.0 ± 13.63 |
| DBP; Week 12; n=8, 8 | -2.9 ± 4.49 | 2.6 ± 12.34 |
| DBP; Week 24; n=9, 8 | -5.2 ± 6.98 | 3.0 ± 14.93 |
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.
| Beats per minute | Placebo | GSK3772847 |
|---|---|---|
| Week 0 (post-dose); n=9, 8 | -0.8 ± 7.63 | -2.5 ± 5.37 |
| Week 4 (pre-dose); n=8, 8 | 0.8 ± 9.60 | -1.8 ± 8.17 |
| Week 4 (post-dose); n=8, 8 | -6.8 ± 9.04 | -1.0 ± 9.80 |
| Week 8 (pre-dose); n=8, 8 | 0.0 ± 8.26 | -1.5 ± 6.55 |
| Week 8 (post-dose); n=8, 8 | -6.3 ± 6.39 | -2.1 ± 6.22 |
| Week 12; n=8, 8 | 1.6 ± 3.66 | -4.1 ± 6.64 |
| Week 24; n=9, 8 | 2.2 ± 6.69 | -0.4 ± 6.99 |
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.
| Participants | Placebo | GSK3772847 |
|---|---|---|
| NCS | 6 | 6 |
| CS | 1 | 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.
| Participants | Placebo | GSK3772847 |
|---|---|---|
| Number of Participants With Abnormal 24-hour Holter Findings | 4 | 7 |
Collected over AEs and SAEs were collected from the start of study treatment up to Week 24. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/9 (0%) | 1/9 (11.1%) | 7/9 (77.8%) |
| GSK3772847 | 0/8 (0%) | 0/8 (0%) | 3/8 (37.5%) |
| Event | Placebo | GSK3772847 |
|---|---|---|
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/9 | 0/8 |
| Event | Placebo | GSK3772847 |
|---|---|---|
| NasopharyngitisInfections and infestations | 2/9 | 1/8 |
| HeadacheNervous system disorders | 2/9 | 1/8 |
| Upper respiratory tract infectionInfections and infestations | 0/9 | 1/8 |
| BronchitisInfections and infestations | 1/9 | 0/8 |
| LethargyNervous system disorders | 1/9 | 0/8 |
| SciaticaNervous system disorders | 1/9 | 0/8 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/9 | 0/8 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 1/9 | 0/8 |
| AnaemiaBlood and lymphatic system disorders | 1/9 | 0/8 |
| TachycardiaCardiac disorders | 1/9 | 0/8 |
| Age, Continuous(Years) | Placebo | GSK3772847 | Total |
|---|---|---|---|
| Mean | 59.9 ± 9.57 | 53.6 ± 12.59 | 56.9 ± 11.21 |
| Sex: Female, Male(Participants) | Placebo | GSK3772847 | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 6 | 6 | 12 |
| Race/Ethnicity, Customized(Participants) | Placebo | GSK3772847 | Total |
|---|---|---|---|
| Asian-Japanese/East Asian (EA)/South EA Heritage | 0 | 2 | 2 |
| White | 9 | 6 | 15 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Apr 2018 to primary completion in Oct 2019, 17 months.
Results were first posted in Oct 2020, 1 year after primary completion.
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Studies of the drug tested here: Melrilimab