Trial Outcomes & Findings for Efficacy and Safety Study of Mepolizumab 100 Milligram (mg) Subcutaneous (SC) in Indian Participants Aged Greater Than or Equal to (>=) 18 Years With Severe Eosinophilic Asthma (NCT NCT04276233)
NCT ID: NCT04276233
Last Updated: 2024-12-10
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Any untoward medical occurrence that, at any dose that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Adverse events which were not serious were considered as non-serious adverse events. Number of participants with SAEs and common (greater than equal to \[\>=\] 3 percent \[%\]) non-SAEs were reported.
COMPLETED
PHASE4
100 participants
Up to Week 24
2024-12-10
Participant Flow
This study evaluated the safety and efficacy of Mepolizumab in participants with severe eosinophilic asthma.
A total of 100 participants were enrolled in the study.
Participant milestones
| Measure |
Mepolizumab 100 mg SC
Participants with severe eosinophilic asthma received mepolizumab 100 milligrams (mg) subcutaneously (SC) into the upper arm, thigh or abdomen every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) were provided as a rescue medication during treatment period.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
90
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Mepolizumab 100 mg SC
Participants with severe eosinophilic asthma received mepolizumab 100 milligrams (mg) subcutaneously (SC) into the upper arm, thigh or abdomen every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) were provided as a rescue medication during treatment period.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Efficacy and Safety Study of Mepolizumab 100 Milligram (mg) Subcutaneous (SC) in Indian Participants Aged Greater Than or Equal to (>=) 18 Years With Severe Eosinophilic Asthma
Baseline characteristics by cohort
| Measure |
Mepolizumab 100 mg SC
n=100 Participants
Participants with severe eosinophilic asthma received mepolizumab 100 milligrams (mg) subcutaneously (SC) into the upper arm, thigh or abdomen every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) were provided as a rescue medication during treatment period.
|
|---|---|
|
Age, Continuous
|
44.8 Years
STANDARD_DEVIATION 12.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 24Population: Safety Population included all participants who took at least 1 dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Any untoward medical occurrence that, at any dose that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Adverse events which were not serious were considered as non-serious adverse events. Number of participants with SAEs and common (greater than equal to \[\>=\] 3 percent \[%\]) non-SAEs were reported.
Outcome measures
| Measure |
Mepolizumab 100 mg SC
n=100 Participants
Participants with severe eosinophilic asthma received mepolizumab 100 milligrams (mg) subcutaneously (SC) into the upper arm, thigh or abdomen every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) were provided as a rescue medication during treatment period.
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)
SAEs
|
3 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)
Non-SAEs
|
9 Participants
|
PRIMARY outcome
Timeframe: Up to Week 24Population: Safety Population included all participants who took at least 1 dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were adverse events associated with the identified and potential risks of mepolizumab. AESIs were systemic/ local site reactions, all infections (Infections from Infections and infestations System Organ Class \[SOC\]), opportunistic infections, neoplasm, malignancies, cardiac disorders and serious cardiac, vascular and thromboembolic (CVT) events.
Outcome measures
| Measure |
Mepolizumab 100 mg SC
n=100 Participants
Participants with severe eosinophilic asthma received mepolizumab 100 milligrams (mg) subcutaneously (SC) into the upper arm, thigh or abdomen every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) were provided as a rescue medication during treatment period.
|
|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
All infections
|
5 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Opportunistic infections
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Neoplasm
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Malignancies
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Cardiac disorders
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Systemic/local site reactions
|
3 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Serious cardiac, vascular and thromboembolic (CVT) events
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Safety Population included all participants who took at least 1 dose of study intervention.
Clinically significant exacerbations of asthma were defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalization and/or ED visits. Exacerbations were treated per the investigator's clinical practice protocol with the use of oral or parenteral corticosteroids. Clinically significant exacerbations were recorded in the electronic case report form (eCRF) by the Investigator or designee were verified using data from the electronic Diary. Number of participants with clinically significant exacerbations were reported.
Outcome measures
| Measure |
Mepolizumab 100 mg SC
n=100 Participants
Participants with severe eosinophilic asthma received mepolizumab 100 milligrams (mg) subcutaneously (SC) into the upper arm, thigh or abdomen every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) were provided as a rescue medication during treatment period.
|
|---|---|
|
Number of Participants With Clinically Significant Exacerbations (Including Exacerbations Requiring Hospitalization or Emergency Department [ED Visits])
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Safety Population included all participants who took at least 1 dose of study intervention.
Exacerbations of asthma are defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalization and/or ED visits. Number of participants with exacerbations requiring hospitalization or ED visits were reported.
Outcome measures
| Measure |
Mepolizumab 100 mg SC
n=100 Participants
Participants with severe eosinophilic asthma received mepolizumab 100 milligrams (mg) subcutaneously (SC) into the upper arm, thigh or abdomen every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) were provided as a rescue medication during treatment period.
|
|---|---|
|
Number of Participants With Exacerbations Requiring Hospitalization or ED Visits
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Safety Population included all participants who took at least 1 dose of study intervention.
Exacerbations of asthma are defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalization. Number of participants with exacerbations requiring hospitalization were reported.
Outcome measures
| Measure |
Mepolizumab 100 mg SC
n=100 Participants
Participants with severe eosinophilic asthma received mepolizumab 100 milligrams (mg) subcutaneously (SC) into the upper arm, thigh or abdomen every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) were provided as a rescue medication during treatment period.
|
|---|---|
|
Number of Participants With Exacerbations Requiring Hospitalization
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Weeks -2 to -1) and Week 24Population: Safety Population included all participants who took at least 1 dose of study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. The change from Baseline in pre-bronchodilator FEV1 was calculated as the value at Week 24 minus the value at Baseline.
Outcome measures
| Measure |
Mepolizumab 100 mg SC
n=86 Participants
Participants with severe eosinophilic asthma received mepolizumab 100 milligrams (mg) subcutaneously (SC) into the upper arm, thigh or abdomen every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) were provided as a rescue medication during treatment period.
|
|---|---|
|
Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24
|
0.081 Liters
Standard Error 0.0667
|
SECONDARY outcome
Timeframe: Baseline (Weeks -2 to -1) and Week 24Population: Safety Population included all participants who took at least 1 dose of study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. The change from Baseline in post-bronchodilator FEV1 was calculated as the value at Week 24 minus the value at Baseline.
Outcome measures
| Measure |
Mepolizumab 100 mg SC
n=83 Participants
Participants with severe eosinophilic asthma received mepolizumab 100 milligrams (mg) subcutaneously (SC) into the upper arm, thigh or abdomen every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) were provided as a rescue medication during treatment period.
|
|---|---|
|
Change From Baseline in Clinic Post-bronchodilator FEV1 at Week 24
|
0.055 Liters
Standard Error 0.0555
|
SECONDARY outcome
Timeframe: Baseline (Weeks -2 to -1) and Week 24Population: Safety Population included all participants who took at least 1 dose of study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
The ACQ-5 is a five-item questionnaire, designed to be self-completed by the participants. The five questions (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms. The response options for all these questions consists of a zero (no impairment/limitation) to six (total impairment/ limitation). The ACQ-5 score is calculated as the mean of these 5 item responses and ranges from scores 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. The change from Baseline was calculated as the value at Week 24 minus the Baseline value.
Outcome measures
| Measure |
Mepolizumab 100 mg SC
n=86 Participants
Participants with severe eosinophilic asthma received mepolizumab 100 milligrams (mg) subcutaneously (SC) into the upper arm, thigh or abdomen every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) were provided as a rescue medication during treatment period.
|
|---|---|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24
|
-0.69 Scores on a scale
Standard Error 0.121
|
SECONDARY outcome
Timeframe: Baseline (Weeks -2 to -1) and Weeks 21 to 24Population: Safety Population included all participants who took at least 1 dose of study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
PEF was defined as the maximum speed of expiration of a participant, measured with electronic peak flow meter. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Mepolizumab 100 mg SC
n=85 Participants
Participants with severe eosinophilic asthma received mepolizumab 100 milligrams (mg) subcutaneously (SC) into the upper arm, thigh or abdomen every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) were provided as a rescue medication during treatment period.
|
|---|---|
|
Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 21 to 24
|
13.67 Liters per minute (L/min)
Standard Error 5.330
|
Adverse Events
Mepolizumab 100 mg SC
Serious adverse events
| Measure |
Mepolizumab 100 mg SC
n=100 participants at risk
Participants with severe eosinophilic asthma received mepolizumab 100 milligrams (mg) subcutaneously (SC) into the upper arm, thigh or abdomen every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) were provided as a rescue medication during treatment period.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.0%
2/100 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (non-SAEs) were collected up to Week 24
All-cause mortality, SAEs and non-SAEs were reported for the Safety Population which included all participants who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.0%
1/100 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (non-SAEs) were collected up to Week 24
All-cause mortality, SAEs and non-SAEs were reported for the Safety Population which included all participants who took at least 1 dose of study intervention.
|
Other adverse events
| Measure |
Mepolizumab 100 mg SC
n=100 participants at risk
Participants with severe eosinophilic asthma received mepolizumab 100 milligrams (mg) subcutaneously (SC) into the upper arm, thigh or abdomen every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) were provided as a rescue medication during treatment period.
|
|---|---|
|
General disorders
Pyrexia
|
5.0%
5/100 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (non-SAEs) were collected up to Week 24
All-cause mortality, SAEs and non-SAEs were reported for the Safety Population which included all participants who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
3.0%
3/100 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (non-SAEs) were collected up to Week 24
All-cause mortality, SAEs and non-SAEs were reported for the Safety Population which included all participants who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.0%
3/100 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (non-SAEs) were collected up to Week 24
All-cause mortality, SAEs and non-SAEs were reported for the Safety Population which included all participants who took at least 1 dose of study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER