CClinicalTrials.gg
CompletedNCT04276233PRISMUpdated Dec 10, 2024Results posted

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

A Phase 4 interventional study of Mepolizumab and Salbutamol in Asthma, sponsored by GlaxoSmithKline. Completed at 14 sites in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-10.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Mepolizumab is a humanized monoclonal antibody (IgG1, kappa) that blocks interleukin- 5 (IL-5) thus inhibits production and survival of eosinophils. The aim of this phase 4, open-label, single-arm study is to evaluate the safety and efficacy of Mepolizumab 100 mg SC administered every 4 weeks in Indian participants aged 18 years or above with severe eosinophilic asthma. After the first dose of mepolizumab, participants will receive 5 more doses of mepolizumab at 4 weekly intervals. Following the last dose of mepolizumab, the end of the study Visit will occur 4 weeks later. During the treatment period, OCS use and dose adjustment in participants will be as per the investigator's discretion and clinical practice.

02

Conditions studied

  • Asthma

Keywords

  • Mepolizumab
  • Oral corticosteroids
  • Prednisolone
  • Prednisone
  • Severe Eosinophilic asthma
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 100 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant must be greater than or equal to (≥) 18 to 65 years of age inclusive, at the time of signing the informed consent.
  • Asthma: Evidence of asthma as documented by either: (a) Airway reversibility (FEV1>=12% and 200 milliliter (ml) demonstrated at Visit 1 (screening) or Visit 2 (Week 0) OR documented in the previous 12 months OR (b) Airway hyperresponsiveness (methacholine: PC20 of \<8mg/mL or histamine: PD20 of \<7.8 μmol; mannitol: decrease in FEV1 as per the labelled product instructions) documented in the 12 months prior to Visit 2 (Week 0) OR (c) Airflow variability in clinic FEV1 >=20% between two consecutive clinic visits documented in the 12 months prior to Visit 2 (FEV1 recorded during an exacerbation should not be considered for this criteria) OR (d) Airflow variability as indicated by >20% diurnal variability in peak flow observed on 3 or more days during the optimization period.
  • Participants with Eosinophilic asthma: prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma as FEV1: Persistent airflow obstruction as indicated by: For participants >=18 years of age at Visit 1 (screening) or Visit 2 (Week 0), a pre- bronchodilator FEV1 \<80% predicted. For predicted FEV1 values National Health and Nutrition Examination Survey (NHANES) III values will be used and adjustments to these values will be made for race.
  • Eosinophilic Phenotype: Airway inflammation characterized as eosinophilic in nature as indicated by one of the following characteristics: (a) An elevated peripheral blood eosinophil level of >=300 cells/microliter(μL) that is related to asthma within the previous 12 months prior to Visit 2 (Week 0). OR (b) Peripheral baseline eosinophil level >=150 cells/μL between Visit 1 (screening) and Visit 2 (Week 0) that is related to asthma.
  • Participants eligible for mepolizumab treatment as per independent clinical judgment of treating physician in alignment with local prescribing information.
  • Inhaled Corticosteroids: requirement for regular treatment with high dose inhaled corticosteroid in the 6 months prior to Visit 1 (screening). For 18 years of age and older: Inhaled corticosteroids (ICS) dose must be >=880 microgram (mcg)/day fluticasone propionate (FP) (ex-actuator) or equivalent daily.
  • Controller Medication: Current treatment with an additional controller medication for at least 3 months OR having used and failed an additional controller medication for at least 3 successive months during the prior 12 months [e.g., long-acting beta2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline].
  • Male or eligible female. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: (a) Is not a woman of childbearing potential (WOCBP) OR (b) Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of \<1% during the intervention period and for at least 16 weeks after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. (c) A WOCBP must have a negative highly sensitive pregnancy test (serum) within 8 weeks before the first dose of study intervention. (d) Additional requirements for pregnancy testing during and after study intervention are located. (e) The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Treatment Period Criteria

  • Eosinophilic asthma: Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma.
  • eDiary Compliance: Compliance with completion of the eDiary defined as: (a) Completion of symptom scores on 4 or more days out of the last 7 days immediately preceding Visit 2 (Week 0). (b) Completion of information relating to rescue medication use on 4 or more days out of the last 7 days immediately preceding Visit 2 (Week 0). (c) Completion of PEF measurements on 4 or more days out of the last 7 days immediately preceding Visit 2 (Week 0).

Exclusion criteria

Exclusion Criteria:

  • Concurrent Respiratory Disease: Presence of a clinically important lung condition other than asthma. This includes but is not limited to current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
  • Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior screening (Participants who had localized carcinoma (i.e. basal or squamous cell) of the skin which was resected for cure will not be excluded).
  • Liver Disease: Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice), cirrhosis, and known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Cardiovascular: Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment. Including but not limited to: (a) known ejection fraction of \<30% OR (b) severe heart failure meeting New York Heart Association Class IV OR (c) hospitalized in the 12 months prior to Visit 1 (screening) for severe heart failure meeting New York Heart Association Class III OR (d) angina diagnosed less than 3 months prior to Visit 1 (screening) or at Visit 1.
  • Other Concurrent Medical Conditions: Participants who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
  • Eosinophilic Diseases: Participants with other conditions that could lead to elevated eosinophils such as Hypereosinophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophaghitis. Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1 (screening) are also to be excluded.
  • Omalizumab Use: Participants who have received omalizumab within 130 days of Visit 1 (screening).
  • Other Monoclonal Antibodies: Participants who have received any monoclonal antibody (other than omalizumab) to treat inflammatory disease within 5 half-lives of Visit 1 (screening).
  • Investigational Medications: Participants who have received treatment with an investigational drug within the past 30 days or five terminal phase half-lives of the drug whichever is longer, prior to Visit 1 (this also includes investigational formulations of marketed products).
  • Participants who have previously participated in any study of mepolizumab and received Investigational Product (including placebo).
  • ECG: ECG assessment QTcF > 450msec or QTcF > 480 msec for participants with Bundle Branch Block. Participants are excluded if an abnormal ECG finding from the 12-lead ECG conducted at Screening (Visit 1) is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the Investigator.
  • Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency virus - HIV), other than that explained by the use of corticosteroids taken as therapy for asthma.
  • Smoking history: Current smokers or former smokers with a smoking history of >=10 pack years. A former smoker is defined as a participant who quit smoking at least 6 months prior to Visit 1 (screening).
  • Hypersensitivity: Participants with a known allergy or intolerance to a monoclonal antibody or biologic.
  • Pregnancy: Participants who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the time of study participation.
  • Alcohol/Substance Abuse: A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1 (screening).
  • Adherence: Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations.

Treatment Period Criteria

  • Laboratory abnormality: Evidence of clinically significant abnormality in the haematological, biochemical or urinalysis screen at Visit 1 (screening), as judged by the investigator.
  • Alanine transferase (ALT) >2 x upper limit of normal (ULN).
  • Bilirubin > 1.5 x ULN (isolated bilirubin>1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
  • No cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice. Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C e.g., presence of hepatitis B surface antigen [HBsAg] or positive hepatitis C antibody test result) is acceptable if the participant otherwise meets eligibility criteria.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Participants with severe eosinophilic asthma

    Participants with severe eosinophilic asthma will receive Mepolizumab 100 mg subcutaneously into the upper arm or thigh every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) will be provided as rescue medication during treatment period.

    Drug: Mepolizumab · Drug: Salbutamol

Interventions

  • DrugMepolizumab

    Mepolizumab will be available as a lyophilized cake in sterile vials and will be reconstituted with sterile water for injection, just prior to use.

  • DrugSalbutamol

    Salbutamol metered dose inhalers (MDIs) will be provided as rescue medication during treatment period.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. 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.

    Time frame: Up to Week 24

  2. Number of Participants With Adverse Events of Special Interest (AESIs)

    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.

    Time frame: Up to Week 24

Secondary outcomes

  1. Number of Participants With Clinically Significant Exacerbations (Including Exacerbations Requiring Hospitalization or Emergency Department [ED Visits])

    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.

    Time frame: Up to Week 24

  2. Number of Participants With Exacerbations Requiring Hospitalization or ED Visits

    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.

    Time frame: Up to Week 24

  3. Number of Participants With Exacerbations Requiring Hospitalization

    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.

    Time frame: Up to Week 24

  4. Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24

    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.

    Time frame: Baseline (Weeks -2 to -1) and Week 24

  5. Change From Baseline in Clinic Post-bronchodilator FEV1 at Week 24

    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.

    Time frame: Baseline (Weeks -2 to -1) and Week 24

  6. Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24

    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.

    Time frame: Baseline (Weeks -2 to -1) and Week 24

  7. Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 21 to 24

    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.

    Time frame: Baseline (Weeks -2 to -1) and Weeks 21 to 24

07

Results

Posted Dec 10, 2024

Participant flow

This study evaluated the safety and efficacy of Mepolizumab in participants with severe eosinophilic asthma.

Participant flow — Overall Study
MilestoneMepolizumab 100 mg SC
Started100
Completed90
Not completed10
Withdrew: Adverse event1
Withdrew: Lost to follow-up3
Withdrew: Physician decision4
Withdrew: Withdrawal by subject2

Outcome measures

PrimaryNumber of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. 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.

Time frame:
Up to Week 24
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)
ParticipantsMepolizumab 100 mg SC
SAEs3
Non-SAEs9
SecondaryNumber of Participants With Clinically Significant Exacerbations (Including Exacerbations Requiring Hospitalization or Emergency Department [ED Visits])

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.

Time frame:
Up to Week 24
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Exacerbations (Including Exacerbations Requiring Hospitalization or Emergency Department [ED Visits])
ParticipantsMepolizumab 100 mg SC
Number of Participants With Clinically Significant Exacerbations (Including Exacerbations Requiring Hospitalization or Emergency Department [ED Visits])8
SecondaryNumber of Participants With Exacerbations Requiring Hospitalization or ED Visits

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.

Time frame:
Up to Week 24
Reported as:
Count of participants · Participants
Number of Participants With Exacerbations Requiring Hospitalization or ED Visits
ParticipantsMepolizumab 100 mg SC
Number of Participants With Exacerbations Requiring Hospitalization or ED Visits2
SecondaryNumber of Participants With Exacerbations Requiring Hospitalization

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.

Time frame:
Up to Week 24
Reported as:
Count of participants · Participants
Number of Participants With Exacerbations Requiring Hospitalization
ParticipantsMepolizumab 100 mg SC
Number of Participants With Exacerbations Requiring Hospitalization2
SecondaryChange From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24

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.

Time frame:
Baseline (Weeks -2 to -1) and Week 24
Reported as:
Least squares mean · Liters
Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24
LitersMepolizumab 100 mg SC
Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 240.081 ± 0.0667
SecondaryChange From Baseline in Clinic Post-bronchodilator FEV1 at Week 24

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.

Time frame:
Baseline (Weeks -2 to -1) and Week 24
Reported as:
Least squares mean · Liters
Change From Baseline in Clinic Post-bronchodilator FEV1 at Week 24
LitersMepolizumab 100 mg SC
Change From Baseline in Clinic Post-bronchodilator FEV1 at Week 240.055 ± 0.0555
SecondaryChange From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24

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.

Time frame:
Baseline (Weeks -2 to -1) and Week 24
Reported as:
Least squares mean · Scores on a scale
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24
Scores on a scaleMepolizumab 100 mg SC
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24-0.69 ± 0.121
SecondaryChange From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 21 to 24

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.

Time frame:
Baseline (Weeks -2 to -1) and Weeks 21 to 24
Reported as:
Least squares mean · Liters per minute (L/min)
Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 21 to 24
Liters per minute (L/min)Mepolizumab 100 mg SC
Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 21 to 2413.67 ± 5.330
PrimaryNumber of Participants With Adverse Events of Special Interest (AESIs)

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.

Time frame:
Up to Week 24
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events of Special Interest (AESIs)
ParticipantsMepolizumab 100 mg SC
Systemic/local site reactions3
All infections5
Opportunistic infections0
Neoplasm0
Malignancies0
Cardiac disorders0
Serious cardiac, vascular and thromboembolic (CVT) events0

Adverse events

Collected over All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (non-SAEs) were collected up to Week 24. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Mepolizumab 100 mg SC1/100 (1%)3/100 (3%)9/100 (9%)
Most frequent serious events
Most frequent serious events
EventMepolizumab 100 mg SC
AsthmaRespiratory, thoracic and mediastinal disorders2/100
Road traffic accidentInjury, poisoning and procedural complications1/100
Most frequent other events
Most frequent other events
EventMepolizumab 100 mg SC
PyrexiaGeneral disorders5/100
HeadacheNervous system disorders3/100
Oropharyngeal painRespiratory, thoracic and mediastinal disorders3/100

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Mepolizumab 100 mg SC
Mean44.8 ± 12.04
Sex: Female, Male
Sex: Female, Male(Participants)Mepolizumab 100 mg SC
Female51
Male49
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Mepolizumab 100 mg SC
Asian - Central/South Asian Heritage100
08

Study locations

14 sites
  • GSK Investigational Site
    Ahmedabad, 380013, India
  • GSK Investigational Site
    Ahmedabad, 380052, India
  • GSK Investigational Site
    Byculla Mumbai, 400008, India
  • GSK Investigational Site
    Hyderabad, 500018, India
  • GSK Investigational Site
    Hyderabad, 500038, India
  • GSK Investigational Site
    Hyderabad, 500082, India
  • GSK Investigational Site
    Jaipur, 302039, India
  • GSK Investigational Site
    Kanpur, 208005, India
  • GSK Investigational Site
    Kolkata, 700014, India
  • GSK Investigational Site
    Nagpur, 440012, India
  • GSK Investigational Site
    New Delhi, 110096, India
  • GSK Investigational Site
    Noida, 201301, India
  • GSK Investigational Site
    Pune, 411001, India
  • GSK Investigational Site
    Pune, 411004, India
09

References and documents

Study documents

  • Study protocol · Aug 23, 2022
  • Statistical analysis plan · Jun 21, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04276233
Lead sponsor
GlaxoSmithKline
Collaborators
Tech Observer
Responsible party
Sponsor
First posted
Feb 19, 2020
Start date
Jun 29, 2021
Primary completion
Oct 28, 2023
Completion
Oct 28, 2023
Results posted
Dec 10, 2024
Last update
Dec 10, 2024

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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