Phase 4
N=100
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
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT04276233 ↗Enrolled (actual)
100
Serious AEs
3.0%
Results posted
Dec 2024
Primary outcome: Primary: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) — 3; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mepolizumab (Drug); Salbutamol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) |
3; 9 | — |
| PRIMARY Number of Participants With Adverse Events of Special Interest (AESIs) |
3; 5; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Exacerbations (Including Exacerbations Requiring Hospitalization or Emergency Department [ED Visits]) |
8 | — |
| SECONDARY Number of Participants With Exacerbations Requiring Hospitalization or ED Visits |
2 | — |
| SECONDARY Number of Participants With Exacerbations Requiring Hospitalization |
2 | — |
| SECONDARY Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24 |
0.081 | — |
| SECONDARY Change From Baseline in Clinic Post-bronchodilator FEV1 at Week 24 |
0.055 | — |
| SECONDARY Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24 |
-0.69 | — |
| SECONDARY Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 21 to 24 |
13.67 | — |
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.
Eligibility Criteria
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 =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 =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 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
Data sourced from ClinicalTrials.gov (NCT04276233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.