The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations.
Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in Informed consent form (ICF). For participants aged 12 to 17 years, signed assent must be obtained from the participant in addition to signed consent from their Legally acceptable representative (LAR).
Participants aged 12 to 80 years at the time of signing the informed consent.
A POCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before each dose of study intervention.
If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of participant safety or study results.
History of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix).
Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia.
New York Heart Association (NYHA) class III or IV heart failure.
Parallel
GSK5784283
DrugGSK5784283 will be administered.
Placebo
DrugPlacebo will be administered.
Standard of care
DrugStandard of care will be administered.
Annualized rate of clinically significant asthma exacerbations
A clinically significant exacerbation is defined as a worsening of asthma symptoms requiring the use of systemic corticosteroids or in-patient hospitalization (that is greater than or equal to \[\>=\] 24 hours) due to asthma.
Change from Baseline in pre-Bronchodilator Forced expiratory volume in 1 second (FEV1)
FEV1 is defined as the volume of air that can be forced out in first second after taking a deep breath by a person and will be measured by spirometry.
Time to first clinically significant asthma exacerbation
Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score
The ACQ-5 is a five-item questionnaire . designed to be self-completed by the . participants to assess the most common asthma symptoms. The scores range from 0 to 6. Higher scores indicated more impairment/limitations.
Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) score
The AQLQ is a 32-item self-administered questionnaire designed to measure the impact of asthma on participants daily life. The score ranges from 1.0 to 7.0. Higher scores indicate better quality of life (QoL).
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