The aim of this study is to evaluate the efficacy of depemokimab administered as an adjunctive therapy, in participants with Type 2 asthma at risk of exacerbations compared to the guideline recommended standard of care (SoC).
Adults and adolescents >=12 years of age, at the time of signing the informed consent/assent. For countries where local regulations or the regulatory status of study medication permit enrolment of adults only, participants recruited will be >=18 years of age.
Participants must have a documented physician diagnosis of asthma for >=2 years that meets the National Heart, Lung, and Blood Institute, National Institute for Health and Care Excellence or Global Initiative for Asthma guidelines
Have previously confirmed history of at least 2 exacerbations over the last 3 years prior to screening, with at least 1 of those exacerbations occurring in the previous year prior to Screening Visit 1.
Exacerbation requiring treatment with systemic Corticosteroid (CS), for at least 3 days, despite the use of low to medium dose Inhaled corticosteroids (ICS)/ Long-acting beta2-adrenergic receptor agonist (LABA).
Participants have had 3 or more exacerbations in the last year prior to Visit 1.
Participants on maintenance OCS or high dose ICS/LABA for asthma.
Participants with a duration of asthma greater than (>)20 years.
Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (Chronic Obstructive Pulmonary Disease other than asthma) are excluded.
Parallel
Depemokimab
DrugDepemokimab will be administered
Placebo
DrugPlacebo will be administered
Annualized rate of clinically significant exacerbations
A clinically significant exacerbation is defined as a worsening of asthma requiring the use of systemic corticosteroids.
Proportion of participants with clinical remission at 2 years
Clinical remission defined as no clinically significant asthma exacerbations during the first 2 years of the treatment period, and no maintenance oral corticosteroids (OCS) for asthma at 2 years, and well controlled asthma based on an Asthma Control Test (ACT) greater than or equal to (\>=) 20 at 2 years, and no deterioration of lung function.
Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total overall score at 2 years
The AQLQ is a 32-item self-administered questionnaire designed to measure the impact of asthma on an individuals daily life over the last 2 weeks across four domains: Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli. Each item is scored on a 7 point scale (1 = severe impairment; 7 = no impairment). The overall score is the mean of all 32 items and ranges from 1.0 (worst quality of life) to 7.0 (best quality of life). Higher scores indicate better quality of life (QoL), with lower impairment on daily functioning and well-being.
Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score at 2 years
The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma symptom control. The questions are designed to be self-completed by the participant. The 5 questions enquire about the frequency and/or severity of symptoms (nocturnal awakening, waking in the morning, activity limitation, shortness of breath, and wheeze) over the previous week. The overall ACQ-5 response option is the mean score of all 5 questions representing 0 with no impairment/limitation and 6 as total impairment/ limitation. Higher scores indicated more limitations and lower score with better asthma control.
Change from Baseline in post-Bronchodilator Forced expiratory volume in 1 second (FEV1) at 2 years
FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath by a person and will be measured by spirometry testing.
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