To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.
Written informed consent from (ICF) at least one parent/caregiver (as per local guidelines) and accompanying informed assent from the participant (where the participant is able to provide assent) prior to admission to the study.
Participants must be 5 to < 12 years of age, at the time of signing the assent form (as applicable per local guidelines) and their caregivers signing the ICF and at Visit 3.
Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1.
Documented physician-prescribed treatment with a total daily dose of either medium or high dose, for at least 3 months with stable dose ≥ 1 month prior to Visit 1.
History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis.
History of any clinically significant disease or disorder other than asthma which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
History of a clinically significant deterioration in asthma or asthma exacerbation including those requiring use of systemic corticosteroids or increase in the maintenance dose of oral corticosteroids within 30 days prior to Visit 1.
Change in ICS dose within 1 month prior to Visit 1.
Parallel
Tezepelumab
Biological/VaccineParticipants will be receiving subcutaneous injection of tezepelumab
Placebo
Other interventionParticipants will be receiving subcutaneous injection of matching placebo
Annualized severe asthma exacerbation rate (AAER)
To assess the effect of tezepelumab on severe asthma exacerbations in children 5 to \< 12 years old with severe uncontrolled asthma compared with placebo.
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) percent predicted normal (PN)
To assess the effect of tezepelumab on pulmonary function (FEV1) in children with severe uncontrolled asthma compared with placebo. Pre-bronchodilator FEV1% PN will be determined by spirometry at the clinic visit.
AAER associated with allergic asthma
AAER will be assessed in association with both allergic asthma (defined by a positive perennial allergen using serum specific IgE \[FEIA\]).
Time to first severe asthma exacerbation
Time to first severe asthma exacerbation will be assessed.
Proportion of participants with ≥ 1 severe asthma exacerbation
Proportion of participants with ≥ 1 severe asthma exacerbation will be assessed.
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AstraZeneca
Lead sponsor
Amgen
Collaborator