A Multicentre, Randomised, Double-Blind, Parallel-Group Placebo-Controlled, Phase 3, Efficacy and Safety Study of Tezepelumab in 5 to < 12 Year Old Children with Severe Uncontrolled Asthma (HORIZON)

Severe Uncontrolled Asthma Asthma (an illness that causes breathing difficulty) that is not fully controlled, so that asthma attacks are still occurring despite the use of other available treatments

Annualised asthma exacerbation rate (AAER)

Change from baseline to Week 52 in pre-BD FEV1%PN., AAER associated with allergic asthma (as defined by a positive perennial allergen using serum specific IgE [FEIA])., Time to first severe asthma exacerbation., Proportion of participants with ≥ 1 severe asthma exacerbation., AAER associated with Emergency Room (ER) visit or hospitalisation., Cumulative exposure to systemic corticosteroids for treatment of severe asthma exacerbations during the 52-week double-blind Treatment period., Change from baseline to Week 52 in PAQLQ-(S)-IA total score., Change from baseline to Week 52 in weekly mean daily PASO reported diary., Change from baseline to Week 52 in ACQ-IA score., Change from baseline to Week 52 in Weekly mean rescue medication use and Weekly mean number of night-time awakenings., Change from baseline to Week 52 in biomarkers (blood eosinophil count, FeNO and total serum IgE)., Change from baseline to Week 52 pre-BD PEF., Asthma specific HRU (eg, unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications)., Participant/caregiver health-related absences from work/school due to asthma., Serum concentrations of tezepelumab., Immunogenicity: Incidence of anti-drug antibodies and neutralising antibodies.

No related papers found yet.

France, Hungary, Italy, Netherlands, Poland, Romania, Spain