A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe AsthmaHORIZON
Study Details
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.
Protocol Summary
Annualized severe asthma exacerbation rate (AAER)
Timeframe: From Baseline to Week 52
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) percent predicted normal (PN)
Timeframe: From Baseline to Week 52
AAER associated with allergic asthma
Timeframe: From Baseline to Week 52
Time to first severe asthma exacerbation
Timeframe: From Baseline to Week 52
Proportion of participants with ≥ 1 severe asthma exacerbation
Timeframe: From Baseline to Week 52
AAER associated with ER visit or hospitalisation
Timeframe: From Baseline to Week 52
Cumulative exposure to systemic corticosteroids for treatment of severe asthma exacerbations
Timeframe: From Baseline to Week 52
Change from baseline in Paediatric Asthma Quality of Life Questionnaire (PAQLQ-(S)-IA) total score
Timeframe: From Baseline to Week 52
Change from baseline in weekly mean daily Paediatric Asthma Symptom Observer (PASO) score
Timeframe: From Baseline to Week 52
Change from baseline in Asthma Control Questionnaire - Interviewer Administered (ACQ-IA) score
Timeframe: From Baseline to Week 52
Change from baseline in weekly mean rescue medication use
Timeframe: From Baseline to Week 52
Change from baseline in weekly mean number of night-time awakenings
Timeframe: From Baseline to Week 52
Change from baseline in blood eosinophil count
Timeframe: From Baseline to Week 52
Change from baseline in fractional exhaled nitric oxide (FeNO)
Timeframe: From Baseline to Week 52
Change from baseline in total serum IgE
Timeframe: From Baseline to Week 52
Change from baseline in pre-bronchodilator (pre-BD) peak expiratory flow (PEF)
Timeframe: From Baseline to Week 52
Number of asthma--related healthcare resource utilization (HRU)
Timeframe: From Baseline to Week 52
Number of participant/caregiver health-related absences
Timeframe: From Baseline to Week 52
Serum concentrations of tezepelumab
Timeframe: At Baseline, Week 4, Week 24, and Week 52
Incidence of anti-drug antibodies (ADAs)
Timeframe: At Baseline, and from time of first dose at Week 0 to end of study at week 64
Incidence of neutralising antibodies (nAbs)
Timeframe: At Baseline, and from time of first dose at Week 0 to end of study at week 64