Table 2 Primary and secondary objectives and endpoints
Objective | Endpoint(s) |
|---|---|
Primary objective | |
Assess the effect of tezepelumab on asthma exacerbations in adults and adolescents with severe, uncontrolled asthma, compared with placebo | AAER |
Key secondary objectives | |
Assess the effect of tezepelumab on pulmonary function compared with placebo | Change from baseline in pre-bronchodilator FEV1 |
Assess the effect of tezepelumab on HRQoL compared with placebo | Change from baseline in AQLQ(S) + 12 total score |
Assess the effect of tezepelumab on asthma control compared with placebo | Change from baseline in ACQ-6 score |
Assess the effect of tezepelumab on asthma symptoms compared with placebo | Change from baseline in weekly mean daily Asthma Symptom Diary score |
Other secondary objectives | |
Assess the effect of tezepelumab on other endpoints associated with exacerbations | Time to first asthma exacerbation Proportion of patients with ≥1 exacerbation Annualized rate of exacerbations associated with hospital, ER or urgent care visits |
Assess the effect of tezepelumab on biomarkers | Change from baseline in FeNO, peripheral blood eosinophil count and total serum IgE |
Assess the effect of tezepelumab on other asthma control metrics | Weekly mean rescue medication use Weekly mean morning and evening PEF Weekly mean number of night-time awakenings |
Assess the effect of tezepelumab on healthcare resource use and productivity loss due to asthma | Asthma-specific resource use: for example, unscheduled physician visits, use of other asthma medications WPAI + CIQ score |
Evaluate the pharmacokinetics and immunogenicity of tezepelumab | Pharmacokinetics: serum trough concentrations Immunogenicity: incidence of anti-drug antibodies |
Assess the effect of tezepelumab on general health-related quality of life | EQ-5D-5L |
Assess the effect of tezepelumab on patient and clinical impression of overall asthma severity | PGI-C/S CGI-C |