Asthma
Conditions
Brief summary
Annualised rate of severe asthma exacerbations.
Detailed description
1. Annualised rate of severe asthma exacerbations (in participants with uncontrolled moderate-to-severe asthma and baseline eosinophils <300 cells/μL and history of ≥2 exacerbations within 12 months prior to screening)., 2. Time-to-first severe asthma exacerbation., 3. Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) over weeks 20-26., 4. Change from baseline in post-bronchodilator FEV1 at week 26., 5. Change from baseline in ACQ-6 at week 26., 6. Change from baseline in AQLQ(S)+12 at week 26., 7. Trough serum concentrations of tozorakimab over 52 weeks treatment period., 8. Anti-drug antibody (ADA) prevalence, incidence, and titre.
Interventions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualised rate of severe asthma exacerbations. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Annualised rate of severe asthma exacerbations (in participants with uncontrolled moderate-to-severe asthma and baseline eosinophils <300 cells/μL and history of ≥2 exacerbations within 12 months prior to screening)., 2. Time-to-first severe asthma exacerbation., 3. Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) over weeks 20-26., 4. Change from baseline in post-bronchodilator FEV1 at week 26., 5. Change from baseline in ACQ-6 at week 26., 6. Change from baseline in AQLQ(S)+12 at week 26., 7. Trough serum concentrations of tozorakimab over 52 weeks treatment period., 8. Anti-drug antibody (ADA) prevalence, incidence, and titre. | — |
Countries
France, Greece, Hungary, Italy, Spain
Outcome results
None listed