Moderate-to-severe Asthma
Conditions
Brief summary
Annualized asthma exacerbation rate (AAER) during the placebo-controlled treatment period (blinded treatment period). Exacerbation events are defined as worsening of asthma requiring the use of systemic corticosteroids for ≥ 3 days, emergency department visit resulting in requirement for systemic corticosteroids for ≥ 3 days or an inpatient hospitalization due to asthma
Detailed description
Change from baseline in Asthma Symptom diary (ASD) score at assessment timepoints, Annualized rate of asthma exacerbation leading to hospitalization or emergency room visits during the blinded treatment period, Time to first asthma exacerbation event, Serum rocatinlimab concentrations at assessment timepoints
Interventions
DRUGRocatinlimab
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized asthma exacerbation rate (AAER) during the placebo-controlled treatment period (blinded treatment period). Exacerbation events are defined as worsening of asthma requiring the use of systemic corticosteroids for ≥ 3 days, emergency department visit resulting in requirement for systemic corticosteroids for ≥ 3 days or an inpatient hospitalization due to asthma | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Asthma Symptom diary (ASD) score at assessment timepoints, Annualized rate of asthma exacerbation leading to hospitalization or emergency room visits during the blinded treatment period, Time to first asthma exacerbation event, Serum rocatinlimab concentrations at assessment timepoints | — |
Countries
Bulgaria, Czechia, Hungary, Poland, Romania
Outcome results
None listed