Treatment of patients with inadequately controlled moderate to severe asthma
Conditions
Brief summary
Absolute change from baseline in pre-BD FEV1 at Week 24
Detailed description
Number of asthma exacerbations during the PC period, defined as a worsening of asthma that leads to any of the following: − Use of systemic CS for at least 3 consecutive days; a single depo-injectable dose of CS will be considered equivalent to a 3-day course of systemic CS, An emergency department or urgent care visit (defined as evaluation and treatment for < 24 hours in an emergency department or urgent care center) due to asthma that required use of systemic CS (as noted above), An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥ 24 hours) due to asthma
Interventions
DRUGPovorcitinib
DRUGPlacebo
Sponsors
Incyte Corp.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in pre-BD FEV1 at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of asthma exacerbations during the PC period, defined as a worsening of asthma that leads to any of the following: − Use of systemic CS for at least 3 consecutive days; a single depo-injectable dose of CS will be considered equivalent to a 3-day course of systemic CS, An emergency department or urgent care visit (defined as evaluation and treatment for < 24 hours in an emergency department or urgent care center) due to asthma that required use of systemic CS (as noted above), An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥ 24 hours) due to asthma | — |
Countries
Germany, Poland, Spain
Outcome results
None listed