A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
Incyte Corporation
Summary
The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Physician-diagnosed asthma requiring treatment with medium- to high-dose ICS-LABA for at least 12 months prior to screening. * Pre-BD FEV1 \< 80% predicted according to central over read value at Visit 2. * Documented historical post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV1. * At least 2 documented asthma exacerbations (requiring treatment with systemic CS, hospitalization, or emergency department visit) within 12 months prior to screening but not within the past 4 weeks prior to screening * ACQ-6 ≥ 1.5 at screening. Exclusion Criteria: * Maintenance use of…
Interventions
- Drugpovorcitinib
povorcitinib
- Otherplacebo
placebo
- DrugICS-LABA
Background Therapy
Locations (83)
- Allervie Clinical ResearchBirmingham, Alabama
- Kern Allergy Medical Clinic, IncBakersfield, California
- Integrated Research of Inland, IncUpland, California
- Qway ResearchHialeah, Florida
- Direct Helpers Research CenterHialeah, Florida
- Care Research IncMiami, Florida