A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Three Doses of Frevecitinib (KN-002) in Patients With Severe Asthma
Kinaset Therapeutics Inc
Summary
A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of Frevecitinib (KN-002) Over a 12-Week Treatment Period in Patients With Severe Asthma Not Controlled With Medium to High Dose ICS/LABA
Description
A Phase 2 Randomized Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Three Doses of Frevecitinib (KN-002) in Patients With Severe Asthma Not Adequately Controlled With Medium to High Dose ICS/LABA Therapy
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Capable of understanding the written informed consent, provides signed and witnessed written informed consent prior to any study-related procedures, and agrees to comply with protocol requirements. Body mass index between 18 to 40 kg/m2 and weight ≥40 kg at screening. Documented physician-diagnosed asthma for at least 12 months prior to screening. Has received a physician-prescribed asthma controller regimen with medium dose or high dose ICS plus LABA, with or without additional controller medications for at least 6 months prior to screening and the dose of ICS and addi…
Interventions
- DrugFrevecitinib
Frevecitinib (KN-002) delivered via a dry powder inhaler (DPI)
- DrugPlacebo
Matching placebo to frevecitinib
Locations (15)
- Research siteLancaster, California
- Research siteSan Jose, California
- Research siteBrandon, Florida
- Research siteMiami, Florida
- Research siteTampa, Florida
- Research siteChicago, Illinois