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
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
• 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 additional controller(s) must be stable for at least 4 weeks prior to screening and throughout the screening/run-in period.
• Has a pre-bronchodilator FEV1 value of ≥40% and ≤80%, predicted, at screening and at Day 1.
• Has a post-bronchodilator reversibility of FEV1 ≥12% and ≥200 mL documented during screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol).
• Has an ACQ-6 score of ≥1.5 during screening (ie, Visit 1 and Visit 2).
• Has a documented history of at least 1 asthma exacerbation in the 12 months prior to the screening visit, while using medium to high dose ICS/LABA therapy
• Acceptable inhaler, peak flow meter, and spirometry techniques during the screening/run-in period.
• ≥80% compliance with required use of the ePRO device within the last 14 days of the screening/run-in period.
• Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception from the time informed consent is obtained and must agree to continue using such precautions throughout the study and continue using such precautions for 16 weeks after the final dose of study treatment.