A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of Frevecitinib (KN-002) in Patients With Severe Asthma

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 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 ma…