A Clinical Study to Evaluate the Efficacy and Safety of Frevecitinib (KN-002) in Patients With Severe Asthma (NCT07532265)

Usually NOT eligible if any of the following apply:

• Exclusion Criteria: Current smokers or participants with a smoking history of ≥10 pack years Participants with a current history of angina or history of myocardial infarction, stroke, or TIAs within the past 12 months from screening are disallowed. Participants with a history of pulmonary embolic or thrombotic events, or genetic or autoimmune (eg anti-phospholipid syndrome) predisposition for thrombosis are disallowed. Any concomitant respiratory disease that, in the opinion of the investigator and/or medical monitor, will interfere with the evaluation of the investigational product or interpretation of participant safety or study results Any clinically relevant abnormal findings in hematology, clinical chemistry, coagulation, or urinalysis (laboratory results from visit), physical examination, vital signs during the screening/run-in period which, in the opinion of the investigator, may put the participant at risk because of his/her participation in the study Evidence of active liver disease including jaundice or AST, ALT, or bilirubin greater than twice the upper limit of normal. History of cancer Participants with a respiratory tract infection that has not fully resolved by screening, or who experience an RTI during screening or at Day 1. Evidence of a clinically significant infection or receiving treatment with systemic antibiotic, anti-parasitic, or antiviral medications at Day 1. Known history of active TB or a positive QFT-G test for TB during screening. A positive hepatitis B surface antigen, or hepatitis C virus antibody serology at screening, or a positive medical history for hepatitis B or C. A positive human immunodeficiency virus test at screening or participant taking antiretroviral medications, as determined by medical history and/or participants verbal report. History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor contraindicates their participation. Use of oral or topical JAK inhibitors for any reason or use of immunosuppressive medication (eg, methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot glucocorticoid, or any experimental anti-inflammatory therapy) within 3 months prior to screening and throughout the study. Receipt of any investigational nonbiologic agent within 30 days or 5 half-lives prior to screening, whichever is longer and throughout the study. Prescription of regular daily oral corticosteroids within 4 weeks prior to screening or during the screening/run-in period and throughout the study. Systemic glucocorticoid burst including taper within 15 days prior to screening or during the screening/run-in period and throughout the study. Prescription of concomitant parenteral monoclonal antibody therapy for the management of asthma or any other condition within a specified period prior to the screening visit Pregnant, breastfeeding, or lactating females. History of chronic alcohol or drug abuse within 12 months prior to screening, as determined by the investigator. Planned surgical procedures requiring general anesthesia or in-patient status for \>1 day during the conduct of the study. Receipt of any live or attenuated vaccines within 15 days prior to screening. Participants who have undergone bronchial thermoplasty. Prolonged QTcF \>470 ms at screening or baseline.