RecruitingSevere Asthma

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

Eligible age

18–75 yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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About this study

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

Sponsor: Kinaset Therapeutics Inc

You may qualify if…

✓ 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

You may not qualify if…

✕ 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.