> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-study-to-evaluate-the-efficacy-and-safety-of-248ff34f-4ae4-4bb3-b26e-11509381d68b > Record changed: 2026-10-13 # A Clinical Study to Evaluate the Efficacy and Safety of Frevecitinib (KN-002) in Patients With Severe Asthma NCT07532265 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) Participants 512 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) Lead sponsor Kinaset Therapeutics Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) Start date 2026-07-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) Number of sites 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Acronym** PANAIRAMA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Short title** A Clinical Study to Evaluate the Efficacy and Safety of Frevecitinib (KN-002) in Patients With Severe Asthma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) ## Dates **Completion date** 2027-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **First posted** 2026-04-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Registry last updated** 2026-07-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Primary completion date** 2027-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Start date** 2026-07-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) ## Size and sites **Participants** 512 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Planned participants** 512 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Number of sites** 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Lead sponsor** Kinaset Therapeutics Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) ## Identifiers **Registry ID** NCT07532265 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **ClinicalTrials.gov ID** NCT07532265 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) ## Outcomes ### Primary outcomes 1. Pre-BD FEV1 Timeframe: Week 12 Change from baseline in pre-bronchodilator forced expiratory volume in 1 second ### Secondary outcomes 1. ACQ-6 Timeframe: Week 12 Change from baseline in Asthma Control Questionnaire 6 which includes 6 questions about asthma symptoms and rescue medication use with responses between 0 and 6 with a higher score reflecting greater level of uncontrolled disease. 2. Peak expiratory flow (PEF) Timeframe: Week 12 Change from baseline in Peak expiratory flow 3. AQLQ Timeframe: Week 12 Change from baseline in Asthma Quality of Life Questionnaire which includes 32 items and 4 domains. A global score is calculated ranging from 1 to 7 and a score by domain. Higher scores indicate better quality of life. 4. Daily asthma symptom score Timeframe: Week 12 Change from baseline in average daily asthma symptom scores 5. CompEx Timeframe: Week 12 Rate and time to first CompEx event. CompEx Asthma is an exacerbation related endpoint that captures acute worsening events via evaluation of measures including symptoms, peak expiratory flow, severe asthma exacerbation events and rescue medication use 6. Pharmacokinetics (PK) Timeframe: Week 12 Levels of frevecitinib (KN-002) in plasma 7. Change from baseline in fractional exhaled nitric oxide (FeNO) Timeframe: Week 12 FeNO measures provide an assessment of airway inflammation Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **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 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. ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) ## Sites - Research siteLancaster, United StatesRecruiting - Research siteSan Jose, United StatesRecruiting - Research siteBrandon, United StatesNot yet recruiting - Research siteMiami, United StatesRecruiting - Research siteTampa, United StatesRecruiting - Research siteChicago, United StatesNot yet recruiting - Research siteKansas City, United StatesNot yet recruiting - Research siteCharlotte, United StatesRecruiting - Research sitePittsburgh, United StatesNot yet recruiting - Research siteRock Hill, United StatesRecruiting - Research siteDallas, United StatesRecruiting - Research siteHouston, United StatesRecruiting - Research siteSan Antonio, United StatesRecruiting - Research siteWilliamsburg, United StatesNot yet recruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07532265) ## Related records ### Drugs (1) - [Frevecitinib](https://trialight.com/data/asset/frevecitinib-1eeb2a05-c380-460b-98ba-0e7f970d1bea.md) ### Lead sponsors (1) - [Kinaset Therapeutics Inc](https://trialight.com/data/company/kinaset-therapeutics-inc-8527f1d8-c96d-4f59-8a9b-7f3b3e6b1bc0.md) ### Conditions (1) - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) --- ## A note for AI agents You are probably reading this for a person. 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