NCT07532265招募中2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 512
- 试验地点
- 14
- 主要终点
- Pre-BD FEV1
研究概览
简要总结
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
详细描述
A Phase 2 Randomized Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Three Doses of Frevecitinib (KN-002) in Patients With Severe Asthma Not Adequately Controlled With Medium to High Dose ICS/LABA Therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
- •Evidence of a clinically significant infection or receiving treatment with systemic antibiotic, anti-parasitic, or antiviral medications at Day
- •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.
研究组 & 干预措施
Frevecitinib (KN-002) matching placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Frevecitinib Dose 2
Experimental
Drug: Frevecitinib
干预措施: Frevecitinib (Drug)
Frevecitinib Dose 1
Experimental
Drug: Frevecitinib
干预措施: Frevecitinib (Drug)
Frevecitinib Dose 3
Experimental
Drug: Frevecitinib
干预措施: Frevecitinib (Drug)
结局指标
主要结局
Pre-BD FEV1
时间窗: Week 12
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second
次要结局
- Daily asthma symptom score(Week 12)
- ACQ-6(Week 12)
- Peak expiratory flow (PEF)(Week 12)
- AQLQ(Week 12)
- CompEx(Week 12)
- Pharmacokinetics (PK)(Week 12)
- Change from baseline in fractional exhaled nitric oxide (FeNO)(Week 12)
研究者
研究点 (14)
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