NCT07532265
尚未招募
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
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 512
- 试验地点
- 15
- 主要终点
- Pre-BD FEV1
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.
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.
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 (15)
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