A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 247
- 试验地点
- 155
- 主要终点
- Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1)
研究概览
简要总结
The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed asthma requiring treatment with medium- to high-dose ICS-LABA for at least 12 months prior to screening.
- •Pre-BD FEV1 < 80% predicted according to central over read value at Visit
- •Documented historical post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV
- •At least 2 documented asthma exacerbations (requiring treatment with systemic CS, hospitalization, or emergency department visit) within 12 months prior to screening but not within the past 4 weeks prior to screening
- •ACQ-6 ≥ 1.5 at screening.
排除标准
- •Maintenance use of asthma controllers other than ICS-LABA.
- •Have undergone bronchial thermoplasty.
- •Current smokers or participants with a smoking history of ≥ 10 pack-years and participants using vaping products, including electronic cigarettes.
- •Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- •Current conditions or history of other diseases, as follows:
- •Clinically important pulmonary disease other than asthma ,Thrombocytopenia, coagulopathy, or platelet dysfunction.
- •Venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, moderate to severe heart failure (NYHA Class III or IV), cerebrovascular accident, myocardial infarction, coronary stenting, or CABG surgery.
- •Diagnosis of other significant cardiovascular diseases, including but not limited to angina, peripheral arterial disease, or uncontrolled arrhythmias such as atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, and forms of carditis.
- •Recipient of an organ transplant that requires continued immunosuppression.
- •Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
- •Any malignancies or history of malignancies.
- •Chronic or recurrent infectious disease.
- •Receipt of any biologic drugs used for asthma < 12 weeks or 5 half-lives (if known), whichever is longer, prior to screening
研究组 & 干预措施
ICS-LABA + povorcitinib Dose 2
Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 2 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
干预措施: povorcitinib (Drug)
ICS-LABA + povorcitinib Dose 1
Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 1 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
干预措施: ICS-LABA (Drug)
ICS-LABA + povorcitinib Dose 3
Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 3 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
干预措施: ICS-LABA (Drug)
Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo
Participants will receive stable background therapy with ICS-LABA in combination with placebo once daily (QD) for 24 weeks during the placebo-controlled period. Participants will be allocated to 1 of 3 doses of povorcitinib during the extension period of 28 weeks
干预措施: placebo (Other)
Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo
Participants will receive stable background therapy with ICS-LABA in combination with placebo once daily (QD) for 24 weeks during the placebo-controlled period. Participants will be allocated to 1 of 3 doses of povorcitinib during the extension period of 28 weeks
干预措施: ICS-LABA (Drug)
ICS-LABA + povorcitinib Dose 2
Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 2 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
干预措施: ICS-LABA (Drug)
ICS-LABA + povorcitinib Dose 1
Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 1 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
干预措施: povorcitinib (Drug)
ICS-LABA + povorcitinib Dose 3
Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 3 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
干预措施: povorcitinib (Drug)
结局指标
主要结局
Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1)
时间窗: Baseline ; Week 24
To assess the effect of povorcitinib on lung function (pre-BD FEV1) between baseline and week 24
次要结局
- Percent change from baseline in pre-BD FEV1 at each visit(Up to 14 months)
- Number of asthma exacerbations during the Placebo Controlled (PC) period(Up to 28 weeks)
- Absolute change from baseline in pre-BD FEV1 at each visit(Up to 14 months)
- Percent change from baseline in post-BD FEV1 at week 24(Baseline; Week 24)
- Percent change from baseline in pre-BD FVC at each visit(Up to 14 months)
- Absolute change from baseline in post-BD FEV1 at week 24(Baseline; Week 24)
- Absolute change from baseline in pre-BD FVC at each visit(Up to 14 months)