A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIb, Effcacy and Safety Study of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Asthma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 52
研究概览
简要总结
This study will assess the effcacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effcacy and safety of 610 in adults with severe eosinophilic asthma. Subjects divided into 3 groups: A group,B group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks, prolonged treatment period of 36 weeks and follow-up period of 8 weeks.
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
- Triple (Participant, Care Provider, Investigator)
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
- •1. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
- •2. Female and male aged 18 to 75 years.
- •3. Diagnosed with asthma for ≥12 months that meet GINA.
- •4. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
- •5. Documented history of ≥ 1 moderate exacerbations within 12 months prior to screening.
- •6. Asthma Control Questionnaire question version (ACQ) score ≥1.5 at the screening visit and the randomization visit.
排除标准
- •1. Presence of a known pre-existing, clinically important lung condition other than Asthma.
- •2. Severe asthma exacerbation within 4 weeks prior to randomization.
- •3. Subjects with any eosinophilic diseases other than asthma.
- •4. Known, pre-existing severe or clinically significant cardiovascular disease.
- •5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
- •6. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- •7. Subjects with allergy/intolerance to a monoclonal antibody.
研究组 & 干预措施
Group A
Subjects will receive 610 for 52 weeks.
干预措施: 610 (Drug)
Group B
Subjects will receive 610 for 52 weeks.
干预措施: 610 (Drug)
Placebo group
Subjects will receive placebo for 52 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 52
时间窗: Baseline (Day 1) and at week 52
FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.
次要结局
- Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 16(Baseline (Day 1) and at week 16)
- Percentage change from baseline in pre-bronchodilator FEV1 at weeks 4, 8,12,16, 20, 28, 36, 44, 52(Baseline (Day 1) and at week 4, 8,12,16, 20, 28, 36, 44, 52)
- Number of asthma exacerbation through study week 52(From baseline (Day 1) to week 52)
- Number of asthma exacerbations requiring hospitalization or emergency room visits(From baseline (Day 1) to week 52)
- Change from baseline in Asthma Control Questionnaire (ACQ) score.(From baseline (Day 1) to week 52)
- Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)(From baseline (Day 1) to week 52)
- Assessment of adverse events (AEs)(Up to week 60)