NCT06323213招募中3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 610 in Chinese Adult Subjects With Severe Eosinophilic Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Annualized rate of severe exacerbation events
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.
详细描述
The total duration of study per patient is approximately 66 weeks, including 6 weeks of screening period, 52 weeks of treatment period and 8 weeks of follow-up period.
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
- •Able to give written informed consent prior to participation in the study.
- •Male or female adults ages 18 to 75 years old when signing the informed consent.
- •Documented diagnosis of asthma for at least one year prior to screening.
- •History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
排除标准
- •Presence of a known pre-existing, clinically important lung condition other than asthma.
- •Severe asthma exacerbation within 4 weeks prior to randomization.
- •Subjects with any eosinophilic diseases other than asthma.
- •Known, pre-existing severe or clinically significant cardiovascular disease.
- •known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
- •Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- •Subjects with allergy/intolerance to a monoclonal antibody.
研究组 & 干预措施
610 group
Experimental
Subjects will receive 610 for 52 weeks.
干预措施: 610 (Drug)
placebo group
Placebo Comparator
Subjects will receive placebo for 52 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Annualized rate of severe exacerbation events
时间窗: Up to 52 weeks
Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period
次要结局
- Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit(Up to 52 weeks)
- Change from baseline in ACQ score(Up to 52 weeks)
- Time to first severe exacerbation event(Up to 52 weeks)
- Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)(Up to 52 weeks)
- Change in pre-bronchodilator forced expiratory volume (FEV1)(Up to 52 weeks)
- Assessment of adverse events (AEs)(Up to 60 weeks)
研究者
研究点 (1)
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