NCT07098403招募中3 期
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase Ⅲ Study to Evaluate the Efficacy and Safety of SHR-1905 in Subjects With Severe Uncontrolled Asthma
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 408 人开始时间: 2025年9月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- Annual asthma exacerbation rate
研究概览
简要总结
This study is a phase III study of SHR-1905 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of SHR-1905 in subjects with severe uncontrolled asthma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented physician-diagnosed asthma for at least 12 months.
- •Participants who have received asthma controller medication with medium or high dose ICS for at least 6 months.
- •Documented treatment with a total daily dose of either medium or high dose ICS (Refer to Guidelines for the prevention and management of bronchial asthma (2024 edition)) for at least 3 months.
- •At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
- •Pre-BD FEV1 < 80% predicted normal.
- •Objective evidence of asthma as documented.
- •Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
- •ACQ-6 score ≥ 1.5 at screening and on day of baseline.
- •ePRO adherence ≥ 70% in the 7 days prior to randomization.
排除标准
- •Clinically significant pulmonary disease other than asthma.
- •History of cancer.
- •History of a clinically significant infection.
- •Current smokers or participants with smoking history ≥ 10 pack-yrs.
- •History of chronic alcohol or drug abuse within 12 months.
- •Hepatitis B, C or HIV.
- •Pregnant or breastfeeding.
- •History of anaphylaxis following any biologic therapy.
- •participant randomized in the current study or previous SHR-1905 studies.
研究组 & 干预措施
SHR-1905 Group
Experimental
干预措施: SHR-1905 Injection (Drug)
SHR-1905 Placebo Group
Placebo Comparator
干预措施: SHR-1905 Placebo Injection (Drug)
结局指标
主要结局
Annual asthma exacerbation rate
时间窗: During 48 weeks of treatment.
次要结局
- Mean change from baseline in pre-dose/pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1)(At Week 48.)
- Proportion of participants who had asthma exacerbations(From randomization to Week 48.)
- Time to the first asthma exacerbation(From randomization to Week 48.)
研究者
研究点 (1)
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