NCT07011524招募中2 期
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM512 Injection in Subjects With Moderate-to-severe Asthma.
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年8月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from the baseline in Forced Expiratory Volume in one second (FEV1)
研究概览
简要总结
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with moderate-to-severe 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and comply with procedures of the protocol, and voluntarily sign the Informed Consent Form.
- •Age ≥ 18 years old and ≤ 75 years old.
- •Body mass index (BMI) ≥ 18.0 kg/(m*m).
- •Documented treatment with medium to high dose Inhaled Corticosteroids (ICS) in combination with asthma controller medication for at least 3 months with a stable dose ≥1 month prior to Visit
- •Documented history of at least 1 severe asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
- •Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5
排除标准
- •Women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating.
- •With a history of drug abuse within the past 5 years before screening visit.
- •Allergic or intolerant to CM512 injection or placebo components, or with a history of severe drug allergies or anaphylactic shock.
- •With any medical or non-medical conditions that are not suitable for participation in this study by investigators.
研究组 & 干预措施
Group 1
Experimental
干预措施: CM512 injection (Biological)
Group 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from the baseline in Forced Expiratory Volume in one second (FEV1)
时间窗: Up to week 12
Change from baseline in pre-bronchodilator FEV1 in each dose group at 12 weeks of CM512 treatment compared with placebo.
次要结局
未报告次要终点
研究者
研究点 (1)
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