A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Adolescent and Adult Patients With Moderate-to-Severe Asthma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- Primary purpose
研究概览
简要总结
A randomized, double-blind, placebo-controlled Phase III clinical trial on the efficacy and safety of MG-K10 humanized monoclonal antibody injection in adolescent and adult patients with moderate to severe asthma.
详细描述
A randomized, double-blind, placebo-controlled Phase III clinical trial on the efficacy and safety of MG-K10 humanized monoclonal antibody injection in adolescent and adult patients with moderate to severe asthma is planned to enroll 504 subjects. These patients will receive multiple subcutaneous injection treatments. This study is divided into: a screening period of 1 week, a lead-in period of 4 weeks, a treatment period of 52 weeks, and a 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MG-K10 placebo
Every four weeks, subcutaneous injection ，total of 52W
干预措施: MG-K10/Placebo (Drug)
MG-K10 Humanized Monoclonal Antibody Injection
Every four weeks, subcutaneous injection ，total of 52W
干预措施: MG-K10/Placebo (Drug)
结局指标
主要结局
Primary purpose
时间窗: 52 weeks of treatment
Compared with placebo, the annualized incidence of severe asthma exacerbation events within 52 weeks of MG - K10 treatment
次要结局
- effectiveness(12week)
- The annualized incidence rate of severe asthma exacerbation events within 52 weeks(52week)
- potentency(12week)
- The annualized incidence rate of acute asthma attacks within 52 weeks after treatment(From the baseline to within 52 weeks)
- The changes compared to the baseline in the absolute values of FEV1 and the percentages of the normal predicted values of FEV1 before and after the use of bronchodilators at various evaluation time points.(From the baseline to within 52 weeks)
- The changes (absolute values and percentages) compared to the baseline in the peak expiratory flow (PEF) in the morning and evening, forced vital capacity (FVC), and forced expiratory flow between 25% and 75% of vital capacity (FEF25-75%) at various eval(From the baseline to within 52 weeks)
- The annualized incidence rate of hospitalizations or emergency department treatments caused by severe asthma exacerbation events within 52 weeks of treatment(From the baseline to within 52 weeks)
- The annualized incidence rate of Loss of Asthma Control (LOAC) events within 52 weeks of treatment(From the baseline to within 52 weeks)
- he time of the first Loss of Asthma Control (LOAC) event(From the baseline to within 52 weeks)
- The time of the first severe asthma exacerbation event(From the baseline to within 52 weeks)
- PK (Pharmacokinetic) parameter: The drug concentration after administration(From the baseline to within 52 weeks)
- Immunogenicity: The incidence rates of anti-drug antibodies (ADA) and neutralizing antibodies (NAb), and their impacts on pharmacokinetics (PK), safety, and efficacy.(From the baseline to within 52 weeks)
- The changes compared to the baseline in the Standard Version of the Asthma Quality of Life Questionnaire (AQLQ(S)) at various evaluation time points.(From the baseline to within 52 weeks)