NCT05728684尚未招募不适用
A Single-arm Study Sponsored by Investigators to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Recurrent IgG4-related Diseases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Response rate
研究概览
简要总结
This study is a single-arm study initiated to evaluate the efficacy and safety of CM310 in subjects with recurrent IgG4-related disease.
详细描述
This study includes three stages: screening period, treatment period and safety follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •≥18 years, male and female.
- •With IGG4-related disease.
排除标准
- •Inoculate live vaccine within 4 weeks before screening.
- •Treponema pallidum antibody positive in screening period.
- •Active hepatitis in screening period.
- •With a history of solid organ or cell transplantation within 6 months before screening.
- •With other medical or non-medical conditions that are not suitable for the study by the investigator.
结局指标
主要结局
Response rate
时间窗: up to week 12
Response rate after administration for 12 weeks
次要结局
未报告次要终点
研究者
Liu Yanying
Deputy Director of Rheumatology Department
Beijing Friendship Hospital
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