NCT06495229进行中（未招募）3 期
A Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of CM310 in Adolescent Patients With Atopic Dermatitis
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年8月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This is a multi-center, single arm, open label phase 3 study to evaluate the safety and efficacy of CM310 in children patients with moderate-to-severe atopic dermatitis.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
- •Subjects who must complete the evaluation of Week 18 of the main study.
- •With Atopic Dermatitis.
排除标准
- •Any major surgery planned during the research period.
- •Subjects with potential fertility do not agree to adopt efficient contraceptive measures throughout the entire study period; Pregnant or breastfeeding women, or women planning to conceive or breastfeed during the study period.
- •With any circumstance that the subject is not suitable to participate in this study.
研究组 & 干预措施
CM310 group
Experimental
干预措施: CM310 (Biological)
结局指标
主要结局
Adverse events
时间窗: up to week 52
Incidence of adverse events.
次要结局
- Change from baseline in Eczema Area and Severity Index (EASI)(up to week 62)
- Proportion of subjects with Immunoglobulin A(IGA) 0 or 1 and a reduction of from baseline of ≥ 2 points(up to week 62)
- Improvement of Numerical Rating Scale (NRS)(up to week 62)
- Body surface area (BSA) of involvement of atopic dermatitis(up to week 62)
- Children Dermatology Life Quality Index (CDLQI)(up to week 62)
- Patient-Oriented Eczema Measure (POEM)(up to week 62)
- EuroQol Five Dimensions Questionnaire (EQ-5D)(up to week 62)
- Pharmacokinetics parameters(up to week 62)
- Immunogenicity(up to week 62)
研究者
研究点 (1)
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