A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Adolescent Patients With Moderate-to-severe Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving EASI-75 at week 18
研究概览
简要总结
This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.
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
- 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).
- •With Atopic Dermatitis.
排除标准
- •Not enough washing-out period for previous therapies.
- •Any major surgery planned during the research period.
- •With intestinal parasitic infection within the 6 months before screening.
- •With any circumstance that is not suitable to participate in this study.
- •Major surgeries are planned during the study period.
研究组 & 干预措施
CM310 group
干预措施: CM310 (Biological)
Placebo
干预措施: placebo (Other)
结局指标
主要结局
Proportion of subjects achieving EASI-75 at week 18
时间窗: Up to week 18
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, edema/papulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of "0" (none) through "3" (severe).
Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline
时间窗: up to week 18
Proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 18. IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).
次要结局
- Percent change of Eczema Area and Severity Index (EASI) score from baseline(up to week 18)
- Percent change of NRS score from baseline(up to week 18)
- Body surface area (BSA) of involvement of atopic dermatitis(up to week 18)
- Children Dermatology Life Quality Index (CDLQI)(up to week 18)
- Patient-Oriented Eczema Measure (POEM)(up to week 18)
- EuroQol Five Dimensions Questionnaire (EQ-5D)(up to week 18)
- Safety parameters(up to week 26)
- Pharmacokinetics parameters(up to week 26)
- Pharmacodynamics(up to week 26)
- Immunogenicity(up to week 26)