NCT03962387Unknown不适用
A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis: 5-year Results From the K0102 Extension Study
Kang Stem Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2019年4月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)
研究概览
简要总结
A multi-center, open, long-term follow-up study to evaluate the efficacy and safety of FURESTEM-AD inj. in patients with moderate to severe chronic atopic dermatitis: 5-year results from the K0102 extension study
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who enrolled K0102 Clinical Trial(parent study).
- •Subjects who understand and voluntarily sign an informed consent form
排除标准
- •In case follow-up is not possible from end of K0102 clinical trial to end of this study period
- •Any other condition which the investigator judges would make patient unsuitable for study participation
结局指标
主要结局
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)
时间窗: 5 years
次要结局
- Rate of change in EASI from baseline(3 years)
- Change in EASI from baseline(3 years)
- Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)(3 years)
- Rate of change in SCORAD index from baseline at each visit(3 years)
- Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at Week 12 (EASI-75)(3 years)
- Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at Week 12 (EASI-50)(3 years)
- Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1(3 years)
- Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher(3 years)
- Change in SCORAD index from baseline at each visit(3 years)
- Rate of change in Body Surface Area(BSA) of the lesion from baseline(3 years)
- Change in Body Surface Area(BSA) of the lesion from baseline(3 years)
- Change in total serum Immunoglobulin E(IgE) from baseline(3 years)
研究者
研究点 (1)
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