NCT04730024尚未招募不适用
Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis: 5-year Results From the K0104 Extension Study
Kang Stem Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2022年3月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 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 Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis: 5-year Results from the K0104 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 K0104 Clinical Trial(parent study).
- •Subjects who understand and voluntarily sign an informed consent form
排除标准
- •Subjects who are expected to be unable to perform at least one follow-up during this study (K0104-E)
- •Subjects who has received/administered clinical trial drugs or medical devices by participating in other clinical trials until the first visit of this trial (K0104-E) after the completion of K0104 clinical trial
- •Subjects who are judged to be unsuitable for other researchers to participate in the research
结局指标
主要结局
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)
时间窗: for 5 years
次要结局
- Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1(for 5 years)
- Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)(for 5 years)
- Change and rate of change in Body Surface Area (BSA)(for 5 years)
- Change and rate of change DLQI(for 5 years)
- Change and rate of change Peak Pruritus NRS(for 5 years)
- Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)(for 5 years)
- Rate of change and Change in EASI from baseline(for 5 years)
- Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)(for 5 years)
- Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher(for 5 years)
- Rate of change and Change in SCORAD index from baseline at each visit(for 5 years)
- Change and rate of change POEM(for 5 years)
- Change and rate of change in total serum Immunoglobulin E (IgE)(for 5 years)
研究者
研究点 (1)
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