NCT04087863招募中不适用
A Multi-center, Open, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis Who Participated in a Placebo Group in K0102 Clinical Trial: 2nd Extension Study of K0102
Kang Stem Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2019年8月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 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, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of FURESTEM-AD inj. in Patients with Moderate to Severe Chronic Atopic Dermatitis Who Participated in a Placebo Group in K0102 Clinical Trial: 2nd Extension Study of K0102
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who enrolled K0102 Clinical Trial(parent study) and be assigned to a placebo group
- •Subjects who understand and voluntarily sign an informed consent form
排除标准
- •Subjects with medical history or surgery/procedure history
- •Subjects with diseases at the time of participation in this study (systemic infection, other serious skin disorders, pigmentation or extensive scarring in atopic dermatitis symptom region)
- •Pregnant, breast-feeding women or women who plan to become pregnant during six months after administering the clinical trial medication
- •Subjects who participate in other clinical trial or participated in other clinical trial within 4 weeks
- •In case follow-up is not possible 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
- 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)
- Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)(3 years)
- Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)(3 years)
- Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at each visit (EASI-50)(3 years)
- Rate of change in EASI from baseline(3 years)
- Change in EASI from baseline(3 years)
- Change in Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit(3 years)
- Change in total serum Immunoglobulin E(IgE) from baseline(3 years)
- Rate of change in total serum Immunoglobulin E(IgE) from baseline(3 years)
- Rate of change in SCORAD index from baseline at each visit(3 years)
- Change in SCORAD index from baseline at each visit(3 years)
- Rate of change in Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit(3 years)
研究者
研究点 (1)
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