NCT03269773已完成3 期
A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis
Kang Stem Biotech Co., Ltd.12 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2018年4月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 12
- 主要终点
- over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)
研究概览
简要总结
This is multi-center, randomized, double-blind, parallel, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe chronic 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Of either gender, aged >=19
- •Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria
- •Chronic Atopic Dermatitis that has been present for at least 3 years
- •EASI>=12 at screening and baseline visit
- •IGA>=3, SCORAD index>=25, BSA >=10% of AD involvement at screegning and baseline visit
- •Subjects with documented record of inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks before participating in the study, or whom are inadvisable due to safety risks
- •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)
- •Subjects who need prohibited medication during clinical period
- •Pregnant, breast-feeding women or women who plan to become pregnant during this study
- •Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks
- •Any other condition which the investigator judges would make patient unsuitable for study participation
研究组 & 干预措施
FURESTEM-AD Inj.
Experimental
hUCB-MSC 5.0x10^7 cells
干预措施: FURESTEM-AD Inj. (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)
时间窗: 12 week
次要结局
- Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1(24weeks)
- Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1, or reduced more than 2 points(24weeks)
- Total number of use and consumed amount of rescue medicine(24weeks)
- Change and rafe of change in Body Surface Area (BSA)(24weeks)
- Change in Cytokine (TNF-a, Interleukin (IL)-4, IL-5, IL-6, IL-8, IL-13, IL-31, TARC (CCL17) and CCL 27 analysis)(24weeks)
- Change in total serum Immunoglobulin E (IgE)(24weeks)
- Change and rafe of change in SCORAD index(24weeks)
- over 75% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-75)(12 week)
- Change and rafe of change in EASI index(24weeks)
- over 50% reduction ratio of SCORing Atopic Dermatitis (SCORAD) INDEX as contrasted with baseline value (SCORAD-50)(24weeks)
研究者
研究点 (12)
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