NCT04725136Unknown1 期
A Phase I/IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis
Kang Stem Biotech Co., Ltd.2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2021年1月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Safety Assessment
研究概览
简要总结
A Phase I/IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis
详细描述
Phase 1: Multicenter, repeated administration, disclosure, dose escalation, Evaluate safety and tolerability and explore efficacy
Phase 2a: Multicenter, repeated administration, random assignment, double blinding, parallel, Efficacy and safety are evaluated for repeated administration compared to placebo and single administration.
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>=16 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)
- •Renal dysfunction with creatinine >2.0 mg/dL at screening
- •Hepatic dysfunction with ALT or AST levels 2.5 times higher than the normal range at screening
- •ALC<800/mm3 at screening
- •Subjects with live vaccine administration within 12 weeks before baseline
- •Receipt of leukotriene receptor antagonists, systemic steroids, systemic or topical antihistamines, phototherapy, or systemic immunosuppressants/modulators including janus kinase (JAK) inhibitors, and/or any other systemic therapy within 4 weeks before Baseline
- •Receipt of topical steroids(class1~6), topical tacrolimus or pimecrolimus within 2 weeks before Baseline
- •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
- •Subjects with experience of administering FURESTEM-AD inj.
- •Any other condition which the investigator judges would make patient unsuitable for study participation
结局指标
主要结局
Safety Assessment
时间窗: 24 weeks follow-up after first treatment
safety information including drug tolerability
次要结局
- Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)(24 weeks follow-up after first treatment)
- Rate of change and Change in SCORAD index from baseline at each visit(24 weeks follow-up after first treatment)
- Change and rate of change in Cytokine(24 weeks follow-up after first treatment)
- Change and rate of change eosinophil(24 weeks follow-up after first treatment)
- Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)(24 weeks follow-up after first treatment)
- Change and rate of change DLQI(24 weeks follow-up after first treatment)
- Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)(24 weeks follow-up after first treatment)
- Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher(24 weeks follow-up after first treatment)
- Change and rate of change in Body Surface Area (BSA)(24 weeks follow-up after first treatment)
- Change and rate of change in total serum Immunoglobulin E (IgE)(24 weeks follow-up after first treatment)
- Change and rate of change POEM(24 weeks follow-up after first treatment)
- Rate of change and Change in EASI from baseline(24 weeks follow-up after first treatment)
- Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1(24 weeks follow-up after first treatment)
- Change and rate of change Peak Pruritus NRS(24 weeks follow-up after first treatment)
- Use the number and total amount of rescue(24 weeks follow-up after first treatment)
研究者
研究点 (2)
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