Molecular Signatures of Cutaneous Dupilumab Response
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks
研究概览
简要总结
This study examines the effect of IL4RA blockade with dupilumab on the immune cells of atopic dermatitis skin lesions.
详细描述
This is a one-arm, open-label study to examine the effect of dupilumab. Dupilumab is a FDA-approved medication for the treatment of atopic dermatitis. This study will examine how dupilumab affects immune cells within atopic dermatitis skin lesions. Fifteen subjects with moderate to severe atopic dermatitis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with and to predict dupilumab treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •atopic dermatitis with a EASI (Eczema Area and Severity Index (EASI)) score of ≥7
排除标准
- •Known pregnancy
- •Known immunodeficiencies
- •Known parasitic infection -
研究组 & 干预措施
dupilumab treatment
Treatment with IL4RA inhibitor
干预措施: Dupilumab (Drug)
结局指标
主要结局
Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks
时间窗: baseline and 8-12 weeks
Change in EASI score from baseline to 8-12 weeks. Scores range from 0 to 72, with higher scores indicating more severity.
次要结局
未报告次要终点