Use of the NMF Biomarker as Predictive Diagnostic for Effective Use of Cyclosporine and Dupilumab in the Treatment of Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- EASI
研究概览
简要总结
The goal of this study is to investigate whether stratification of children with atopic dermatitis on the NMF biomarkers results in an improvement of effectiveness and efficiency in the use of systemic treatment (ciclosporin and dupilumab) in moderate-to-severe 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
- Single (Outcomes Assessor)
盲法说明
Personnel involved assessing disease severity are blinded for the NMF biomarker result.
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents, aged 2-18 years, with moderate-to-severe atopic dermatitis (diagnosed according to the UK working party criteria)
- •Patient and parents/guardians able to participate in the study and willing to give written informed consent
- •EASI (Eczema Area Severity Index) ≥ 6 at screening and baseline (corresponding with moderate-to-severe disease)
- •IGA (Investigator Global Assessment) ≥ 3 at screening and baseline (corresponding with moderate-to-severe disease)
排除标准
- •Children under the age of 2 years and patients older than 18 years
- •Contraindication for ciclosporin
- •Contraindication for dupilumab
- •Patient (or one of the parents/guardians) not willing to be randomized
- •Children with a history of any known primary immunodeficiency disorder
- •Children with a history of cancer
- •EASI < 6 at screening or baseline
- •IGA < 3 at screening or baseline
研究组 & 干预措施
Topical corticosteroids (control)
This group will receive topical corticosteroids.
干预措施: Topical corticosteroids (Drug)
Systemic cyclosporine
This group will receive topical corticosteroids and systemic cyclosporin.
干预措施: Topical corticosteroids (Drug)
Systemic cyclosporine
This group will receive topical corticosteroids and systemic cyclosporin.
干预措施: Systemic cyclosporine (Drug)
Systemic dupilumab
his group will receive topical corticosteroids and systemic dupilumab.
干预措施: Topical corticosteroids (Drug)
Systemic dupilumab
his group will receive topical corticosteroids and systemic dupilumab.
干预措施: Systemic dupilumab (Drug)
结局指标
主要结局
EASI
时间窗: t = 0, 1 month, 2 months, 3 months and 6 months
Change from baseline Eczema Area and Severity Index (0-72) over the course of 6 months, with higher scores meaning worse outcomes.
次要结局
- IGA 0 or IGA 1(t = 0, 1 month, 2 months, 3 months and 6 months)
- POEM(t = 0, 1 month, 2 months, 3 months and 6 months)
- NRS-11 reduction for itch ≥ 4 points(t = 0, 1 month, 2 months, 3 months and 6 months)
- EASI75(t = 1 month, 2 months, 3 months and 6 months)
- SCORAD(t = 0, 1 month, 2 months, 3 months and 6 months)
- RECAP(t = 0, 1 month, 2 months, 3 months and 6 months)
研究者
Suzanne G.M.A. Pasmans
Prof. S.G.M.A. Pasmans, MD PhD
Erasmus Medical Center