Early and Long-term Clinical Efficacy and Local Tissue and Peripheral Immune Changes Following Dupilumab Treatment in Prurigo Nodularis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Peak Pruritus NRS (PP-NRS)
研究概览
简要总结
With the arrival of dupilumab as the first available targeted therapy for PN, there is an unmet need for real-world data and translational research on the working mechanism of dupilumab on PN, to optimize individualized targeted treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients with moderate-to-severe prurigo nodularis starting dupilumab treatment
排除标准
- •Unwilling to participate in the BioDay registry
- •(For translational endpoints only) Unwilling to participate in UMC Utrecht Biobank
结局指标
主要结局
Peak Pruritus NRS (PP-NRS)
时间窗: From enrollment to 52 weeks of treatment
Peak pruritus NRS of the past 24 hours
Investigator Global Assessment scale of Prurigo Nodularis stage (IGA-PN)
时间窗: From enrollment to 52 weeks of treatment
Investigator Global Assessment scale of Prurigo Nodularis stage
Drug survival
时间窗: From enrollment to 52 weeks of treatment
Duration of dupilumab treatment, reasons for discontinuation
Adverse events
时间窗: From enrollment to 52 weeks of treatment
Data on the incidence, severity, relation to dupilumab and clinical consequences of adverse events
Skin homing T cell subtypes
时间窗: Up to 52 weeks of treatment
Serum levels of relevant proteins
时间窗: Up to 52 weeks of treatment
Systemic epigenetic changes
时间窗: Up to 52 weeks of treatment
次要结局
未报告次要终点