Real-World Evaluation of Secukinumab in Moderate-to-Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
研究概览
简要总结
This single-center, prospective, observational study aimed to evaluate the efficacy and safety of Secukinumab in treating moderate-to-severe hidradenitis suppurativa (HS). The study was conducted from June 1, 2025, to June 1, 2026, and all participants were treated at the Department of Dermatology, Peking Union Medical College Hospital. The study was approved by the Clinical and Research Ethics Committee of the Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (Ethics Approval No. I-24PJ1844). All procedures involving human participants adhered to the Declaration of Helsinki. Written informed consent form was signed and obtained from the participant.
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
- •age ≥18 years
- •diagnosis of moderate-to-severe HS with Hurley stage II or III
- •Disease duration of ≥6 months, presence of at least one draining tunnel or two inflammatory nodules
- •inadequate response to prior treatments, such as antibiotics, isotretinoin, or TNF inhibitors
排除标准
- •active infections (e.g., viral hepatitis, active tuberculosis)
- •use of other biologics or systemic immunosuppressants within the past three months
- •severe organ dysfunction (e.g., hepatic or renal failure)
- •any other conditions that might affect study results
结局指标
主要结局
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
时间窗: From enrollment to the end of treatment at Week 12
a ≥50% reduction in the combined count of inflammatory nodules and abscesses from baseline, without an increase in the number of abscesses or draining tunnels
次要结局
- Dermatology Life Quality Index(From enrollment to the end of treatment at week 12)
研究者
Xiao Ma
Resident physician of dermatology
Peking Union Medical College