NCT04061395已完成2 期
Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. The HiGUS-trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab.
研究概览
简要总结
This is a multicenter open-label mode of action study. Twenty patients with moderate to severe hidradenitis suppurativa will be treated with guselkumab 200 mg Q4W subcutaneously. Main objectie is to investigate changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab, in HS lesional skin.
The total duration of the treatment period per subject is 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe HS
- •treatment history of at least one systemic anti-inflammatory / immunosuppressive agent;
- •HS diagnosis of at least 1 year;
- •minimum of two anatomical locations with HS lesions
- •minimum of 4 active abscesses and/or inflammatory nodules (AN).
排除标准
- •contra-indication for guselkumab;
- •previous use of guselkumab;
- •use of treatment with biologics or any immunosuppressives for HS in the last 3 months prior to randomization;
- •presence of other uncontrolled major disease;
- •pregnant or lactating women
结局指标
主要结局
Changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab.
时间窗: Week 0 and 16
Pangenomic gene expression profiling at week 0 and week 16 will be performed on skin biopsies to investigate changes in levels of cytokines in the skin.
次要结局
- Patient reported outcomes - Pain Numeric Rating Scale(Week 0, 4, 8, 12 and 16)
- Patient reported outcomes - Patient treatment satisfaction score(Week 0 and 16)
- Patient reported outcomes - Dermatology Life Quality Index(Week 0, 4, 8, 12 and 16)
- Clinical efficacy - International Hidradenitis Suppurativa Severity Score System (IHS4).(Week 0, 4, 12, 16.)
- Clinical efficacy - Inflammatory lesion count and Hidradenitis Suppurativa Clinical Response (HiSCR)(Week 0, 4, 12, 16.)
- Patient reported outcomes - Patient Global Assessment(Every four weeks)
- Patient reported outcomes - Itch Numeric Rating Scale(Week 0, 4, 8, 12 and 16)
研究者
研究点 (3)
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