Immune Spatial Features of Guselkumab Cutaneous Response
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in psoriasis scalp severity index score (PSSI)
研究概览
简要总结
This study examines the effect of IL-23 blockade with Guselkumab on the immune cells of scalp psoriasis lesions.
详细描述
This is a one-arm, open-label study to examine the effect of Guselkumab . Guselkumab is a FDA-approved medication for the treatment of psoriasis. This study will examine how Guselkumab affects immune cells within scalp psoriasis lesions. Ten subjects with moderate to severe scalp psoriasis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with Guselkumab 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
- 是
入选标准
- •possess a PSSI (psoriasis scalp severity index) of ≥12
排除标准
- •taking systemic immunosuppressives in the last 4 weeks
- •severe immunodeficiency (either from genetic or infectious causes).
- •tuberculosis or other active serious infection
- •active systemic malignancy.
- •breast-feeding
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- •Males who are trying to conceive
研究组 & 干预措施
Guselkumab treatment
Guselkumab treatment for ~ 9 months
干预措施: Guselkumab (Drug)
结局指标
主要结局
Change in psoriasis scalp severity index score (PSSI)
时间窗: baseline and 9 months
PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. PSSI scores will be taken pre- and mid-treatment. Scores range from 0 to 72, with higher scores indicating more severity.
次要结局
未报告次要终点