Predicting Inflammatory Skin Disease Response to IL-23 Blockade
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Psoriasis Area and Severity Index (PASI) Score
研究概览
简要总结
This study examines the effect of IL-23 blockade with Tildrakizumab on the immune cells of psoriatic skin lesions.
详细描述
This is a one-arm, open-label study to examine the effect of Tildrakizumab. Tildrakizumab is a FDA-approved medication for the treatment of cutaneous psoriasis. This study will examine how Tildrakizumab affects immune cells within psoriatic skin lesions. Fifteen subjects with moderate to severe psoriasis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with and to predict Tildrakizumab 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
- 否
入选标准
- •Male or female ≥18 years of age at clinic visit.
- •Documentation of moderate-severe psoriasis or atypical psoriasis.
- •Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
排除标准
- •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
- •Tuberculosis, active serious infection, active systemic malignancy,
- •Received a systemic medication for psoriasis within 3 months of study screening
结局指标
主要结局
Psoriasis Area and Severity Index (PASI) Score
时间窗: baseline and 3 months
Psoriasis Area and Severity Index (PASI) is a measure of psoriasis severity. The maximum score is 72, minimum score is 0. The higher the number, the more severe the psoriasis is.
次要结局
未报告次要终点