Psoriatic Immune Response to Tildrakizumab
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 Area and Severity Index (PASI) Score at baseline and 3 months of treatment
研究概览
简要总结
This study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the IL23 blocker, tildrakizumab.
详细描述
This is a one-arm, open-label study to examine the effect of Tildrakizumab on cutaneous and blood immune cells of psoriatic patients. Ten subjects with moderate to severe psoriasis will be enrolled. Biopsy and blood samples will be collected before and during treatment and undergo molecular profiling to assess for tildrakizumab-corrected signatures.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Patients with moderate-severe psoriasis or > 5% body surface area affected.
排除标准
- •taking systemic immunosuppressives in the last 4 weeks
- •pregnancy
- •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.
研究组 & 干预措施
Tildrakizumab treatment
Biological/vaccine: tildrakizumab
干预措施: Tildrakizumab Prefilled Syringe (Drug)
结局指标
主要结局
Change in Psoriasis Area and Severity Index (PASI) Score at baseline and 3 months of treatment
时间窗: Baseline, 3 months
Change in severity and extent of psoriasis (calculated by Psoriasis Area and Severity Index (PASI) score); scale range of 0 to 72, 72 being maximal disease.
次要结局
未报告次要终点