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临床试验/NCT07244744
NCT07244744进行中(未招募)不适用

Investigating the Mechanisms of Short- and Long-term Responses to IL-23 Inhibition Using Tildrakizumab in Moderate to Severe Plaque Psoriasis Using High-definition Multiomics

University Hospital Schleswig-Holstein1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2023年6月27日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
3
试验地点
1
主要终点
Change in tissue-resident memory T cells (Trm) to regulatory T cells (Treg) ratio in lesional, non-lesional, and resolved skin at weeks 2 and 16 after Tildrakizumab treatment, assessed by high-definition spatial transcriptomics (Visium HD) and high-dimen

研究概览

简要总结

Define the mechanisms underlying the short- and the long-lasting effects of IL-23 targeting in plaque PsO, by characterizing the longitudinal effects of IL-23 inhibition on the ratio of Trm/Treg cells in the skin of moderate to severe plaque PsO patients. HDST (Visium HD) and HDSP (MICS) are used to characterize the early (2 weeks) and late (16 weeks) molecular effects of treatment with tildrakizumab on the skin of three patients with moderate to severe plaque psoriasis. Non-lesional and lesional skin samples taken at the start of treatment with tildrakizumab will be used, as well as healed skin adjacent to the original sampling sites at week 2 and week 16 after the start of treatment with tildrakizumab. The same samples will be examined using Visium HD and the MACSima imaging system.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (18 years or older) with a diagnosis of moderate to severe chronic plaque psoriasis.
  • Patients eligible for treatment with an IL-23 inhibitor, specifically Tildrakizumab.

排除标准

  • Patients unable to comply with the study requirements.
  • Known hypersensitivity to IL-23 inhibitors.

结局指标

主要结局

Change in tissue-resident memory T cells (Trm) to regulatory T cells (Treg) ratio in lesional, non-lesional, and resolved skin at weeks 2 and 16 after Tildrakizumab treatment, assessed by high-definition spatial transcriptomics (Visium HD) and high-dimen

时间窗: Assessment of changes in Trm/Treg cell ratio at early (2 weeks) and late (16 weeks) time points after initiation of Tildrakizumab treatment.

次要结局

未报告次要终点

研究者

发起方
University Hospital Schleswig-Holstein
申办方类型
Other
责任方
Sponsor

研究点 (1)

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