Non-interventional Study to Evaluate Cutaneous and Circulating Inflammatory Biomarkers for a Novel IRAK4-targeted Therapeutic in Hidradenitis Suppurativa and Atopic Dermatitis Patient Samples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Biomarker Identification
研究概览
简要总结
This non-intervention study will identify the biomarker profiles in hidradenitis suppurativa (HS) and atopic dermatitis (AD) (as a comparator) that would have the most utility in interventional studies evaluating efficacy during therapeutic intervention. Study data will also be used to correlate cellular/molecular changes in blood (cells and serum), and tissue, with clinical/histopathological phenotypes.
详细描述
This study is an exploratory correlative study in subjects with HS or AD. Blood samples and skin biopsies will be collected from all subjects and used to assess the following: cutaneous and circulating inflammatory biomarkers and IRAK4 target levels in primary samples, correlations between cutaneous and circulating inflammatory biomarkers and disease severity, effects of IRAK4 degradation on IRAK4 levels and downstream inflammatory biomarkers in ex vivo-treated whole blood from patients.
De-identified routine clinical data that is collected will be correlated with the research findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Age 18 or older
- •Active HS or AD disease, diagnosed by PI
- •Patients with mild (HS only), moderate, or severe disease using the HS-PGA or PGA assessment.
- •Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to participate in the study.
排除标准
- •Patient is currently on a biologic or other immunosuppressive treatment for HS or AD.
- •Use of biologic treatment for HS or AD within 3 months or 5 half-lives, whichever is longer
- •Use of non-biologic immunosuppressive treatment (eg. Cyclosporin) in the last 4 weeks.
结局指标
主要结局
Biomarker Identification
时间窗: Day 1
Assessment of cutaneous and circulating inflammatory biomarkers and IRAK4 target levels in primary samples
Determination of Biomarker Correlations
时间窗: Day 1
Determine correlations between cutaneous and circulating inflammatory biomarkers and disease severity
Examination of IRAK4 Degradation Effects Ex Vivo
时间窗: Day 1
Examine effect of IRAK4 degrader on IRAK4 levels and downstream inflammatory biomarkers in ex vivo-treated whole blood from patients
次要结局
未报告次要终点