A Small Pilot Study to Develop Biomarkers of Weekly Brodalumab Administration in Hidradenitis Suppurativa Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Interleukin-17 receptor A (IL-17RA) saturation during brodalumab administration at week 12 vs baseline
研究概览
简要总结
Hidradenitis suppurativa is a disease involving skin folds, causing swelling of the skin and surrounding tissues, pain, and foul-smelling discharges. Effective treatment options are lacking. Recently, clinical trials conducted in our lab found Brodalumab was an effective drug for this disease. Weekly dosing achieved superior therapeutic outcomes compared to a dosing given once in every other week. Brodalumab was safe in both regimens, but blood and tissue studies to better understand this response are still needed. By performing this small pilot study and collecting blood and tissue samples from participants treated with Brodalumab once weekly we would like to better characterize the molecular response to this treatment, identify blood and tissue markers reflecting disease severity, and better understand disease mechanisms.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed clinical diagnosis of Hidradenitis Suppurativa by the Principal Investigator
- •Age 18 to 99 years old
- •Moderate to severe Hidradenitis Suppurativa with draining tunnels (Hidradenitis Suppurativa Severity Score System/IHS4>4)
- •Must have medical insurance that is willing to pay for the study drug throughout the duration of the study
排除标准
- •Inflammatory Bowel Disease
- •HIV Positive
- •Active Hepatitis B or C Infection
- •Pregnant or Breastfeeding
- •No concurrent use of any systemic antibiotics/retinoids/immunosuppressants/biologics (require washout period of >5 half-lives)
- •A Score of >10 on the Beck's Depression Inventory (BDI) or on the Patient Health Questionnaire (PHQ)-9
- •History of Keloid Scarring
- •Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data
研究组 & 干预措施
Brodalumab treated moderate-to-severe HS patients
Weekly Brodalumab treatment 210mg/1.5ml, given subcutaneously for 12 weeks.
干预措施: Brodalumab (Drug)
结局指标
主要结局
Interleukin-17 receptor A (IL-17RA) saturation during brodalumab administration at week 12 vs baseline
时间窗: 12 weeks
Percentage change in saturation
次要结局
- Change in levels of IL-17A, IL-17C, IL-17, CXCL1, and CXCL8(12 weeks)
- Correlate IL-17R saturation (measured by the frequencies of immune cells positive to IL-17RA by flow cytometry) with clinical measures, such as pain or the Hidradenitis Suppurativa Severity Score System (IHS4)(12 weeks)
研究者
Yael Renert-Yuval
Instructor in clinical investigation
Rockefeller University