An Alternative Dose Interval Study to Examine Safety and Identify Potential Biomarkers in Participants With Hidradenitis Suppurativa Receiving Brodalumab
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
Phase 0 Study of an alternative dosing interval of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa to identify biomarkers of disease activity and clinical response.
详细描述
Phase 0, Open Label study of an alternative dosing interval of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa. Consisting of n=10 patients receiving 210mg subcutaneously every week for 24 weeks. Patients will be followed for a period of 36 weeks (12 weeks after last dose of Brodalumab) to assess for safety.
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 Diagnosis of Hidradenitis Suppurativa by the PI
- •Age 18 or older
- •Moderate to Severe Hidradenitis Suppurativa as determined by the PI
- •Previously enrolled in JFR-0989
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/imunosuppressants (require washout period of >5 half lives)
- •Any medical, psychological or social condition that, in the opinion of the investigator, would jeopardize the health or well being go the participant during any study procedures or the integrity of the data
- •High Suicide Risk as determined by the Columbia Suicide Severity Rating Scale
研究组 & 干预措施
Brodalumab
Brodalumab 210mg subcutaneously every week for 24 weeks
干预措施: Brodalumab (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Week 0 to Week 24
Incidence of Grade 2/3 adverse events during the study
Biomarkers at Week 12
时间窗: Week 12 compared with baseline.
Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL
Biomarkers at Week 24
时间窗: Week 24 compared with baseline.
Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL
次要结局
- Clinical Response at Week 12 (as measured by HiSCR)(Week 12 compared with Baseline)
- Clinical Response at Week 12 (as measured by modified Sartorius Score)(Week 12 compared with Baseline)
- Clinical Response at Week 24 (as measured by modified Sartorius Score)(Week 24 compared with Baseline)
- Clinical Response at Week 12 (as measured by IHS4)(Week 12 compared with Baseline)
- Clinical Response at Week 24 (as measured by HiSCR)(Week 24 compared with Baseline)
- Clinical Response at Week 24 (as measured by IHS4)(Week 24 compared with Baseline)