INCB018424 in the Treatment of Cutaneous Lichen Planus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Total Body Lesion Count
研究概览
简要总结
To evaluate the safety and efficacy of INCB018424 PHOSPHATE CREAM in cutaneous LP as assessed by the change in Physician Global Assessment (PGA), Body Surface Area (BSA), Index Treatment and Control Lesion by Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (CAILS) score, Pruritus Numerical Rating Scale (NRS), and Skindex-16. To predict responses through the identification of unique biomarkers of LP at week 0 and utilizing RNA sequencing on responsive and non-responsive tissue at week 4.
详细描述
This is a single center, exploratory, open-label, single-arm design study of 12 patients. Treatment naïve and treatment refractory patients with LP will be treated with INCB018424 PHOSPHATE CREAM. Patients who are non-responders, to physician choice standard of care, will undergo a washout period and will be enrolled in the study. The study consists of 3 epochs: screening/washout period (of at least 1 week and up to 4 weeks), treatment epoch (of 8 weeks from screen/washout), and follow up epoch (of 4 weeks). The screening and washout period will allow for treatment naïve/ new diagnosis LP to undergo evaluation and diagnosis and for treatment refractory to undergo a washout. The total duration of the study will be 13-16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
INCB018424
INCB018424 Cream
干预措施: INCB018424 (Drug)
结局指标
主要结局
Change in Total Body Lesion Count
时间窗: week 0, week 4
The number of total body lesions.
Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS)
时间窗: week 0, week 4
mCAILS summation score as measured by Erythema (0-8), Scaling (0-8) Plaque elevation (0-8) Hyper/hypopigmentation (0-8) Size (0-18), Total score ranging from 0-50 with higher score indicating higher severity
次要结局
- Change in Pruritus Numerical Rating Scale(week 0, week 4)
- Change in Overall Quality of Life Skindex-16 Score(week 0, week 4)
- Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score(week 0, week 4)
- Body Surface Area (BSA) Affected by Cutaneous Lichen Planus(week 0, week 4)
研究者
Aaron R. Mangold
Assistant Professor of Dermatology
Mayo Clinic