Baricitinib (LY3009104) 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
- Physician Global Assessment (PGA) of Skin Overall Response
研究概览
简要总结
This research study is evaluating the safety and efficacy of Baricitinib in treating Cutaneous Lichen Planus (LP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
Cutaneous LP
Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period
干预措施: Baricitinib (LY3009104) 2 mg (Drug)
Dose Escalation Extension Group
Subject that demonstrate a response to the 16 weeks of treatment with 2 mg of Baricitinib (LY3009104), but have not achieved a PGA 0 will receive 4 mg of Baricitinib (LY3009104) for 12 weeks
干预措施: Baricitinib (LY3009104) 4 mg (Drug)
结局指标
主要结局
Physician Global Assessment (PGA) of Skin Overall Response
时间窗: Week 16
Measured by Physician Global Assessment (PGA) of skin by grade. The assessment ranges from Grade 0 (completely clear with no evidence of disease; 100% improvement) to Grade 6 (worse than at baseline evaluation by ≥25%; more progressive disease).
次要结局
- Change in Skin Lesion Count(Week 16, Week 28)
- Change in Pruritus Numerical Rating Scale (NRS)(Week 16, Week 28)
- Change in Overall Skindex-16 Assessment(Week 16, Week 28)
- Change in Modified CAILS Score of the Cutaneous Index Treatment(Week 16, Week 28)
研究者
Aaron R. Mangold
Principal Investigator
Mayo Clinic