NCT06050928已完成1 期
Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria (CALM-CIndU)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 15
- 主要终点
- Safety and tolerability of EP262
研究概览
简要总结
This phase 1b trial will evaluate the effects of EP262 in subjects with Chronic Inducible Urticaria (CIndU), including symptomatic dermographism and cold urticaria.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CIndU (symptomatic dermographism or cold urticaria) for greater than 3 months and positive response to applicable skin provocation testing
- •Willing to discontinue chronic treatment with antihistamines during the study
排除标准
- •Urticaria with a clear underlying etiology other than symptomatic dermographism or cold urticaria
- •Other active skin diseases that might confound the study evaluations (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)
- •Regularly experience wheals covering the area of the body where skin testing will be conducted (eg, more than one third of the volar surface of the forearms)
研究组 & 干预措施
EP262 150 mg
Experimental
Once daily
干预措施: Oral EP262 (Drug)
结局指标
主要结局
Safety and tolerability of EP262
时间窗: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)
Assessed by the incidence of treatment-emergent adverse events
次要结局
- Change in Critical Temperature Threshold (CTT)(Measured from Baseline to Week 4)
- Change in Critical Friction Threshold (CFT)(Measured from Baseline to Week 4)
研究者
研究点 (15)
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