NCT06603220已完成2 期
An Open Label Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 36
- 主要终点
- Safety and tolerability
研究概览
简要总结
This phase 2a trial will evaluate the safety and efficacy of EVO756 in subjects with chronic inducible urticaria, 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of chronic inducible urticaria for at least 3 months.
- •Positive response following provocation using the TempTest or FricTest at Screening and Day 1.
排除标准
- •History of diseases other than chronic inducible urticaria or chronic spontaneous urticaria with urticaria or angioedema symptoms, such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema.
- •Concurrent use of certain medications, including antihistamines.
- •Any clinically significant disease, or other skin disease or skin markings (e.g., extensive scarring, tattoos), that might confound the evaluation of safety or efficacy.
结局指标
主要结局
Safety and tolerability
时间窗: Day 1 to Week 6
Safety will be assessed through an evaluation of treatment emergent adverse events, physical exams, vital signs, laboratory tests, and 12-lead ECGs.
次要结局
- Change in Critical Temperature Threshold (CTT)(Day 1 to Week 4)
- Change in pruritus severity at the provocation test site(Day 1 to Week 4)
- Change in Total Fric Score (TFS)(Day 1 to Week 4)
研究者
研究点 (36)
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