NCT06873516已完成2 期
A Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 104
- 主要终点
- Mean change from baseline in UAS7
研究概览
简要总结
This study will evaluate the efficacy and safety of different doses of EVO756 in adults with moderate to severe chronic spontaneous urticaria (CSU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Confirmed CSU diagnosis for at least 3 months with an inadequate response to H1-antihistamines.
- •Subjects who are taking H1-antihistamines must be on a stable regimen 4 weeks prior to Day 1 and while on study.
- •Urticaria Activity Score (UAS7) equal to or greater than 16 at Day
- •UAS entries must be completed for a minimum of 4 out of the 7 days prior to Day 1.
排除标准
- •Any clinically significant abnormality in laboratory evaluations, physical examinations, vital signs, or ECG at Screening, according to the Investigator's discretion.
- •Use of certain medications.
- •History of diseases with urticaria or angioedema symptoms, other than CSU and symptomatic dermographism.
- •Significant medical history other than CSU, or any other condition which might interfere with the evaluation of CSU.
研究组 & 干预措施
Dose 2
Experimental
Orally administered EVO756, dose 2
干预措施: EVO756 (Drug)
Dose 3
Experimental
Orally administered EVO756, dose 3
干预措施: EVO756 (Drug)
Dose 1
Experimental
Orally administered EVO756, dose 1
干预措施: EVO756 (Drug)
Placebo control
Placebo Comparator
Orally administered placebo control
干预措施: Placebo control (Drug)
结局指标
主要结局
Mean change from baseline in UAS7
时间窗: Week 12
次要结局
- Percent change from baseline in UAS7(Week 12)
- Mean and percent change from baseline in UAS7(Weeks 1, 2, 4, 8)
- Mean and percent change from baseline in HSS7(Weeks 1, 2, 4, 8, 12)
- Mean and percent change from baseline in ISS7(Weeks 1, 2, 4, 8, 12)
- Mean and percent change from baseline in AAS7(Weeks 1, 2, 4, 8, 12)
- Proportion of subjects achieving UAS7 ≤ 6(Weeks 1, 2, 4, 8, 12)
- Proportion of subjects achieving UAS7 = 0(Weeks 1, 2, 4, 8, 12)
研究者
研究点 (104)
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