Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (CALM-CSU)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 113
- 试验地点
- 48
- 主要终点
- Change From Baseline to Visit 4 (Week 6) in the Urticaria Activity Score Over a 7-day Period (UAS7)
研究概览
简要总结
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria
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
- Double (Participant, Investigator)
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
- •Documented history of chronic spontaneous urticaria (CSU) with a UAS7 greater than or equal to 16 despite stable treatment with H1 antihistamine consistent with standard of care
- •Must be on a stable dose of H1 antihistamine up to 4 times the approved dose per local treatment guidelines
排除标准
- •Urticaria with a clear underlying etiology other than CSU
- •Urticaria with a clearly defined or sole trigger (chronic inducible urticaria)
- •Other active skin diseases associated with chronic pruritus (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)
研究组 & 干预措施
EP262 50 mg
干预措施: Oral EP262 (Drug)
EP262 150 mg
干预措施: Oral EP262 (Drug)
Placebo
干预措施: Placebo (Drug)
EP262 25 mg
干预措施: Oral EP262 (Drug)
结局指标
主要结局
Change From Baseline to Visit 4 (Week 6) in the Urticaria Activity Score Over a 7-day Period (UAS7)
时间窗: Baseline; Week 6
The UAS is a chronic spontaneous urticaria (CSU)-specific, 24-hour self-evaluation, patient-reported outcome measure based on the assessment of key CSU symptoms: intensity of itch (assessed as the Itch Severity Score \[ISS\]) and number of wheals (assessed as the Hive Severity Score \[HSS\]). The UAS scales for both itch and wheal assessment are recorded as a score from 0 to 3, with 0 representing no itch/hives to 3 representing intense itch/hives. ISS and HSS scores are summed over 7 consecutive days to create the ISS7 and HSS7 scores, which range from 0 to 21. Higher scores indicate greater disease severity. The UAS score is the sum of the ISS and HSS scores. Daily UAS scores are summed over 7 consecutive days to create the UAS7 score, which ranges from 0 to 42. Higher scores indicate greater disease severity. The 7 daily UAS/ISS/HSS scores prior to or on the nominal Visit 4 (Week 6) date (including the nominal Week 6 visit date UAS/ISS/HSS score) were summed.
次要结局
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to 81 days)
- Number of Participants With Any ≥Grade 3 TEAE(up to 81 days)
- Number of Participants With Any Clinically Meaningful Change From Baseline in Electrocardiogram Parameters(up to 81 days)
- Number of Participants With Any Clinically Meaningful Change From Baseline in Vital Sign Measurements(up to 81 days)
- Number of Participants With Any Clinically Meaningful Change From Baseline in Clinical Laboratory Test Results(up to 81 days)
- Change From Baseline to Visit 4 (Week 6) in the Itch Severity Score Over a 7-day Period (ISS7)(Baseline; Week 6)
- Change From Baseline to Visit 4 (Week 6) in the Hive Severity Score Over a 7-day Period (HSS7)(Baseline; Week 6)