A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus in Adults With Prurigo Nodularis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 49
- 主要终点
- Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10
研究概览
简要总结
Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with prurigo nodularis
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
5 mg Serlopitant Tablets
干预措施: 5mg Serlopitant Tablets (Drug)
Matching Placebo Tablets
干预措施: Placebo Tablets (Drug)
结局指标
主要结局
Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10
时间窗: At Week 10
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. Subjects were considered responders if they had at least a 4-point reduction from baseline in weekly average WI-NRS at Week 10.
次要结局
- Percent of Subjects With WI-NRS 4-point Responder at Week 2(At Week 2)
- Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10(At Weeks 2, 4, and 10)
- Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10(At Weeks 2, 4, and 10)
- Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10(At Week 10)
- Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10(At Weeks 2, 4, 6, and 10)
- Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10(At Weeks 2, 4, and 10)
- Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs)(35 days (+3 days) after Week 10 or Early Treatment Discontinuation)
- Percent of Subjects With WI-NRS 4-point Responder at Week 4(At Week 4)
- Change From Baseline in DLQI Question 1 to Week 10(At Week 10)