A Randomized, Double-Blind, Placebo Controlled Study Of The Efficacy, Safety, And Tolerability Of Serlopitant For The Treatment Of Pruritus In Adults And Adolescents With A History Of Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 484
- 试验地点
- 52
- 主要终点
- Change in WI-NRS From Baseline to Week 6
研究概览
简要总结
Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis
详细描述
This is a double-blind, randomized, placebo-controlled study. Approximately 450 subjects will be randomized in a 1:1:1 ratio to receive daily oral doses of serlopitant 1 mg, 5 mg, or placebo for 6 weeks. During the screening period, subjects will be provided with an electronic device for recording electronic diary (eDiary) assessments throughout the study. This eDiary will be used to capture efficacy endpoint data and treatment information. At the Baseline visit, eligible subjects will be randomized, and study drug dispensed beginning with a loading dose of 3 tablets to be taken at bedtime that same day. Starting on Study Day 2, subjects will take one tablet per day at bedtime. Treatment will continue for 6 weeks. The primary efficacy endpoint will be assessed during Week 6. After completion of the 6-week treatment period, all subjects will enter a 4-week follow-up period.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 13 years or older
- •Pruritus prior to and during the initial screening period
- •Diagnosis of atopic dermatitis
- •Judged to be in good health in the investigator's opinion
排除标准
- •Prior treatment with study drug or similar drug
- •Pruritus due to another reason besides atopic dermatitis
- •Presence of any medical condition or disability that could interfere with study
- •History of hypersensitivity to serlopitant or any of its components
- •Currently pregnant or male partner of pregnant female
- •Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding
研究组 & 干预措施
Serlopitant High Dose
serlopitant tablets - high dose
干预措施: Serlopitant High Dose (Drug)
Serlopitant Low Dose
serlopitant tablets - low dose
干预措施: Serlopitant Low Dose (Drug)
Placebo Oral Tablet
matching placebo tablets
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change in WI-NRS From Baseline to Week 6
时间窗: Week 6 compared to Baseline
Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.
次要结局
- Change in Quality of Life (ItchyQoL) From Baseline to Week 6(Week 6 compared to Baseline)
- WI-NRS 4-point Responder Rate at Week 6(Week 6 compared to Baseline)