NCT05696392终止4 期
An Open-Label, Single-Arm, Phase 4 Study of Ruxolitinib Cream in Adults With Atopic Dermatitis Experiencing Sleep Disturbance in the United States (MORPHEUS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 30
- 主要终点
- Change From Baseline in Total Sleep Time (TST) as Measured by Ōura Ring Wearable Device at Week 8
研究概览
简要总结
The purpose of the study is to evaluate the effect of ruxolitinib cream on sleep disturbances with participants with Atopic Dermatitis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has clinically confirmed diagnosis of active AD according to Hanifin and Rajka (1980) criteria.
- •Has at least a 2-year history of AD (information obtained from medical chart, participant's physician, or directly from the participant).
- •Has an overall BSA affected by AD of 3%-20% (excluding scalp) at the screening and baseline visits.
- •Has an IGA score ≥ 2 at the screening and baseline visits.
- •Has an Itch NRS score ≥ 4 at the screening and baseline visits.
- •Willing to complete the once-daily Itch NRS (24-hour recall period) entries at approximately the same time each day during the study.
- •Agrees to maintain a regular sleep schedule during the study period.
- •Willing and able to follow required study procedures for measuring sleep for the duration of the study.
排除标准
- •Currently using a wearable or other device for monitoring sleep patterns and unwilling to discontinue its use during the study.
- •Currently has a schedule that includes nighttime work shifts.
- •Has had significant flares or unstable course in AD (ie, condition worsened significantly or required significant change in medications, as per medical judgment) in the previous 4 weeks before screening (information obtained from medical chart, participant's physician, or directly from the participant).
- •Has received any ultraviolet B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to the screening period.
- •Has had psoralen plus ultraviolet A treatment within 4 weeks prior to the screening period.
- •Has received a nonbiological investigational product or device within 4 weeks prior to the screening period, or is currently enrolled in another investigational drug study.
- •Has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the screening period.
- •Has had prior treatment with a JAK inhibitor that was discontinued for safety reasons or tolerance problems.
- •Has a known or suspected allergy to ruxolitinib or any component of the study drug.
研究组 & 干预措施
Treatment Group: Ruxolitinib
Experimental
ruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film.
干预措施: ruxolitinib cream (Drug)
结局指标
主要结局
Change From Baseline in Total Sleep Time (TST) as Measured by Ōura Ring Wearable Device at Week 8
时间窗: Baseline; Week 8
TST is the total amount of time spent during a planned sleep episode. Decreased TST is indicative of increased sleep disturbance. Baseline TST was the average hours of sleep within the last 7 nights prior to Visit 1. The Week 8 TST was the average hours of sleep within the last 7 nights prior to Visit 3/Week 8. Change from baseline was calculated as the post-baseline value minus the baseline value.
次要结局
- Change From Baseline in PROMIS Sleep Disturbance - Short Form 8b Score (24-hour Recall) at Week 8(Baseline; Week 8)
研究者
研究点 (30)
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