NCT04839380已完成2 期
An Open-Label, Single-Arm Study to Evaluate the Effect of Ruxolitinib 1.5% Cream on Itch in Adult Participants With Atopic Dermatitis
适应症
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
- 49
- 试验地点
- 2
- 主要终点
- Change From Baseline in the Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Day 2 (24-hour Recall Period After First Application)
研究概览
简要总结
The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in 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
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has clinically confirmed diagnosis of active AD for at least a 6-months.
- •Participant has chronic pruritus related to AD for at least 3 months .
- •Participant has an overall BSA (excluding palms, soles, scalp, genitals, and folds) affected by AD of 1%-20% on Day
- •Participant has an IGA score of at least 2 on Day
- •Participant has a single PP-NRS score ≥ 4 in the 24-hour period prior to the screening visit.
- •Willingness to avoid pregnancy or fathering children.
- •Participant must be willing to comply with all study procedures and restrictions including discontinuation of all current therapies for AD and pruritus (unless otherwise specified), and must be available for the duration of the study.
排除标准
- •Female participnat who is breastfeeding, pregnant, or planning to become pregnant during the study.
- •Participant had significant flares or unstable course in AD.
- •Participant has clinically infected AD or has used antibiotics (systemic or topical) for their infected AD within 2 weeks prior to the run-in period.
- •Participant has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
- •Participant has any clinically significant medical condition or physical/laboratory/vital sign abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
- •Participant has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the run-in period.
- •Participant is unlikely, in the opinion of the investigator, to be compliant with study procedures and requirements.
研究组 & 干预措施
Treatment Group : Ruxolitinib
Experimental
ruxolitinib cream 1.5% will be applied twice daily as a thin film.
干预措施: ruxolitinib cream (Drug)
结局指标
主要结局
Change From Baseline in the Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Day 2 (24-hour Recall Period After First Application)
时间窗: Baseline; Day 2
The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period.
次要结局
- Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)(Baseline; Day 3 through Day 29)
- Change From Baseline in the Modified Peak-Pruritus Numerical Rating Scale (mPP-NRS) Score (Current Itch Intensity) at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1(Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose))
- Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1(Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose))
- Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29(Baseline; Day 2 through Day 29)
- Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1(Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose))
- Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29(Baseline; Day 2 through Day 29)
- Time to Minimal Clinically Important Difference (MCID) for PP-NRS (≥2-grade Reduction in PP-NRS From Baseline )(from Baseline up to Day 29)
- Time to MCID for mPP-NRS (≥2-grade Reduction in mPP-NRS From Baseline)(Baseline; Day 1)
- Change From Baseline in Investigator Global Assessment (IGA) at Day 8, Day 15, and Day 29(Baseline; Days 8, 15, and 29)
- Percentage of Participants Achieving Investigator Global Assessment-Treatment Success (IGA-TS) (Score of 0 or 1 in IGA With a ≥2-grade Reduction From Baseline) at Day 8, Day 15, and Day 29(Baseline; Days 8, 15, and 29)
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to Day 43)
- Number of Participants With Any Grade 3 or Higher TEAE(up to Day 43)
研究者
研究点 (2)
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