A Maximal Use Trial of Ruxolitinib Cream in Adult Participants With Prurigo Nodularis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 20
- 主要终点
- Number of participants with Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This study is being conducted to determine the safety and tolerability of ruxolitinib 1.5% cream under maximal use conditions in participants with Prurigo Nodularis (PN).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of PN ≥ 3 months before screening.
- •Pruriginous lesions (defined as papules, nodules, plaques, umbilicated lesions, and linear lesions) on ≥ 2 different body areas (such as right and left leg) at screening and baseline.
- •Total estimated treatment BSA ≥ 25% (excluding the scalp) at screening and baseline.
- •IGA-CPG-S score of ≥ 2 at screening and baseline.
- •Baseline PN-related WI-NRS score ≥
- •Baseline WI-NRS score is defined as the 7-day average of WI-NRS scores before Day 1 (data from a minimum of 4 out of 7 days prior to Day 1 is needed).
排除标准
- •Chronic or acute pruritus due to a condition other than PN.
- •Active AD lesions (signs and symptoms other than dry skin) within 6 months of screening and baseline.
- •Acute or chronic active HBV or HCV infection.
- •Any underlying condition known to be associated with the clinical presentation of PN that is not under control (stable) prior to the baseline visit.
- •Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- •Other protocol-defined Inclusion/Exclusion Criteria may apply.
研究组 & 干预措施
Maximal Use Ruxolitinib 1.5%
Participants will apply ruxolitinib 1.5% cream BID through Week 4 to all pruriginous lesions. At Week 4, participants who have completed 4 weeks of treatment with no safety concerns may enter the optional 4-week treatment extension period, during which all participants will apply ruxolitinib 1.5% cream BID to existing pruriginous lesions.
干预措施: Ruxolitinib Cream 1.5% (Drug)
结局指标
主要结局
Number of participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 16 weeks, including 30 days of safety follow-up
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Number of participants with TEAEs leading to dose interruption or discontinuation
时间窗: Up to 16 weeks, including 30 days of safety follow-up
Number of participants with TEAEs leading to dose interruption or discontinuation.
次要结局
- Ruxolitinib pharmacokinetic (PK) parameters in plasma(Up to 16 weeks, including 30 days of safety follow-up)