NCT07049575招募中1 期
A Maximal Use Trial of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 21
- 主要终点
- Number of participants with Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the maximal use of ruxolitinib cream in adult and adolescent participants with hidradenitis suppurativa.
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of HS for at least 6 months before screening visit.
- •Diagnosis of HS (Hurley Stage I, II, III) with a total abscess and inflammatory nodule count of at least 4 and affecting at least 3 distinct anatomical areas at screening and Day 1 visits.
- •Total estimated treatment BSA > 20% at screening and baseline.
- •Agreement to not use topical or systemic antibiotics for treatment of HS during the Maximal Use Treatment Period.
- •Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol.
- •Further inclusion criteria apply.
排除标准
- •Current or history of skin condition(s) other than HS that might confound the evaluation of HS; clinically uncontrolled cardiovascular disease; thrombosis; certain cancers; certain infections; severe anemia, thrombocytopenia, or neutropenia; other medical conditions at the discretion of the investigator.
- •Laboratory values outside of the protocol-defined ranges.
- •Further exclusion criteria apply.
研究组 & 干预措施
Ruxolitinib 1.5 % Cream
Experimental
Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
干预措施: Ruxolitinib Cream (Drug)
结局指标
主要结局
Number of participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 24 weeks
Defined as adverse events reported for the first time or worsening of a pre-existing event after the first application of study drug.
Number of participants with TEAEs leading to treatment interruption, discontinuation
时间窗: Up to 24 weeks
Number of participants with TEAEs leading to dose interruption or discontinuation
次要结局
- Pharmacokinetics Parameter (PK): Cmax of INCB018424(Up to 24 weeks)
- Pharmacokinetics Parameter: Tmax of INCB018424(Up to 24 weeks)
- Pharmacokinetics Parameter: AUC 0-12 of INCB018424(Up to 24 weeks)
研究者
研究点 (21)
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