A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 14
- 主要终点
- Percentage of Participants With ITCH4 at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants With Lichen Sclerosus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 12 weeks followed by an open label period (OLE) period of 12 weeks.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven LS in the anogenital area.
- •Baseline IGA score ≥ 2 for LS.
- •Baseline Itch NRS score ≥ 4 in anogenital area.
- •Willingness to avoid pregnancy.
排除标准
- •Participants who do not have LS involving anogenital area.
- •Concurrent conditions and history of other diseases:
- •Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including: candidiasis, chlamydia trachomatis, trichomonas vaginalis, neisseria gonorrhoeae, bacterial vaginosis, or herpes simplex.
- •Have active genital/vulvar lesions at screening and Day 1, not related to LS
- •Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
- •Laboratory values outside of the protocol-defined criteria
- •Pregnant or lactating participants or those considering pregnancy during the period of their study participation..
- •Other exclusion criteria may apply.
研究组 & 干预措施
Ruxolitinib cream
Ruxolitinib 1.5% cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.
干预措施: Ruxolitinib cream (Drug)
Ruxolitinib cream
Ruxolitinib 1.5% cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.
干预措施: Vehicle cream (Drug)
Vehicle Cream
Vehicle cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.
干预措施: Vehicle cream (Drug)
结局指标
主要结局
Percentage of Participants With ITCH4 at Week 12
时间窗: Baseline; Week 12
ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
次要结局
- Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12(Baseline; Week 12)
- Change From Baseline in the Skin Pain NRS Score at Week 12(Baseline; Week 12)
- Time to Achieve ITCH4(up to 99.0 days)
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period(from Baseline to Week 12 plus 30 days)
- Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period(from Baseline to Week 12 plus 30 days)
- Number of Participants With Any TEAE During the Open-label Extension Period(from Week 12 to Week 24 plus 30 days)
- Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period(from Week 12 to Week 24 plus 30 days)
- Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period(from Baseline to Week 12 plus 30 days)
- Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period(from Baseline to Week 12 plus 30 days)
- Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Open-label Extension Period(from Week 12 to Week 24 plus 30 days)
- Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Open-label Extension Period(from Week 12 to Week 24 plus 30 days)