NCT05593432已完成2 期
A Randomized, Double-Blind, Vehicle-Controlled Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
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
- 64
- 试验地点
- 24
- 主要终点
- Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16
研究概览
简要总结
The purpose of this study will be to evaluate efficacy and safety of Ruxolitinib cream in participants With Cutaneous Lichen Planus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 16 weeks followed by an open label period (OLE) period of 16 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
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of LP with predominant cutaneous involvement.
- •IGA score of 3 or 4 at screening and baseline.
- •Baseline LP-related Itch NRS score ≥
- •Willingness to avoid pregnancy or fathering children.
排除标准
- •Concurrent conditions and history of other diseases:
- •Variants of LP deemed by the investigators to be inappropriate for topical treatment, including but not limited to predominant mucosal (such as oral or vaginal) LP.
- •Active ongoing inflammatory diseases of the skin other than LP that might confound the evaluation of LP lesions or compromise participant safety.
- •Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of LP lesions or compromise participant safety.
- •Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).
- •Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
- •Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, clinically infected AD, or impetigo) within 1 week 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 exclusive criteria may apply.
研究组 & 干预措施
Ruxolitinib cream
Experimental
Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.
干预措施: Ruxolitinib cream (Drug)
Ruxolitinib cream
Experimental
Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.
干预措施: Vehicle cream (Drug)
Vehicle Cream
Placebo Comparator
Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension.
干预措施: Vehicle cream (Drug)
结局指标
主要结局
Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16
时间窗: Baseline; Week 16
The Investigator's Global Assessment (IGA) is a modified global assessment tool to assess the severity of lesions. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at Week 16.
次要结局
- Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period(Baseline; Weeks 2, 4, 8, 12, and 16)
- Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period(Baseline; Weeks 18, 20, 24, 28, and 32)
- Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period(Baseline; Weeks 2, 4, 8, 12, and 16)
- Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period(Baseline; Weeks 18, 20, 24, 28, and 32)
- Time to Achieve ITCH4 in the Double-blind, Vehicle-controlled Period(up to Week 16)
- Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period(Baseline; Weeks 2, 4, 8, 12, and 16)
- Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period(Baseline; Weeks 18, 20, 24, 28, and 32)
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period(from Baseline to Week 16 plus 30 days)
- Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period(from Baseline to Week 16 plus 30 days)
- Number of Participants With Any TEAE During the Open-label Extension Period(from Week 17 to Week 32 plus 30 days)
- Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period(from Week 17 to Week 32 plus 30 days)
研究者
研究点 (24)
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