An Open-Label, Phase 2, Safety, and Efficacy Study of Ruxolitinib Cream in Participants With Genital Vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 13
- 主要终点
- Percentage of Participants Achieving a Genital Vitiligo Noticeability Scale (VNS) of "4 - A Lot Less Noticeable" or "5 - No Longer Noticeable" at Week 48
研究概览
简要总结
An open-label study in which participants with non-segmental vitiligo with genital involvement will apply ruxolitinib 1.5% cream twice a day (BID) to all depigmented areas (up to 10% BSA) for up to 48 weeks. Participants should continue to treat depigmented areas identified for treatment at baseline regardless of whether the area begins to improve or fully repigment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of nonsegmental vitiligo with genital involvement
- •At least ≥ 0.25% BSA of nonsegmental vitiligo in the genital area.
- •Pigmented hair within some of the genital vitiligo areas.
- •At least 1 genital target lesion that is ≥ 0.1% BSA that has a pigmented hair within it.
- •Vitiligo on areas of the body besides the genitals.
- •Total body vitiligo area not exceeding 10% BSA.
- •Willing to have genital photography conducted.
- •Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
排除标准
- •Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders.
- •Prior or current use of depigmentation treatments (eg, monobenzone).
- •Active or recurrent genital warts or herpes.
- •Male participants with partners with known current/active cervical intraepithelial neoplasia or anal intraepithelial neoplasia.
- •An active sexually transmitted disease, sexually transmitted infection, or other skin disorder affecting the genital area (eg, scabies, fungal infection, molluscum).
- •Had ≥ 3 laser hair removal treatments in an area to be treated for vitiligo.
- •Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study or interpretation of study data.
- •Clinical laboratory test results outside of protocol defined ranges
- •Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
研究组 & 干预措施
Ruxolitinib Cream
Participants with non-segmental vitiligo with genital involvement will receive ruxolitinib 1.5% cream BID for up to 48 weeks
干预措施: Ruxolitinib Cream (Drug)
结局指标
主要结局
Percentage of Participants Achieving a Genital Vitiligo Noticeability Scale (VNS) of "4 - A Lot Less Noticeable" or "5 - No Longer Noticeable" at Week 48
时间窗: Baseline; Week 48
The VNS is a patient-reported measure of vitiligo treatment success that has a 5-point scale. The participant was asked to respond to the following query: "Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, or (5) no longer noticeable. The baseline genital photograph was shown to the participant for reference. A VNS score of 4 or 5 can be interpreted as representing treatment success.
次要结局
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to approximately 14 months)
- Percentage of Participants Achieving Genital-Physician Global Vitiligo Assessment (PhGVA) of 0 or 1 at Week 48(Week 48)
- Change From Baseline in Affected Body Surface Area (BSA) in the Genital Region at Weeks 24 and 48(Baseline; Weeks 24 and 48)
- Percentage of Participants Achieving ≥50% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI50) at Weeks 24 and 48(Baseline; Weeks 24 and 48)
- Percentage of Participants Achieving ≥75% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI75) at Weeks 24 and 48(Baseline; Weeks 24 and 48)
- Percentage of Participants Achieving ≥90% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI90) at Weeks 24 and 48(Baseline; Weeks 24 and 48)
- Percentage of Participants Achieving a Genital VNS of "4 - A Lot Less Noticeable" or "5 - No Longer Noticeable" at Week 24(Baseline; Week 24)
- Percentage of Participants in Each Category of the Color-matching Question at Weeks 24 and 48(Baseline; Weeks 24 and 48)