NCT04530344已完成3 期
A Double-Blind, Vehicle-Controlled, Randomized Withdrawal and Treatment Extension Study to Assess the Long-Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 458
- 试验地点
- 84
- 主要终点
- Time to Relapse (Defined as <F-VASI75)
研究概览
简要总结
The purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who have completed either Study NCT04052425 or NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream BID for the previous 28 to 52 weeks depending on their initial randomization in the parent study.
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
- Double (Participant, Investigator)
盲法说明
Double Blind
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently enrolled and receiving treatment in INCB 18424-306 (NCT04052425) or INCB 18424-307 (NCT04057573) studies evaluating ruxolitinib cream in participants with vitiligo.
- •Currently tolerating ruxolitinib cream in the parent study and no safety concerns per investigators judgment.
- •Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
- •Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.
- •Male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child.
- •Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and written assent from the participant when possible.
排除标准
- •Has been permanently discontinued from study treatment in the parent study for any reason.
- •Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
- •Pregnant or breastfeeding woman.
- •Participants who live with anyone participating in any current Incyte-sponsored ruxolitinib cream study.
研究组 & 干预措施
Cohort A : ruxolitinib cream
Experimental
Participants who achieve complete or almost complete facial repigmentation (achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to ruxolitinib cream.
干预措施: ruxolitinib (Drug)
Cohort A : Vehicle
Placebo Comparator
Participants who achieve complete or almost complete facial repigmentation (ie, achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to vehicle cream.
干预措施: Vehicle (Drug)
Cohort B : roxolitinib cream
Experimental
Participants who did not achieve ≥ F-VASI90 at Week 52 of the parent studies will be assigned to Cohort B and will continue ruxolitinib cream.
干预措施: ruxolitinib (Drug)
结局指标
主要结局
Time to Relapse (Defined as <F-VASI75)
时间窗: from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study)
Relapse was defined as a loss of 75% improvement from Baseline in the Face Vitiligo Area Scoring Index score (F-VASI75) response, assessed as percentage improvement in the F-VASI score at Baseline (Day 1 of the parent study) to \<75%.
次要结局
- Time to Loss of Adequate Response(from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study))
- Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period(up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period(up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period(up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Mean F-VASI Scores During the Extension Treatment Period(up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Change From Baseline in F-VASI Scores During the Extension Treatment Period(Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period(Baseline (BL); up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period(up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Mean T-VASI Scores During the Extension Treatment Period(up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period(up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period(up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Change From Baseline in T-VASI Scores During the Extension Treatment Period(Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period(Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period(up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Change From Baseline in F-BSA During the Extension Treatment Period(Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Percent Change From Baseline in F-BSA During the Extension Treatment Period(Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period(up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Change From Baseline in T-BSA During the Extension Treatment Period(Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Percent Change From Baseline in T-BSA During the Extension Treatment Period(Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period(Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period(Week 52; up to up to Week 104 of Extension Study (Week 52 was the first visit of this Treatment Extension study.))
- Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period(Week 52; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.))
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.))
- Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104(Weeks 80 (predose); Week 104 (any time post-dose) (Week 52 was the first visit of this Treatment Extension study.))
研究者
研究点 (84)
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