EUCTR2020-000987-53-FR进行中（未招募）1 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 - TRuE-V LTE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Currently enrolled and receiving treatment in INCB 18424-306 or INCB 18424-307 studies evaluating ruxolitinib cream in participants with vitiligo.
- •2. Currently tolerating ruxolitinib cream in the parent study and no safety concerns per investigators judgment.
- •3. Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
- •4. Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.
- •5. Male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation with the exception of the following:
- •a. Females of non-childbearing potential (ie, or surgically sterile with a hysterectomy and/or bilateral oophorectomy OR postmenopausal, = 12 months of amenorrhea without an alternative medical cause).
- •b. Prepubescent adolescents (age 12-18 years old at the time enrolled in parent studies).
- •6. For adult participant, ability to comprehend and willingness to sign an ICF; for adolescent participant, written informed consent of the parent(s) or legal guardian and written assent from the adolescent participant when possible.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 380
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Has been permanently discontinued from study treatment in the parent study for any reason.
- •2. 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.
- •3. Pregnant or breastfeeding woman.
- •4. Participants who live with anyone participating in any current Incyte-sponsored ruxolitinib cream study.
研究者
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