A Clinical Trial of Multiple Doses of GR2301 Injection in Participants With Vitiligo. (GREVIT-II)
A Phase II, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Administrations of GR2301 Injection in Participants With Vitiligo.
This is a Phase II, randomized, double-blind, placebo-controlled clinical trial of multiple subcutaneous administrations of GR2301 Injection to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics in trial participants with vitiligo. Eligible trial participants will be randomized using stratified block randomization, with competitive enrollment across sites; they will be assigned to the experimental group or the control group in the order of successful screening.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：liaison officer
- 电话号码：021-50805988-8039
- 邮箱：nianhanli@genrixbio.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Main Inclusion Criteria:
- Meet the clinical diagnosis of non-segmental vitiligo at screening visit and baseline visit, and meet the following criteria: clinical diagnosis of vitiligo for at least 3 months at screening visit; F-VASI and T-VASI scores meet the criteria at screening visit and baseline visit.
- Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and provide signed written informed consent by the trial participant or their legally authorized representative.
Main Exclusion Criteria:
- Vitiligo-related medical conditions and other dermatologic diseases/conditions.
- Prior permanent tattooing or grafting within the vitiligo lesions.
- Are unwilling or unable to comply with the permitted and prohibited concomitant medications/treatment specifications of this trial, and cannot meet the protocol-required washout period for medications/treatments prior to randomization.
- Have a serious underlying disease that, in the investigator's opinion, may pose a safety risk to the trial participant if enrolled in the clinical trial.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
|
Placebo |
|
实验性的：GR2301 injection Group1
|
IL15 monoclonal antibody |
|
实验性的：GR2301 injection Group2
|
IL15 monoclonal antibody |
|
实验性的：GR2301 injection Group3
|
IL15 monoclonal antibody |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of trial participants achieving F-VASI50 at the Week 24 (W24) visit.
大体时间：Week 24
|
VASI(vitiligo area scoring index) is a clinician-reported outcome used to assess the affected body surface area and the degree of depigmentation. F-VASI represents the assessment of facial vitiligo lesions. F-VASI50 means percentage of subjects with at least a 50% decrease from baseline in F-VASI. The higher the VASI score, the more severe the skin lesion. |
Week 24
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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