NCT04774809终止2 期
A Randomized, Double-blind, Vehicle-Controlled, Phase II/Ⅲ Seamless Adaptive Clinical Trail to Evaluate the Efficacy and Safety of SHR0302 Ointment in Adult Patients With Vitiligo
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 16
- 主要终点
- Phase 3
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of SHR0302 ointment in adult patients with Vitiligo.
详细描述
This study is a phase II/Ⅲ seamless adaptive clinical trial to evaluate the efficacy and safety of SHR0302 ointment in adult patients with non-segmental vitiligo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who voluntarily signed an informed consent form.
- •Ages at ≥18 and ≤ 65 years
- •Clinical diagnosis of non-segmental vitiligo.
- •All women and men who are likely to give birth must be willing to use at least one efficient method of contraception from the signing of the informed consent form to 1 month after the last dose of IP.
- •Subjects who agree to discontinue all vitiligo-related treatments and camouflage cosmetics with therapeutic effect between screening visit and the last follow-up visit.
- •Subjects who are willing and able to comply with the scheduled visits and treatment plan, laboratory testing and other study procedures.
排除标准
- •Subjects who were diagnosed with segmental vitiligo, mixed vitiligo or unclassified vitiligo.
- •Subjects with historical or current evidence of clinically significant disease or lab test abnormalities or with disease that require the administration of prohibited drugs in this study.
- •Subjects with a malignant tumor or a history of malignant tumor (except for fully treated or resected skin non-metastatic basal cell carcinoma or squamous cell carcinoma).
- •Pregnant or lactating female subjects;
- •Subjects who have previously received JAK inhibitors therapy, systemic or oral
- •Subjects who had used any biologics within12 weeks before the baseline or 5 half-lives (whichever is longer).
- •Subjects who participated in other interventional clinical studies within 4 weeks before the baseline visit, or who were still within 5 half-lives of the last dose of the intervention clinical study drug at baseline.
- •Subjects who received a live or live-attenuated vaccination within 8 weeks before the baseline visit.
- •Any other condition that causes the subject to be unfit for the study as per discretion of the investigator.
研究组 & 干预措施
SHR0302 Low Dose
Active Comparator
Drug: SHR0302 SHR0302 Ointment BID Low Dose
干预措施: Low Dose SHR0302 Ointment BID (Drug)
SHR0302 High Dose
Active Comparator
Drug: SHR0302 SHR0302 Ointment BID High Dose
干预措施: High Dose SHR0302 Ointment BID (Drug)
结局指标
主要结局
Phase 3
时间窗: 24 weeks
Phase 3: Percentage of subjects whose face and neck vitiligo area scoring index improved by at least 75% (F-VASI75) compared with the baseline at week 24.
Phase 2
时间窗: 24 weeks
Phase 2: Percentage of change in face and neck vitiligo area scoring index (F-VASI) compared with baseline at week 24.
次要结局
未报告次要终点
研究者
研究点 (16)
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