NCT07102888尚未招募2 期
A Phase II Clinical Study to Evaluate the Safety and Pharmacokinetics of Topical RSS0393 Ointment in Children and Adolescents With Plaque Psoriasis
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse events (AEs).
研究概览
简要总结
This study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of RSS0393 topical ointment in the treatment of plaque psoriasis in children and adolescents.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 6 years old and < 18 years old at screening.
- •History of plaque psoriasis ≥ 3 months.
- •The subjects and their parents or legal guardians voluntarily signed informed consent before any study-related procedures began.
排除标准
- •Diagnosis of psoriasis other than plaque at screening.
- •Subjects have other skin diseases or conditions that may affect the evaluation of the relevant endpoints of this study.
- •Subjects with any other persistent active autoimmune disease.
- •Subjects who have received topical medication for psoriasis within 14 days before baseline, or systemic medication or phototherapy for psoriasis within 28 days before baseline, or biological agents for psoriasis within a specified time before baseline.
研究组 & 干预措施
RSS0393 Ointment Group
Experimental
干预措施: RSS0393 Ointment (Drug)
结局指标
主要结局
Adverse events (AEs).
时间窗: About 4 weeks.
次要结局
- The trough concentration of RSS0393.(About 4 weeks.)
研究者
研究点 (1)
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