NCT07158151进行中（未招募）2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of RSS0393 Ointment in Adults With Mild to Moderate Atopic Dermatitis
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Percentage of subjects with vIGA-AD success
研究概览
简要总结
This study is ongoing to explore the efficacy and safety of different strengths of RSS0393 ointment in adults with atopic dermatitis
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old and ≤75 years old at screening.
- •History of atopic dermatitis ≥ 6 months.
- •BSA is between 3% and 20% (inclusive) and EASI score is ≥ 5 and vIGA-AD is 2 or
- •The subjects signed informed consent before any study-related procedures began.
排除标准
- •Diagnosis of other dermatologic diseases 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
Treatment group 1: RSS0393 ointment 0.05%
Experimental
干预措施: RSS0393 ointment (Drug)
Treatment group 2: RSS0393 ointment 0.01%
Experimental
干预措施: RSS0393 ointment (Drug)
Treatment group 3: RSS0393 ointment 0.03%
Experimental
干预措施: RSS0393 ointment (Drug)
Treatment group 4: RSS0393 ointment placebo
Sham Comparator
干预措施: RSS0393 ointment (Drug)
结局指标
主要结局
Percentage of subjects with vIGA-AD success
时间窗: Baseline, week 4
The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear). IGA sucess is defined as a vIGA-AD score of 'clear' or 'almost clear' plus at least 2-grade improvement from baseline
次要结局
- Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75)(Up to 8 weeks)
- Percentage of subjects with vIGA-AD of "clear" or "almost clear"(Up to 8 weeks)
- Safety: treatment emergence adverse events(Up to 8 weeks)
- The change of WI-NRS(Up to 8 weeks)
研究者
研究点 (1)
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