NCT03630939已完成1 期
A Multicenter, Double-Blind, Randomized, Vehicle-Controlled Phase 1/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 Gel in Subjects With Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 10
- 主要终点
- Change in Total Lesion Severity Score
研究概览
简要总结
This is a multicenter, double-blind, randomized, vehicle-controlled, parallel-group proof-of-concept study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of topically applied ESR-114 following twice daily (BID) application for 42 days (6 weeks).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a history of plaque psoriasis for at least 6 months.
- •Subject has PGA of mild (2) or moderate (3) at Day
- •Subject has total LSS of ≥6 at Day
- •Subjects with plaque psoriasis-affected BSA to be treated of 1% to 15% at Screening and Day 1.
排除标准
- •Subject has non-plaque psoriasis at Screening and Day
- •Subject has a history of skin disease or presence of skin condition that, in the opinion of the Investigator, would interfere with the study assessments at Screening and Day
- •Subject has used any topical therapy to treat psoriasis within 2 weeks prior to Day 1.
研究组 & 干预措施
ESR-114 1.5%
Experimental
ESR-114 1.5% Topical Gel BID for 6 weeks
干预措施: ESR-114 (Drug)
ESR-114 5.0%
Experimental
ESR-114 5.0% Topical Gel BID for 6 weeks
干预措施: ESR-114 (Drug)
Vehicle Gel
Placebo Comparator
Placebo Topical Gel BID for 6 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Change in Total Lesion Severity Score
时间窗: 6 weeks
Change from Baseline in Total Lesion Severity Score (sum of scores for Induration, Erythema, \& Desquamation; score range: 0-12; lower score is better outcome) at Week 6
次要结局
- Change from Baseline in erythema score over time(6 weeks)
- Change from Baseline in induration score over time(6 weeks)
- Proportion of subjects with PASI75(6 weeks)
- Proportion of subjects with clear or almost clear on the Physician Global Assessment(6 weeks)
- Change from Baseline in desquamation score over time(6 weeks)
研究者
研究点 (10)
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