NCT02995473已完成2 期
Multi-center, Randomized, Vehicle-controlled, Investigator-blinded, Parallel Groups Study to Evaluate the Efficacy and Safety of NP000888 in Subjects With Plaque and Nail Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 61
- 试验地点
- 8
- 主要终点
- Percent change from baseline in total mtNAPSI scores
研究概览
简要总结
This study is to evaluate the efficacy and safety of topical application of NP000888 ointment compared to vehicle in plaque and fingernail psoriasis subjects.
Duration of administration: 24 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
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with a clinical diagnosis of plaque psoriasis defined as an IGA score at least 2 (mild) at Screening and Baseline visits
- •Subject with a plaque psoriasis total Body Surface Area (BSA) involvement of at least equal to 3% but less than 20% at Screening and Baseline visits
- •Subject with a clinical diagnosis of fingernail psoriasis on at least 1 fingernail with a fingernail PGA score from 2 (mild) to 4 (severe) at Screening and Baseline visits
排除标准
- •Subject with guttata, erythrodermic, exfoliative, inverse, pustular or palmo plantar, infected or ulcerated psoriasis or psoriasis involvement >=20% BSA or an unstable form of psoriasis, defined as at least one flare in the previous month before Screening visit
- •Subject with chronic plaque psoriasis who are candidates for systemic therapy at Screening and Baseline visits
- •Subject with clinical signs of psoriatic arthritis at Screening and Baseline visits
- •Subject with a clinical diagnosis of fingernail psoriasis on at least 1 fingernail with a nail-PGA score from 2 (mild) to 4 (severe) at Screening and Baseline visits.
研究组 & 干预措施
NP000888
Experimental
Pharmaceutical form: Ointment
干预措施: NP000888 (Drug)
Vehicle
Placebo Comparator
Pharmaceutical form: Ointment
干预措施: Vehicle (Drug)
结局指标
主要结局
Percent change from baseline in total mtNAPSI scores
时间窗: Baseline - Week 24
Mean percent change from baseline in total mtNAPSI scores
Success rate in IGA score (clear or almost clear)
时间窗: Baseline - Week 12
Success rate in IGA score (clear or almost clear)
次要结局
未报告次要终点
研究者
研究点 (8)
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