NCT00987870已完成1 期
A Proof of Concept Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Topical Administrations of BFH772 in Patients With 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
- 15
- 试验地点
- 1
- 主要终点
- Measure: Plaque PASI score
研究概览
简要总结
This study will determine the efficacy of topical BFH772 in psoriasis patients and the safety after multiple dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- •Stable mild to moderate plaque psoriasis (BSA involvement < 10% or PASI < 10
- •Category "mild to moderate" on PGA as according to the EMEA (CHMP 2004) (Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis), with or without arthritis
- •Diagnosed or history of psoriasis for at least 6 months prior to screening
排除标准
- •Nonplaque forms of psoriasis
- •Drug-induced psoriasis
- •Current use of beta blockers
- •Congestive heart failure (NYHA >III), QT interval >450msec or poorly controlled diabetes mellitus
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BFH772 cream 1%
Experimental
干预措施: BFH772 (Drug)
Placebo to BFH772 cream 1%
Placebo Comparator
干预措施: Placebo (Drug)
BFH772 ointment 1%
Experimental
干预措施: BFH772 (Drug)
Placebo to BFH772 ointment
Placebo Comparator
干预措施: Placebo (Drug)
calcipotriol/betamethasone ointment
Active Comparator
干预措施: calcipotriol/betamethasone (Drug)
结局指标
主要结局
Measure: Plaque PASI score
时间窗: 4 weeks
次要结局
- Measure: Local tolerability(Time Frame: baseline (predose Day 1) and 1h, 3h, 6h after the morning dose, then before each application (morning and evening) until the morning application on Day 5 and then at each visit before the morning application, and at study completion)
- Measure: BFH772 concentration in plasma(Day 1: Pre-dose; 4h post dose.)
- Measure: BFH772 concentration in skin(Week 4)
研究者
研究点 (1)
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