NCT01989429已完成3 期
A Randomized, Double-blind, Parallel Group Phase III Multi-center Trial to Compare Twice Daily Topical Application of M518101, Daivonex® and Vehicle in Patients With Plaque Psoriasis III
Maruho Europe Limited6 个研究点 分布在 6 个国家目标入组 788 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 788
- 试验地点
- 6
- 主要终点
- Severity of psoriasis
研究概览
简要总结
M5181 - a novel vitamin D3 analogue - is currently under development for the treatment of plaque psoriasis and is being developed as a topical ointment formulation (M518101)
Clinical and non-clinical studies indicate that M5181 is an effective treatment for plaque psoriasis.
Based on the results of previous phase II trials the phase III trial has been designed to evaluate efficacy and safety of an 8-week treatment period with 50 μg/g M518101 in a larger population of patients with stable plaque psoriasis.
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, Investigator, Outcomes Assessor)
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
- •Male or female patients aged 18 years or older on the day of signing the informed consent form (ICF)
- •Psoriasis patients with up to 20% affected body surface area ( BSA) (not including face or scalp)
- •Investigator Global Assessment(IGA) of moderate to severe and who are suitable for topical therapy
排除标准
- •Pregnant or lactating females;
- •Patients with known allergic reactions, irritations or sensitivity to vitamin D3 derivatives drug hypersensitivity to other components of the investigational products;
- •Patients who have been treated with topical steroids, topical immunosuppressive/ immunomodulative drugs, topical vitamin D3 derivative, topical retinoids, anthralin, coal tar (except when used as shampoo) salicylic acid within 14 days of randomization
- •Patients, who in the opinion of the investigator, have clinically relevant history or presence of any disease, any other skin disorder, any chronic medical condition which is not well controlled or surgical history which may interfere with the conduct of the trial
- •Patients whose calcium test at screening exceed the upper limit of reference range (including serum calcium, albumin, phosphate, parathyroid hormone);
- •Patients who have used any study drug (including experimental biologics) and/or participated in any clinical trial within the last 60 days before the day of randomization
- •Patients who have been treated with any biologics for their psoriasis within 30 days or 5 half-lives (whichever is longer) of the biologic before the day of randomization the longest documented half-life of the biologic should be used to calculate the 5 half-lives;
- •Patients who have been treated with phototherapy (laser, oral steroids, oral retinoid, oral immunosuppressive/immunomodulative drugs, cytostatics, cyclosporine or methotrexate within 30 days of randomization
研究组 & 干预措施
Daivonex
Active Comparator
topical application
干预措施: M518101 (Drug)
vehicle
Placebo Comparator
topical application
干预措施: M518101 (Drug)
M518101
Experimental
topical application
干预措施: M518101 (Drug)
结局指标
主要结局
Severity of psoriasis
时间窗: 8 weeks
% reduction in mPASI(modified psoriasis area and severity index) will be measured
次要结局
- Duration of response following 8 week treatment(8 weeks)
研究者
研究点 (6)
Loading locations...
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