NCT01873677已完成3 期
A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center Phase III Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 537
- 试验地点
- 30
- 主要终点
- Investigator Global Assessment
研究概览
简要总结
This study is to evaluate the efficacy and safety of M518101 in subjects with 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
- Double (Participant, 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
- •Who are able and willing to give signed informed consent
- •Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
- •Who have up to 20% of body surface area (BSA) afflicted with plaques
- •Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.
排除标准
- •Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity.
- •Who are pregnant or lactating.
- •Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
- •Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
- •Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study.
- •Whose serum calcium levels exceed the upper limit of reference range
- •Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization.
- •Who have been treated with systemic therapy within 30days of randomization.
- •Who have treated with biologics within 5 half-lives of the biologics before the day of randomization
- •Who have been treated with topical therapy within 14days before the day of randomization.
研究组 & 干预措施
Vehicle
Placebo Comparator
Proper quantity twice a day
干预措施: Vehicle (Drug)
M518101
Experimental
Proper quantity twice a day
干预措施: M518101 (Drug)
结局指标
主要结局
Investigator Global Assessment
时间窗: 8 weeks after dosing
次要结局
未报告次要终点
研究者
研究点 (30)
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