NCT01301157已完成2 期
Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 294
- 试验地点
- 30
- 主要终点
- severity of plaque psoriasis
研究概览
简要总结
This study is to evaluate the efficacy and safety of M518101 and the dose relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients.
详细描述
This study is to evaluate the efficacy and safety of M518101 and the dose response relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients and to confirm the persistence of the effect of M518101.
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 less than 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.
- •Who have a history of relevant drug hypersensitivity.
- •Who have a history of contact dermatitis induced by a topical medicine.
- •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 before the day of signing the ICF.
- •Who have been treated with systemic therapy within 2 weeks before the day of signing the ICF and during the wash-out period.
- •Who have been treated with biologics within 5 half-lives of the biologics before the day of randomization.
- •Who have been treated with topical therapy during the wash-out period.
研究组 & 干预措施
25ug M518101
Experimental
干预措施: M518101 (Drug)
Vehicle
Placebo Comparator
干预措施: placebo (Drug)
Dovonex
Active Comparator
干预措施: Dovonex (Drug)
50ug M518101
Experimental
干预措施: M518101 (Drug)
结局指标
主要结局
severity of plaque psoriasis
时间窗: 8 weeks after dosing
次要结局
- Investigator global assessment(8 weeks after dosing)
研究者
研究点 (30)
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