NCT00884169已完成2 期
Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Severity of plaque psoriasis
研究概览
简要总结
This study is to investigate the efficacy and safety of M518101 in male and female plaque psoriasis patients with refractory plaques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（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 between 18 and 65 years 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 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 24 weeks
- •Who have been treated with systemic therapy within 8 weeks
- •Who have been treated with biologics within 12 weeks
- •Who have been treated with topical therapy during the wash-out and lead-in period.
结局指标
主要结局
Severity of plaque psoriasis
次要结局
- Investigator and Patient overall assessment
研究者
研究点 (2)
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