NCT02888236已完成2 期
LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Psoriasis Area and Severity Index (PASI) at week 16
研究概览
简要总结
A study of LEO 32731 in the treatment of psoriasis vulgaris
详细描述
This is an investigation of the efficacy of LEO 32731 30 mg as compared to placebo after 16 weeks of oral treatment of psoriasis vulgaris
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed and dated informed consent
- •Aged between 18 years and
- •Males or females of non-childbearing potential.
- •Clinical diagnosis of psoriasis vulgaris with or without psoriatic arthritis
- •Have moderate to severe psoriasis vulgaris
- •Candidates of systemic anti-psoriatic treatment and/or phototherapy
排除标准
- •Subjects with therapy resistant psoriasis
- •Previously exposed to apremilast
- •Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris
- •Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris
研究组 & 干预措施
LEO 32731 tablet
Experimental
LEO 32731 30 mg two times daily for 16 weeks
干预措施: LEO 32731 (Drug)
LEO 32731 Placebo tablet
Placebo Comparator
LEO 32731 placebo two times daily for 16 weeks
干预措施: LEO 32731 Placebo (Drug)
结局指标
主要结局
Psoriasis Area and Severity Index (PASI) at week 16
时间窗: Week 16
次要结局
- Itch evaluated by itch Numerical Rating Scale (NRS) at week 16(Week 16)
- Proportion of subjects with Physician's Global Assessment of Disease Severity (PGA) treatment success, defined as clear or almost clear at week 16(Week 16)
研究者
研究点 (1)
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