NCT01900782撤回3 期
A Randomized, Double-blind, Double-dummy, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- PASI (psoriasis area and severity index) and IGA (investigator's global assessment)
研究概览
简要总结
This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type 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
- •Chronic plaque-type psoriasis, moderate to severe
- •Candidate for systemic therapy defined as having psoriasis not adequately controlled by: topical treatment, phototherapy and/or previous systemic therapy
排除标准
- •Forms of psoriasis other than chronic plaque-type
- •Ongoing use of treatments not allowed for psoriasis
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
PASI (psoriasis area and severity index) and IGA (investigator's global assessment)
时间窗: Week 12
次要结局
- Patient reported outcome questionnaires(Week 12 and 52)
- PASI (psoriasis area and severity index) and IGA (investigator's global assessment)(Week 52)
- Vital signs, laboratory values, electrocardiograms (ECG), adverse events(Week 12 and 52)
研究者
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