A Phase 3, Multi-center, Open-label Continuation Study in Moderate to Severe Plaque Psoriasis in Subjects Who Completed a Preceding Psoriasis Study With ABT-874
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,301
- 试验地点
- 152
- 主要终点
- Proportion of subjects achieving a > PASI 50 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit.
研究概览
简要总结
The purpose of this study is to evaluate long term safety, efficacy and tolerability of ABT-874 in adults with moderate to severe psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Having participated in a preceding ABT-874 clinical trial for ABT-874
- •Subject has a clinical diagnosis of moderate to severe plaque psoriasis
排除标准
- •Subjects who prematurely discontinued in any preceding psoriasis study with ABT-874 other than protocol-required discontinuation
研究组 & 干预措施
1
干预措施: ABT-874 (Drug)
结局指标
主要结局
Proportion of subjects achieving a > PASI 50 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit.
时间窗: Visit (12 weeks)
Proportion of subjects achieving PGA "clear" (0) or "minimal" (1) scores by visit.
时间窗: Visit (12 weeks)
Proportion of subjects achieving a > PASI 75 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit.
时间窗: Visit (12 weeks)
AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study
时间窗: Visit (12 weeks)
次要结局
未报告次要终点