NCT01101100终止2 期
A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Percent Change in Psoriasis Area and Severity Index (PASI)
研究概览
简要总结
This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing.
详细描述
This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing of AMG 827 for up to 362 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Subject was randomized into Study 20090062 and completed the week 16 evaluation.
排除标准
- •Subject had any Serious Adverse Event (SAE) reported during Study 20090062 that was considered possibly related to IP.
- •Subject experienced an adverse event in Study 20090062 that, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject.
研究组 & 干预措施
AMG 827
Experimental
AMG 827
干预措施: AMG 827 (Drug)
结局指标
主要结局
Percent Change in Psoriasis Area and Severity Index (PASI)
时间窗: 264 weeks
Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement.
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1)
时间窗: 264 weeks
Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1)
次要结局
未报告次要终点
研究者
研究点 (1)
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