JPRN-jRCT2051210135暂停2 期
[M20-371]A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacyof ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD
Yamazaki Hayato0 个研究点目标入组 265 人开始时间: 2021年12月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 265
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of Crohn's Disease (CD) for at least 3 months prior to Baseline of the Induction Period.
- •- Crohn's Disease Activity Index (CDAI) score 220 to 450 at Baseline of the Induction Period.
- •- Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's
- •Disease (SES-CD) of >= 6 for ileocolonic or colonic disease or SES-CD of >= 4 for isolated ileal disease as scored by a central reader. All eligible scores must exclude the presence of narrowing component.
- •- Demonstrated intolerance or inadequate response to one or more of the following biologic agents: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, or ustekinumab.
排除标准
- •- Participants with prior intolerance to adalimumab.
研究者
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