EUCTR2021-002869-18-BE进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD - Moderate to Severe Crohn’s Disease: A Phase 2 Safety and Efficacy Study of ABBV-154
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female between 18 and 75 years of age inclusive at the time of Screening.
- •2. Confirmed diagnosis of CD for at least 3 months prior to Baseline of the Induction Period.
- •3. CDAI score 220 to 450 at Baseline of the Induction Period.
- •4. Endoscopic evidence of mucosal inflammation as documented by an 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.
- •5. Demonstrated intolerance or inadequate response to one or more of the following biologic agents: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, ustekinumab or risankizumab.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 239
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •1. Subjects with prior intolerance to adalimumab are not eligible to enroll.
- •2. Subjects who discontinued biologic agents only for reasons other than inadequate response or intolerance (e.g., change of insurance) are not eligible to enroll.
研究者
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