EUCTR2012-004098-26-CZ进行中（未招募）1 期
A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening.
- •Men or women age 18 - 65 years at the time of screening.
- •Moderate-severe active CD, defined by a CDAI score of = 220 and = 450 at Day 1.
- •No known history of active TB.
- •Received at least one anti-TNFa agent for the treatment of CD and did not initially respond.
- •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 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant or breastfeeding women.
- •Presence of ileostomy and/or colostomy.
- •Short bowel syndrome.
- •Bowel performation or obstruction.
- •History of cancer.
研究者
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