jRCT2031260002尚未招募不适用
Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis
未提供0 个研究点目标入组 30 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Diagnosis of UC for >=3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening
- •Active UC with disease extent of >=15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)
- •Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of >=1, and Mayo endoscopic subscore >=2
排除标准
- •Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined
- •Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction
- •Failed 4 or more approved or investigational advanced therapy classes
研究者
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