CTIS2023-504737-41-00进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn's Disease - CNTO1959CRD3004
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 510
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Clinically active Crohn's disease or fistulizing Crohn's disease of at least 3 months duration, Endoscopic evidence of active ileocolonic Crohn's disease, Current treatment with oral corticosteroids and/or immunomodulators, OR history of failure to respond to or tolerate oral corticosteroids and/or immunomodulators, OR history of corticosteroid dependence, OR has previously demonstrated lack of initial response, lost response or were intolerant to 1 or more biologic agents.
排除标准
- •Has a draining stoma or ostomy., Presence on screening endoscopy or history of adenomatous colonic polyps that were not removed., Has previously received a biologic agent targeting IL-12/23 or IL-23.
研究者
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