EUCTR2020-006165-11-DE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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
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- Clinically active Crohn’s disease or fistulizing Crohn’s disease of at least 3 months duration
- •2- Endoscopic evidence of active ileocolonic Crohn's disease
- •4- 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.
- •Please refer to protocol for the overall inclusion criteria
- •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 274
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 76
排除标准
- •1-Has a draining stoma or ostomy.
- •2- Presence on screening endoscopy or history of adenomatous colonic polyps that were not removed.
- •3- Has previously received a biologic agent targeting IL-12/23 or IL-23.
- •Please refer to protocol for the overall exclusion criteria
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