2023-504737-41-00招募中3 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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 219
- 试验地点
- 39
- 主要终点
- Clinical remission at Week 12
研究概览
简要总结
To evaluate the efficacy, including clinical remission and endoscopic response, of guselkumab SC induction
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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.
结局指标
主要结局
Clinical remission at Week 12
Clinical remission at Week 12
Endoscopic response at Week 12
Endoscopic response at Week 12
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen - Cilag International
研究点 (39)
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