JPRN-jRCT2080225202已完成3 期
A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Have Crohn's Disease (CD) or fistulizing CD of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
- •- Have moderate to severe CD as assessed by CDAI components of stool frequency (SF), and abdominal pain (AP) scores, and endoscopic evidence
- •- Have screening laboratory test results within the protocol specified parameters
- •- A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
- •- Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
排除标准
- •- Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
- •- Unstable doses of concomitant Crohn's disease therapy
- •- Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted time frame as specified in the protocol
- •- Prior exposure to p40 inhibitors or p19 inhibitors
- •- Any medical contraindications preventing study participation
研究者
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