jRCT2031220426进行中（未招募）不适用
A Phase 3, 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 Ulcerative Colitis (ASTRO)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 主要终点
- -
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 Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Signed informed consent form
- •18 years of age or older
- •Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
- •Moderately to severely active UC as per the modified Mayo score
- •Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in
- •the protocol
排除标准
- •Diagnosis of indeterminate colitis, microscopic colitis,
- •ischemic colitis, or Crohn's disease
- •Surgery within 8 weeks before screening or planned
- •surgery during the study that may confound the evaluation
- •of benefit from study intervention
- •Receiving prohibited medications and treatments
结局指标
主要结局
-
Clinical Remission:Week 12:Clinical remission per modified Mayo score.
次要结局
- Symptomatic Remission(Week 12 and 24)
- Endoscopic Improvement(Week 12 and 24)
- Clinical Response(Week 12 and 24)
- Clinical Remission(Week 24)
- Histologic-Endoscopic Mucosal Improvement(Week 12)
- Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention(Up to Week 268)
研究者
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