JPRN-jRCT2051230129招募中3 期
A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease - I6T-MC-AMAY
Masaki Takeshi0 个研究点目标入组 90 人开始时间: 2023年11月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
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
- >= 2age old 至 <= 17age old（—）
- 性别
- All
入选标准
- •Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
- •Participants must have moderately to severely active CD (as defined by a baseline PCDAI score >30).
- •Participants must have endoscopy with evidence of active CD defined as as SES-CD score >=6 (or >=4 for participants with isolated ileal disease) during screening into this study.
- •Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.
排除标准
- •Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.
- •Participants must not have an abscess.
- •Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.
研究者
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