CTIS2023-509248-86-00招募中1 期
A phase 2/3, multicenter, randomized, double-blind study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of oral ozanimod (RPC1063) in pediatric subjects with moderately to severely active ulcerative colitis with an inadequate response to conventional therapy. - IM047-001
Celgene International II S.a.r.l.0 个研究点目标入组 128 人开始时间: 2024年2月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 128
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
- 0 至 17（—）
- 性别
- All
入选标准
- •Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit, Evidence of UC extending beyond the rectum, as determined by baseline endoscopy, Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy
排除标准
- •Diagnosis of Crohn's disease or indeterminate colitis, Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool, Apheresis within 2 weeks of randomization, History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis
研究者
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