NL-OMON54524已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis - M16-067
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AbbVie B.V.
- 入组人数
- 16
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
- 18 至 99（—）
入选标准
- •- Male or female aged >= 18 to <= 80 years, or minimum age of adult consent
- •according to local regulations at the Baseline Visit. In addition for sub-study
- •2 only: Where locally permissible, subjects 16 to < 18 years of age who meet
- •the definition of Tanner stage 5 for development at the Baseline Visit
- •- Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to
- •- Active UC.
- •- Demonstrated intolerance or inadequate response to one or more of then
- •following categories of drugs: aminosalicylates, oral locally acting sterioids,
- •systemic steroids, immunomodulators, and/or biologic therapies
排除标准
- •- Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel
- •disease-unclassified (IBD-U) or a history of radiation or ischemic colitis.
- •- Subject receiving prohibited medications and treatment.
- •- Extent of inflammatory disease limited to the rectum as assessed by screening
- •- Subject with currently known complications of UC.
研究者
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