NL-OMON38611已完成不适用
An open label, experimental medicine investigation of the safety and tolerability of 400 mg b.i.d. GSK2586184 in patients with moderate to severely active ulcerative colitis (200208) - 200208 (JAK)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
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, between 18 and 75 years of age inclusive.
- •* Moderate to severely active UC at least 6 months prior to Screening confirmed by colonoscopy or sigmoidoscopy with video recording, and biopsy.
- •* Mayo score of 6 to 12 points and endoscopy sub score of 2 to 3 at screening, despite concurrent treatment (see protocol page 20 for details).
- •* Females of non-childbearing potential. See protocol page 21 for details.
- •* Female partners of child-bearing potential of male participants must agree to use
- •acceptable contraception methods.
排除标准
- •* Fulminant UC, or UC limited to rectum.
- •* Previous colonic surgery, histological evidence of colonic dysplasia, or bowel stricture.
- •* Live vaccination within 4 weeks before the first dose of study medication, or a live vaccination planned during the course of the study.
- •* Acute or chronic infections (see protocol page 22 for details).
- •* Females of child-bearing potential.
研究者
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