NL-OMON35581撤回2 期
A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis (CCX115393) - CCX115393
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 20
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 and female patients 18 years or above with a history of UC for at least 3 months who remain symptomatic despite receiving oral aminosalicylate (with or without topical aminosalicylate) at a dose of >2.4mg/day mesalazine/mesalamine or equivalent for at least 2 weeks.
- •* At screening: active ulcerative colitis with spread at least 15 cm from the anal verge and MAYO score of 5-10 inclusive.
- •* Safe contraception for women of childbearing potential.
排除标准
- •* Breastfeeding, pregnancy.
- •* Known coeliac disease, those who follow a gluten-free diet to manage symptoms of suspected coeliac disease and subjects with a positive screening test for celiac disease.
- •* Known or suspicion of CD, indeterminate colitis, microscopic colitis, ischaemic colitis or radiation-induced colitis.
- •* Imminent need for surgery for UC.
- •* Bowel surgery in the past that might interfere with MAYO score.
- •* Use of prohibited medications (see protocol for details).
- •* Usual exclusion criteria for biologicals.
- •* QTc *450 msec (480 msec for those with Bundle Branch Block)
研究者
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