NL-OMON47670已完成2 期
Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy - BI 655130 in patient with mild to moderate ulcerative colitis.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
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 64（—）
入选标准
- •- 18 * 60 years at screening and randomisation
- •- Diagnosis of ulcerative colitis *5 months prior to screening
- •- ReceivingTNFi treatment with doses (i.e. dose and dosing interval) unchanged for *4 months prior to randomisation
- •- Mild or moderate disease activity, defined as total Mayo Score (MCS) (*10)
- •- Further criteria apply, refer to protocol section 3.3.2.
排除标准
- •- Prior use of more than one different TNF inhibitor or vedolizumab
- •- Extensive colonic resection
- •- Evidence of infection with C. difficile or other intestinal pathogen <28 days prior to screening
- •- Active or latent tuberculosis
- •- Further criteria apply, refer to protocol section 3.3.3
研究者
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