jRCT2041240200招募中不适用
A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREAT-THROUGH STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 16age old over 至 80age old under（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of UC
- •Moderately to severely active UC assessed by mMS
- •Bodyweight >= 40 kilogram (kg)
- •Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
- •Males and females of childbearing potential must meet protocol criteria for contraception requirements
排除标准
- •Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
- •Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
- •Presence of an ostomy or ileoanal pouch
- •Current diagnosis or suspicion of primary sclerosing cholangitis
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- •Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
- •History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
- •Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
- •Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
- •Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
研究者
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