jRCT2080222367未知2 期
A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate Efficacy and Safety of 3 dose of MEDI7183 Subcutaneously Administered in Japanese Subjects with Moderate to Severe Ulcerative Colitis
适应症
试验速览
- 阶段
- 2 期
- 发起方
- AstraZeneca
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized, Efficacy Study, Parallel Assignment, Double Blind
入排标准
- 年龄范围
- 18age old over 至 65age old under（—）
- 性别
- All
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Diagnosis of UC established by clinical and endoscopic evidence and corroborated by a histopathology report
- •Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with rectosigmoidoscopy score 2 during screening period or more
- •Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of immunomodulators or Anti- TNF-alpha agents.
排除标准
- •Disease limited to the rectum
- •Toxic megacolon
- •Crohn's Disease
- •History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC
- •Planned bowel surgery within 12 weeks from Visit 2
- •Stool positive for C. difficile toxin at screening
- •Primary Sclerosing Cholangitis
- •History of gastrointestinal surgery within 8 weeks of Visit 2
- •Any uncontrolled or clinically significant systemic disease
- •Condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluation, procedures or completion
- •Subjects with positive HBsAg, HBsAb, HBcAb or HCVAb serology at screening etc
研究者
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