NCT01959165已完成2 期
MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Number of Participants With Remission at Week 8
研究概览
简要总结
This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with moderate to severe UC
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of immunomodulators or Anti- TNF-α agents. etc.
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
研究组 & 干预措施
MEDI7183 dose 1
Experimental
Double blinded
干预措施: MEDI7183 low dose (Drug)
MEDI7183 dose 2
Experimental
Double blinded
干预措施: MEDI7183 medium dose (Drug)
MEDI7183 dose 3
Experimental
Double blinded
干预措施: MEDI7183 high dose (Drug)
Placebo
Placebo Comparator
Double blinded
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Number of Participants With Remission at Week 8
时间窗: 8 weeks
Remission at Week 8 was defined as a total Mayo score 2 points or smaller, and with no individual subscore more than 1 point.
次要结局
- Number of Participants With Response at Week 8(8 weeks)
- Number of Participants With Mucosal Healing at Week 8(8 weeks)
- Number of Participants With Response at Week 12(12 weeks)
研究者
研究点 (1)
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