EUCTR2018-004614-18-SK进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,150
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
- 性别
- All
入选标准
- •Diagnosis of CD for at least 3 months prior to baseline
- •Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
- •Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
- •If female, subject must meet the contraception recommendations
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1045
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •Have a current diagnosis of ulcerative colitis or inflammatory bowel disease-unclassified (formerly known as indeterminate colitis) or short bowel syndrome
- •Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery.
- •Have a stoma, ileoanal pouch or ostomy
- •Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
- •Have ever received anti-IL-23p19 antibodies
研究者
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