Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease : EMINENT-CD
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 12
- 主要终点
- Transmural response (TR25)
研究概览
简要总结
Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CD
- •≥ 18 to ≤ 75 years-old
- •Symptomatic CD according to PRO-2 (stool > 3 or abdominal pain score > 1)
- •Transmural inflammation on baseline MRI (C-score > 0.5 in at least one segment)
排除标准
- •Prior exposure to anti-p19 biological therapy
- •Exposure to more than 1 class of advanced therapies at a dose approved for the treatment of Crohn's disease (janus kinase [JAK] inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or approved biosimilars for these agents
- •Exclude any previous use of p19 IL23s agents
- •Contra-indication to mirikizumab
- •Definitive ostomy
- •Colectomy with IPAA
- •Isolated or uncontrolled perianal lesions
- •Severe obstructive symptoms
- •Intra-abdominal abscess
- •Contra-indication to MRI
- •No health insurance
- •Pregnant or lactating women
- •Patients already included in biomedical research other than an observational study (e.g., registry, cohort)
- •Concomitant Clostridioides difficile infection
- •HIV infection
- •Patient under guardianship, curatorship or safeguard of justice
研究组 & 干预措施
Mirikizumab treatment
Mirikizumab will be used as scheduled in the drug label: induction with IV infusions (900 mg) at week 0, week 4 and week 8.
For clinical responders: SC injections (300 mg) at W12 and every 4 weeks For clinical non-responders: SC injections (300 mg) at W12 and every 4 weeks
干预措施: Mirikizumab - SC (Drug)
Mirikizumab treatment
Mirikizumab will be used as scheduled in the drug label: induction with IV infusions (900 mg) at week 0, week 4 and week 8.
For clinical responders: SC injections (300 mg) at W12 and every 4 weeks For clinical non-responders: SC injections (300 mg) at W12 and every 4 weeks
干预措施: Mirikizumab - IV (Drug)
结局指标
主要结局
Transmural response (TR25)
时间窗: From week 0 to week 24
Transmural response (TR25) define as the decrease of at least (\>=) 25% of C-score in each and all active segment from baseline to week 24
次要结局
- Transmural healing(at Week 0, Week 24, Week 76)
- BU clinical meaningful improvement(Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76)
- Clinical remission(Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76)
- Improvement or normalization of bowel urgency(Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76)
- Transmural response (TR50)(Week 0, Week 24, Week 76)
- Disease activity(Week 0, Week 24, Week 76)
- IUS transmural response/healing(Week 4, Week 8, Week 12, Week 24)
- Bowel damage(Week 24, Week 76)
- Transmural response (TR25)(Week 0, Week 4, Week 24, Week 76)