2025-521889-95-00招募中4 期
Efficacy of MIrikizumab to achieve traNsmural healing in patiENTs with Crohn’s Disease : EMINENT CD
Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif6 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2026年2月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 6
- 主要终点
- Transmural response (TR25): decrease of at least (>=) 25% of C-score in each and all active segment from baseline to week 24
研究概览
简要总结
To describe the efficacy of mirikizumab therapy to achieve transmural response in patients with CD.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Experimental arm - mirikizumab
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with CD
- •≥ 18 years-old ≤ 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
- •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
- •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
- •Contra-indication to mirikizumab
- •Definitive ostomy
- •Colectomy with IPAA
- •Isolated or uncontrolled perianal lesions
- •Severe obstructive symptoms
- •Intra-abdominal abscess
- •Contra-indication to MRI
结局指标
主要结局
Transmural response (TR25): decrease of at least (>=) 25% of C-score in each and all active segment from baseline to week 24
Transmural response (TR25): decrease of at least (>=) 25% of C-score in each and all active segment from baseline to week 24
次要结局
- Composite endpoint combining clinical remission and transmural response (TR25) at 6 months
- Clinical remission will be defined according to PRO-2
- Transmural response will be defined as a decrease of at least 25% of C-score in each active segment at baseline
- Improvement or normalization of bowel urgency according to UNRS and Urgent score BU clinical meaningful improvement was defined as decrease of >=3 points
- BU Remission was defined as UNRS =<2
- Transmural response (TR50): decrease of at least 50% of C-score in each active segment at baseline
- Transmural healing: C-score < 0.5 in each active segment at baseline/TRENCH definition
- Complete transmural healing: C-score = 0 in each active segment at baseline
- MaRIA at 6 months
- IUS transmural response/healing at week 4,8, 12 and 24
- Bowel damage (Lemann Index) at 6 and 18 months
- Clinical response and remission at week 4,8, 12 and 24
- Biochemical remission at week 4,8, 12 and 24
- Drug retention
- IBD-disability index
- IBDQ
- 10 points-Acceptability numerical scale (ANS)
- Adverse events and severe adverse events
研究者
Anthony BUISSON
Scientific
Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif
研究点 (6)
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