RecruitingPhase 4NCT07292012
Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease
Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease : EMINENT-CD
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Enrollment
75 participants
Start Date
May 11, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria4
- 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)
Exclusion Criteria16
- 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
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Interventions
DRUGMirikizumab - IV
Mirikizumab induction with IV infusions (900 mg) at week 0, week 4 and week 8.
DRUGMirikizumab - SC
SC injections (300 mg) at W12 and every 4 weeks For clinical responders and non-responders
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT07292012
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