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Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease

RecruitingPhase 4Ages 18 Years - 75 YearsAllGroupe d'Etude Therapeutique des Affections Infla…
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In plain words

What the trial is, and whether it could suit you

Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Mirikizumab - IV
  • Mirikizumab - SC
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Where

6 sites
CHU de Brest - Hôpital de la Cavale Blanche
Brest, France
CHU de Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand, France
CHU de Nîmes Carémeau
Nîmes, France
Institut Mutualiste Monsouris
Paris, France
CHU de Toulouse - Hôpital Rangueil
Toulouse, France
CH de Valence
Valence, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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