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Recruiting NCT07292012

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

Conditions: Crohn Disease (CD)

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 75
Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Location: CHU de Brest - Hôpital de la Cavale Blanche Brest

Summary

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

Eligibility Criteria

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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07292012). StuddyBuddy aggregates publicly available trial information.