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