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

Recruiting · NCT07292012 · Interventional (participants receive a specific treatment) · Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Interventions studied

Mirikizumab - IVMirikizumab - SC

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

Age range

18 Years to 75 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 4

Study type

Interventional (participants receive a specific treatment)

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)

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

6 locations listed.