Mirikizumab for Crohn's Disease: See if it helps heal the bowel walls

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 4 interventional study evaluating mirikizumab given by IV or subcutaneous routes in adults with Crohn's disease. Eligible participants have active symptoms and evidence of transmural inflammation on MRI. The trial will measure whether treatment leads to healing across the bowel wall and improvements in symptoms, aiming to inform long-term disease management. Exclusion criteria include prior exposure to p19 IL-23 therapies and several prior surgeries or contraindications that could affect safety or MRI participation.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU de Brest - Hôpital de la Cavale Blanche
  Brest, France Recruiting
• CHU de Clermont Ferrand - Hôpital d'Estaing
  Clermont-Ferrand, France Recruiting
• CHU de Nîmes Carémeau
  Nîmes, France Recruiting
• CHU de Toulouse - Hôpital Rangueil
  Toulouse, France Recruiting
• CH de Valence
  Valence, France Recruiting
• CHU Caen Normandie
  Caen, France Not yet recruiting

Study contacts

• Principal investigator: Anthony BUISSON, MD — University Hospital, Clermont-Ferrand
• Study coordinator: Julie MUSSOT
• Email: jmussot@getaid.org
• Phone: +33 6 27 49 29 10

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Impact of sucralose on gut health in Crohn's disease

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.