Cure8 trial brief
A Phase 4 trial is evaluating whether mirikizumab can produce MRI-defined transmural healing in adults with Crohn's disease — an objective outcome that may matter for long-term disease control beyond symptom improvement.
Adults with Crohn's disease, clinicians treating Crohn's disease, researchers studying biologic outcomes, and patients interested in biologic therapies and objective (MRI) healing measures.
This is a registered, multicenter Phase 4 trial in France enrolling adults (18–75) with symptomatic Crohn's disease and baseline transmural inflammation on MRI. Participants receive mirikizumab IV induction (900 mg at weeks 0, 4, 8) and SC 300 mg at week 12 then every 4 weeks; the main outcome is a ≥25% decrease in MRI C-score in active segments by week 24.
The study excludes people with prior exposure to p19 (anti‑IL‑23) biologics, prior use of more than one class of advanced therapies, certain surgical histories (definitive ostomy, colectomy with IPAA), uncontrolled perianal disease, abscess, contraindications to MRI, pregnancy, and other standard trial exclusions.
Practical note: The record provides protocol details (dosing, primary outcome, eligibility) but does not report results. If you are considering participation or impacted by treatment planning, discuss eligibility and potential risks/benefits with your treating clinician.
This is a clinical trial registry entry (recruiting Phase 4) that describes the study design, interventions, and eligibility but does not provide trial results. Mirikizumab is being used per its label dosing schedule in this protocol; the study excludes prior exposure to IL‑23 p19 agents.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
Long-term extension trials help show whether a drug’s benefits and safety persist over time. For people with Crohn’s disease, this study focuses on maintaining endoscopic improvement and clinical remission with...
Strictures are a common, clinically important complication of Crohn's disease that can cause obstructive symptoms and sometimes lead to endoscopic dilation or surgery.
This trial is testing whether continued mirikizumab treatment helps children and teens with ulcerative colitis or Crohn’s disease achieve and maintain remission over the long term. Results could expand pediatric...
