Cure8 trial brief
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 an IL‑23 blocker can reduce inflammation in strictures and improve radiologic and symptom measures without immediate procedural intervention.
Adults with ileal or ileocolonic Crohn's disease and inflammatory strictures, clinicians treating stricturing CD, and researchers interested in biologic treatments targeting IL‑23 and imaging/histology endpoints.
This ClinicalTrials.gov record describes a Phase 4, open‑label, single‑arm study testing mirikizumab (an IL‑23 antagonist) in ~60 adults with ileal or ileocolonic Crohn's disease and inflammatory strictures. Participants undergo MRE and ileocolonoscopy with biopsies at screening and Week 24; the primary endpoint is radiologic response at Week 24.
Dosing: 900 mg IV at Day 1 and Weeks 4 and 8, then 300 mg SC every 4 weeks from Week 12–24. Safety labs, CRP, fecal calprotectin, and multiple PRO measures are collected; a safety follow‑up visit occurs 4 weeks after the last dose.
This is a Phase 4, open‑label, single‑arm interventional trial (recruiting). The record describes study design, eligibility, interventions, and planned assessments but does not report results. Because the trial is nonrandomized and open‑label, outcome interpretation will depend on trial conduct and comparator context.
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.
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