Cure8 trial brief
A Phase 3 trial is testing whether guselkumab can produce MRI-detected transmural healing in Crohn's disease — an outcome that could reflect deeper intestinal healing than symptom improvement alone. If successful, it may expand evidence for an IL-23–targeted biologic in Crohn's disease.
Adults with moderate-to-severe Crohn's disease; clinicians managing IBD; researchers studying biologics, imaging endpoints, or transmural healing; patients on or considering biologic therapy.
This is an interventional Phase 3 trial sponsored by Janssen assessing guselkumab given IV induction followed by two different SC maintenance regimens (200 mg every 4 weeks or 100 mg every 8 weeks, with permitted escalation). The primary outcome is the percentage of participants achieving a MaRIA score below or equal to 7 at Week 48.
Planned enrollment is about 120 adults with luminal Crohn's disease and evidence of transmural activity on MRI. The study excludes people with significant surgical complications, recent major surgery, active abscesses, or functioning stomas; participants may have prior exposure or loss of response to some advanced therapies per the listed criteria.
This record describes the trial design, eligibility, and planned outcomes but does not report results. MaRIA is an MRI-based index used in the study as the primary outcome measure. As a registered trial, outcomes and timeline are subject to completion and reporting.
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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