Cure8 trial brief
This Phase 3 trial directly compares two IL-23–targeting biologic therapies in moderate-to-severe Crohn's disease with a 52-week deep remission endpoint, which could inform future treatment choices if results are positive.
Adults with moderately to severely active Crohn's disease; patients considering or currently on biologic (IL-23) therapy; gastroenterologists and IBD researchers.
This is a registered, actively recruiting Phase 3 interventional trial sponsored by Janssen. About 530 adults with moderately to severely active Crohn's disease are planned for enrollment.
Participants are randomized to receive either subcutaneous guselkumab (induction at Weeks 0, 4, 8 then q4w maintenance) or risankizumab (IV induction at Weeks 0, 4, 8 then SC q8w maintenance) with the primary endpoint of deep remission (clinical plus endoscopic remission) at Week 52.
The protocol excludes people with certain surgical needs, recent major surgery, active abscess or fistula requiring surgery, or recent/current malignancy. The trial will use endoscopy to assess endoscopic remission as part of the composite primary outcome.
This ClinicalTrials.gov record describes trial design and eligibility but does not report outcomes. As a recruiting Phase 3 study, it will provide comparative data only after completion and analysis.
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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