Cure8 trial brief
Phase 3 testing of guselkumab (an IL-23–targeting biologic) in moderately to severely active ulcerative colitis could expand treatment options if the trial meets its endpoints and shows an acceptable safety profile. The study’s primary endpoint is clinical remission at Week 12, a patient-relevant outcome.
Adults with moderately to severely active UC; patients who have not responded to prior therapies; gastroenterologists and IBD clinicians; clinical researchers tracking biologic treatments.
This is the Phase 3 clinical trial record for guselkumab given by subcutaneous injection to adults with moderately to severely active ulcerative colitis (UC). The study is evaluating induction efficacy with clinical remission at Week 12 as the registered primary outcome using Mayo subscores and endoscopy.
Participants are randomized to two guselkumab dosing sequences or matching placebo; planned enrollment is about 418 adults with UC who have had an inadequate response or intolerance to prior conventional or advanced therapies. Key eligibility excludes Crohn's disease and certain other colitis types.
The registry status is ACTIVE_NOT_RECRUITING and the record lists multiple US study sites. This entry describes study design, interventions, and the clinical remission definition but does not report trial results or safety findings.
This record is a trial registration (not a results report). The clinical remission definition uses Mayo stool frequency, rectal bleeding, and endoscopy subscores. Results and regulatory conclusions are not included here.
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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