Cure8 trial brief
A Phase 2/3 trial of guselkumab could expand biologic treatment options for people with moderate to severe ulcerative colitis if efficacy and safety are demonstrated. The trial’s use of standard clinical endpoints (modified Mayo score) means its results would be directly relevant to clinical decisions.
Adults with moderately to severely active ulcerative colitis, patients considering biologic therapy, gastroenterology clinicians, and researchers tracking emerging UC treatments.
This is a registry record for a Janssen‑sponsored Phase 2/3 trial (active, not recruiting) evaluating guselkumab given IV or SC versus placebo, with planned induction and maintenance periods and clinical response/remission measured by the modified Mayo score.
The study enrolls adults with moderately to severely active UC who have had inadequate response or intolerance to prior therapies; nonresponders in some arms may be switched to active treatment per the protocol.
The record lists planned enrollment (~1064), primary endpoints (clinical response/remission at Week 12 for induction and Week 44 for maintenance), and typical inclusion/exclusion criteria (e.g., excludes patients with Crohn's disease, fistula, or stoma). Locations are U.S. centers. This entry reports the trial design and outcomes being measured, not results.
Enrollment and design details come from the trial registry entry; this is a trial record, not a peer‑reviewed study report.
This is a ClinicalTrials.gov trial record (sponsored by Janssen) describing study design and endpoints; it does not report trial results. Guselkumab is an IL‑23 inhibitor. Patients should not change therapy based on this registry entry alone and should consult their clinicians about treatment decisions.
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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