Cure8 trial brief
Real-world data may help show how guselkumab performs in routine clinical practice for adults with moderate-to-severe UC who haven’t had prior biologics, information that could be useful to patients and clinicians weighing treatment options.
Adult patients with moderate-to-severe ulcerative colitis (especially biologic‑naive), clinicians treating UC, and researchers following real-world evidence for IL-23 inhibition.
This is an observational, recruiting study (planned n=200) that will not provide the drug — it will record outcomes from patients who begin guselkumab per their treating physician. The main measured outcome listed is percentage achieving a clinical response at week 12 defined by changes in the partial Mayo score and rectal bleeding subscore.
The study enrolls biologic‑naive adults with moderate-to-severe UC (modified Mayo 4–9, endoscopic subscore ≥2) and excludes patients with acute severe UC likely to need colectomy, prior colectomy/pouch, concurrent advanced therapy, or contraindication to guselkumab.
Locations include multiple tertiary hospitals in China; data come from standard clinical practice and medical records.
This is an observational registry record on ClinicalTrials.gov (recruiting). It will collect routine-care data rather than test a randomized intervention; no results are reported in the registry entry.
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.
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...
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