Cure8 trial brief
This trial is testing guselkumab (an IL‑23 inhibitor) in a real‑world UC cohort and will measure endoscopic and histologic remission at 48 weeks — outcomes that matter to people managing moderate‑to‑severe ulcerative colitis.
The study also uses biochemical markers and intestinal ultrasound, which could provide broader information about treatment effects beyond symptoms alone.
Adults with moderate‑to‑severe ulcerative colitis, clinicians who treat UC, researchers studying IL‑23 inhibitors or real‑world outcomes, and patients considering biologic therapy or with prior biologic exposure.
This ClinicalTrials.gov record describes a prospective, observational "real-world" cohort at a single center in China evaluating guselkumab (IV induction then SC maintenance with dose adjustments) for adults with moderate-to-severe ulcerative colitis.
Planned enrollment is 97, primary outcomes are 48‑week endoscopic and histologic remission assessed by Mayo endoscopic subscore, Geboes score, and the Nancy Histological Index. The study is currently listed as not yet recruiting.
The protocol enrolls adults (≥18) with moderate-to-severe UC who have had inadequate response or intolerance to at least one conventional therapy; patients may be biologic‑naive or have prior biologic failures.
Imaging (intestinal ultrasound), biochemical markers (CRP, fecal calprotectin), endoscopy with biopsies, and symptom scores are used for eligibility and outcomes.
Exclusion criteria include other intestinal diseases, active infection, severe comorbidities, pregnancy/lactation (handled separately), prior total colectomy/stoma, and participation in conflicting interventional trials. This is a trial record (observational design) describing planned assessments and dosing schedules rather than reporting results.
It can inform clinicians and patients about an upcoming real‑world study of guselkumab in UC and the kinds of outcomes the investigators plan to measure.
This is an observational, not yet recruiting, single‑center registry from the Second Affiliated Hospital of Wenzhou Medical University. The record describes planned methods and endpoints but does not contain study results. As a ClinicalTrials.gov entry, it should be interpreted as a trial registration rather than a peer‑reviewed report.
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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