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Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Recruitment opened
    • Start date: Aug 1, 2026 to Jul 31, 2026
    • Site details revised
    v3
  2. Minor Secondary endpoints: details revised at 3 of 11 entries
    • Study title shortened, about 4 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In a real-world setting, this study systematically evaluates the clinical efficacy and safety of guselkumab (GUS) in the treatment of ulcerative colitis (UC), encompassing multi-dimensional outcomes including clinical remission, biochemical remission, endoscopic remission, histologic healing, and intestinal ultrasound changes.
Trial Details
NCT Number NCT07726888
Lead Sponsor Second Affiliated Hospital of Wenzhou Medical University
Collaborators: Xian-Janssen Pharmaceutical Ltd.
Conditions
(from sponsor)
Ulcerative Colitis (Disorder), Guselkumab
Related terms Colitis, Ulcerative
Enrollment 97 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov