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

Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Study ID
NCT07726888
Status
Recruiting
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Conditions

  • Guselkumab
  • Ulcerative Colitis (Disorder)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    All the patients receive GUS (IV) 200 mg induction therapy at weeks 0, 4, and 8, and who met the criteria for clinical symptom remission, biochemical remission, and improvement in intestinal ultrasound based on the clinical assessment at week 12, proceeded to receive GUS (SC) 100 mg every 8 weeks as maintenance therapy. Patients who did not meet the above criteria received GUS (SC) 200 mg every 4 weeks as maintenance therapy. At week 24, based on clinical and endoscopic evaluations, patients who achieved endoscopic remission were switched to GUS (SC) 100 mg every 8 weeks for maintenance, while those who did not achieve endoscopic remission continued to receive GUS (SC) 200 mg every 4 weeks for maintenance treatment.

Study Details

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.

Key Dates

First listed
Jul 24, 2026
Start date
Jul 31, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
97 participants (estimated)

Arms

  • Arm: Guselkumab treatment group

Primary Outcome Measure

48-week endoscopic remission [ Time Frame: 48 weeks ]

Central Contacts

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