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

NCT07726888 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 97

Last updated 2026-08-07

No results posted yet for this study

Summary

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.

Conditions

  • Ulcerative Colitis (Disorder)
  • Guselkumab

Interventions

DRUG

Guselkumab

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.

Sponsors & Collaborators

  • Xian-Janssen Pharmaceutical Ltd.

    collaborator INDUSTRY

  • Second Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Yi Jiang · Second Affiliated Hospital of Wenzhou Medical University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07726888 on ClinicalTrials.gov