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An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

NCT07528040 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 88

Last updated 2026-04-14

No results posted yet for this study

Summary

The goal of this single arm ,non-interventional, prospective, descriptive study is to evaluate the efficacy of guselkumab treatment in preventing endoscopic recurrence of Crohn's Disease in adult participants who have a documented diagnosis of moderate to severe CD and have undergone an ileocolonic surgical resection. The primary endpoint is Endoscopic recurrence rate at week24.

Conditions

  • Crohn's Disease (CD)

Interventions

DRUG

Guselkumab

Guselkumab is an IL23 p19 subunit antagonist that binds to IL-23 with high affinity and potency and also binds to the CD64 receptor (high affinity Fcγ receptor 1) on the surface of human inflammatory monocytes, which enables it to neutralize IL-23 at its predominant source of production, potentially enriching the presence of guselkumab in the inflamed tissue microenvironment.GALAXI and GRAVITI studies have demonstrated that Guselkumab treatment was both safe and effective for induction and maintenance of remission is patients with moderate to severely active CD. No study is about the efficacy of IL-23is in POCD

Sponsors & Collaborators

  • Shanghai 10th People's Hospital

    lead OTHER

  • Xian-Janssen Pharmaceutical Ltd.

    collaborator INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2028-12-31
Completion
2029-05-31

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 NCT07528040 on ClinicalTrials.gov