NCT07487480

A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-center, observational study aimed at evaluating the efficacy and safety of guselkumab in patients with moderate to severe Crohn's disease (CD) who have previously failed or were intolerant to ustekinumab therapy. The study plans to enroll approximately 60 participants aged 18-75 years. Participants will receive guselkumab treatment following a defined induction and maintenance regimen over a total observation period of 52 weeks. The primary endpoint is the proportion of patients achieving clinical remission at Week 52. Secondary endpoints include clinical response, endoscopic improvement, biomarker normalization, quality of life assessment, and safety monitoring.

Detailed description

Crohn's disease is a chronic, progressive, and disabling inflammatory bowel disease. Ustekinumab, a monoclonal antibody targeting the p40 subunit of IL-12/23, is an established treatment option. However, a significant proportion of patients experience primary non-response, secondary loss of response, or intolerance. Guselkumab is a fully human monoclonal antibody that selectively targets the p19 subunit of IL-23, a key cytokine in the Th17-mediated inflammatory pathway in CD. While guselkumab has demonstrated efficacy in biologic-naïve or TNF-antagonist failed CD patients, real-world prospective data in ustekinumab-experienced patients are limited. This study aims to fill this evidence gap by providing prospective observational data on the effectiveness and safety of guselkumab in this specific patient population.

Conditions

• Inflamatory Bowel Disease
• Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)

Interventions

Type	Name	Description
OTHER	Observation	observation

Timeline

• Start date: 2025-02-10
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: China