NCT07487311

A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat Inflammatory Bowel Disease (IBD)

Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat IBD

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 14 Years – 80 Years
• Healthy volunteers: —

Summary

Patients with refractory inflammatory bowel disease (IBD) show inadequate response to conventional biologics and small molecule drugs, with persistently active disease that severely impacts quality of life and long-term prognosis. Current treatment options are limited, and the substantial disease heterogeneity makes traditional randomized controlled trials difficult to implement in this population. This study aims to explore the efficacy and safety of guselkumab (GUS) with JAK inhibitors (such as upadacitinib/tofacitinib) in this patient population, providing novel therapeutic strategies for clinical practice.

Conditions

• Inflamatory Bowel Disease

Interventions

Type	Name	Description
DRUG	guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib)	guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib)

Timeline

• Start date: 2026-01-07
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: China