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)

NCT07487311 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Phase

Observational

Started

2026-01-07

Last updated

2026-03-23

Condition(s) studied

Inflamatory Bowel Disease

Investigational drug(s) / intervention(s)

guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib)

guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib): guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib)

Study 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.

Eligibility

Sex

ALL

Min age

14 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Age 14-80 years with confirmed diagnosis of IBD; * Meeting the definition of refractory IBD (1. Failure of at least two biologics with different mechanisms of action; 2. Crohn's disease with recurrence after two or more intestinal resections; 3. Complex perianal disease despite treatments 1 and 2); * Moderate to severe active IBD (CD: CDAI 220-450, SES-CD ≥6 or isolated ileal disease ≥4; UC: Baseline modified Mayo score (mMayo) of 4-9, rectal bleeding score ≥1, endoscopic score ≥2); * Signed informed consent. Exclusion Criteria: * Active infection, abscess, malignancy, severe cardiopulmonary disease, pregnancy or lactation; * History of thromboembolism, severe hepatic or renal insufficiency, severe cytopenia; * Prior intolerance to JAK inhibitors or IL-23 inhibitors.

Primary outcome measure(s)

12-week clinical response and 52-week endoscopic response — The composite endpoint achievement rate of 12-week clinical response (CDAI decrease ≥100) and 52-week endoscopic response (SES-CD improvement ≥50%).

Trial sites (1)

Facility	City	Region	Status
Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	Recruiting

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

Microneedle Intra-Arterial Injection for Retinal Artery Occlusion Recruiting

Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease Recruiting

Multicenter Study on the Use of Intraoperative OCT in the Diagnosis and Management of Lens Diseases Active, not recruiting

China Longitudinal Aging and Cognitive Impairment Study Recruiting

Effect of Incentive Integrated E-IBD Chronic Disease Management Model on the Quality of Life in IBD Patients Starting soon

Other trials for the same condition

Construction and Validation of a Predictive Model for the Efficacy of Different Biologics in Inflammatory Bowel Disease Recruiting

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

Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07487311 on ClinicalTrials.gov ↗ ← All trials in China