RecruitingNCT07487311

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

80 participants

Start Date

Jan 7, 2026

Study Type

OBSERVATIONAL

Conditions

Inflamatory Bowel Disease

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

Min Age: 14 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria3

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.

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