Actively Recruiting
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)
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-03-23
80
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14-80 years with confirmed diagnosis of inflammatory bowel disease (IBD)
- Refractory IBD defined by failure of at least two biologics with different mechanisms of action, or Crohn's disease with recurrence after two or more intestinal resections, or complex perianal disease despite prior treatments
- Moderate to severe active IBD characterized by CDAI 220-450 and SES-CD ≥6 or isolated ileal disease ≥4 for Crohn's disease, or baseline modified Mayo score 4-9 with rectal bleeding score ≥1 and endoscopic score ≥2 for ulcerative colitis
- Signed informed consent
You will not qualify if you...
- Active infection, abscess, malignancy, severe cardiopulmonary disease, pregnancy or lactation
- History of thromboembolism, severe liver or kidney failure, severe low blood cell counts
- Prior intolerance to JAK inhibitors or IL-23 inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
S
Shurong Hu, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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