Actively Recruiting
Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat IBD
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-03-23
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore new treatment options for patients with refractory inflammatory bowel disease (IBD) who have not responded well to conventional biologics and small molecule drugs. These patients experience persistent active disease that significantly affects their quality of life and long-term health. The study focuses on evaluating the efficacy and safety of combining guselkumab (GUS) with JAK inhibitors, such as upadacitinib or tofacitinib, to provide novel therapeutic approaches for this challenging condition. Participants will receive treatment involving guselkumab along with JAK inhibitors like upadacitinib or tofacitinib. The study is observational, meaning researchers will monitor patients as they receive these treatments without assigning them randomly to groups or using placebos. The goal is to gather real-world data on how well this combination works and its safety profile in patients with difficult-to-treat IBD. During the study, researchers will assess patients' clinical responses at 12 weeks and evaluate endoscopic responses at 52 weeks, measuring improvements in disease activity through specific clinical indices. Participants will be monitored for treatment outcomes and safety throughout the study duration. The lead sponsor is the Second Affiliated Hospital, School of Medicine, Zhejiang University, and the study is expected to continue until the end of 2028.
CONDITIONS
Brief 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
- Crohn's disease with recurrence after two or more intestinal resections or complex perianal disease despite prior treatments
- Moderate to severe active IBD (Crohn's disease: CDAI 220-450, SES-CD 1 or isolated ileal disease 4; Ulcerative colitis: modified Mayo score 4-9, rectal bleeding score 1, endoscopic score 2)
- Signed informed consent
You will not qualify if you...
- Active infection, abscess, or 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants who receive guselkumab (GUS) combined with JAK inhibitors are observed to evaluate treatment efficacy and safety.
Regular visits during the 52-week period to assess clinical and endoscopic response
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here