Actively Recruiting
A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-03-23
60
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-center, observational study aimed at evaluating the efficacy and safety of guselkumab in patients with moderate to severe Crohn's disease (CD) who have previously failed or were intolerant to ustekinumab therapy. The study plans to enroll approximately 60 participants aged 18-75 years. Participants will receive guselkumab treatment following a defined induction and maintenance regimen over a total observation period of 52 weeks. The primary endpoint is the proportion of patients achieving clinical remission at Week 52. Secondary endpoints include clinical response, endoscopic improvement, biomarker normalization, quality of life assessment, and safety monitoring.
CONDITIONS
Official Title
A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years.
- Diagnosis of Crohn's disease for at least 3 months.
- Moderate to severe disease activity (CDAI 220-450).
- Previous treatment with at least one standard dose of ustekinumab showing primary non-response, secondary loss of response, or intolerance.
- Willing and able to comply with all study visits and procedures.
You will not qualify if you...
- Previous exposure to any anti-IL-23p19 therapy, including guselkumab.
- Active intestinal infection, unremoved stenotic lesions with obstructive symptoms, short bowel syndrome, stoma, or abdominal abscess within the last 8 weeks.
- History of malignancy (except certain skin cancers), active tuberculosis, or severe opportunistic infection.
- Pregnancy, lactation, or planned pregnancy during the study period.
AI-Screening
AI-Powered Screening
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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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