A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
Recruiting now
Conditions studied: Inflamatory Bowel Disease, Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)
In brief
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.
Key facts
- Study ID
- NCT07487480
- Run by
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- People needed
- 60
- Starts
- 2025-02-10
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-03-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 with documented:
- Primary non-response, or Secondary loss of response, or Intolerance leading to discontinuation.
- Willing and able to comply with all study visits and procedures.
You may not qualify if…
- Previous exposure to any anti-IL-23p19 therapy (including guselkumab).
- Active intestinal infection, unremoved stenotic lesions with obstructive symptoms, short bowel syndrome, stoma, or recent abdominal abscess (<8 weeks).
- History of malignancy (except certain skin cancers), active tuberculosis, or severe opportunistic infection.
- Pregnancy, lactation, or planned pregnancy during the study period.
Where it is running
- Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.