A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
Recruiting · NCT07487480 · Observational (researchers observe without assigning treatment) · Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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
2 locations listed.
- Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine - Hangzhou, Zhejiang, China
- Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine - Hangzhou, Zhejiang, China