NCT07487480 A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
| NCT ID | NCT07487480 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Inflamatory Bowel Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-02-10 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07487480 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Inflamatory Bowel Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07487480 currently recruiting?
Yes, NCT07487480 is actively recruiting participants. Contact the research team at hushurong@zju.edu.cn for enrollment information.
Where is the NCT07487480 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07487480 clinical trial?
NCT07487480 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 60 participants.