NCT07487480Recruiting
A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 17 Mar 2026
- Start date
- 10 Feb 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07487480
What you commit to
- Study type: Observational
- Planned participants: 60
- From 10 Feb 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous exposure to any anti-IL-23p19 therapy (including guselkumab).
Other illness
- 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.
Other
- Pregnancy, lactation, or planned pregnancy during the study period.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.