Guselkumab for Crohn's disease in people previously treated with ustekinumab
Studies guselkumab in adults with Crohn's disease who had ustekinumab before.
Key facts
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Where
- Hangzhou, ChinaSee the site
- Trial code
- Registry title
- A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 10 Feb 2025
- Expected to end
- 31 Dec 2028
- Type of study
- Observational
- Treatments tested
- Observation
- Record updated
- 23 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate to severe Crohn's disease who stopped ustekinumab because it did not work, stopped working, or caused side effects.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Crohn's disease for at least 3 months, with moderate to severe activity (CDAI 220-450).
- Earlier treatment
- Must have had at least one standard dose of ustekinumab, with no response, loss of response, or intolerance that led to stopping it. Must not have had any anti-IL-23p19 therapy, including guselkumab.
Main reasons for not taking part
- Earlier treatment with any anti-IL-23p19 therapy, including guselkumab
- Active intestinal infection, narrowing of the bowel with blockage symptoms that was not removed, short bowel syndrome, stoma, or abdominal abscess in the last 8 weeks
- History of cancer (except certain skin cancers), active tuberculosis, or severe opportunistic infection
- Pregnancy, breastfeeding, or planned pregnancy during the study
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of MedicineHangzhou, ChinaContact: Yan ChenTaking people
About the trial
What the trial wants to find out
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.
Treatments tested
- Observation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Guselkumab for Crohn's disease in people previously treated with ustekinumabGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07487480, who can take part
- Record updated
- 23 March 2026