Guselkumab for adults with Crohn's disease after ustekinumab failure
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
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT07487480 · Data updated 2026-11-12
This study will try guselkumab for adults with moderate to severe Crohn's disease who did not respond to or could not tolerate ustekinumab to see if they reach remission after 52 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Drugs / interventions | ustekinumab, guselkumab |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | February 10, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT07487480 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with a Crohn's disease diagnosis of at least 3 months, moderate to severe activity (CDAI 220–450), and prior documented primary non-response, secondary loss of response, or intolerance to ustekinumab are eligible.
✕Probably not a fit
Patients previously treated with any anti‑IL‑23p19 therapy (including guselkumab), those with active intestinal infections, obstructive lesions, recent abscess, certain serious infections or malignancies, or who are pregnant/lactating are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center, observational study enrolling about 60 adults (18–75 years) with moderate to severe Crohn's disease who previously failed or were intolerant to ustekinumab. Participants will receive guselkumab following a defined induction and maintenance dosing schedule and will be followed for 52 weeks. The primary outcome is the proportion of patients achieving clinical remission at Week 52, with secondary endpoints including clinical response, endoscopic improvement, biomarker changes, quality of life, and safety. The study collects real-world effectiveness and safety data in the specific population of ustekinumab-experienced patients.
Why it matters
Potential benefit: If successful, the study could show that guselkumab helps patients who failed ustekinumab achieve remission and better quality of life.
How similar studies have gone: Guselkumab has shown efficacy in biologic‑naïve and some TNF‑antagonist–failed Crohn's disease populations in prior studies, but prospective data specifically in patients who failed ustekinumab are limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Shurong Hu, PhD
- Email: hushurong@zju.edu.cn
- Phone: 008619857407061
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.