Guselkumab for adults with Crohn's disease after ustekinumab failure
A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | ustekinumab, guselkumab |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07487480 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.