A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
Observational · No treatment assigned · 1 site · Second Affiliated Hospital, Zhejiang University, School of Medicine
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflamatory Bowel Disease and Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- Age 18-75 years.
- Diagnosis of Crohn's disease for at least 3 months.
- Moderate to severe disease activity (CDAI 220-450).
Plus 3 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 60 participants are expected to take part.
- Start date: 2025-02-10.
- Main results expected around 2028-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Proportion of patients achieving clinical remission (CDAI <150 or HBI <4) at Week 52. (52weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflamatory Bowel Disease; Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis) |
| Lead sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Enrollment | 60 (estimated) |
| Start date | 2025-02-10 |
| Primary completion (est.) | 2028-12-31 |
| First posted | 2026-03-23 |
| Last updated | 2026-03-23 |
| 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 |
| ClinicalTrials.gov ID | NCT07487480 |
Interventions
- Observation (Other)
observation
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou, Zhejiang | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.