An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
Observational · No treatment assigned · 1 site · Shanghai 10th People's Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn's Disease (CD). 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 and older
- Any sex
Some of the main requirements, copied from the record:
- Patients≥ 18，
- Have a documented diagnosis of moderate to severe CD
- Have undergone an ileocolonic surgical resection
There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 88 participants are expected to take part.
- Start date: 2026-04-15 (planned).
- Main results expected around 2028-12-31 (estimate from the record).
- 1 study site listed in China.
Main thing being measured
- Endoscopic recurrence rate at Wk 24 (From enrollment to Week 24)
In the researchers’ words
The goal of this single arm ,non-interventional, prospective, descriptive study is to evaluate the efficacy of guselkumab treatment in preventing endoscopic recurrence of Crohn's Disease in adult participants who have a documented diagnosis of moderate to severe CD and have undergone an ileocolonic surgical resection. The primary endpoint is Endoscopic recurrence rate at week24.
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 | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn's Disease (CD) |
| Lead sponsor | Shanghai 10th People's Hospital |
| Collaborators | Xian-Janssen Pharmaceutical Ltd. |
| Enrollment | 88 (estimated) |
| Start date | 2026-04-15 |
| Primary completion (est.) | 2028-12-31 |
| First posted | 2026-04-14 |
| Last updated | 2026-04-14 |
| Official title | An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection |
| ClinicalTrials.gov ID | NCT07528040 |
Interventions
- Guselkumab (Drug)
Guselkumab is an IL23 p19 subunit antagonist that binds to IL-23 with high affinity and potency and also binds to the CD64 receptor (high affinity Fcγ receptor 1) on the surface of human inflammatory monocytes, which enables it to neutralize IL-23 at its predominant source of production, potentially enriching the presence of guselkumab in the inflamed tissue microenvironment.GALAXI and GRAVITI stu…
Full eligibility criteria (from the record)
Inclusion Criteria: * Patients≥ 18， * Have a documented diagnosis of moderate to severe CD * Have undergone an ileocolonic surgical resection Exclusion Criteria: * Has complications of CD, such as short bowel syndrome Currently has or is suspected to have an abscess * Active infection * Currently has a malignancy or has a history of malignancy within 5 years
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai 10th People's Hospital, Tongji University School of Medicine | Shanghai | China |
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.