A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat Inflammatory Bowel Disease (IBD)
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. 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 14 to 80
- Any sex
Some of the main requirements, copied from the record:
- Age 14-80 years with confirmed diagnosis of IBD;
- Meeting the definition of refractory IBD (1. Failure of at least two biologics with different mechanisms of action; 2. Crohn's disease with recurrence after two or more intestinal resections; 3. Complex perianal disease despite treatments…
- Moderate to severe active IBD (CD: CDAI 220-450, SES-CD ≥6 or isolated ileal disease ≥4; UC: Baseline modified Mayo score (mMayo) of 4-9, rectal bleeding score ≥1, endoscopic score ≥2);
Plus 1 more requirement(s). 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 80 participants are expected to take part.
- Start date: 2026-01-07.
- Main results expected around 2027-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- 12-week clinical response and 52-week endoscopic response (The composite endpoint achievement rate of 12-week clinical response (CDAI decrease ≥100) and 52-week endoscopic…)
In the researchers’ words
Patients with refractory inflammatory bowel disease (IBD) show inadequate response to conventional biologics and small molecule drugs, with persistently active disease that severely impacts quality of life and long-term prognosis. Current treatment options are limited, and the substantial disease heterogeneity makes traditional randomized controlled trials difficult to implement in this population.
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 |
| Lead sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Enrollment | 80 (estimated) |
| Start date | 2026-01-07 |
| Primary completion (est.) | 2027-12-31 |
| First posted | 2026-03-23 |
| Last updated | 2026-03-23 |
| Official title | Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat IBD |
| ClinicalTrials.gov ID | NCT07487311 |
Interventions
- guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib) (Drug)
guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib)
Full eligibility criteria (from the record)
Inclusion Criteria: * Age 14-80 years with confirmed diagnosis of IBD; * Meeting the definition of refractory IBD (1. Failure of at least two biologics with different mechanisms of action; 2. Crohn's disease with recurrence after two or more intestinal resections; 3. Complex perianal disease despite treatments 1 and 2); * Moderate to severe active IBD (CD: CDAI 220-450, SES-CD ≥6 or isolated ileal disease ≥4; UC: Baseline modified Mayo score (mMayo) of 4-9, rectal bleeding score ≥1, endoscopic score ≥2); * Signed informed consent. Exclusion Criteria: * Active infection, abscess, malignancy, severe cardiopulmonary disease, pregnancy or lactation; * History of thromboembolism, severe hepatic or renal insufficiency, severe cytopenia; * Prior intolerance to JAK inhibitors or IL-23 inhibitors.
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.