Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).
Observational · No treatment assigned · 1 site · University of Calgary
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn's Disease of Both Small and Large Intestine. 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
- Up to age 80
- Any sex
Some of the main requirements, copied from the record:
- Male or female, 18 to 80 years old
- BWT on IUS > 3.0mm in the ileum and colonic disease permitted.
- Patients naïve to guselkumab.
Plus 2 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 90 participants are expected to take part.
- Start date: 2025-10-31.
- Main results expected around 2027-09 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Main thing being measured
- Proportion of patients with IUS response in patients with and without Crohn's disease strictures on Guselkumab therapy over 1 year (52 weeks)
In the researchers’ words
The goal of this observational study is to evaluate the response of guselkumab in adult patients with Crohn's disease (CD) as measured on intestinal ultrasound (IUS), the relative quantities of CD64 in endoscopic tissue biopsies, and the protein signature in the blood of patients with and without therapy response. The main question it aims to answer is: * What is the proportion of ileal Crohn's disease patients with…
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 | Crohn's Disease of Both Small and Large Intestine |
| Lead sponsor | University of Calgary |
| Enrollment | 90 (estimated) |
| Start date | 2025-10-31 |
| Primary completion (est.) | 2027-09 |
| First posted | 2025-11-24 |
| Last updated | 2025-11-24 |
| Official title | UPGRADE: Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease. |
| ClinicalTrials.gov ID | NCT07246460 |
Interventions
- Guselkumab Subcutaneous (Drug)
Guselkumab will be prescribed by the patient's primary physician according to approved doses by Health Canada for moderate to severe Crohn's disease. Dosing includes: Induction: 200 mg IV or 400mg sc at Weeks 0, 4, and 8 Maintenance: 100 mg SC every 8 weeks or 200 mg SC every 4 weeks
Full eligibility criteria (from the record)
Inclusion Criteria: Male or female, 18 to 80 years old BWT on IUS > 3.0mm in the ileum and colonic disease permitted. Patients naïve to guselkumab. Stricture phenotype - BWT > 3 mm, luminal apposition < 1cm or < 50% of adjacent normal bowel diameter, and prestenotic dilation of distal ileum. Naïve or anastomotic strictures permitted. Non-stricture phenotype- ileal CD with no evidence of stricture on IUS, computed tomography enterography (CTE), or magnetic resonance enterography (MRE), ever or fistulizing phenotype. Exclusion Criteria: Pregnancy Ileostomy or colostomy Significant obesity (BMI > 35) Contraindications to initiating GUS such as active infection. Active malignancy within five years. Conditions with fibrosis involving other organs such as lungs, kidneys, brain, or skin.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Calgary | Calgary, Alberta | Canada | 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.