Ultrasound and Blood Tests to Track Guselkumab Response in Crohn's Disease
Studies how adults with Crohn's disease respond to guselkumab using imaging and tests.
Plain-language title generated from the registry record
Registry title: Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).
Key facts
- Where
- Calgary, CanadaSee the site
Where in Canada
- University Of CalgaryCalgary, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Calgary
- Trial code
- NCT07246460
- Record updated
- 24 November 2025
- Original description
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:Read full original descriptionShow less
UPGRADE: Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease.
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 and without strictures who achieve an intestinal ultrasound response? * What is the quantity of CD64 in tissue in CD patients at baseline and at week 52 with and without IUS response? * Are there proteomic signatures in blood of CD patients that respond to GUS?
Inclusion: 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: 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; Pregnancy; Ileostomy or colostomy; Significant obesity (BMI > 35).