NCT07246460Recruiting
Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).
UPGRADE: Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease.
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 31 Oct 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- University of Calgary
- Diseases
- Crohn's disease
- NCT number
- NCT07246460
What you commit to
- Study type: Observational
- Planned participants: 90
- From 31 Oct 2025 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Pregnancy
- Ileostomy or colostomy
- Significant obesity (BMI \> 35)
Who the study is looking for
- 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.
Age in the registry: - to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.