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Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).

UPGRADE: Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease.

Sponsor

University of Calgary

Enrollment

90 participants

Start Date

Oct 31, 2025

Study Type

OBSERVATIONAL

Conditions

Crohn's Disease of Both Small and Large Intestine

Summary

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?

Eligibility

Max Age: 80 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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.

Interventions

DRUGGuselkumab Subcutaneous

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

Locations(1)

University of Calgary

Calgary, Alberta, Canada

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NCT07246460