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

What this study is about

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?

Who can join (things the study team will check)

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.…

Where this trial is running

• University of Calgary, Calgary, Alberta, Canada

Who to contact

Cathy Lu, MD · 403-220-6166 · luc@ucalgary.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07246460.