RecruitingNCT07246460

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

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

Plain Language Summary

Simplified for easier understanding

This study uses intestinal ultrasound and blood protein analysis (proteomics) to monitor how well people with Crohn's disease respond to the biologic drug guselkumab (an IL-23 inhibitor). The goal is to find measurable markers that can tell doctors early whether the treatment is working without relying solely on colonoscopy. **You may be eligible if...** - You are 18 to 80 years old - You have Crohn's disease with active inflammation in the small intestine (ileum) visible on intestinal ultrasound - You have not previously received guselkumab - You may have either a non-stricturing or stricturing (narrowing) type of disease **You may NOT be eligible if...** - You have already received guselkumab - You are currently on medications that would interfere with the study drug or assessments - You have active infections or other conditions that preclude biologic therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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