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

Sponsor
University of Calgary
Study ID
NCT07246460
Status
Recruiting
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Conditions

  • Crohn's Disease of Both Small and Large Intestine

Eligibility Criteria

Sex
ALL
Age
N/A - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab Subcutaneous — DRUG
    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

Study Details

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?

Key Dates

Start date
Oct 31, 2025
Status verified
Nov 2025
Primary completion
Sep 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: Inflammatory Ileal Crohn's Disease
    Ileal or ileocolonic Crohn's disease patients without fibrostenotic behaviour on endoscopy and diagnostic imaging will receive guselkumab.
  • Arm: Fibrostenotic Ileal Crohn's disease
    Patients with ileal or ileocolonic Crohn's disease with fibrostenotic behaviour on diagnostic imaging will receive guselkumab.

Primary Outcome Measure

Proportion of patients with IUS response in patients with and without Crohn's disease strictures on Guselkumab therapy over 1 year [ Time Frame: 52 weeks ]

Central Contacts