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

NCT07246460 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2025-11-24

No results posted yet for this study

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?

Conditions

  • Crohn's Disease of Both Small and Large Intestine

Interventions

DRUG

Guselkumab 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

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Cathy Lu · University of Calgary

Eligibility

Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2027-09-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07246460 on ClinicalTrials.gov