RecruitingNot Applicable

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

Canada90 participantsStarted 2025-10-31

Plain-language 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?

Who can participate

Age range

80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients with IUS response in patients with and without Crohn's disease strictures on Guselkumab therapy over 1 year

Timeframe: 52 weeks

Trial details

NCT IDNCT07246460

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-09

Contact for this trial

Cathy Lu, MD

403-220-6166 luc@ucalgary.ca

View on ClinicalTrials.gov More Crohn's Disease of Both Small and Large Intestine trials