Using ultrasound and protein tests to see who responds to guselkumab for ileal Crohn's disease
Official title: UPGRADE: Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease.
Run by University of Calgary · NCT07246460 · Data updated 2026-11-12
This project will try to see if intestinal ultrasound plus blood and tissue protein signatures can show who responds to the medicine guselkumab in adults with ileal Crohn's disease, with or without strictures.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 80 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | University of Calgary Academic / other |
| Drugs / interventions | guselkumab |
| Locations | 1 site (Calgary, Alberta) |
| Status | Recruiting |
| Started | October 31, 2025 |
| Main results expected | September 2027 |
| Study ends | November 2027 |
| Registry record updated | November 24, 2025 |
| Trial ID | NCT07246460 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–80 with histologically confirmed distal ileal Crohn's disease (with or without colonic involvement) who are naïve to guselkumab and able to undergo ultrasound and colonoscopy are ideal candidates.
✕Probably not a fit
People who are pregnant, have an ileostomy/colostomy, have BMI >35, active infection, recent malignancy, or contraindications to guselkumab are unlikely to qualify and therefore would not receive direct benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-centre observational cohort enrolling adults with histologically confirmed distal ileal Crohn's disease who are starting guselkumab. Participants are classified as stricture or non-stricture based on intestinal ultrasound and will have IUS and blood samples at baseline, weeks 12, 24, and 52, plus colonoscopy with biopsies at baseline and week 48–52. Tissue CD64 will be quantified from enzymatically digested biopsies using flow-based methods and blood will undergo proteomic profiling to search for response-related signatures. The study aims to compare IUS response rates between phenotypes and to relate changes in tissue CD64 and circulating proteins to clinical and imaging response.
Why it matters
Potential benefit: If successful, the approach could help identify which patients are likely to benefit from guselkumab and guide more personalized treatment decisions, potentially avoiding ineffective therapy.
How similar studies have gone: Intestinal ultrasound is an established monitoring tool and CD64/proteomic biomarkers have shown promise in IBD, but combining IUS, tissue CD64, and blood proteomics specifically to predict guselkumab response is a novel approach with limited prior validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
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University of Calgary
Calgary, Alberta, Canada Recruiting
Study contacts
- Principal investigator: Cathy Lu — University of Calgary
- Study coordinator: Cathy Lu, MD
- Email: luc@ucalgary.ca
- Phone: 403-220-6166
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.