Using ultrasound and protein tests to see who responds to guselkumab for ileal Crohn's disease
UPGRADE: Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease.
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 |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | N/A to 80 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Drugs / interventions | guselkumab |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT07246460 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Calgary, Alberta
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.