Recruiting

Guselkumab

Sponsor:

University of Calgary

Code:

NCT07246460

Conditions

Crohn's Disease of Both Small and Large Intestine

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Interventions

Guselkumab Subcutaneous

Study Details

Brief 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

Study ID

NCT07246460

Start date

Oct 31, 2025

Status verified date

Nov, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

Inflammatory Ileal Crohn's Disease

Ileal or ileocolonic Crohn's disease patients without fibrostenotic behaviour on endoscopy and diagnostic imaging will receive guselkumab.

Fibrostenotic Ileal Crohn's disease

Patients with ileal or ileocolonic Crohn's disease with fibrostenotic behaviour on diagnostic imaging will receive guselkumab.

Interventions

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

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 and Locations

Central contacts

Cathy Lu, MD

403-220-6166luc@ucalgary.ca

Maureen O'Brien

403-210-7979

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T3H 1S7

Contacts

Cathy Lu, MD

403-944-6546luc@ucalgary.ca

Heather Baylis

403-220-6166hbaylis@ucalgary.ca

Principal Investigator:

Cathy Lu, MD

More Information

Sponsor

University of Calgary

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

  • Stricture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2025-11-24.