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

NCT07246460 | Recruiting FDA Drug

• 1 other identifier: REB25-0321
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Stricture

Outcome Measures

Primary Outcomes (1)

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

  IUS response: decreased bowel wall thickness of \> 25%, or \> 2.0mm, or \> 1.0mm and one colour Doppler signal reduction. Transmural remission: Bowel wall thickness \< 3mm, colour Doppler signal (modified Limberg grade 0), normal stratification, normal inflammatory fat, and no complications (abscess, phlegmon, fistulas).

  52 weeks

Study Arms (2)

Inflammatory Ileal Crohn's Disease

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

Drug: Guselkumab Subcutaneous

Fibrostenotic Ileal Crohn's disease

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

Drug: Guselkumab Subcutaneous

Interventions

Guselkumab Subcutaneous DRUG

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

Fibrostenotic Ileal Crohn's disease; Inflammatory Ileal Crohn's Disease

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

University of Calgary IBD Clinic and endoscopy University of Alberta IBD Clinic and endoscopy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T3H 1S7, Canada

RECRUITING

Related Publications (2)

• Kucharzik T, Wilkens R, D'Agostino MA, Maconi G, Le Bars M, Lahaye M, Bravata I, Nazar M, Ni L, Ercole E, Allocca M, Machkova N, de Voogd FAE, Palmela C, Vaughan R, Maaser C; STARDUST Intestinal Ultrasound study group. Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn's Disease. Clin Gastroenterol Hepatol. 2023 Jan;21(1):153-163.e12. doi: 10.1016/j.cgh.2022.05.055. Epub 2022 Jul 14.

  PMID: 35842121 RESULT

• Hart A, Panaccione R, Steinwurz F, Danese S, Hisamatsu T, Cao Q, Ritter T, Seidler U, Olurinde M, Vetter ML, Yee J, Yang Z, Wang Y, Johanns J, Han C, Sahoo A, Terry NA, Sands BE, D'Haens G; GRAVITI Study Group. Efficacy and Safety of Guselkumab Subcutaneous Induction and Maintenance in Participants With Moderately to Severely Active Crohn's Disease: Results From the Phase 3 GRAVITI Study. Gastroenterology. 2025 Aug;169(2):308-325. doi: 10.1053/j.gastro.2025.02.033. Epub 2025 Mar 18.

  PMID: 40113101 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Ileal and colonic tissue from endoscopic biopsies Blood samples

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Cathy Lu

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy Lu, MD

CONTACT

403-220-6166; luc@ucalgary.ca

Maureen O'Brien

CONTACT

403-210-7979

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)