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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

IUS Predicts Guselkumab Efficacy in Patients With Moderate to Severe Crohn's Disease：a Prospective Study

NCT07034664

Crohn's Disease Guselkumab Intestinal Ultrasound +1 more

RECRUITING

IUS Predicts Upadacitinib Efficacy in Patients With Moderate to Severe Crohn's Disease：a Prospective Study

NCT06573944

Crohn's Disease Upadacitinib Intestinal Ultrasound +1 more

RECRUITING

Validation of an IUS Activity Index

NCT05407350

Crohn Disease

UNKNOWN

Contrast-Enhanced Ultrasound in Human Crohn's Disease

NCT02061163

Crohn's Disease

WITHDRAWN PHASE1/PHASE2

Endoscopic Ultrasound Determines Disease Activity in Crohn's Disease And Ulcerative Colitis

NCT03863886

Crohn Disease Ulcerative Colitis

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective, single-centre observational study conducted at conducted at the University of Calgary and the University of Alberta. All patients with histologically confirmed distal ileal CD with or without colonic involvement initiating guselkumab (GUS) will be consecutively enrolled. Patients will be sub-divided into the following phenotypes: 1) Stricture: Bowe wall thickness \> 3 mm, luminal apposition \< 1cm and prestenotic dilation of distal ileum, or 2) Non-Stricture (inflammatory): ileal CD with no evidence of stricture on intestinal ultrasound (IUS) or prior cross-sectional imaging.

Recruited patients providing informed consent will undergo IUS within 14 days of GUS start with blood collection prior to GUS start. Blood collection and IUS will be performed at weeks 0, 12, 24, and 52. Length of visit windows will be within 14 days of study visit due date. Gastroenterologists with bowel sonography expertise will perform standard of care IUS on all consented CD patients meeting inclusion criteria in clinic at baseline, weeks 12, 24, and 52. Colonoscopy will be performed in all patients at baseline and between week 48 and 52 with segmental biopsies for proteomic and CD64 analysis. For tissue CD64 quantification, a single-cell suspension will be obtained using collagenase type 4 and deoxyribonuclease I for enzymatic digestion followed by mechanical dissociation. CD64 will be tagged using the same markers as described for serum, and samples will be submitted to flow cytometry at the local university facility (Calgary or Alberta). Serum will be collected for proteomic analysis at baseline and week 52.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn's Disease of Both Small and Large Intestine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fibrostenotic Ileal Crohn's disease

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

Guselkumab Subcutaneous

Intervention Type 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

Inflammatory Ileal Crohn's Disease

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

Guselkumab Subcutaneous

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No