Crohn's Disease of Both Small and Large IntestineUPGRADENCT07246460
Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).
An observational study of Crohn's Disease of Both Small and Large Intestine, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Crohn's Disease of Both Small and Large Intestine
- What is being tested?
- Guselkumab Subcutaneous
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 31 Oct 2025to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: University of Calgary IBD Clinic and endoscopy University of Alberta IBD Clinic and endoscopy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maureen O'Brien contact
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T3H 1S7
Cathy Lu, MD, 403-944-6546, luc@ucalgary.ca
Heather Baylis, 403-220-6166, hbaylis@ucalgary.ca
About this study
Official title: UPGRADE: Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease.
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?
Read the detailed description
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.
- Being tested
- Guselkumab Subcutaneous
- Keywords
- Stricture
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guselkumab SubcutaneousDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Ileal Crohn's Disease | Ileal or ileocolonic Crohn's disease patients without fibrostenotic behaviour on endoscopy and diagnostic imaging will receive guselkumab. Receives: 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. Receives: Drug: Guselkumab Subcutaneous |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start31 Oct 2025
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn's Disease of Both Small and Large IntestineStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cathy Lu, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246460
- Sponsor's protocol ID
- REB25-0321
- Acronym
- UPGRADE
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared for this study. The study team does not plan to share deidentified individual participant data due to privacy concerns and limitations in consent for data sharing. Compiled results will be disseminated through scientific publications and presentations.
Publications
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.
PubMed 35842121Hart 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.
PubMed 40113101
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UPGRADE: Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease.
- ClinicalTrials.gov ID
- NCT07246460
- Acronym / sponsor ID
- UPGRADE / REB25-0321
- Keywords
- Stricture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Ileal Crohn's Disease | – | Drug: Guselkumab SubcutaneousIleal or ileocolonic Crohn's disease patients without fibrostenotic behaviour on endoscopy and diagnostic imaging will receive guselkumab. |
| Fibrostenotic Ileal Crohn's disease | – | Drug: Guselkumab SubcutaneousPatients with ileal or ileocolonic Crohn's disease with fibrostenotic behaviour on diagnostic imaging will receive guselkumab. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- University of Calgary IBD Clinic and endoscopy University of Alberta IBD Clinic and endoscopy
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Pregnancy
- Ileostomy or colostomy
- Significant obesity (BMI > 35)
- Contraindications to initiating GUS such as active infection.
- Active malignancy within five years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guselkumab SubcutaneousGuselkumab 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 | Drug | Fibrostenotic Ileal Crohn's disease, Inflammatory Ileal Crohn's Disease |
Primary outcome
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
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Results publication: PubMed 35842121Kucharzik 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.
- Results publication: PubMed 40113101Hart 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared for this study. The study team does not plan to share deidentified individual participant data due to privacy concerns and limitations in consent for data sharing. Compiled results will be disseminated through scientific publications and presentations.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maureen O'Brien contact
Cathy Lu principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease of Both Small and Large Intestine, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cathy Lu, MD (403-220-6166, luc@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07246460, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.