Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 6:41 PM
Study NCT ID:
NCT07246460
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003251', 'term': 'Constriction, Pathologic'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Ileal and colonic tissue from endoscopic biopsies Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Proportion of patients with IUS response in patients with and without Crohn's disease strictures on Guselkumab therapy over 1 year", 'timeFrame': '52 weeks', 'description': 'IUS response: decreased bowel wall thickness of \\> 25%, or \\> 2.0mm, or \\> 1.0mm and one colour Doppler signal reduction.\n\nTransmural remission: Bowel wall thickness \\< 3mm, colour Doppler signal (modified Limberg grade 0), normal stratification, normal inflammatory fat, and no complications (abscess, phlegmon, fistulas).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stricture'], 'conditions': ["Crohn's Disease of Both Small and Large Intestine"]}, 'referencesModule': {'references': [{'pmid': '35842121', 'type': 'RESULT', 'citation': "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': '40113101', 'type': 'RESULT', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "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:\n\n* What is the proportion of ileal Crohn's disease patients with and without strictures who achieve an intestinal ultrasound response?\n* What is the quantity of CD64 in tissue in CD patients at baseline and at week 52 with and without IUS response?\n* Are there proteomic signatures in blood of CD patients that respond to GUS?", 'detailedDescription': '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.\n\nRecruited 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'University of Calgary IBD Clinic and endoscopy University of Alberta IBD Clinic and endoscopy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale or female, 18 to 80 years old\n\nBWT on IUS \\> 3.0mm in the ileum and colonic disease permitted.\n\nPatients naïve to guselkumab.\n\nStricture 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.\n\nNon-stricture phenotype- ileal CD with no evidence of stricture on IUS, computed tomography enterography (CTE), or magnetic resonance enterography (MRE), ever or fistulizing phenotype.\n\nExclusion Criteria:\n\nPregnancy\n\nIleostomy or colostomy\n\nSignificant obesity (BMI \\> 35)\n\nContraindications to initiating GUS such as active infection.\n\nActive malignancy within five years.\n\nConditions with fibrosis involving other organs such as lungs, kidneys, brain, or skin.'}, 'identificationModule': {'nctId': 'NCT07246460', 'acronym': 'UPGRADE', 'briefTitle': "Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).", 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': "UPGRADE: Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease.", 'orgStudyIdInfo': {'id': 'REB25-0321'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Inflammatory Ileal Crohn's Disease", 'description': "Ileal or ileocolonic Crohn's disease patients without fibrostenotic behaviour on endoscopy and diagnostic imaging will receive guselkumab.", 'interventionNames': ['Drug: Guselkumab Subcutaneous']}, {'label': "Fibrostenotic Ileal Crohn's disease", 'description': "Patients with ileal or ileocolonic Crohn's disease with fibrostenotic behaviour on diagnostic imaging will receive guselkumab.", 'interventionNames': ['Drug: Guselkumab Subcutaneous']}], 'interventions': [{'name': 'Guselkumab Subcutaneous', 'type': 'DRUG', 'description': "Guselkumab will be prescribed by the patient's primary physician according to approved doses by Health Canada for moderate to severe Crohn's disease.\n\nDosing includes:\n\nInduction: 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", 'armGroupLabels': ["Fibrostenotic Ileal Crohn's disease", "Inflammatory Ileal Crohn's Disease"]}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3H 1S7', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Cathy Lu, MD', 'role': 'CONTACT', 'email': 'luc@ucalgary.ca', 'phone': '403-944-6546'}, {'name': 'Heather Baylis', 'role': 'CONTACT', 'email': 'hbaylis@ucalgary.ca', 'phone': '403-220-6166'}, {'name': 'Cathy Lu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'Cathy Lu, MD', 'role': 'CONTACT', 'email': 'luc@ucalgary.ca', 'phone': '403-220-6166'}, {'name': "Maureen O'Brien", 'role': 'CONTACT', 'phone': '403-210-7979'}], 'overallOfficials': [{'name': 'Cathy Lu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}