Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT05246267
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2022-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-13', 'size': 218238, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-26T14:37', 'hasProtocol': True}, {'date': '2021-09-13', 'size': 188953, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-01-26T14:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Nasal inferior turbinate tissue, fluid, and microbiome collection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2022-01-26', 'studyFirstSubmitQcDate': '2022-02-08', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Sinonasal outcome test (SNOT-22) score, scale 0-110, higher is worse outcome', 'timeFrame': 'at 2, 16, 36, and 52 weeks of treatment', 'description': 'Measure changes in SNOT-22 values from baseline'}, {'measure': 'Change in University of Pennsylvania Smell Identification Test (UPSIT) scores, scale 0-40, lower is worse outcome values', 'timeFrame': 'at 2, 16, 36, and 52 weeks of treatment', 'description': 'Measure changes in UPSIT scores from baseline'}, {'measure': 'Change in nasal peak flow (NPF) value (L/min)', 'timeFrame': 'at 2, 16, 36, and 52 weeks of treatment', 'description': 'Measure changes in the NPF values from baseline'}], 'secondaryOutcomes': [{'measure': 'Change in urinary levels of Leukotriene E4 (uLTE4) levels in ug/L', 'timeFrame': 'at 2, 16, 36, and 52 weeks of treatment', 'description': 'Measure changes in uLTE4 levels from baseline'}, {'measure': 'Change in peripheral blood eosinophil counts in k/uL', 'timeFrame': 'at 2, 16, 36, and 52 weeks of treatment', 'description': 'Measure changes in peripheral blood eosinophil counts from baseline'}, {'measure': 'Change in Immunoglobulin E (IgE) level in IU/mL', 'timeFrame': 'at 2, 16, 36, and 52 weeks of treatment', 'description': 'Measure changes in IgE levels from baseline'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CRSwNP', 'dupilumab'], 'conditions': ['Chronic Rhinosinusitis With Nasal Polyps']}, 'descriptionModule': {'briefSummary': 'The central hypothesis of this study is that the addition of dupilumab treatment onto standard-of-care intranasal corticosteroids will improve patient-reported measures of disease activity and sense of smell in a cohort of mostly ethnical and racial minority patients with CRSwNP', 'detailedDescription': 'First, it will confirm the effectiveness of dupilumab in the treatment of CRSwNP in ethnic and racial minority patients who have traditionally been underrepresented in existing clinical trials of biologics in CRSwNP Second, this research will establish a biomarker of therapeutic response to dupilumab identifying the biological effect of dupilumab in CRSwNP patients and its association with symptom improvement.\n\nFinally, the investigators will measure the effect of dupilumab on asthma symptoms and lung function in patients with CRSwNP and comorbid asthma.\n\nThere will be a screening visit, followed by a baseline visit where the medication will be given. Follow-up visits will be scheduled at 2 weeks and then 16 weeks from baseline. Long-term visits will take place in 36 and 52 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '60 patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab. These patients will be 18 years and older and will have insurance that allows Dupilumab coverage or Dupilumab coverage obtained through "Dupixent MyWay Program"', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab.\n* Patients aged 18 years and older.\n* Patient willing to provide consent to be a participant in the study.\n* Patients with insurance that allows Dupilumab coverage or Dupilumab coverage obtained through "Dupixent MyWay Program"\n\nExclusion Criteria:\n\n* Age under 18\n* Suspected or diagnosed allergic fungal rhinosinusitis.\n* Suspected or diagnosed cystic fibrosis.\n* Dupilumab coverage denied through insurance or "Dupixent MyWay Program"\n* Patients who required a steroid taper in the preceding 30 days. However, patients on chronic steroids less or equal to 20 mg of prednisone daily, are eligible.\n* Patients who were on a different biologic medication in the preceding 3 months.\n* Patients with a diagnosis of EGPA/Churg-Strauss Syndrome\n* Pregnant patients\n* Patients with inverted papilloma growth'}, 'identificationModule': {'nctId': 'NCT05246267', 'briefTitle': 'Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)', 'orgStudyIdInfo': {'id': '2021-13161'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab.', 'interventionNames': ['Biological: Dupilumab']}], 'interventions': [{'name': 'Dupilumab', 'type': 'BIOLOGICAL', 'description': 'Standard of care treatment with dupilumab', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Golda Hudes, MD', 'role': 'CONTACT', 'email': 'ghudes@montefiore.org', 'phone': '866-633-8255'}, {'name': 'Golda Hudes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'Golda Hudes, MD', 'role': 'CONTACT', 'email': 'ghudes@montefiore.org', 'phone': '866-633-8255'}], 'overallOfficials': [{'name': 'Golda Hudes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}