Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT04979520
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2021-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571216', 'term': 'brodalumab'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2021-07-09', 'studyFirstSubmitQcDate': '2021-07-27', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin-17 receptor A (IL-17RA) saturation during brodalumab administration at week 12 vs baseline', 'timeFrame': '12 weeks', 'description': 'Percentage change in saturation'}], 'secondaryOutcomes': [{'measure': 'Change in levels of IL-17A, IL-17C, IL-17, CXCL1, and CXCL8', 'timeFrame': '12 weeks', 'description': 'In Brodalumab treated participants at week 12 compared with baseline'}, {'measure': 'Correlate IL-17R saturation (measured by the frequencies of immune cells positive to IL-17RA by flow cytometry) with clinical measures, such as pain or the Hidradenitis Suppurativa Severity Score System (IHS4)', 'timeFrame': '12 weeks', 'description': 'In Brodalumab treated participants at week 12 compared with baseline'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hidradenitis Suppurativa', 'Acne Inversa', 'Brodalumab'], 'conditions': ['Hidradenitis Suppurativa', 'Acne Inversa']}, 'descriptionModule': {'briefSummary': 'Hidradenitis suppurativa is a disease involving skin folds, causing swelling of the skin and surrounding tissues, pain, and foul-smelling discharges. Effective treatment options are lacking. Recently, clinical trials conducted in our lab found Brodalumab was an effective drug for this disease. Weekly dosing achieved superior therapeutic outcomes compared to a dosing given once in every other week. Brodalumab was safe in both regimens, but blood and tissue studies to better understand this response are still needed. By performing this small pilot study and collecting blood and tissue samples from participants treated with Brodalumab once weekly we would like to better characterize the molecular response to this treatment, identify blood and tissue markers reflecting disease severity, and better understand disease mechanisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed clinical diagnosis of Hidradenitis Suppurativa by the Principal Investigator\n* Age 18 to 99 years old\n* Moderate to severe Hidradenitis Suppurativa with draining tunnels (Hidradenitis Suppurativa Severity Score System/IHS4\\>4)\n* Must have medical insurance that is willing to pay for the study drug throughout the duration of the study\n\nExclusion Criteria:\n\n* Inflammatory Bowel Disease\n* HIV Positive\n* Active Hepatitis B or C Infection\n* Pregnant or Breastfeeding\n* No concurrent use of any systemic antibiotics/retinoids/immunosuppressants/biologics (require washout period of \\>5 half-lives)\n* A Score of \\>10 on the Beck's Depression Inventory (BDI) or on the Patient Health Questionnaire (PHQ)-9\n* History of Keloid Scarring\n* Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data"}, 'identificationModule': {'nctId': 'NCT04979520', 'briefTitle': 'Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa', 'organization': {'class': 'OTHER', 'fullName': 'Rockefeller University'}, 'officialTitle': 'A Small Pilot Study to Develop Biomarkers of Weekly Brodalumab Administration in Hidradenitis Suppurativa Patients', 'orgStudyIdInfo': {'id': 'YYU1014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brodalumab treated moderate-to-severe HS patients', 'description': 'Weekly Brodalumab treatment 210mg/1.5ml, given subcutaneously for 12 weeks.', 'interventionNames': ['Drug: Brodalumab']}], 'interventions': [{'name': 'Brodalumab', 'type': 'DRUG', 'otherNames': ['Siliq'], 'description': 'Subcutaneously Brodalumab/Siliq, 210mg/1.5ml once a week', 'armGroupLabels': ['Brodalumab treated moderate-to-severe HS patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Rockefeller University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Yael Renert-Yuval, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Rockefeller University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rockefeller University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor in clinical investigation', 'investigatorFullName': 'Yael Renert-Yuval', 'investigatorAffiliation': 'Rockefeller University'}}}}