Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-27 @ 6:29 PM
Study NCT ID:
NCT04060550
Status:
UNKNOWN
Last Update Posted:
2021-03-05
First Post:
2019-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Increased Immunoglobulin E to Anti-herpes Simplex Virus -1 Innate Immune Responses in Atopic Dermatitis Patients With Eczema Herpeticum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D007617', 'term': 'Kaposi Varicelliform Eruption'}, {'id': 'D006561', 'term': 'Herpes Simplex'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069444', 'term': 'Omalizumab'}], 'ancestors': [{'id': 'D000888', 'term': 'Antibodies, Anti-Idiotypic'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Peripheral blood, monocytes purified from peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-04', 'studyFirstSubmitDate': '2019-08-07', 'studyFirstSubmitQcDate': '2019-08-16', 'lastUpdatePostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monocytes surface bound IgE quantities', 'timeFrame': 'One day', 'description': 'Relative quantities of surface bound IgE'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atopic dermatitis', 'Eczema herpeticum', 'Immunoglobulin E', 'Herpes simplex virus'], 'conditions': ['Atopic Dermatitis With a History of Eczema Herpeticum', 'Atopic Dermatitis Without a History of Eczema Herpeticum', 'Health Controls Without Atopy']}, 'descriptionModule': {'briefSummary': "This study investigates whether blood monocytes' surface bound- immunoglobulin E affects the innate immune responses against herpes simplex viruses in atopic dermatitis patients with eczema herpeticum.", 'detailedDescription': "Some of atopic dermatitis patients (AD) have severe herpes simplex viral (HSV) infections, which could cause erosive skin lesions all over the body. This condition is termed as eczema herpeticum (ADEH+). Scientists have found that ADEH+ patients have significantly increased blood immunoglobulin (Ig) E compared to AD patients without eczema herpeticum and healthy people. Increased IgE in blood could bound to immune cells' surface, such as monocytes. Since monocytes serve as the first line defense to fight viral infection, their surface-bound IgE may interfere their anti-viral immune responses, and consequently results in more severe viral infections. The purpose of this study is to learn more about how increased IgE affect body's immune ability to fight herpes simplex viruses. This study includes three groups: AD patient without eczema herpeticum complication(ADEH-); AD patient with eczema herpeticum complication(ADEH+) and healthy controls. Study results will be compared between groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'One of the following groups:\n\n1. A history of AD with a history of eczema herpeticum, ADEH+, as diagnosed using the Atopic Dermatitis Research Network Standard Diagnostic Criteria.\n2. A history of AD without a history of eczema herpeticum, ADEH-, as diagnosed using Atopic Dermatitis Research Network Standard Diagnostic Criteria, and no first degree relatives with a history of EH.\n3. Non-atopic as diagnosed using Atopic Dermatitis Research Network Standard Diagnostic Criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 16-65 years old, age, sex and race match among non-atopic, ADEH- and ADEH+.\n* Participant and/or parent guardian must be able to understand and provide informed consent, and fits in one of the following conditions:\n\n 1. A history of AD with a history of eczema herpeticum, ADEH+, as diagnosed using the Atopic Dermatitis Research Network Standard Diagnostic Criteria.\n 2. A history of AD without a history of eczema herpeticum, ADEH-, as diagnosed using Atopic Dermatitis Research Network Standard Diagnostic Criteria, and no first degree relatives with a history of EH.\n 3. Non-atopic as diagnosed using Atopic Dermatitis Research Network Standard Diagnostic Criteria.\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant to give written informed consent or comply with study protocol\n* Known or suspected immunosuppression\n* Severe concomitant illness(es)\n* Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding\n* Known sensitivity to study drug(s) or class of study drug(s)\n* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)\n* Use of any other investigational agent in the last 30 days'}, 'identificationModule': {'nctId': 'NCT04060550', 'briefTitle': 'Impact of Increased Immunoglobulin E to Anti-herpes Simplex Virus -1 Innate Immune Responses in Atopic Dermatitis Patients With Eczema Herpeticum', 'organization': {'class': 'OTHER', 'fullName': 'National Jewish Health'}, 'officialTitle': 'Investigate the Impact of Increased IgE on Innate Anti-herpes Simplex Virus 1 Responses in the Eczema Herpeticum Patients', 'orgStudyIdInfo': {'id': 'ML41620'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal controls', 'description': 'No history of skin disease and atopy', 'interventionNames': ['Biological: Xolair']}, {'label': 'ADEH-', 'description': 'Atopic dermatitis without a history of eczema herpeticum', 'interventionNames': ['Biological: Xolair']}, {'label': 'ADEH+', 'description': 'Atopic dermatitis with a history of eczema herpeticum', 'interventionNames': ['Biological: Xolair']}], 'interventions': [{'name': 'Xolair', 'type': 'BIOLOGICAL', 'otherNames': ['omalizumab'], 'description': 'This is in vitro mechanistic study. No drug will be given in vivo to patients.', 'armGroupLabels': ['ADEH+', 'ADEH-', 'Normal controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patricia Taylor, NP-C', 'role': 'CONTACT', 'email': 'taylorp@njhealth.org', 'phone': '303-398-1067', 'phoneExt': '1067'}, {'name': 'Lianghua Bin, MD & PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Donald Leung, MD & PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'centralContacts': [{'name': 'Lianghua Bin, MD&PhD', 'role': 'CONTACT', 'email': 'binl@njhealth.org', 'phone': '3032702055'}, {'name': 'Donald Leung, MD&PhD', 'role': 'CONTACT', 'email': 'leungd@njhealth.org', 'phone': '3033981886'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Jewish Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}