Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-30 @ 3:30 PM
Study NCT ID:
NCT05372003
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2022-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IL-4 and Insulin Resistance for Treatment of Patients With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}, {'id': 'D010789', 'term': 'Phototherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2022-04-29', 'studyFirstSubmitQcDate': '2022-05-10', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Homa IR', 'timeFrame': 'baseline', 'description': 'Homeostatic Model Assessment of Insulin Resistance will be calculated by multiplying the fasting glucose concentration (mg/dl) by the fasting insulin concentration (mmol/L).'}, {'measure': 'Matsuda Index', 'timeFrame': 'baseline', 'description': 'The Matsuda index is able to estimate peripheral insulin sensitivity by computing the product of glucose and insulin collected during the OGTT.'}], 'secondaryOutcomes': [{'measure': 'Adipo-IR', 'timeFrame': 'baseline', 'description': 'Adipo-IR will be calculated by multiplying the fasting FFA concentration (mmol/L) by the fasting insulin concentration (pmol/L) obtained during the baseline blood collection during the oral glucose tolerance test'}, {'measure': 'Systemic inflammatory markers', 'timeFrame': 'baseline', 'description': 'Circulating plasma levels of inflammatory markers interleukin 1 (IL1), Tumor necrosis factor alpha (TNFa), highly sensitive C-reactive protein (hs-CRP), Monocyte Chemoattractant Protein 1 (MCP1), interleukin 6 (IL-6), Interleukin 4 (IL-4) and interleukin 13 (IL13)'}, {'measure': 'Adipokines', 'timeFrame': 'baseline', 'description': 'We will measure the plasma levels of adipokines (leptin and adiponectin) by radioimmunoassay and ELISA in all subjects recruited and compared across study group'}, {'measure': 'Fasting Free Fatty Acid', 'timeFrame': 'baseline', 'description': 'During the OGTT, we will collect fasting blood to assess levels of plasma free fatty acid (mmol/L). These values will be compared across the 2 different group studied.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils, their secreted cytokines (interleukin-4), and metabolism in human health and disease states such as obesity and insulin resistance.', 'detailedDescription': 'Patients with a body mass index (BMI) less than 30 kg/m2 and a history of atopic dermatitis on long-term (greater than 6 months) treatment with dupilumab. Researchers will compare in vivo evaluations of insulin sensitivity in subjects on dupilumab vs subjects matched for similar weight and BMI, with atopic dermatitis, but without dupilumab therapy (phototherapy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to sign informed consent form.\n* Body mass index (BMI), 22-29 kg/m\\^2.\n* Diagnosis of Atopic Dermatitis treated with dupilumab for longer than 6 months.\n* Diagnosis of Atopic Dermatitis treated with topical steroids or phototherapy.\n\nExclusion Criteria:\n\n* Any prescription for systemic glucocorticoid, immunosuppressant, antidiabetic medications in the past 6 months.\n* Evidence of diabetes mellitus.\n* Morning Cortisol \\< 5 mg/dl (collected before 10.30 am).\n* Presence of acute illness.\n* Low hemoglobin or hematocrit.\n* Current participation in a weight-loss regimen, with a weight loss \\> 10% total body weight in the last 6 months).\n* Smoking history in the last 6 months (tobacco, nicotine-containing products including e-cigarettes).\n* Pregnant or breastfeeding.\n* Personal history of gastric bypass surgery.\n* Previous participation in a clinical trial with an investigational product in the past 30 days, or 5 half-lives, or twice the duration of the biological effect of the investigational drug (whichever is longest).\n* Exposed to more than 4 new chemical entities within 12 months before study enrollment.\n* Any other condition or event considered exclusionary by the PI and the study physician.'}, 'identificationModule': {'nctId': 'NCT05372003', 'briefTitle': 'IL-4 and Insulin Resistance for Treatment of Patients With Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'IL-4 & Insulin Resistance in Patients With Atopic Dermatitis', 'orgStudyIdInfo': {'id': '22-002567'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects on Dupilumab', 'description': 'individuals with atopic dermatitis placed on dupilumab for more than 6 months will be eligible to this study. Their metabolic profile will be compared to the group of "Subjects on Phototherapy"', 'interventionNames': ['Drug: Dupilumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subjects on Phototherapy', 'description': 'individuals with atopic dermatitis placed on phototherapy for more than 6 months will be eligible to this study to serve as an active comparator to the "Subjects with Dupilumab"', 'interventionNames': ['Other: Photo therapy']}], 'interventions': [{'name': 'Dupilumab', 'type': 'DRUG', 'description': 'dupilumab injections will be prescribed and managed by dermatology as standard of care', 'armGroupLabels': ['Subjects on Dupilumab']}, {'name': 'Photo therapy', 'type': 'OTHER', 'otherNames': ['light therapy'], 'description': 'light therapy will be prescribed and managed by dermatology as standard of care', 'armGroupLabels': ['Subjects on Phototherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Elena Anna De Filippis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elena Anna (Eleanna) De Filippis, M.D., Ph.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}