Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT05265234
Status:
UNKNOWN
Last Update Posted:
2022-03-03
First Post:
2021-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004485', 'term': 'Eczema'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D003872', 'term': 'Dermatitis'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}, {'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-22', 'studyFirstSubmitDate': '2021-12-16', 'studyFirstSubmitQcDate': '2022-02-22', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eczema Area and Severity Index (EASI)', 'timeFrame': 'Baseline to 16 weeks', 'description': 'The Eczema Area and Severity Index (EASI) is a tool used to measure the extent (area) and severity of atopic eczema, ranging 0-72, 0 being least severe and 72 being most severe.'}, {'measure': 'Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD)', 'timeFrame': 'Baseline to 16 weeks', 'description': 'Investigator will use the Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) a tool used to measure the severity of atopic eczema, ranging 0-4, 0 is clear and 4 is most severe.'}, {'measure': 'Noninvasive Imaging (clinical response) with Reflectance Confocal Microscopy (RCM)', 'timeFrame': 'Baseline to 16 weeks', 'description': 'Reflectance Confocal Microscopy (RCM) is a noninvasive imaging device that can be used to monitor the severity of inflammatory skin disorders without the need for a biopsy. RCM can visualize cells with a resolution comparable to a light microscope, allowing the investigators to identify the degree of inflammation and damage to the skin.\n\nAn overall disease severity score ranging from 0-3 (0=none, 1=mild, 2= moderate, 3=severe) will use aggregates of the following \\*features:\n\n* Spongiosis\n* Parakeratosis\n* Epidermal thickness\n* Quality of honeycomb structure of the stratum spinosum\n* Appearance of the dermal-epidermal junction\n* Appearance of the superficial dermis\n* Recognition of the dermal papilla\n* Caliber of blood vessels\n* Presence of inflammatory cells\n\n * Grading will be scored (0=none, 1=mild, 2= moderate, 3=severe), a greater numerical score indicates more advanced disease.'}, {'measure': 'Noninvasive Imaging (clinical response) with Optical Coherence Tomography (OCT)', 'timeFrame': 'Baseline to 16 weeks', 'description': 'Optical Coherence Tomography (OCT) is a noninvasive imaging device that can be used to monitor the severity of inflammatory skin disorders without the need for a biopsy. OCT can detect deep structures in the skin, identify areas of inflammation, and determine the thickness of the skin. These measures will be consolidated to a severity score ranging 0-3, (0= no disease, 3= severe disease) and will be tracked throughout the duration of the study.\n\nThe following features will be aggregated to form an Optical Coherence Tomography-severity-score:\n\n* Change in the epidermal thickness\n* Changes in anatomy or appearance of the dermo-epidermal junction and the dermis.\n* Changes in vascular flow patterns, including the number and density of vessels in skin using the dynamic feature of Optical Coherence Tomography\n\n * Grading will be scored 0=none, 1=mild, 2= moderate, 3=severe'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['dermatitis', 'Dupilumab', 'Inflammatory Skin Diseases', 'itch relief', 'biologic'], 'conditions': ['Eczema', 'Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '25282559', 'type': 'BACKGROUND', 'citation': 'Leung DY, Guttman-Yassky E. Deciphering the complexities of atopic dermatitis: shifting paradigms in treatment approaches. J Allergy Clin Immunol. 2014 Oct;134(4):769-79. doi: 10.1016/j.jaci.2014.08.008.'}, {'pmid': '27690741', 'type': 'BACKGROUND', 'citation': 'Simpson EL, Bieber T, Guttman-Yassky E, Beck LA, Blauvelt A, Cork MJ, Silverberg JI, Deleuran M, Kataoka Y, Lacour JP, Kingo K, Worm M, Poulin Y, Wollenberg A, Soo Y, Graham NM, Pirozzi G, Akinlade B, Staudinger H, Mastey V, Eckert L, Gadkari A, Stahl N, Yancopoulos GD, Ardeleanu M; SOLO 1 and SOLO 2 Investigators. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. N Engl J Med. 2016 Dec 15;375(24):2335-2348. doi: 10.1056/NEJMoa1610020. Epub 2016 Sep 30.'}, {'pmid': '25467783', 'type': 'BACKGROUND', 'citation': 'Meinke MC, Richter H, Kleemann A, Lademann J, Tscherch K, Rohn S, Schempp CM. Characterization of atopic skin and the effect of a hyperforin-rich cream by laser scanning microscopy. J Biomed Opt. 2015 May;20(5):051013. doi: 10.1117/1.JBO.20.5.051013.'}, {'pmid': '29675335', 'type': 'BACKGROUND', 'citation': 'Byers RA, Maiti R, Danby SG, Pang EJ, Mitchell B, Carre MJ, Lewis R, Cork MJ, Matcher SJ. Sub-clinical assessment of atopic dermatitis severity using angiographic optical coherence tomography. Biomed Opt Express. 2018 Mar 29;9(4):2001-2017. doi: 10.1364/BOE.9.002001. eCollection 2018 Apr 1.'}, {'pmid': '24655575', 'type': 'BACKGROUND', 'citation': 'Tang TS, Bieber T, Williams HC. Are the concepts of induction of remission and treatment of subclinical inflammation in atopic dermatitis clinically useful? J Allergy Clin Immunol. 2014 Jun;133(6):1615-25.e1. doi: 10.1016/j.jaci.2013.12.1079. Epub 2014 Mar 18.'}], 'seeAlsoLinks': [{'url': 'https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process', 'label': 'FDA Approved Drugs: Dupixent'}]}, 'descriptionModule': {'briefSummary': 'The study is trying to answer the following question: "Can we use non-invasive imaging to evaluate the response of atopic dermatitis (eczema) to Dupixent (dupilumab)?"', 'detailedDescription': 'Participating in this research will allow the subject to undergo a noninvasive imaging alternative to conventional monitoring in response to a biologic. Normally, subjects would undergo a clinical examination, serial photography, and possible biopsies to assess the progression of the disease. This study will get rid of the need for a biopsy but will require multiple scans with non-invasive imaging. This research examines a new approach to monitoring response to a biologic drug used for atopic dermatitis, and can also, be used to grade disease severity without the need for a biopsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age\n* Atopic dermatitis (AD) affecting ≥10% body surface area (BSA) at baseline\n* IGA score ≥3, on the IGA scale of 0-4 at baseline\n* Eczema Area and Severity Index (EASI) score of ≥16 at baseline\n\nExclusion Criteria:\n\n* Prior treatment with Dupilumab (REGN668/SAR231893)\n* Treatment with TCS or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline visit\n* Bodyweight \\<30 kg (65lb) at Baseline\n* Known or suspected immunodeficiency including human immunodeficiency virus (HIV) infection\n* Pregnancy, breastfeeding or planning to become pregnant or breastfeed during the study'}, 'identificationModule': {'nctId': 'NCT05265234', 'briefTitle': 'Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.', 'organization': {'class': 'OTHER', 'fullName': 'OptiSkin Medical'}, 'officialTitle': 'Monitoring Response to Therapy in Atopic Dermatitis Patients Treated With Dupilumab Using Noninvasive Reflectance Confocal Microscopy and Optical Coherence Tomography', 'orgStudyIdInfo': {'id': 'OPTI-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dupixent', 'description': 'Patients will receive initial dose of 600 mg (two 300 mg injections in different injection sites), followed by 300 mg given every other week for 16 weeks.\n\nPatients will self-administer by subcutaneous injection at home, instructions will be provided at first visit.', 'interventionNames': ['Drug: Dupilumab', 'Device: Optical Coherence Tomography', 'Device: Reflectance confocal microscopy']}], 'interventions': [{'name': 'Dupilumab', 'type': 'DRUG', 'otherNames': ['Dupixent'], 'description': 'IL-4 antagonist to improve moderate-severe atopic dermatitis', 'armGroupLabels': ['Dupixent']}, {'name': 'Optical Coherence Tomography', 'type': 'DEVICE', 'otherNames': ['OCT'], 'description': 'OCT is a noninvasive imaging device that can be used to monitor inflammatory skin disorders.', 'armGroupLabels': ['Dupixent']}, {'name': 'Reflectance confocal microscopy', 'type': 'DEVICE', 'otherNames': ['RCM'], 'description': 'RCM is a noninvasive imaging device, with resolution approaching that of histology, which can monitor structural changes in the epidermis and superficial dermis, monitor inflammatory cells, and can overcome the limitations of a traditional biopsy.', 'armGroupLabels': ['Dupixent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10128', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Moshe Bressler, DO', 'role': 'CONTACT', 'email': 'moshe@optiskinmedical.com', 'phone': '212-828-3120'}, {'name': 'Orit Markowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'OptiSkin Medical', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Moshe Bressler, DO', 'role': 'CONTACT', 'email': 'moshe@optiskinmedical.com', 'phone': '212-828-3120'}, {'name': 'Orit Markowitz, MD', 'role': 'CONTACT', 'email': 'clinicaltrials@optiskinmedical.com', 'phone': '212-828-3120'}], 'overallOfficials': [{'name': 'Orit Markowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OptiSkin Medical', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Orit Markowitz MD', 'investigatorAffiliation': 'OptiSkin Medical'}}}}