Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT00146003
Status:
COMPLETED
Last Update Posted:
2008-08-07
First Post:
2005-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efalizumab for Eczema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2007-12'}, 'lastUpdateSubmitDate': '2008-08-06', 'studyFirstSubmitDate': '2005-09-01', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2008-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of subjects achieving "clear" to "almost clear" on the Investigator Global Assessment [IGA] (success is achieved if 2 of 10 patients achieve "clear" or "almost clear" at any point in the study)'}], 'secondaryOutcomes': [{'measure': 'Percent of subjects achieving "mild," "almost clear," or "clear" on the IGA'}, {'measure': 'Percent improvement from baseline on the EASI (eczema area and severity index)'}, {'measure': 'Photography (quarter-body views, front and back)'}, {'measure': 'Pruritus improvement from baseline (rated on a scale of 1 to 10)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['eczema', 'atopic dermatitis', 'efalizumab'], 'conditions': ['Dermatitis, Atopic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate a measurable improvement on a validated scale in a small population of adult patients with atopic dermatitis (eczema).', 'detailedDescription': 'The study involves administration of efalizumab (previously approved for psoriasis) to ten adult patients with atopic dermatitis. Biologic plausibility rests on similarities in pathophysiology of the two conditions. The drug (efalizumab) will be administered according to the dosing approved for plaque psoriasis for a period of 24 weeks. The subjects will self-administer efalizumab weekly and measurements will be performed on a monthly basis. Efalizumab is not being compared to placebo or other drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 years or older) with atopic dermatitis with 5% or more body surface area involvement\n* Investigator Global Assessment (IGA) score of "moderate" or worse\n* In general good health with well-controlled medical problems\n* Ability to provide written informed consent and comply with study assessments for the full duration of the study.\n* If a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary.\n* If a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary.\n* Normal platelet count\n\nExclusion Criteria:\n\n* Patients with known hypersensitivity to efalizumab or any of its components\n* Pregnancy or lactation\n* Patients receiving immunosuppressive agents\n* Prior enrollment in the study\n* Participation in another simultaneous medical investigation or trial\n* IGA score of "mild," "almost clear" or "clear"\n* Systemic therapy for atopic dermatitis, phototherapy or topical therapy (other than moisturizer) within 1 week\n* Medical condition which would make use of efalizumab unsafe; would limit compliance with study requirements; or would limit accurate assessment of efficacy.\n* Ongoing, active, serious infection\n* History of malignancy (except excised basal or squamous cell carcinoma of the skin)'}, 'identificationModule': {'nctId': 'NCT00146003', 'briefTitle': 'Efalizumab for Eczema', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Investigator-Initiated Trial of Efalizumab for Atopic Dermatitis: A Proof of Concept Study in Adults', 'orgStudyIdInfo': {'id': '5163'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Efalizumab treatment', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'UMDNJ Psoriasis Center of Excellence', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Melissa Magliocco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Medicine and Dentistry of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}]}}}