Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-03 @ 10:22 PM
Study NCT ID:
NCT02258867
Status:
TERMINATED
Last Update Posted:
2015-12-29
First Post:
2014-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D001528', 'term': 'Behcet Syndrome'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014606', 'term': 'Uveitis, Anterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C547697', 'term': 'gevokizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-28', 'studyFirstSubmitDate': '2014-10-02', 'studyFirstSubmitQcDate': '2014-10-02', 'lastUpdatePostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first ocular exacerbation', 'timeFrame': 'Randomization through Day 280', 'description': 'Time to first ocular exacerbation is defined as the number of days from randomization to the first ocular exacerbation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Uveitis', "Behcet's Disease Uveitis", "Behcet's Disease"], 'conditions': ["Behcet's Disease Uveitis"]}, 'descriptionModule': {'briefSummary': "The objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have characteristics of Behcet's disease consistent with International Criteria for Behcet's disease\n* Have a documented history of active uveitis with or without retinal vasculitis within the past 12 months\n* Best corrected visual acuity (BCVA) \\>= 20 ETDRS letters in both eyes at baseline\n* Effective contraceptive measures\n\nExclusion Criteria:\n\n* Infectious uveitis and masquerade syndromes\n* End stage ocular disease\n* History of allergic or anaphylactic reactions to monoclonal antibodies\n* Active tuberculosis disease\n* History of recurrent infection or predisposition to infection; active ocular infection\n* Pregnant or nursing women\n\nOther protocol-defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT02258867', 'acronym': 'EYEGUARD™-US', 'briefTitle': "Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis", 'organization': {'class': 'INDUSTRY', 'fullName': 'XOMA (US) LLC'}, 'officialTitle': "A Randomized-Withdrawal, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Subjects With Behcet's Disease Uveitis", 'orgStudyIdInfo': {'id': 'X052133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Gevokizumab', 'interventionNames': ['Drug: Gevokizumab']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Solution for subcutaneous injection', 'armGroupLabels': ['Placebo']}, {'name': 'Gevokizumab', 'type': 'DRUG', 'description': 'Solution for subcutaneous injection', 'armGroupLabels': ['Gevokizumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Ellsworth', 'state': 'Maine', 'country': 'United States', 'geoPoint': {'lat': 44.54341, 'lon': -68.41946}}, {'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}, {'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'XOMA (US) LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}