Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-02-27 @ 7:05 PM
Study NCT ID:
NCT01882504
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2013-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017511', 'term': 'Pyoderma Gangrenosum'}], 'ancestors': [{'id': 'D011711', 'term': 'Pyoderma'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012883', 'term': 'Skin Ulcer'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C547697', 'term': 'gevokizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-02', 'studyFirstSubmitDate': '2013-06-17', 'studyFirstSubmitQcDate': '2013-06-17', 'lastUpdatePostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer", 'timeFrame': 'Day 1 through Day 84'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pyoderma Gangrenosum', 'Classic Pyoderma Gangrenosum', 'Atypical Pyoderma Gangrenosum', 'Peristomal Pyoderma Gangrenosum'], 'conditions': ['Pyoderma Gangrenosum']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An established diagnosis of pyoderma gangrenosum\n* Currently experiencing an inflammatory episode of pyoderma gangrenosum\n* Contraceptive measures adequate to prevent pregnancy during the study\n\nExclusion Criteria:\n\n* Clinical evidence of acutely infected pyoderma gangrenosum\n* History of allergic or anaphylactic reactions to monoclonal antibodies\n* History of recurrent or chronic systemic infections\n* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01882504', 'briefTitle': 'Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum', 'organization': {'class': 'INDUSTRY', 'fullName': 'XOMA (US) LLC'}, 'officialTitle': 'An Open-label, Proof of Concept Study of Gevokizumab in the Treatment of the Acute, Inflammatory Phase of Pyoderma Gangrenosum', 'orgStudyIdInfo': {'id': 'X052170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'gevokizumab', 'description': 'Solution for subcutaneous injection', 'interventionNames': ['Drug: gevokizumab']}], 'interventions': [{'name': 'gevokizumab', 'type': 'DRUG', 'armGroupLabels': ['gevokizumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami Shores', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.86315, 'lon': -80.19283}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Verona', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.82982, 'lon': -74.24015}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'XOMA (US) LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}