Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-01-24 @ 9:55 PM
Study NCT ID:
NCT02464605
Status:
COMPLETED
Last Update Posted:
2016-10-21
First Post:
2015-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacodynamics of SEL-037 (Pegsiticase) in Subjects With Elevated Blood Uric Acid Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-19', 'studyFirstSubmitDate': '2015-05-29', 'studyFirstSubmitQcDate': '2015-06-04', 'lastUpdatePostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability as assessed by frequency of drug related adverse events, graded by severity', 'timeFrame': '30 days', 'description': 'To assess the safety and tolerability of a single infusion of SEL-037 as assessed by frequency of drug related adverse events, graded by severity'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of SEL-037 (AUC)', 'timeFrame': '30 days', 'description': 'Measurement of the pharmacokinetics of SEL-037 over 30 days by area under the serum concentration versus time curve (AUC)'}, {'measure': 'Pharmacodynamics of SEL-037 (blood uric acid levels)', 'timeFrame': '30 days', 'description': 'Pharmacodynamics of SEL-037 by measurement of blood uric acid levels over 30 days'}, {'measure': 'Immunogenicity of SEL-037 (measurement of anti-drug antibody levels)', 'timeFrame': '30 days', 'description': 'Immunogenicity of SEL-037 by measurement of anti-drug antibody levels over 30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gout']}, 'referencesModule': {'references': [{'pmid': '35022448', 'type': 'DERIVED', 'citation': 'Sands E, Kivitz A, DeHaan W, Leung SS, Johnston L, Kishimoto TK. Tolerogenic nanoparticles mitigate the formation of anti-drug antibodies against pegylated uricase in patients with hyperuricemia. Nat Commun. 2022 Jan 12;13(1):272. doi: 10.1038/s41467-021-27945-7.'}]}, 'descriptionModule': {'briefSummary': 'This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted.', 'detailedDescription': 'This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted. Cohorts of Subjects will be given a single, ascending dose intravenous infusion of SEL-037 and then monitored for safety, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects ages 21 to 75 inclusive. Female subjects must be of non-childbearing potential;\n* Has at the Screening Visit a serum uric acid ≥ 6 mg/dL, with or without a history of gout;\n* The use of allopurinol, febuxostat (Uloric®), or probenecid as uric acid-lowering therapy is permissible if dosing has been stable for at least the month prior to the Screening Visit\n* Has adequate venous access and able to receive IV therapy;\n* Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study;\n\nExclusion Criteria:\n\n* Prior exposure to any experimental or marketed uricase;\n* History of any allergy to pegylated products,\n* Glucose-6-phosphate dehydrogenase deficiency or known catalase deficiency;\n* History of hematological or autoimmune disorders, is immunosuppressed or immunocompromised;\n* Has participated in a clinical trial within 30 days of the Screening;'}, 'identificationModule': {'nctId': 'NCT02464605', 'briefTitle': 'Safety and Pharmacodynamics of SEL-037 (Pegsiticase) in Subjects With Elevated Blood Uric Acid Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Selecta Biosciences, Inc.'}, 'officialTitle': 'An Open-Label, Sequential, Ascending Single-Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of an Intravenous Infusion of SEL-037 in Subjects With Elevated Blood Uric Acid Levels', 'orgStudyIdInfo': {'id': 'SEL-037/101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SEL-037 (pegsiticase)', 'description': 'Pegylated uricase', 'interventionNames': ['Biological: SEL-037 (pegsiticase)']}], 'interventions': [{'name': 'SEL-037 (pegsiticase)', 'type': 'BIOLOGICAL', 'description': 'Intravenous infusion of SEL-037', 'armGroupLabels': ['SEL-037 (pegsiticase)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clincal Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Metroplex Clinical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selecta Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}