Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04155918
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2019-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2a Study of AR882 Alone and in Combination With Febuxostat or Allopurinol in Gout Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D033461', 'term': 'Hyperuricemia'}, {'id': 'D006073', 'term': 'Gout'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069465', 'term': 'Febuxostat'}, {'id': 'D000493', 'term': 'Allopurinol'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-18', 'studyFirstSubmitDate': '2019-10-25', 'studyFirstSubmitQcDate': '2019-11-05', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PD profile of AR882 administered alone or in combination with febuxostat', 'timeFrame': '22 Days', 'description': 'Profile from serum uric acid concentration over time'}, {'measure': 'PD profile of AR882 administered alone or in combination with allopurinol', 'timeFrame': '22 Days', 'description': 'Profile from serum uric acid concentration over time.'}, {'measure': 'Serum uric acid (sUA) response rate', 'timeFrame': '22 Days', 'description': 'sUA response rate to achieve sUA \\<6, \\<5, \\<4, and \\<3 mg/dL'}], 'secondaryOutcomes': [{'measure': 'Area under the curve (AUC) for plasma AR882', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of AUC for AR882'}, {'measure': 'Time to maximum plasma concentration (Tmax) for AR882', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of Tmax for AR882'}, {'measure': 'Maximum plasma concentration (Cmax) for AR882', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of Cmax for AR882'}, {'measure': 'Apparent terminal half-life (t1/2) for AR882', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of t1/2 for AR882'}, {'measure': 'Amount excreted (Ae) into urine for AR882', 'timeFrame': '22 Days', 'description': 'Profile from urine in terms of Ae for AR882'}, {'measure': 'Renal clearance (CLr) for AR882', 'timeFrame': '22 Days', 'description': 'Profile from urine in terms of CLr for AR882'}, {'measure': 'AUC for plasma for febuxostat', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of AUC for febuxostat'}, {'measure': 'Tmax for febuxostat', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of Tmax for febuxostat'}, {'measure': 'Cmax for febuxostat', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of Cmax for febuxostat'}, {'measure': 't1/2 for febuxostat', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of t1/2 for febuxostat'}, {'measure': 'AUC for plasma allopurinol/oxypurinol', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of AUC for allopurinol/oxypurinol'}, {'measure': 'Tmax for allopurinol/oxypurinol', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of Tmax for allopurinol/oxypurinol'}, {'measure': 'Cmax for allopurinol/oxypurinol', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of Cmax for allopurinol/oxypurinol'}, {'measure': 't1/2 for for allopurinol/oxypurinol', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of t1/2 for allopurinol/oxypurinol'}, {'measure': 'Ae in urine for allopurinol/oxypurinol', 'timeFrame': '22 Days', 'description': 'Profile from urine in terms of Ae for allopurinol/oxypurinol'}, {'measure': 'CLr for allopurinol/oxypurinol', 'timeFrame': '22 Days', 'description': 'Profile from urine in terms of CLr for allopurinol/oxypurinol'}, {'measure': 'AUC for plasma for colchicine', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of AUC for colchicine'}, {'measure': 'Tmax for colchicine', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of Tmax for colchicine'}, {'measure': 'Cmax for colchicine', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of Cmax for colchicine'}, {'measure': 't1/2 for for colchicine', 'timeFrame': '22 Days', 'description': 'Profile from plasma in terms of t1/2 for colchicine'}, {'measure': 'Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs', 'timeFrame': '28 Days'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyperuricemia', 'Gout', 'URAT1'], 'conditions': ['Gout Patients']}, 'descriptionModule': {'briefSummary': 'The study is designed to evaluate the PK/PD, safety and tolerability of AR882 alone or in combination with febuxostat or allopurinol when administered to gout patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* History of gout\n* sUA \\> 7 mg/dL\n* Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m2\n\nKey Exclusion Criteria:\n\n* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin\n* History of cardiac abnormalities\n* Active peptic ulcer disease or active liver disease\n* History of kidney stones\n* Allergy or intolerance to colchicine, febuxostat, and allopurinol'}, 'identificationModule': {'nctId': 'NCT04155918', 'briefTitle': 'Phase 2a Study of AR882 Alone and in Combination With Febuxostat or Allopurinol in Gout Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arthrosi Therapeutics'}, 'officialTitle': 'A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of AR882 Administered Alone or in Combination With Febuxostat or Allopurinol in Gout Patients', 'orgStudyIdInfo': {'id': 'AR882-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AR882/FBX', 'interventionNames': ['Drug: Group 1: AR882 Alone and in Combination with Febuxostat (FBX)']}, {'type': 'EXPERIMENTAL', 'label': 'AR882/ALLO', 'interventionNames': ['Drug: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)']}], 'interventions': [{'name': 'Group 1: AR882 Alone and in Combination with Febuxostat (FBX)', 'type': 'DRUG', 'otherNames': ['Febuxostat (Adenuric®, Uloric®)'], 'description': 'AR882 + Febuxostat, AR882 alone, Febuxostat alone', 'armGroupLabels': ['AR882/FBX']}, {'name': 'Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)', 'type': 'DRUG', 'otherNames': ['Allopurinol (Allosig®, Progout®, Zyloprim®)'], 'description': 'AR882 + Allopurinol, AR882 alone, Allopurinol alone', 'armGroupLabels': ['AR882/ALLO']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Christchurch Clinical Studies Trust, Ltd (CCST)', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}], 'overallOfficials': [{'name': 'Christopher Wynne, MBChB, Grad Dip Pharm Med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christchurch Clinical Studies Trust Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arthrosi Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}