protocolSection identificationModule nctId: NCT06276556, orgStudyIdInfo id: ABP-671-302, briefTitle: Extension Study of ABP-671 in Participants With Gout, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-07-02, completionDateStruct date: 2025-07-02, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3)., conditionsModule conditions: Gout, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 580, type: ESTIMATED, armsInterventionsModule interventions name: ABP-671, interventions name: Allopurinol, outcomesModule primaryOutcomes measure: Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L), primaryOutcomes measure: Incidence of treatment-emergent adverse events (Safety and Tolerability), secondaryOutcomes measure: Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L), eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alliance for Multispecialty Research, city: Tempe, state: Arizona, zip: 85281, country: United States, geoPoint lat: 33.41477, lon: -111.90931, locations facility: Tucson Neuroscience Research, LLC, city: Tucson, state: Arizona, zip: 85710, country: United States, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Anaheim Clinical Trials (Cenexel ACT), city: Anaheim, state: California, zip: 92801, country: United States, geoPoint lat: 33.83529, lon: -117.9145, locations facility: Center for Clinical Trials of Sacramento, city: Sacramento, state: California, zip: 95823, country: United States, geoPoint lat: 38.58157, lon: -121.4944, locations facility: Access Research Institute, city: Brooksville, state: Florida, zip: 34613, country: United States, geoPoint lat: 28.55554, lon: -82.38991, locations facility: Nature Coast Clinical Reasearch, city: Crystal River, state: Florida, zip: 34429, country: United States, geoPoint lat: 28.90248, lon: -82.5926, locations facility: JY Research Institute Inc., city: Cutler Bay, state: Florida, zip: 33189, country: United States, geoPoint lat: 25.5783, lon: -80.3377, locations facility: Accel Clinical Research Site, city: DeLand, state: Florida, zip: 32720, country: United States, geoPoint lat: 29.02832, lon: -81.30312, locations facility: Jacksonville Center for Clinical Research, city: Jacksonville, state: Florida, zip: 32216, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: A & D Doctor Center, city: Miami, state: Florida, zip: 33135, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Bioclinical Research Alliance, city: Miami, state: Florida, zip: 33155, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Cordova Research Institute, city: Miami, state: Florida, zip: 33155, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Century Research LLC, city: Miami, state: Florida, zip: 33173, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: ITB Research, city: Miami, state: Florida, zip: 33173, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Combined Research Orlando Phase I-IV, city: Orlando, state: Florida, zip: 32807, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: New Horizons Research, city: Palmetto Bay, state: Florida, zip: 33158, country: United States, geoPoint lat: 25.62177, lon: -80.32477, locations facility: Advanced Clinical Research of Atlanta, city: Atlanta, state: Georgia, zip: 30309, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Centricity Research, city: Columbus, state: Georgia, zip: 31904, country: United States, geoPoint lat: 32.46098, lon: -84.98771, locations facility: Alliance for Multispecialty Research, LLC., city: Newton, state: Kansas, zip: 67114, country: United States, geoPoint lat: 38.04668, lon: -97.34504, locations facility: DelRicht Research, city: New Orleans, state: Louisiana, zip: 70115, country: United States, geoPoint lat: 29.95465, lon: -90.07507, locations facility: AMR, city: New Orleans, state: Louisiana, zip: 70119, country: United States, geoPoint lat: 29.95465, lon: -90.07507, locations facility: Annapolis Internal Medicine/CCT Research, city: Annapolis, state: Maryland, zip: 21401, country: United States, geoPoint lat: 38.97845, lon: -76.49218, locations facility: DelRicht Research of Gulfport, city: Gulfport, state: Mississippi, zip: 39501, country: United States, geoPoint lat: 30.36742, lon: -89.09282, locations facility: Quality Clinical Research, Inc, city: Omaha, state: Nebraska, zip: 68114, country: United States, geoPoint lat: 41.25626, lon: -95.94043, locations facility: Santa Rosa Medical Center, city: Las Vegas, state: Nevada, zip: 89119, country: United States, geoPoint lat: 36.17497, lon: -115.13722, locations facility: Inspire Santa Fe Medical Group, city: Santa Fe, state: New Mexico, zip: 87505, country: United States, geoPoint lat: 35.68698, lon: -105.9378, locations facility: OnSite Clinical Solutions, city: Salisbury, state: North Carolina, zip: 28144, country: United States, geoPoint lat: 35.67097, lon: -80.47423, locations facility: Altoona Center for Clinical Research, city: Duncansville, state: Pennsylvania, zip: 16635, country: United States, geoPoint lat: 40.42341, lon: -78.4339, locations facility: ClinSearch, city: Chattanooga, state: Tennessee, zip: 37421, country: United States, geoPoint lat: 35.04563, lon: -85.30968, locations facility: Medical Care/CCT, city: Elizabethton, state: Tennessee, zip: 37643, country: United States, geoPoint lat: 36.34872, lon: -82.21069, locations facility: PanAmerican Clinical Research, LLC, city: Brownsville, state: Texas, zip: 78520, country: United States, geoPoint lat: 25.90175, lon: -97.49748, locations facility: Quality Research Inc., city: San Antonio, state: Texas, zip: 78209, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Worldwide Clinical Trials, city: San Antonio, state: Texas, zip: 78217, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Paratus Clinical Research Western Sydney, city: Blacktown, state: New South Wales, zip: 2148, country: Australia, geoPoint lat: -33.76667, lon: 150.91667, locations facility: Emeritus Research Sydney, city: Botany, state: New South Wales, zip: 2019, country: Australia, geoPoint lat: -33.94599, lon: 151.19591, locations facility: Paratus Clinical Research Central Coast, city: Kanwal, state: New South Wales, zip: 2259, country: Australia, geoPoint lat: -33.253, lon: 151.4911, locations facility: A R Houston Medical Pty Ltd, city: Kippa-Ring, state: Queensland, zip: 4021, country: Australia, geoPoint lat: -27.22586, lon: 153.0835, locations facility: Emeritus Research Melbourne, city: Camberwell, state: Victoria, zip: 3124, country: Australia, geoPoint lat: -37.84205, lon: 145.0694, locations facility: Austin Health - Repatriation Hospital, city: Heidelberg, state: Victoria, zip: 3084, country: Australia, geoPoint lat: -37.75, lon: 145.06667, locations facility: New Hospitals, city: Tbilisi, zip: 0114, country: Georgia, geoPoint lat: 41.69411, lon: 44.83368, locations facility: Evex Hospitals Caraps Medline, city: Tbilisi, zip: 0159, country: Georgia, geoPoint lat: 41.69411, lon: 44.83368, locations facility: Aversi Clini, city: Tbilisi, zip: 0160, country: Georgia, geoPoint lat: 41.69411, lon: 44.83368, locations facility: The First Medical Center, city: Tbilisi, zip: 0180, country: Georgia, geoPoint lat: 41.69411, lon: 44.83368, locations facility: Academician Vakhtang Bochorishvili Clinic, city: Tbilisi, zip: 0186, country: Georgia, geoPoint lat: 41.69411, lon: 44.83368, locations facility: Innova, city: Tbilisi, zip: 0186, country: Georgia, geoPoint lat: 41.69411, lon: 44.83368, locations facility: Clinical Research Center (CRC), city: C.p., zip: 01010, country: Guatemala, locations facility: Clínica Médica Especializada en Medicina Interna y Reumatología (CREER), city: C.p., zip: 01010, country: Guatemala, locations facility: Clínica Médica Especializada en Medicina Interna y Reumatología, city: C.p., zip: 01010, country: Guatemala, locations facility: Clínica Médica Especializada en Medicina Interna, city: C.p., zip: 01010, country: Guatemala, locations facility: Buddhist Dalin Tzu Chi General Hospital, city: Chiayi City, zip: 62247, country: Taiwan, geoPoint lat: 23.47917, lon: 120.44889, locations facility: Chang Gung Memorial Hospital CGMH, city: Kaohsiung City, zip: 833, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, locations facility: Chung Shan Medical Univ. Hospital, city: Taichung, zip: 402367, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, locations facility: Cheng-Shin General Hospital, city: Taipei City, zip: 112401, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Chang Gung Memorial Hospital LinKou, city: Taoyuan, zip: 333423, country: Taiwan, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False