nctId: NCT06276556 id: ABP-671-302 briefTitle: Extension Study of ABP-671 in Participants With Gout overallStatus: ENROLLING_BY_INVITATION date: 2024-04-22 date: 2025-07-02 date: 2025-07-02 date: 2024-02-26 date: 2024-02-26 name: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. class: INDUSTRY 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). conditions: Gout studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 580 type: ESTIMATED name: ABP-671 name: Allopurinol measure: Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L) measure: Incidence of treatment-emergent adverse events (Safety and Tolerability) measure: Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L) sex: ALL minimumAge: 19 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alliance for Multispecialty Research city: Tempe state: Arizona zip: 85281 country: United States lat: 33.41477 lon: -111.90931 facility: Tucson Neuroscience Research, LLC city: Tucson state: Arizona zip: 85710 country: United States lat: 32.22174 lon: -110.92648 facility: Anaheim Clinical Trials (Cenexel ACT) city: Anaheim state: California zip: 92801 country: United States lat: 33.83529 lon: -117.9145 facility: Center for Clinical Trials of Sacramento city: Sacramento state: California zip: 95823 country: United States lat: 38.58157 lon: -121.4944 facility: Access Research Institute city: Brooksville state: Florida zip: 34613 country: United States lat: 28.55554 lon: 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