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TerminatedPhase 2/3

Extension Study of ABP-671 in Participants With Gout

Reason given: For business consideration, a new long-term safety study will be conducted in the next new pivotal studies.

Key facts

Where
Anaheim, Annapolis, Atlanta, Brooksville, Brownsville, Chattanooga, Columbus, Crystal River, Cutler Bay, DeLand, Duncansville, Elizabethton, Gulfport, Jacksonville, Las Vegas, Miami, New Orleans, Newton, Omaha, Orlando, Palmetto Bay, Sacramento, Salisbury, San Antonio, Santa Fe, Tempe, and Tucson, United StatesSee the 33 sites
Phase
Phase 2/3

Where in United States

  • Anaheim Clinical Trials (Cenexel ACT)Anaheim, United StatesNo longer taking part
  • Annapolis Internal Medicine/CCT ResearchAnnapolis, United StatesNo longer taking part
  • Advanced Clinical Research of AtlantaAtlanta, United StatesNo longer taking part
  • Access Research InstituteBrooksville, United StatesNo longer taking part
  • PanAmerican Clinical Research LLCBrownsville, United StatesNo longer taking part
  • ClinSearchChattanooga, United StatesNo longer taking part
  • Centricity ResearchColumbus, United StatesNo longer taking part
  • Nature Coast Clinical ReasearchCrystal River, United StatesNo longer taking part
  • JY Research Institute IncCutler Bay, United StatesNo longer taking part
  • DeLand, FloridaHospital not named in the registryNo longer taking part
  • Altoona Center For Clinical ResearchDuncansville, United StatesNo longer taking part
  • Medical Care/CCTElizabethton, United StatesNo longer taking part
  • DelRicht Research of GulfportGulfport, United StatesNo longer taking part
  • Jacksonville Center for Clinical ResearchJacksonville, United StatesNo longer taking part
  • Santa Rosa Medical CenterLas Vegas, United StatesNo longer taking part
  • A & D Doctor CenterMiami, United StatesNo longer taking part
  • Bioclinical Research AllianceMiami, United StatesNo longer taking part
  • Century Research LLCMiami, United StatesNo longer taking part
  • Cordova Research InstituteMiami, United StatesNo longer taking part
  • ITB ResearchMiami, United StatesNo longer taking part
  • AMRNew Orleans, United StatesNo longer taking part
  • Delricht ResearchNew Orleans, United StatesNo longer taking part
  • Alliance for Multispecialty Research, LLCNewton, United StatesNo longer taking part
  • Quality Clinical Research, Inc.Omaha, United StatesNo longer taking part
  • Combined Research Orlando Phase I-IVOrlando, United StatesNo longer taking part
  • New Horizons ResearchPalmetto Bay, United StatesNo longer taking part
  • Center for Clinical Trials of SacramentoSacramento, United StatesNo longer taking part
  • Onsite Clinical SolutionsSalisbury, United StatesNo longer taking part
  • Quality Research IncSan Antonio, United StatesNo longer taking part
  • Worldwide Clinical TrialsSan Antonio, United StatesNo longer taking part
  • Inspire Santa Fe Medical GroupSanta Fe, United StatesNo longer taking part
  • Alliance for Multispecialty ResearchTempe, United StatesNo longer taking part
  • Tucson Neuroscience Research, LLCTucson, United StatesNo longer taking part

Trial details

Who runs it
Atom Therapeutics Co., Ltd
Trial code
NCT06276556
Record updated
16 July 2025
Original description
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).Read full original descriptionShow less

A Multicenter, Double-blind, Phase 2b/3 Extension Study to Assess the Safety and Efficacy of ABP-671 in Participants With Gout Who Completed the Double-blind Treatment Period in Study ABP-671-301

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).

Inclusion: Must have completed the double-blind Treatment Period in Study ABP-671-301 (Part 1 or Part 2) and are actively receiving and tolerating the study drug up to the Week 28 visit in Study ABP-671-301.

Exclusion: Is planning to become pregnant or breastfeed during the study or within ≤30 days after the last dose of the study drug; Has a new medical or psychological condition that, in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the participant, interfere with the participant's ability to comply with the protocol requirements to complete the Extension Study, or potentially compromise the results or interpretation of the Extension Study; Is intolerant or unwilling to take colchicine or naproxen.

ClinicalTrials.gov NCT06276556