Extension Study of ABP-671 in Participants With Gout

Recruitment Status: TERMINATED
(See Contacts and Locations)Verified July 2024 by Atom Therapeutics Co., Ltd
Sponsor: Atom Therapeutics Co., Ltd
Information Provided by (Responsible Party): Atom Therapeutics Co., Ltd

Clinicaltrials.gov Identifier: NCT06276556
Other Study ID Numbers:: ABP-671-302

First Submitted: February 11, 2024
First Posted: February 25, 2024
Last Update Posted: July 15, 2025
Last Verified: July 2024

ClinicalTrials.gov processed this data on July 2025. Link to the current ClinicalTrials.gov record .

Study Details

Study Description

Condition or Disease	Intervention/Treatment
Gout	Drug: ABP-671Drug: Allopurinol

Study Design

Study Type	Interventional
Actual Enrollment	43 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Quadruple
Primary Purpose	Treatment
Official Title	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
Study Start Date	April 21, 2024
Actual Primary Completion Date	September 4, 2024
Actual Study Completion Date	September 4, 2024

Groups and Cohorts

Group/Cohort	Intervention/Treatment
ABP-671	Drug: ABP-671 Participants who were randomized to any of the ABP-671 treatment groups in Part 1 or Part 2 of Study ABP-671-301 will continue to receive the same dose level and dosing regimen during the Treatment Period of this Extension Study. Participants who were randomized to receive placebo in Part 1 or Part 2 of Study ABP-671-301 will receive ABP-671 during the Treatment Period of the Extension Study.
Allopurinol	Drug: Allopurinol Participants who were randomized to receive allopurinol in Part 1 of Study ABP-671-301 will continue to receive allopurinol during the Treatment Period of the Extension Study.

Group/Cohort

Intervention/Treatment

ABP-671

Drug: ABP-671: Participants who were randomized to any of the ABP-671 treatment groups in Part 1 or Part 2 of Study ABP-671-301 will continue to receive the same dose level and dosing regimen during the Treatment Period of this Extension Study. Participants who were randomized to receive placebo in Part 1 or Part 2 of Study ABP-671-301 will receive ABP-671 during the Treatment Period of the Extension Study.

Allopurinol

Drug: Allopurinol: Participants who were randomized to receive allopurinol in Part 1 of Study ABP-671-301 will continue to receive allopurinol during the Treatment Period of the Extension Study.

Outcome Measures

Primary Outcome Measures

Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)
Incidence of treatment-emergent adverse events (Safety and Tolerability)
Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation

Secondary Outcome Measures

Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)

Eligibility Criteria

Ages Eligible for Study	(Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
Inclusion Criteria	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 Criteria	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 planning to become pregnant or breastfeed during the study or within ≤30 days after the last dose of the study drug. Is intolerant or unwilling to take colchicine or naproxen.

Contacts and Locations

Sponsors and Collaborators	Atom Therapeutics Co., Ltd
Locations	Alliance for Multispecialty Research \| Tempe Arizona, United States, 85281Tucson Neuroscience Research, LLC \| Tucson Arizona, United States, 85710Anaheim Clinical Trials (Cenexel ACT) \| Anaheim California, United States, 92801Center for Clinical Trials of Sacramento \| Sacramento California, United States, 95823Access Research Institute \| Brooksville Florida, United States, 34613Nature Coast Clinical Reasearch \| Crystal River Florida, United States, 34429JY Research Institute Inc. \| Cutler Bay Florida, United States, 33189Accel Clinical Research Site \| DeLand Florida, United States, 32720Jacksonville Center for Clinical Research \| Jacksonville Florida, United States, 32216A & D Doctor Center \| Miami Florida, United States, 33135Bioclinical Research Alliance \| Miami Florida, United States, 33155Cordova Research Institute \| Miami Florida, United States, 33155Century Research LLC \| Miami Florida, United States, 33173ITB Research \| Miami Florida, United States, 33173Combined Research Orlando Phase I-IV \| Orlando Florida, United States, 32807New Horizons Research \| Palmetto Bay Florida, United States, 33158Advanced Clinical Research of Atlanta \| Atlanta Georgia, United States, 30309Centricity Research \| Columbus Georgia, United States, 31904Alliance for Multispecialty Research, LLC. \| Newton Kansas, United States, 67114DelRicht Research \| New Orleans Louisiana, United States, 70115AMR \| New Orleans Louisiana, United States, 70119Annapolis Internal Medicine/CCT Research \| Annapolis Maryland, United States, 21401DelRicht Research of Gulfport \| Gulfport Mississippi, United States, 39501Quality Clinical Research, Inc \| Omaha Nebraska, United States, 68114Santa Rosa Medical Center \| Las Vegas Nevada, United States, 89119Inspire Santa Fe Medical Group \| Santa Fe New Mexico, United States, 87505OnSite Clinical Solutions \| Salisbury North Carolina, United States, 28144Altoona Center for Clinical Research \| Duncansville Pennsylvania, United States, 16635ClinSearch \| Chattanooga Tennessee, United States, 37421Medical Care/CCT \| Elizabethton Tennessee, United States, 37643PanAmerican Clinical Research, LLC \| Brownsville Texas, United States, 78520Quality Research Inc. \| San Antonio Texas, United States, 78209Worldwide Clinical Trials \| San Antonio Texas, United States, 78217Paratus Clinical Research Western Sydney \| Blacktown New South Wales, Australia, 2148Emeritus Research Sydney \| Botany New South Wales, Australia, 2019Paratus Clinical Research Central Coast \| Kanwal New South Wales, Australia, 2259A R Houston Medical Pty Ltd \| Kippa-Ring Queensland, Australia, 4021Emeritus Research Melbourne \| Camberwell Victoria, Australia, 3124Austin Health - Repatriation Hospital \| Heidelberg Victoria, Australia, 3084New Hospitals \| Tbilisi , Georgia, 0114Evex Hospitals Caraps Medline \| Tbilisi , Georgia, 0159Aversi Clini \| Tbilisi , Georgia, 0160The First Medical Center \| Tbilisi , Georgia, 0180Academician Vakhtang Bochorishvili Clinic \| Tbilisi , Georgia, 0186Innova \| Tbilisi , Georgia, 0186Clinical Research Center (CRC) \| Guatemala City , Guatemala, 01010Clínica Médica Especializada en Medicina Interna y Reumatología (CREER) \| Guatemala City , Guatemala, 01010Clínica Médica Especializada en Medicina Interna y Reumatología \| Guatemala City , Guatemala, 01010Clínica Médica Especializada en Medicina Interna \| Guatemala City , Guatemala, 01010Buddhist Dalin Tzu Chi General Hospital \| Chiayi City , Taiwan, 62247Chang Gung Memorial Hospital CGMH \| Kaohsiung City , Taiwan, 833Chung Shan Medical Univ. Hospital \| Taichung , Taiwan, 402367Cheng-Shin General Hospital \| Taipei , Taiwan, 112401Chang Gung Memorial Hospital LinKou \| Taoyuan , Taiwan, 333423

Sponsors and Collaborators

Atom Therapeutics Co., Ltd

Locations

Alliance for Multispecialty Research | Tempe Arizona, United States, 85281Tucson Neuroscience Research, LLC | Tucson Arizona, United States, 85710Anaheim Clinical Trials (Cenexel ACT) | Anaheim California, United States, 92801Center for Clinical Trials of Sacramento | Sacramento California, United States, 95823Access Research Institute | Brooksville Florida, United States, 34613Nature Coast Clinical Reasearch | Crystal River Florida, United States, 34429JY Research Institute Inc. | Cutler Bay Florida, United States, 33189Accel Clinical Research Site | DeLand Florida, United States, 32720Jacksonville Center for Clinical Research | Jacksonville Florida, United States, 32216A & D Doctor Center | Miami Florida, United States, 33135Bioclinical Research Alliance | Miami Florida, United States, 33155Cordova Research Institute | Miami Florida, United States, 33155Century Research LLC | Miami Florida, United States, 33173ITB Research | Miami Florida, United States, 33173Combined Research Orlando Phase I-IV | Orlando Florida, United States, 32807New Horizons Research | Palmetto Bay Florida, United States, 33158Advanced Clinical Research of Atlanta | Atlanta Georgia, United States, 30309Centricity Research | Columbus Georgia, United States, 31904Alliance for Multispecialty Research, LLC. | Newton Kansas, United States, 67114DelRicht Research | New Orleans Louisiana, United States, 70115AMR | New Orleans Louisiana, United States, 70119Annapolis Internal Medicine/CCT Research | Annapolis Maryland, United States, 21401DelRicht Research of Gulfport | Gulfport Mississippi, United States, 39501Quality Clinical Research, Inc | Omaha Nebraska, United States, 68114Santa Rosa Medical Center | Las Vegas Nevada, United States, 89119Inspire Santa Fe Medical Group | Santa Fe New Mexico, United States, 87505OnSite Clinical Solutions | Salisbury North Carolina, United States, 28144Altoona Center for Clinical Research | Duncansville Pennsylvania, United States, 16635ClinSearch | Chattanooga Tennessee, United States, 37421Medical Care/CCT | Elizabethton Tennessee, United States, 37643PanAmerican Clinical Research, LLC | Brownsville Texas, United States, 78520Quality Research Inc. | San Antonio Texas, United States, 78209Worldwide Clinical Trials | San Antonio Texas, United States, 78217Paratus Clinical Research Western Sydney | Blacktown New South Wales, Australia, 2148Emeritus Research Sydney | Botany New South Wales, Australia, 2019Paratus Clinical Research Central Coast | Kanwal New South Wales, Australia, 2259A R Houston Medical Pty Ltd | Kippa-Ring Queensland, Australia, 4021Emeritus Research Melbourne | Camberwell Victoria, Australia, 3124Austin Health - Repatriation Hospital | Heidelberg Victoria, Australia, 3084New Hospitals | Tbilisi , Georgia, 0114Evex Hospitals Caraps Medline | Tbilisi , Georgia, 0159Aversi Clini | Tbilisi , Georgia, 0160The First Medical Center | Tbilisi , Georgia, 0180Academician Vakhtang Bochorishvili Clinic | Tbilisi , Georgia, 0186Innova | Tbilisi , Georgia, 0186Clinical Research Center (CRC) | Guatemala City , Guatemala, 01010Clínica Médica Especializada en Medicina Interna y Reumatología (CREER) | Guatemala City , Guatemala, 01010Clínica Médica Especializada en Medicina Interna y Reumatología | Guatemala City , Guatemala, 01010Clínica Médica Especializada en Medicina Interna | Guatemala City , Guatemala, 01010Buddhist Dalin Tzu Chi General Hospital | Chiayi City , Taiwan, 62247Chang Gung Memorial Hospital CGMH | Kaohsiung City , Taiwan, 833Chung Shan Medical Univ. Hospital | Taichung , Taiwan, 402367Cheng-Shin General Hospital | Taipei , Taiwan, 112401Chang Gung Memorial Hospital LinKou | Taoyuan , Taiwan, 333423

More Information

Additional Relevant MeSH Terms

GoutArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases