Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified November 2025 by Atom Therapeutics Co., Ltd
Sponsor
Atom Therapeutics Co., Ltd
Information Provided by (Responsible Party)
Atom Therapeutics Co., Ltd
Clinicaltrials.gov Identifier
NCT05818085
Other Study ID Numbers:
ABP-671-301
First Submitted
April 4, 2023
First Posted
April 17, 2023
Last Update Posted
December 21, 2025
Last Verified
November 2025

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

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Gout
Drug: ABP-671Drug: AllopurinolOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment300 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Multicenter, Randomized, Double-blind, Controlled, Phase 2b/3 Study to Assess the Efficacy and Safety of ABP-671 in Participants With Gout
Study Start DateAugust 10, 2023
Actual Primary Completion DateJanuary 29, 2025
Actual Study Completion DateMarch 29, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
ABP-671
Drug: ABP-671
Low, medium or high dose (Part 1); Selected dose(s) (Part 2)
Allopurinol
Drug: Allopurinol
Standard of care according to American College of Rheumatology (ACR) guideline for the management of gout
Placebo
Other: Placebo
ABP-671 matching placebo

Outcome Measures

Primary Outcome Measures
  1. Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)
Secondary Outcome Measures
  1. 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
  2. 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 StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Male and female participants aged ≥19 and \<70 years of age at the time of informed consent.
A body mass index (BMI) of ≥18 kg/m2 to ≤40 kg/m2.
Diagnosis of gout per American College of Rheumatology/European Alliance of Associations for Rheumatology 2015 Gout Classification Criteria and must meet the criteria as follows:
At Screening, participants with gout on ULT (including allopurinol) must be willing to discontinue ULT.
At Screening, participants with gout who are not currently treated with any UA lowering therapy must have an sUA ≥7.5 mg/dL (≥0.450 mmol/L).
At the confirmatory sUA visit, all participants must have an sUA ≥7.0 mg/dL (≥0.420 mmol/L).
Women of childbearing potential (WOCBP) must be surgically sterile (eg, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or willing to use acceptable and highly effective double contraception from Screening until at least 30 days after the last dose of the study drug. Double contraception is defined as a condom AND one other form of the following:
Established hormonal contraception (with approved oral contraceptive pills, long-acting implantable hormones, injectable hormones);
A vaginal ring or an intrauterine device OR
Documented evidence of surgical sterilization at least 6 months prior to Screening (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men \[with appropriate post-vasectomy documentation of the absence of sperm in semen\] provided the male partner is the sole partner). The absence of records will not exclude screening the participant; if medical records cannot be obtained, serum pregnancy testing will be conducted to confirm the participant is not pregnant. Note: Women not of childbearing potential must be postmenopausal for ≥12 months. Postmenopausal status will be confirmed through follicle stimulating hormone (FSH) concentration testing. -Men must be surgically sterile (\>30 days since vasectomy), abstinent, or if engaged in sexual relations with a female partner of childbearing potential, the participant must use an acceptable form of contraception from Screening until at least 30 days after the last dose of the study drug. Acceptable methods of contraception include the use of condoms in addition to the use of an effective contraceptive for the female partner that includes approved oral contraceptive pills, long-acting implantable hormones, injectable hormones, a vaginal ring, or an intrauterine device. Participants who practice abstinence (abstinence from penile-vaginal intercourse) are eligible when this is in line with their preferred and usual lifestyle. In addition, men must not donate sperm for at least 30 days after the last dose of the study drug.
Exclusion Criteria
History of rheumatoid arthritis or other autoimmune disease.
Clinically significant hepatic, cardiovascular, renal, neoplastic, psychiatric, or hematological disorders such as polycythemia vera, sickle cell disease, or myelodysplastic disorder.
Positive test result for HIV, hepatitis B surface antigen, or hepatitis C virus antibody. Active hepatitis C virus infection is defined as a participant with a positive hepatitis C antibody and detectable hepatitis C viral load RNA.
Participants who, in the opinion of the Investigator, have a high genetic risk of allopurinol hypersensitivity syndrome unless they have been found to be negative for Human leukocyte antigen (HLA)-B\
5801, either clinically by prior exposure to allopurinol or by laboratory evaluation.
Liver function tests \>2x the laboratory upper limit of normal (ULN) range of aspartate aminotransferase, alkaline phosphatase, or alanine aminotransferase; total bilirubin \>1.5x ULN at Screening.
Inadequate renal function with serum creatinine \>1.5 mg/dL (\>0.133 mmol/L) or estimated glomerular filtration rate (eGFR) \< 60 mL/min/m2 (by the 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine-based eGFR equation).
History of malignancy within the previous 5 years; with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia, or treated in situ grade 1 cervical cancer.
History within the last 12 months of unstable angina, New York Heart Association functional class III or IV heart failure, myocardial infarction, stroke, venous thromboembolism, or a history of percutaneous coronary intervention.
Uncontrolled hypertension (systolic BP ≥160 mmHg and/or diastolic BP ≥90 mmHg). If BP is controlled while taking antihypertensive medication, the participant must be on stable dose for previous 2 months.
Active liver disease or impaired hepatic function as assessed by liver function tests.
Received any investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening.
Any other 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 study, or potentially compromise the results or interpretation of the study.
Pregnant, breastfeeding, or planning a pregnancy during the study or ≤30 days after the last dose of the study drug.
Intolerant or unwilling to take colchicine or naproxen.

Contacts and Locations

Sponsors and CollaboratorsAtom Therapeutics Co., Ltd
Locations
Alliance for Multispecialty Research | Tempe Arizona, United States, 85281Tucson Neuroscience Research, LLC | Tuscon 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, 32216Accel Research Sites Network - St. Pete-Largo Clinical Research Unit | Largo Florida, United States, 33777A & 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, 28144DelRicht Research | Tulsa Oklahoma, United States, 74133Altoona 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, 78209Centricity Research | Suffolk Virginia, United States, 23435Paratus 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, 01010Clínica Médica Especializada en Medicina Interna y Reumatología | Guatemala City , Guatemala, 1011Buddhist 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