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

A Multicenter, Randomized, Double-blind, Controlled, Phase 2b/3 Study to Assess the Efficacy and Safety of ABP-671 in Participants With Gout

This is a multicenter, randomized, double-blind, Phase 2b/3 study to evaluate the efficacy and safety of ABP-671. Part 1 of the study will compare the efficacy and safety of different doses and regimens of ABP-671 with placebo and allopurinol. Part 2 of the study will compare the dosing regimen(s) of ABP-671 selected from Part 1 with placebo in participants who have not been enrolled for Part 1.

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: ABP-671; Drug: Allopurinol; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Paratus Clinical Research Western Sydney
    • Botany, New South Wales, Australia, 2019
      • Emeritus Research Sydney
    • Kanwal, New South Wales, Australia, 2259
      • Paratus Clinical Research Central Coast
  • Queensland
    • Kippa-Ring, Queensland, Australia, 4021
      • A R Houston Medical Pty Ltd
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research Melbourne
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health - Repatriation Hospital
• Georgia
  • Tbilisi, Georgia, 0114
    • New Hospitals
  • Tbilisi, Georgia, 0180
    • The First Medical Center
  • Tbilisi, Georgia, 0159
    • Evex Hospitals Caraps Medline
  • Tbilisi, Georgia, 0160
    • Aversi Clini
  • Tbilisi, Georgia, 0186
    • Academician Vakhtang Bochorishvili Clinic
  • Tbilisi, Georgia, 0186
    • Innova
• Guatemala
  • Guatemala City, Guatemala, 01010
    • Clinical Research Center (CRC)
  • Guatemala City, Guatemala, 01010
    • Clínica Médica Especializada en Medicina Interna y Reumatología (CREER)
  • Guatemala City, Guatemala, 01010
    • Clínica Médica Especializada en Medicina Interna y Reumatología
  • Guatemala City, Guatemala, 01010
    • Clínica Médica Especializada en Medicina Interna
  • Guatemala City, Guatemala, 1011
    • Clínica Médica Especializada en Medicina Interna y Reumatología
• Taiwan
  • Chiayi City, Taiwan, 62247
    • Buddhist Dalin Tzu Chi General Hospital
  • Kaohsiung City, Taiwan, 833
    • Chang Gung Memorial Hospital CGMH
  • Taichung, Taiwan, 402367
    • Chung Shan Medical Univ. Hospital
  • Taipei, Taiwan, 112401
    • Cheng-Shin General Hospital
  • Taoyuan District, Taiwan, 333423
    • Chang Gung Memorial Hospital LinKou
• United States
  • Arizona
    • Tempe, Arizona, United States, 85281
      • Alliance for Multispecialty Research
    • Tuscon, Arizona, United States, 85710
      • Tucson Neuroscience Research, LLC
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials (Cenexel ACT)
    • Sacramento, California, United States, 95823
      • Center for Clinical Trials of Sacramento
  • Florida
    • Brooksville, Florida, United States, 34613
      • Access Research Institute
    • Crystal River, Florida, United States, 34429
      • Nature Coast Clinical Reasearch
    • Cutler Bay, Florida, United States, 33189
      • JY Research Institute Inc.
    • DeLand, Florida, United States, 32720
      • Accel Clinical Research Site
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Largo, Florida, United States, 33777
      • Accel Research Sites Network - St. Pete-Largo Clinical Research Unit
    • Miami, Florida, United States, 33155
      • Cordova Research Institute
    • Miami, Florida, United States, 33173
      • ITB Research
    • Miami, Florida, United States, 33173
      • Century Research LLC
    • Miami, Florida, United States, 33135
      • A & D Doctor Center
    • Miami, Florida, United States, 33155
      • Bioclinical Research Alliance
    • Orlando, Florida, United States, 32807
      • Combined Research Orlando Phase I-IV
    • Palmetto Bay, Florida, United States, 33158
      • New Horizons Research
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Advanced Clinical Research of Atlanta
    • Columbus, Georgia, United States, 31904
      • Centricity Research
  • Kansas
    • Newton, Kansas, United States, 67114
      • Alliance for Multispecialty Research, LLC.
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Research
    • New Orleans, Louisiana, United States, 70119
      • AMR
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Annapolis Internal Medicine/CCT Research
  • Mississippi
    • Gulfport, Mississippi, United States, 39501
      • DelRicht Research of Gulfport
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Santa Rosa Medical Center
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • Inspire Santa Fe Medical Group
  • North Carolina
    • Salisbury, North Carolina, United States, 28144
      • Onsite Clinical Solutions
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • DelRicht Research
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch
    • Elizabethton, Tennessee, United States, 37643
      • Medical Care/CCT
  • Texas
    • Brownsville, Texas, United States, 78520
      • PanAmerican Clinical Research, LLC
    • San Antonio, Texas, United States, 78209
      • Quality Research Inc.
  • Virginia
    • Suffolk, Virginia, United States, 23435
      • Centricity Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)	Week 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)		Week 28
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	Week 28

Collaborators and Investigators

• Sponsor: Atom Therapeutics Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2023
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Gout; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Purines; Allopurinol
• Other Study ID Numbers: ABP-671-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No