Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout
NCT ID: NCT05818085
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2023-08-11
2025-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ABP-671
ABP-671
Low, medium or high dose (Part 1); Selected dose(s) (Part 2)
Allopurinol
Allopurinol
Standard of care according to American College of Rheumatology (ACR) guideline for the management of gout
Placebo
Placebo
ABP-671 matching placebo
Interventions
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ABP-671
Low, medium or high dose (Part 1); Selected dose(s) (Part 2)
Allopurinol
Standard of care according to American College of Rheumatology (ACR) guideline for the management of gout
Placebo
ABP-671 matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
19 Years
75 Years
ALL
No
Sponsors
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Atom Therapeutics Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Alliance for Multispecialty Research
Tempe, Arizona, United States
Tucson Neuroscience Research, LLC
Tuscon, Arizona, United States
Anaheim Clinical Trials (Cenexel ACT)
Anaheim, California, United States
Center for Clinical Trials of Sacramento
Sacramento, California, United States
Access Research Institute
Brooksville, Florida, United States
Nature Coast Clinical Reasearch
Crystal River, Florida, United States
JY Research Institute Inc.
Cutler Bay, Florida, United States
Accel Clinical Research Site
DeLand, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Accel Research Sites Network - St. Pete-Largo Clinical Research Unit
Largo, Florida, United States
A & D Doctor Center
Miami, Florida, United States
Bioclinical Research Alliance
Miami, Florida, United States
Cordova Research Institute
Miami, Florida, United States
Century Research LLC
Miami, Florida, United States
ITB Research
Miami, Florida, United States
Combined Research Orlando Phase I-IV
Orlando, Florida, United States
New Horizons Research
Palmetto Bay, Florida, United States
Advanced Clinical Research of Atlanta
Atlanta, Georgia, United States
Centricity Research
Columbus, Georgia, United States
Alliance for Multispecialty Research, LLC.
Newton, Kansas, United States
DelRicht Research
New Orleans, Louisiana, United States
AMR
New Orleans, Louisiana, United States
Annapolis Internal Medicine/CCT Research
Annapolis, Maryland, United States
DelRicht Research of Gulfport
Gulfport, Mississippi, United States
Quality Clinical Research, Inc
Omaha, Nebraska, United States
Santa Rosa Medical Center
Las Vegas, Nevada, United States
Inspire Santa Fe Medical Group
Santa Fe, New Mexico, United States
OnSite Clinical Solutions
Salisbury, North Carolina, United States
DelRicht Research
Tulsa, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
ClinSearch
Chattanooga, Tennessee, United States
Medical Care/CCT
Elizabethton, Tennessee, United States
PanAmerican Clinical Research, LLC
Brownsville, Texas, United States
Quality Research Inc.
San Antonio, Texas, United States
Centricity Research
Suffolk, Virginia, United States
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia
Emeritus Research Sydney
Botany, New South Wales, Australia
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia
A R Houston Medical Pty Ltd
Kippa-Ring, Queensland, Australia
Emeritus Research Melbourne
Camberwell, Victoria, Australia
Austin Health - Repatriation Hospital
Heidelberg, Victoria, Australia
New Hospitals
Tbilisi, , Georgia
Evex Hospitals Caraps Medline
Tbilisi, , Georgia
Aversi Clini
Tbilisi, , Georgia
The First Medical Center
Tbilisi, , Georgia
Academician Vakhtang Bochorishvili Clinic
Tbilisi, , Georgia
Innova
Tbilisi, , Georgia
Clinical Research Center (CRC)
Guatemala City, , Guatemala
Clínica Médica Especializada en Medicina Interna y Reumatología (CREER)
Guatemala City, , Guatemala
Clínica Médica Especializada en Medicina Interna y Reumatología
Guatemala City, , Guatemala
Clínica Médica Especializada en Medicina Interna
Guatemala City, , Guatemala
Clínica Médica Especializada en Medicina Interna y Reumatología
Guatemala City, , Guatemala
Buddhist Dalin Tzu Chi General Hospital
Chiayi City, , Taiwan
Chang Gung Memorial Hospital CGMH
Kaohsiung City, , Taiwan
Chung Shan Medical Univ. Hospital
Taichung, , Taiwan
Cheng-Shin General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital LinKou
Taoyuan District, , Taiwan
Countries
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Other Identifiers
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ABP-671-301
Identifier Type: -
Identifier Source: org_study_id