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GoutPhase 2/3NCT05818085

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

A Phase 2/3 study testing ABP-671 and Allopurinol in people with Gout, run by Atom Therapeutics Co., Ltd at 57 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Gout
What is being tested?
ABP-671 and Allopurinol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
57 sitesin 5 countries
Study dates
11 Aug 2023to 30 Mar 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

57 sites in 5 countries.

57 sites in 5 countries

United States35 sites

  • Anaheim Clinical Trials (Cenexel ACT)

    Anaheim, California, 92801

  • Annapolis Internal Medicine/CCT Research

    Annapolis, Maryland, 21401

  • Advanced Clinical Research of Atlanta

    Atlanta, Georgia, 30309

  • Access Research Institute

    Brooksville, Florida, 34613

  • PanAmerican Clinical Research, LLC

    Brownsville, Texas, 78520

  • ClinSearch

    Chattanooga, Tennessee, 37421

  • Centricity Research

    Columbus, Georgia, 31904

  • Nature Coast Clinical Reasearch

    Crystal River, Florida, 34429

  • JY Research Institute Inc.

    Cutler Bay, Florida, 33189

  • Accel Clinical Research Site

    DeLand, Florida, 32720

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Medical Care/CCT

    Elizabethton, Tennessee, 37643

  • DelRicht Research of Gulfport

    Gulfport, Mississippi, 39501

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Accel Research Sites Network - St. Pete-Largo Clinical Research Unit

    Largo, Florida, 33777

  • Santa Rosa Medical Center

    Las Vegas, Nevada, 89119

  • A & D Doctor Center

    Miami, Florida, 33135

  • Bioclinical Research Alliance

    Miami, Florida, 33155

  • Cordova Research Institute

    Miami, Florida, 33155

  • Century Research LLC

    Miami, Florida, 33173

  • ITB Research

    Miami, Florida, 33173

  • DelRicht Research

    New Orleans, Louisiana, 70115

  • AMR

    New Orleans, Louisiana, 70119

  • Alliance for Multispecialty Research, LLC.

    Newton, Kansas, 67114

  • Quality Clinical Research, Inc

    Omaha, Nebraska, 68114

  • Combined Research Orlando Phase I-IV

    Orlando, Florida, 32807

  • New Horizons Research

    Palmetto Bay, Florida, 33158

  • Center for Clinical Trials of Sacramento

    Sacramento, California, 95823

  • OnSite Clinical Solutions

    Salisbury, North Carolina, 28144

  • Quality Research Inc.

    San Antonio, Texas, 78209

  • Inspire Santa Fe Medical Group

    Santa Fe, New Mexico, 87505

  • Centricity Research

    Suffolk, Virginia, 23435

  • Alliance for Multispecialty Research

    Tempe, Arizona, 85281

  • DelRicht Research

    Tulsa, Oklahoma, 74133

  • Tucson Neuroscience Research, LLC

    Tuscon, Arizona, 85710

Other trials in United States

Australia6 sites

  • Paratus Clinical Research Western Sydney

    Blacktown, New South Wales, 2148

  • Emeritus Research Sydney

    Botany, New South Wales, 2019

  • Emeritus Research Melbourne

    Camberwell, Victoria, 3124

  • Austin Health - Repatriation Hospital

    Heidelberg, Victoria, 3084

  • Paratus Clinical Research Central Coast

    Kanwal, New South Wales, 2259

  • A R Houston Medical Pty Ltd

    Kippa-Ring, Queensland, 4021

Other trials in Australia

Georgia6 sites

  • New Hospitals

    Tbilisi, 0114

  • Evex Hospitals Caraps Medline

    Tbilisi, 0159

  • Aversi Clini

    Tbilisi, 0160

  • The First Medical Center

    Tbilisi, 0180

  • Academician Vakhtang Bochorishvili Clinic

    Tbilisi, 0186

  • Innova

    Tbilisi, 0186

Other trials in Georgia

Guatemala5 sites

  • Clinical Research Center (CRC)

    Guatemala City, 01010

  • Clínica Médica Especializada en Medicina Interna y Reumatología (CREER)

    Guatemala City, 01010

  • Clínica Médica Especializada en Medicina Interna y Reumatología

    Guatemala City, 01010

  • Clínica Médica Especializada en Medicina Interna

    Guatemala City, 01010

  • Clínica Médica Especializada en Medicina Interna y Reumatología

    Guatemala City, 1011

Other trials in Guatemala

Taiwan5 sites

  • Buddhist Dalin Tzu Chi General Hospital

    Chiayi City, 62247

  • Chang Gung Memorial Hospital CGMH

    Kaohsiung City, 833

  • Chung Shan Medical Univ. Hospital

    Taichung, 402367

  • Cheng-Shin General Hospital

    Taipei, 112401

  • Chang Gung Memorial Hospital LinKou

    Taoyuan, 333423

Other trials in Taiwan

About this study

Official title: 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.

Conditions
Gout
Being tested
ABP-671, Allopurinol, Placebo
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABP-671Drug

    Low, medium or high dose (Part 1); Selected dose(s) (Part 2)

  • AllopurinolDrug

    Standard of care according to American College of Rheumatology (ACR) guideline for the management of gout

  • PlaceboOther

    ABP-671 matching placebo

Study groups in NCT05818085
Study groupRoleWhat they receive
ABP-671ExperimentalNot described
Receives: Drug: ABP-671
AllopurinolActive comparatorNot described
Receives: Drug: Allopurinol
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)

    Measured: Week 28

Secondary outcomes (2)

  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

    Measured: Week 28

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

    Measured: Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start11 Aug 2023
  3. Primary completion30 Jan 2025
  4. Study completion30 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05818085
Sponsor's protocol ID
ABP-671-301
Status last verified
Dec 2025
First submitted
5 Apr 2023
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ABP-671 and Allopurinol in people with Gout, run by Atom Therapeutics Co., Ltd at 57 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Australia, Georgia, Guatemala, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L) (time frame: Week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05818085.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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