Extension Study of ABP-671 in Participants With Gout

July 13, 2025 updated by: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

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

The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
  • 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 City, Taiwan, 112401
        • Cheng-Shin General Hospital
      • Taoyuan, Taiwan, 333423
        • Chang Gung Memorial Hospital Linkou
  • United States
    • Arizona
      • Tempe, Arizona, United States, 85281
        • Alliance for Multispecialty Research
      • Tucson, 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
      • 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
    • 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, 78217
        • Worldwide Clinical Trials
      • San Antonio, Texas, United States, 78209
        • Quality Research Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)
Time Frame: Week 26
Week 26
Incidence of treatment-emergent adverse events (Safety and Tolerability)
Time Frame: Week 26
Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation
Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)
Time Frame: Week 26
Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2024

Primary Completion (Actual)

September 5, 2024

Study Completion (Actual)

September 5, 2024

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 13, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABP-671-302

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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