Extension Study of ABP-671 in Participants With Gout

Last updated: September 12, 2024
Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Overall Status: Terminated

Phase

2/3

Condition

Arthritis And Arthritic Pain (Pediatric)

Joint Injuries

Musculoskeletal Diseases

Treatment

ABP-671

Allopurinol

Clinical Study ID

NCT06276556
ABP-671-302
  • Ages 19-75
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must have completed the double-blind Treatment Period in Study ABP-671-301 (Part 1or Part 2) and are actively receiving and tolerating the study drug up to the Week 28 visit in Study ABP-671-301

Exclusion

Exclusion Criteria:

  • Has a new medical or psychological condition that, in the opinion of theInvestigator and/or Medical Monitor, might create undue risk to the participant,interfere with the participant's ability to comply with the protocol requirements tocomplete the Extension Study, or potentially compromise the results orinterpretation of the Extension Study.

  • Is planning to become pregnant or breastfeed during the study or within ≤30 daysafter the last dose of the study drug.

  • Is intolerant or unwilling to take colchicine or naproxen.

Study Design

Total Participants: 43
Treatment Group(s): 2
Primary Treatment: ABP-671
Phase: 2/3
Study Start date:
April 22, 2024
Estimated Completion Date:
September 05, 2024

Connect with a study center

  • Paratus Clinical Research Western Sydney

    Blacktown, New South Wales 2148
    Australia

    Site Not Available

  • Emeritus Research Sydney

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • Paratus Clinical Research Central Coast

    Kanwal, New South Wales 2259
    Australia

    Site Not Available

  • A R Houston Medical Pty Ltd

    Kippa-Ring, Queensland 4021
    Australia

    Site Not Available

  • Emeritus Research Melbourne

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • Austin Health - Repatriation Hospital

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Academician Vakhtang Bochorishvili Clinic

    Tbilisi, 0186
    Georgia

    Site Not Available

  • Aversi Clini

    Tbilisi, 0160
    Georgia

    Site Not Available

  • Evex Hospitals Caraps Medline

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Innova

    Tbilisi, 0186
    Georgia

    Site Not Available

  • New Hospitals

    Tbilisi, 0114
    Georgia

    Site Not Available

  • The First Medical Center

    Tbilisi, 0180
    Georgia

    Site Not Available

  • Clinical Research Center (CRC)

    C.p., 01010
    Guatemala

    Site Not Available

  • Clínica Médica Especializada en Medicina Interna

    C.p., 01010
    Guatemala

    Site Not Available

  • Clínica Médica Especializada en Medicina Interna y Reumatología

    C.p., 01010
    Guatemala

    Site Not Available

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

    C.p., 01010
    Guatemala

    Site Not Available

  • Clinical Research Center (CRC)

    Guatemala city, 01010
    Guatemala

    Site Not Available

  • Clínica Médica Especializada en Medicina Interna

    Guatemala city, 01010
    Guatemala

    Site Not Available

  • Clínica Médica Especializada en Medicina Interna y Reumatología

    Guatemala city, 01010
    Guatemala

    Site Not Available

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

    Guatemala city, 01010
    Guatemala

    Site Not Available

  • Buddhist Dalin Tzu Chi General Hospital

    Chiayi City, 62247
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital CGMH

    Kaohsiung City, 833
    Taiwan

    Site Not Available

  • Chung Shan Medical Univ. Hospital

    Taichung, 402367
    Taiwan

    Site Not Available

  • Cheng-Shin General Hospital

    Taipei City, 112401
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital LinKou

    Taoyuan, 333423
    Taiwan

    Site Not Available

  • Alliance for Multispecialty Research

    Tempe, Arizona 85281
    United States

    Site Not Available

  • Tucson Neuroscience Research, LLC

    Tucson, Arizona 85710
    United States

    Site Not Available

  • Anaheim Clinical Trials (Cenexel ACT)

    Anaheim, California 92801
    United States

    Site Not Available

  • Center for Clinical Trials of Sacramento

    Sacramento, California 95823
    United States

    Site Not Available

  • Access Research Institute

    Brooksville, Florida 34613
    United States

    Site Not Available

  • Nature Coast Clinical Reasearch

    Crystal River, Florida 34429
    United States

    Site Not Available

  • JY Research Institute Inc.

    Cutler Bay, Florida 33189
    United States

    Site Not Available

  • Accel Clinical Research Site

    DeLand, Florida 32720
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • A & D Doctor Center

    Miami, Florida 33135
    United States

    Site Not Available

  • Bioclinical Research Alliance

    Miami, Florida 33155
    United States

    Site Not Available

  • Century Research LLC

    Miami, Florida 33173
    United States

    Site Not Available

  • Cordova Research Institute

    Miami, Florida 33155
    United States

    Site Not Available

  • ITB Research

    Miami, Florida 33173
    United States

    Site Not Available

  • Combined Research Orlando Phase I-IV

    Orlando, Florida 32807
    United States

    Site Not Available

  • New Horizons Research

    Palmetto Bay, Florida 33158
    United States

    Site Not Available

  • Advanced Clinical Research of Atlanta

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Centricity Research

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC.

    Newton, Kansas 67114
    United States

    Site Not Available

  • AMR

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Annapolis Internal Medicine/CCT Research

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • DelRicht Research of Gulfport

    Gulfport, Mississippi 39501
    United States

    Site Not Available

  • Quality Clinical Research, Inc

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Santa Rosa Medical Center

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Inspire Santa Fe Medical Group

    Santa Fe, New Mexico 87505
    United States

    Site Not Available

  • OnSite Clinical Solutions

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • ClinSearch

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Medical Care/CCT

    Elizabethton, Tennessee 37643
    United States

    Site Not Available

  • PanAmerican Clinical Research, LLC

    Brownsville, Texas 78520
    United States

    Site Not Available

  • Quality Research Inc.

    San Antonio, Texas 78209
    United States

    Site Not Available

  • Worldwide Clinical Trials

    San Antonio, Texas 78217
    United States

    Site Not Available

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