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

ClinicalTrials.gov processed this data on September 12, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

TERMINATED (See Contacts and Locations)
Verified August 2024 by Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Sponsor

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Information Provided by (Responsible Party)

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Clinicaltrials.gov Identifier

NCT06276556
Other Study ID Numbers: ABP-671-302
First Submitted: February 12, 2024
First Posted: February 26, 2024
Last Update Posted: September 19, 2024
Last Verified: August 2024
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Gout
  • Drug: ABP-671
  • Drug: Allopurinol

Study Design

Study TypeInterventional
Actual Enrollment43 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateApril 22, 2024
Actual Primary Completion DateSeptember 5, 2024
Actual Study Completion DateSeptember 5, 2024

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • 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.
  • Allopurinol
  • Drug: Allopurinol

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L) [Week 26]
    2. Incidence of treatment-emergent adverse events (Safety and Tolerability) [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

    Secondary Outcome Measures

    1. Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L) [Week 26]

    Eligibility Criteria

    Ages Eligible for Study 19 Years to 75 Years (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    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.

    Contacts and Locations

    Sponsors and Collaborators Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
    Locations
    • Alliance for Multispecialty Research | Tempe, Arizona, United States, 85281
    • Tucson Neuroscience Research, LLC | Tucson, Arizona, United States, 85710
    • Anaheim Clinical Trials (Cenexel ACT) | Anaheim, California, United States, 92801
    • Center for Clinical Trials of Sacramento | Sacramento, California, United States, 95823
    • Access Research Institute | Brooksville, Florida, United States, 34613
    • Nature Coast Clinical Reasearch | Crystal River, Florida, United States, 34429
    • JY Research Institute Inc. | Cutler Bay, Florida, United States, 33189
    • Accel Clinical Research Site | DeLand, Florida, United States, 32720
    • Jacksonville Center for Clinical Research | Jacksonville, Florida, United States, 32216
    • A & D Doctor Center | Miami, Florida, United States, 33135
    • Bioclinical Research Alliance | Miami, Florida, United States, 33155
    • Cordova Research Institute | Miami, Florida, United States, 33155
    • Century Research LLC | Miami, Florida, United States, 33173
    • ITB Research | Miami, Florida, United States, 33173
    • Combined Research Orlando Phase I-IV | Orlando, Florida, United States, 32807
    • New Horizons Research | Palmetto Bay, Florida, United States, 33158
    • Advanced Clinical Research of Atlanta | Atlanta, Georgia, United States, 30309
    • Centricity Research | Columbus, Georgia, United States, 31904
    • Alliance for Multispecialty Research, LLC. | Newton, Kansas, United States, 67114
    • DelRicht Research | New Orleans, Louisiana, United States, 70115
    • AMR | New Orleans, Louisiana, United States, 70119
    • Annapolis Internal Medicine/CCT Research | Annapolis, Maryland, United States, 21401
    • DelRicht Research of Gulfport | Gulfport, Mississippi, United States, 39501
    • Quality Clinical Research, Inc | Omaha, Nebraska, United States, 68114
    • Santa Rosa Medical Center | Las Vegas, Nevada, United States, 89119
    • Inspire Santa Fe Medical Group | Santa Fe, New Mexico, United States, 87505
    • OnSite Clinical Solutions | Salisbury, North Carolina, United States, 28144
    • Altoona Center for Clinical Research | Duncansville, Pennsylvania, United States, 16635
    • ClinSearch | Chattanooga, Tennessee, United States, 37421
    • Medical Care/CCT | Elizabethton, Tennessee, United States, 37643
    • PanAmerican Clinical Research, LLC | Brownsville, Texas, United States, 78520
    • Quality Research Inc. | San Antonio, Texas, United States, 78209
    • Worldwide Clinical Trials | San Antonio, Texas, United States, 78217
    • Paratus Clinical Research Western Sydney | Blacktown, New South Wales, Australia, 2148
    • Emeritus Research Sydney | Botany, New South Wales, Australia, 2019
    • Paratus Clinical Research Central Coast | Kanwal, New South Wales, Australia, 2259
    • A R Houston Medical Pty Ltd | Kippa-Ring, Queensland, Australia, 4021
    • Emeritus Research Melbourne | Camberwell, Victoria, Australia, 3124
    • Austin Health - Repatriation Hospital | Heidelberg, Victoria, Australia, 3084
    • New Hospitals | Tbilisi, Georgia, 0114
    • Evex Hospitals Caraps Medline | Tbilisi, Georgia, 0159
    • Aversi Clini | Tbilisi, Georgia, 0160
    • The First Medical Center | Tbilisi, Georgia, 0180
    • Academician Vakhtang Bochorishvili Clinic | Tbilisi, Georgia, 0186
    • Innova | Tbilisi, Georgia, 0186
    • 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, 01010
    • Buddhist Dalin Tzu Chi General Hospital | Chiayi City, Taiwan, 62247
    • Chang Gung Memorial Hospital CGMH | Kaohsiung City, Taiwan, 833
    • Chung Shan Medical Univ. Hospital | Taichung, Taiwan, 402367
    • Cheng-Shin General Hospital | Taipei City, Taiwan, 112401
    • Chang Gung Memorial Hospital LinKou | Taoyuan, Taiwan, 333423

    More Information

    Additional Relevant MeSH Terms

    • Gout
    • Arthritis
    • Joint Diseases
    • Musculoskeletal Diseases
    • Crystal Arthropathies
    • Rheumatic Diseases
    • Purine-Pyrimidine Metabolism, Inborn Errors
    • Metabolism, Inborn Errors
    • Genetic Diseases, Inborn
    • Metabolic Diseases