Extension Study of ABP-671 in Participants With Gout

NCT ID: NCT06276556

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-22

Study Completion Date

2024-09-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gout

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ABP-671

Group Type EXPERIMENTAL

ABP-671

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Allopurinol

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Atom Therapeutics Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alliance for Multispecialty Research

Tempe, Arizona, United States

Site Status

Tucson Neuroscience Research, LLC

Tucson, Arizona, United States

Site Status

Anaheim Clinical Trials (Cenexel ACT)

Anaheim, California, United States

Site Status

Center for Clinical Trials of Sacramento

Sacramento, California, United States

Site Status

Access Research Institute

Brooksville, Florida, United States

Site Status

Nature Coast Clinical Reasearch

Crystal River, Florida, United States

Site Status

JY Research Institute Inc.

Cutler Bay, Florida, United States

Site Status

Accel Clinical Research Site

DeLand, Florida, United States

Site Status

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status

A & D Doctor Center

Miami, Florida, United States

Site Status

Bioclinical Research Alliance

Miami, Florida, United States

Site Status

Cordova Research Institute

Miami, Florida, United States

Site Status

Century Research LLC

Miami, Florida, United States

Site Status

ITB Research

Miami, Florida, United States

Site Status

Combined Research Orlando Phase I-IV

Orlando, Florida, United States

Site Status

New Horizons Research

Palmetto Bay, Florida, United States

Site Status

Advanced Clinical Research of Atlanta

Atlanta, Georgia, United States

Site Status

Centricity Research

Columbus, Georgia, United States

Site Status

Alliance for Multispecialty Research, LLC.

Newton, Kansas, United States

Site Status

DelRicht Research

New Orleans, Louisiana, United States

Site Status

AMR

New Orleans, Louisiana, United States

Site Status

Annapolis Internal Medicine/CCT Research

Annapolis, Maryland, United States

Site Status

DelRicht Research of Gulfport

Gulfport, Mississippi, United States

Site Status

Quality Clinical Research, Inc

Omaha, Nebraska, United States

Site Status

Santa Rosa Medical Center

Las Vegas, Nevada, United States

Site Status

Inspire Santa Fe Medical Group

Santa Fe, New Mexico, United States

Site Status

OnSite Clinical Solutions

Salisbury, North Carolina, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

ClinSearch

Chattanooga, Tennessee, United States

Site Status

Medical Care/CCT

Elizabethton, Tennessee, United States

Site Status

PanAmerican Clinical Research, LLC

Brownsville, Texas, United States

Site Status

Quality Research Inc.

San Antonio, Texas, United States

Site Status

Worldwide Clinical Trials

San Antonio, Texas, United States

Site Status

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, Australia

Site Status

Emeritus Research Sydney

Botany, New South Wales, Australia

Site Status

Paratus Clinical Research Central Coast

Kanwal, New South Wales, Australia

Site Status

A R Houston Medical Pty Ltd

Kippa-Ring, Queensland, Australia

Site Status

Emeritus Research Melbourne

Camberwell, Victoria, Australia

Site Status

Austin Health - Repatriation Hospital

Heidelberg, Victoria, Australia

Site Status

New Hospitals

Tbilisi, , Georgia

Site Status

Evex Hospitals Caraps Medline

Tbilisi, , Georgia

Site Status

Aversi Clini

Tbilisi, , Georgia

Site Status

The First Medical Center

Tbilisi, , Georgia

Site Status

Academician Vakhtang Bochorishvili Clinic

Tbilisi, , Georgia

Site Status

Innova

Tbilisi, , Georgia

Site Status

Clinical Research Center (CRC)

Guatemala City, , Guatemala

Site Status

Clínica Médica Especializada en Medicina Interna y Reumatología (CREER)

Guatemala City, , Guatemala

Site Status

Clínica Médica Especializada en Medicina Interna y Reumatología

Guatemala City, , Guatemala

Site Status

Clínica Médica Especializada en Medicina Interna

Guatemala City, , Guatemala

Site Status

Buddhist Dalin Tzu Chi General Hospital

Chiayi City, , Taiwan

Site Status

Chang Gung Memorial Hospital CGMH

Kaohsiung City, , Taiwan

Site Status

Chung Shan Medical Univ. Hospital

Taichung, , Taiwan

Site Status

Cheng-Shin General Hospital

Taipei, , Taiwan

Site Status

Chang Gung Memorial Hospital LinKou

Taoyuan District, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Georgia Guatemala Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ABP-671-302

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Allopurinol Combination Study
NCT01001338 COMPLETED PHASE2