Study Stopped
For business consideration, a new long-term safety study will be conducted in the next new pivotal studies.
Extension Study of ABP-671 in Participants With Gout
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
1 other identifier
interventional
43
5 countries
54
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2024
Shorter than P25 for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2024
CompletedFirst Posted
Study publicly available on registry
February 26, 2024
CompletedStudy Start
First participant enrolled
April 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2024
CompletedJuly 16, 2025
August 1, 2024
5 months
February 12, 2024
July 13, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)
Week 26
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
Week 26
Secondary Outcomes (1)
Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)
Week 26
Study Arms (2)
ABP-671
EXPERIMENTALAllopurinol
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Alliance for Multispecialty Research
Tempe, Arizona, 85281, United States
Tucson Neuroscience Research, LLC
Tucson, Arizona, 85710, United States
Anaheim Clinical Trials (Cenexel ACT)
Anaheim, California, 92801, United States
Center for Clinical Trials of Sacramento
Sacramento, California, 95823, United States
Access Research Institute
Brooksville, Florida, 34613, United States
Nature Coast Clinical Reasearch
Crystal River, Florida, 34429, United States
JY Research Institute Inc.
Cutler Bay, Florida, 33189, United States
Accel Clinical Research Site
DeLand, Florida, 32720, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
A & D Doctor Center
Miami, Florida, 33135, United States
Bioclinical Research Alliance
Miami, Florida, 33155, United States
Cordova Research Institute
Miami, Florida, 33155, United States
Century Research LLC
Miami, Florida, 33173, United States
ITB Research
Miami, Florida, 33173, United States
Combined Research Orlando Phase I-IV
Orlando, Florida, 32807, United States
New Horizons Research
Palmetto Bay, Florida, 33158, United States
Advanced Clinical Research of Atlanta
Atlanta, Georgia, 30309, United States
Centricity Research
Columbus, Georgia, 31904, United States
Alliance for Multispecialty Research, LLC.
Newton, Kansas, 67114, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
AMR
New Orleans, Louisiana, 70119, United States
Annapolis Internal Medicine/CCT Research
Annapolis, Maryland, 21401, United States
DelRicht Research of Gulfport
Gulfport, Mississippi, 39501, United States
Quality Clinical Research, Inc
Omaha, Nebraska, 68114, United States
Santa Rosa Medical Center
Las Vegas, Nevada, 89119, United States
Inspire Santa Fe Medical Group
Santa Fe, New Mexico, 87505, United States
OnSite Clinical Solutions
Salisbury, North Carolina, 28144, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
ClinSearch
Chattanooga, Tennessee, 37421, United States
Medical Care/CCT
Elizabethton, Tennessee, 37643, United States
PanAmerican Clinical Research, LLC
Brownsville, Texas, 78520, United States
Quality Research Inc.
San Antonio, Texas, 78209, United States
Worldwide Clinical Trials
San Antonio, Texas, 78217, United States
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, 2148, Australia
Emeritus Research Sydney
Botany, New South Wales, 2019, Australia
Paratus Clinical Research Central Coast
Kanwal, New South Wales, 2259, Australia
A R Houston Medical Pty Ltd
Kippa-Ring, Queensland, 4021, Australia
Emeritus Research Melbourne
Camberwell, Victoria, 3124, Australia
Austin Health - Repatriation Hospital
Heidelberg, Victoria, 3084, Australia
New Hospitals
Tbilisi, 0114, Georgia
Evex Hospitals Caraps Medline
Tbilisi, 0159, Georgia
Aversi Clini
Tbilisi, 0160, Georgia
The First Medical Center
Tbilisi, 0180, Georgia
Academician Vakhtang Bochorishvili Clinic
Tbilisi, 0186, Georgia
Innova
Tbilisi, 0186, Georgia
Clinical Research Center (CRC)
Guatemala City, 01010, Guatemala
Clínica Médica Especializada en Medicina Interna y Reumatología (CREER)
Guatemala City, 01010, Guatemala
Clínica Médica Especializada en Medicina Interna y Reumatología
Guatemala City, 01010, Guatemala
Clínica Médica Especializada en Medicina Interna
Guatemala City, 01010, Guatemala
Buddhist Dalin Tzu Chi General Hospital
Chiayi City, 62247, Taiwan
Chang Gung Memorial Hospital CGMH
Kaohsiung City, 833, Taiwan
Chung Shan Medical Univ. Hospital
Taichung, 402367, Taiwan
Cheng-Shin General Hospital
Taipei, 112401, Taiwan
Chang Gung Memorial Hospital LinKou
Taoyuan District, 333423, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2024
First Posted
February 26, 2024
Study Start
April 22, 2024
Primary Completion
September 5, 2024
Study Completion
September 5, 2024
Last Updated
July 16, 2025
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share