Extension Study of ABP-671 in Participants With Gout
- Registration Number
- NCT06276556
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 580
- 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
- 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 โค30 days after the last dose of the study drug.
- Is intolerant or unwilling to take colchicine or naproxen.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Allopurinol Allopurinol - ABP-671 ABP-671 -
- Primary Outcome Measures
Name Time Method 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
Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L) Week 26
- Secondary Outcome Measures
Name Time Method Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L) Week 26
Trial Locations
- Locations (54)
Tucson Neuroscience Research, LLC
๐บ๐ธTucson, Arizona, United States
New Horizons Research
๐บ๐ธPalmetto Bay, Florida, United States
DelRicht Research of Gulfport
๐บ๐ธGulfport, Mississippi, United States
Annapolis Internal Medicine/CCT Research
๐บ๐ธAnnapolis, Maryland, United States
Emeritus Research Sydney
๐ฆ๐บBotany, New South Wales, Australia
Paratus Clinical Research Western Sydney
๐ฆ๐บBlacktown, New South Wales, Australia
Austin Health - Repatriation Hospital
๐ฆ๐บHeidelberg, Victoria, Australia
A R Houston Medical Pty Ltd
๐ฆ๐บKippa-Ring, Queensland, Australia
Cheng-Shin General Hospital
๐จ๐ณTaipei City, Taiwan
Chang Gung Memorial Hospital CGMH
๐จ๐ณKaohsiung City, Taiwan
Nature Coast Clinical Reasearch
๐บ๐ธCrystal River, Florida, United States
Bioclinical Research Alliance
๐บ๐ธMiami, Florida, United States
A & D Doctor Center
๐บ๐ธMiami, Florida, United States
Cordova Research Institute
๐บ๐ธMiami, Florida, United States
Century Research LLC
๐บ๐ธMiami, Florida, United States
ITB Research
๐บ๐ธMiami, Florida, United States
Alliance for Multispecialty Research, LLC.
๐บ๐ธNewton, Kansas, United States
Santa Rosa Medical Center
๐บ๐ธLas Vegas, Nevada, United States
Quality Research Inc.
๐บ๐ธSan Antonio, Texas, United States
Worldwide Clinical Trials
๐บ๐ธSan Antonio, Texas, United States
AMR
๐บ๐ธNew Orleans, Louisiana, United States
Alliance for Multispecialty Research
๐บ๐ธTempe, Arizona, United States
ClinSearch
๐บ๐ธChattanooga, Tennessee, United States
Medical Care/CCT
๐บ๐ธElizabethton, Tennessee, United States
Academician Vakhtang Bochorishvili Clinic
๐ฌ๐ชTbilisi, Georgia
Clรญnica Mรฉdica Especializada en Medicina Interna
๐ฌ๐นGuatemala city, Guatemala
Buddhist Dalin Tzu Chi General Hospital
๐จ๐ณChiayi City, Taiwan
Emeritus Research Melbourne
๐ฆ๐บCamberwell, Victoria, Australia
Aversi Clini
๐ฌ๐ชTbilisi, Georgia
Innova
๐ฌ๐ชTbilisi, Georgia
New Hospitals
๐ฌ๐ชTbilisi, Georgia
The First Medical Center
๐ฌ๐ชTbilisi, Georgia
Clinical Research Center (CRC)
๐ฌ๐นGuatemala city, Guatemala
Evex Hospitals Caraps Medline
๐ฌ๐ชTbilisi, Georgia
Chung Shan Medical Univ. Hospital
๐จ๐ณTaichung, Taiwan
Chang Gung Memorial Hospital LinKou
๐จ๐ณTaoyuan, Taiwan
Clรญnica Mรฉdica Especializada en Medicina Interna y Reumatologรญa
๐ฌ๐นGuatemala city, Guatemala
Quality Clinical Research, Inc
๐บ๐ธOmaha, Nebraska, United States
Paratus Clinical Research Central Coast
๐ฆ๐บKanwal, New South Wales, Australia
Anaheim Clinical Trials (Cenexel ACT)
๐บ๐ธAnaheim, California, United States
Accel Clinical Research Site
๐บ๐ธDeLand, Florida, United States
Access Research Institute
๐บ๐ธBrooksville, Florida, United States
Jacksonville Center for Clinical Research
๐บ๐ธJacksonville, Florida, United States
JY Research Institute Inc.
๐บ๐ธCutler Bay, Florida, United States
Advanced Clinical Research of Atlanta
๐บ๐ธAtlanta, Georgia, United States
Centricity Research
๐บ๐ธColumbus, Georgia, United States
Inspire Santa Fe Medical Group
๐บ๐ธSanta Fe, New Mexico, United States
OnSite Clinical Solutions
๐บ๐ธSalisbury, North Carolina, United States
Altoona Center for Clinical Research
๐บ๐ธDuncansville, Pennsylvania, United States
PanAmerican Clinical Research, LLC
๐บ๐ธBrownsville, Texas, United States
Clรญnica Mรฉdica Especializada en Medicina Interna y Reumatologรญa (CREER)
๐ฌ๐นGuatemala city, Guatemala
Center for Clinical Trials of Sacramento
๐บ๐ธSacramento, California, United States
Combined Research Orlando Phase I-IV
๐บ๐ธOrlando, Florida, United States
DelRicht Research
๐บ๐ธNew Orleans, Louisiana, United States