Clinical trial NCT06276556: Extension Study of ABP-671 in Participants With Gout
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Gout
Lead sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 43
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)
timeFrame: Week 26
measure: Incidence of treatment-emergent adverse events (Safety and Tolerability)
timeFrame: Week 26
Secondary outcomes:
measure: Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)
timeFrame: Week 26
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Alliance for Multispecialty Research
state: Arizona
city: Tucson
country: United States
facility: Tucson Neuroscience Research, LLC
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials (Cenexel ACT)
state: California
city: Sacramento
country: United States
facility: Center for Clinical Trials of Sacramento
state: California
city: Brooksville
country: United States
facility: Access Research Institute
state: Florida
city: Crystal River
country: United States
facility: Nature Coast Clinical Reasearch
state: Florida
city: Cutler Bay
country: United States
facility: JY Research Institute Inc.
state: Florida
city: DeLand
country: United States
facility: Accel Clinical Research Site
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: A & D Doctor Center
state: Florida
city: Miami
country: United States
facility: Bioclinical Research Alliance
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute
state: Florida
city: Miami
country: United States
facility: Century Research LLC
state: Florida
city: Miami
country: United States
facility: ITB Research
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando Phase I-IV
state: Florida
city: Palmetto Bay
country: United States
facility: New Horizons Research
state: Florida
city: Atlanta
country: United States
facility: Advanced Clinical Research of Atlanta
state: Georgia
city: Columbus
country: United States
facility: Centricity Research
state: Georgia
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC.
state: Kansas
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: New Orleans
country: United States
facility: AMR
state: Louisiana
city: Annapolis
country: United States
facility: Annapolis Internal Medicine/CCT Research
state: Maryland
city: Gulfport
country: United States
facility: DelRicht Research of Gulfport
state: Mississippi
city: Omaha
country: United States
facility: Quality Clinical Research, Inc
state: Nebraska
city: Las Vegas
country: United States
facility: Santa Rosa Medical Center
state: Nevada
city: Santa Fe
country: United States
facility: Inspire Santa Fe Medical Group
state: New Mexico
city: Salisbury
country: United States
facility: OnSite Clinical Solutions
state: North Carolina
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Elizabethton
country: United States
facility: Medical Care/CCT
state: Tennessee
city: Brownsville
country: United States
facility: PanAmerican Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc.
state: Texas
city: San Antonio
country: United States
facility: Worldwide Clinical Trials
state: Texas
city: Blacktown
country: Australia
facility: Paratus Clinical Research Western Sydney
state: New South Wales
city: Botany
country: Australia
facility: Emeritus Research Sydney
state: New South Wales
city: Kanwal
country: Australia
facility: Paratus Clinical Research Central Coast
state: New South Wales
city: Kippa-Ring
country: Australia
facility: A R Houston Medical Pty Ltd
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research Melbourne
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health - Repatriation Hospital
state: Victoria
city: Tbilisi
country: Georgia
facility: New Hospitals
city: Tbilisi
country: Georgia
facility: Evex Hospitals Caraps Medline
city: Tbilisi
country: Georgia
facility: Aversi Clini
city: Tbilisi
country: Georgia
facility: The First Medical Center
city: Tbilisi
country: Georgia
facility: Academician Vakhtang Bochorishvili Clinic
city: Tbilisi
country: Georgia
facility: Innova
city: Guatemala city
country: Guatemala
facility: Clinical Research Center (CRC)
city: Guatemala city
country: Guatemala
facility: Clínica Médica Especializada en Medicina Interna y Reumatología (CREER)
city: Guatemala city
country: Guatemala
facility: Clínica Médica Especializada en Medicina Interna y Reumatología
city: Guatemala city
country: Guatemala
facility: Clínica Médica Especializada en Medicina Interna
city: Chiayi City
country: Taiwan
facility: Buddhist Dalin Tzu Chi General Hospital
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Memorial Hospital CGMH
city: Taichung
country: Taiwan
facility: Chung Shan Medical Univ. Hospital
city: Taipei City
country: Taiwan
facility: Cheng-Shin General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital LinKou
Study officials:
References: