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NCT06276556 Clinical Trial

Extension Study of ABP-671 in Participants With Gout

Gout Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06276556
Other study ID # ABP-671-302
Secondary ID
Status Enrolling by invitation
Phase Phase 2/Phase 3
First received
Last updated
Start date April 22, 2024
Est. completion date July 2, 2025

Study information
Verified date February 2024
Source Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 580
Est. completion date July 2, 2025
Est. primary completion date July 2, 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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
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.

Locations
Country Name City State
Australia Paratus Clinical Research Western Sydney Blacktown New South Wales
Australia Emeritus Research Sydney Botany New South Wales
Australia Emeritus Research Melbourne Camberwell Victoria
Australia Austin Health - Repatriation Hospital Heidelberg Victoria
Australia Paratus Clinical Research Central Coast Kanwal New South Wales
Australia A R Houston Medical Pty Ltd Kippa-Ring Queensland
Georgia Academician Vakhtang Bochorishvili Clinic Tbilisi
Georgia Aversi Clini Tbilisi
Georgia Evex Hospitals Caraps Medline Tbilisi
Georgia Innova Tbilisi
Georgia New Hospitals Tbilisi
Georgia The First Medical Center Tbilisi
Guatemala Clínica Médica Especializada en Medicina Interna C.p.
Guatemala Clínica Médica Especializada en Medicina Interna y Reumatología C.p.
Guatemala Clínica Médica Especializada en Medicina Interna y Reumatología (CREER) C.p.
Guatemala Clinical Research Center (CRC) C.p.
Taiwan Buddhist Dalin Tzu Chi General Hospital Chiayi City
Taiwan Chang Gung Memorial Hospital CGMH Kaohsiung City
Taiwan Chung Shan Medical Univ. Hospital Taichung
Taiwan Cheng-Shin General Hospital Taipei City
Taiwan Chang Gung Memorial Hospital LinKou Taoyuan
United States Anaheim Clinical Trials (Cenexel ACT) Anaheim California
United States Annapolis Internal Medicine/CCT Research Annapolis Maryland
United States Advanced Clinical Research of Atlanta Atlanta Georgia
United States Access Research Institute Brooksville Florida
United States PanAmerican Clinical Research, LLC Brownsville Texas
United States ClinSearch Chattanooga Tennessee
United States Centricity Research Columbus Georgia
United States Nature Coast Clinical Reasearch Crystal River Florida
United States JY Research Institute Inc. Cutler Bay Florida
United States Accel Clinical Research Site DeLand Florida
United States Altoona Center for Clinical Research Duncansville Pennsylvania
United States Medical Care/CCT Elizabethton Tennessee
United States DelRicht Research of Gulfport Gulfport Mississippi
United States Jacksonville Center for Clinical Research Jacksonville Florida
United States Santa Rosa Medical Center Las Vegas Nevada
United States A & D Doctor Center Miami Florida
United States Bioclinical Research Alliance Miami Florida
United States Century Research LLC Miami Florida
United States Cordova Research Institute Miami Florida
United States ITB Research Miami Florida
United States AMR New Orleans Louisiana
United States DelRicht Research New Orleans Louisiana
United States Alliance for Multispecialty Research, LLC. Newton Kansas
United States Quality Clinical Research, Inc Omaha Nebraska
United States Combined Research Orlando Phase I-IV Orlando Florida
United States New Horizons Research Palmetto Bay Florida
United States Center for Clinical Trials of Sacramento Sacramento California
United States OnSite Clinical Solutions Salisbury North Carolina
United States Quality Research Inc. San Antonio Texas
United States Worldwide Clinical Trials San Antonio Texas
United States Inspire Santa Fe Medical Group Santa Fe New Mexico
United States Alliance for Multispecialty Research Tempe Arizona
United States Tucson Neuroscience Research, LLC Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

United States,  Australia,  Georgia,  Guatemala,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L) Week 26
Primary 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 Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L) Week 26
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