Extension Study of ABP-671 in Participants With Gout

Phase 3TerminatedNCT06276556

Atom Therapeutics Co., Ltd43 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Gout

Interventions

ABP-671DRUG

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.

AllopurinolDRUG

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

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (54)

Outcomes

Primary Outcomes

Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)

Time frame: 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

Time frame: Week 26

Secondary Outcomes

Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)

Time frame: Week 26

Data from ClinicalTrials.gov

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Alliance for Multispecialty Research

Tempe, Arizona, United States

Tucson Neuroscience Research, LLC

Tucson, Arizona, United States

Anaheim Clinical Trials (Cenexel ACT)

Anaheim, California, United States

Center for Clinical Trials of Sacramento

Sacramento, California, United States

Access Research Institute

Brooksville, Florida, 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

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

A & D Doctor Center

Miami, Florida, United States

...and 44 more locations