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Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout

NCT05818085 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-12-22

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, Phase 2b/3 study to evaluate the efficacy and safety of ABP-671. Part 1 of the study will compare the efficacy and safety of different doses and regimens of ABP-671 with placebo and allopurinol. Part 2 of the study will compare the dosing regimen(s) of ABP-671 selected from Part 1 with placebo in participants who have not been enrolled for Part 1.

Conditions

Interventions

DRUG

ABP-671

Low, medium or high dose (Part 1); Selected dose(s) (Part 2)

DRUG

Allopurinol

Standard of care according to American College of Rheumatology (ACR) guideline for the management of gout

OTHER

Placebo

ABP-671 matching placebo

Sponsors & Collaborators

  • Atom Therapeutics Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-11
Primary Completion
2025-01-30
Completion
2025-03-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Georgia
  • Guatemala
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05818085 on ClinicalTrials.gov