Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)

Description

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months

Conditions

Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic

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Study Overview

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Study Details

Study overview

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months

A Phase 3 Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of AR882 in Participants with Gout

Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)

Condition
Gout
Intervention / Treatment

-

Contacts and Locations

Omaha

Arthrosi Investigative Site (651), Omaha, Nebraska, United States, 68144

Horsham

Arthrosi Investigative Site (647), Horsham, Pennsylvania, United States, 19044

Fort Mill

Arthrosi Investigative Site (604), Fort Mill, South Carolina, United States, 29707

Hendersonville

Arthrosi Investigative Site (624), Hendersonville, Tennessee, United States, 37075

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * History of gout
  • * Occurrence of ≥ 2 self-reported gout flares in the last 12 months
  • * Body weight no less than 50 kg
  • * Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA ≥ 7 mg/dL
  • * Patients who are on medically appropriate ULT must have sUA \> 6 mg/dL
  • * Serum creatinine must be \< 3.0 mg/dL and estimated CLcr ≥ 30 mL/min
  • * Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
  • * Pregnant or breastfeeding
  • * History of symptomatic kidney stones within the past 6 months

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arthrosi Therapeutics,

Robert Keenan, MD, STUDY_DIRECTOR, Arthrosi Therapeutics, Inc.

Study Record Dates

2026-04