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NCT Number: NCT06846515

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Gout Arthritis Arthritis, Gouty Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Chronic Hyperuricemia Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arthrosi Investigative Site (620), Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

Exclusion criteria

  • 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

Treatment and study plan

AR882 50 mg

Drug

Solid Oral Capsule

AR882 75 mg

Drug

Solid Oral Capsule

Placebo

Drug

Matching Solid Oral Capsule Placebo

Primary outcomes

  1. Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6

    Time frame: 24 weeks

    Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL at month 6

Secondary outcomes

  1. Change in tophus burden by month 12

    Time frame: 48 weeks

    Comparison of the treatment groups for the proportion of patients who experience a complete response, marked or partial response, of at least 1 target tophus at Month 12, with no evidence of disease progression (no new tophus or single tophus showing progression) and patients with no new tophi formation at month 12 as determined using the computer-assisted photographic evaluation in rheumatology (CAPER) method

  2. Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12

    Time frame: 12 weeks

    Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL for the 3-month period from the end of month 9 to the end of month 12

  3. No gout flares from the end of month 9 to the end of month 12

    Time frame: 12 weeks

    Comparison of the treatment groups for the proportion of patients with no gout flares for the 3-month period from the end of month 9 to the end of month 12

  4. Incidence of Adverse Events

    Time frame: 56 weeks

    Treatment Emergent Adverse Events and Serious Adverse Event incidence

Sponsors and collaborators

Lead sponsor

Arthrosi Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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