Evaluating AR882 for lowering uric acid in gout patients

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 Interventional Arthrosi Therapeutics · NCT06846515

This study is testing a new medication called AR882 to see if it can lower uric acid levels in people with gout who have had multiple flare-ups.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment750 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorArthrosi Therapeutics Industry-sponsored
Locations78 sites (Birmingham, Alabama and 77 other locations)
Trial IDNCT06846515 on ClinicalTrials.gov

What this trial studies

This phase 3 trial aims to evaluate the efficacy and safety of AR882, a medication designed to lower serum uric acid levels in patients with gout. Participants will receive either AR882 at doses of 50 mg or 75 mg, or a placebo, over a period of 12 months. The study will focus on patients who have experienced multiple gout flares and are either not on urate-lowering therapy or have specific serum uric acid levels while on therapy. The primary outcome will be the reduction in serum uric acid levels compared to the placebo group.

Who should consider this trial

Good fit: Ideal candidates include adults with a history of gout who have experienced at least two gout flares in the past year and meet specific serum uric acid criteria.

Not a fit: Patients with recent malignancies, those who are pregnant or breastfeeding, or individuals with a history of symptomatic kidney stones in the last six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing gout and reducing flare-ups.

How similar studies have performed: Other studies have shown promise in lowering uric acid levels with similar approaches, but the specific efficacy of AR882 is being evaluated for the first time in this phase.

Eligibility criteria

Show full inclusion / exclusion criteria
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

Where this trial is running

Birmingham, Alabama and 77 other locations

+28 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions GoutArthritis, GoutyHyperuricemiaGout Chronic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.