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

• AR882 50 mg (Drug): Solid Oral Capsule
• AR882 75 mg (Drug): Solid Oral Capsule
• Placebo (Drug): Matching Solid Oral Capsule Placebo

Primary outcomes

• Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6 [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

• Change in tophus burden by month 12 [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
• Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12 [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
• Change in tophus burden by month 6 [24 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 6, with no evidence of disease progression (no new tophus or single tophus showing progression) and patients with no new tophi formation at month 6 as determined using the computer-assisted photographic evaluation in rheumatology (CAPER) method
• Incidence of Adverse Events [56 weeks]: Treatment Emergent Adverse Events and Serious Adverse Event incidence

Sex: All, ages: 18 Years to 85 Years

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

• Robert Keenan, MD, Study director, Arthrosi Therapeutics, Inc.