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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
750
Solid Oral Capsule
Solid Oral Capsule
Matching Solid Oral Capsule Placebo
Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 6 mg/dL at month 6
Time frame: 24 weeks
Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12
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
Time frame: 12 weeks
No gout flares from the end of month 9 to the end of month 12
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
Time frame: 12 weeks
Change in tophus burden by month 12
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
Time frame: 48 weeks
Incidence of Adverse Events
Treatment Emergent Adverse Events and Serious Adverse Event incidence
Time frame: 56 weeks
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