This study that compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who have had an inadequate response to allopurinol.
Allopurinol is the standard of care for the treatment of gout. Nevertheless, most patients treated with allopurinol do not achieve the recommended serum urate (sUA) target of \< 6.0 mg/dL and need additional therapy to achieve the target. Probenecid and benzbromarone are uric acid transporter 1 (URAT1) inhibitors, generally recommended as second-line agents for patients who are either resistant to or intolerant of allopurinol. However, benzbromarone is not available in the US and probenecid is rarely used. Consequently, there is a clear unmet medical need for a new safe and effective therapy for gout, such as lesinurad, a potent URAT1 inhibitor, that can be used in combination with allopurinol in patients not responding adequately to allopurinol monotherapy so that very high rates of response can be achieved by nearly all gout patients, rather than a minority.The subjects selected for this study will have moderate to severe gout with an inadequate response to allopurinol
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
607
Proportion of Subjects With an sUA Level That is < 6.0 mg/dL
Time frame: 6 Months, analysis after all subjects complete 12 months
Gout Flares
Mean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12
Time frame: 12 Months
Tophus
Proportion of subjects with ≥ 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12
Time frame: 12 Months
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Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
Unnamed facility
Athens, Alabama, United States
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Gulf Shores, Alabama, United States
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Mobile, Alabama, United States
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Pinson, Alabama, United States
Unnamed facility
Glendale, Arizona, United States
...and 155 more locations