Summary:
A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Hyperuricemia Associated With Gout
Qualified Participants Must:
• Provide written informed consent and any authorizations required by local law.
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Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
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Diagnosis of gout based on 2015 ACR-EULAR criteria for at least 1 year. Had at least 2 gout flares in the 12 months prior to Screening (reported by the participant or documented in the participant’s medical records).
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Participant must be on a stable background allopurinol dose of ≥300 mg/day (200 mg/day for those with moderate renal impairment) up to 600 mg/day for at least 3 months prior to Screening and remain on their dosing regimen until Day 1.
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Uric Acid level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
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Renal function eGFR ≥45 mL/min/1.73 m2 (using the creatinine-based CKD-EPI formula for adults) during Screening
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Body mass index (BMI) ≥18.5 and ≤45.0 (kg/m2) and a body weight ≥50 kg (110 lbs during Screening.
Qualified Participants May Receive:
$100 for Each clinic visit