A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients

Inclusion criteria

• for screening

• ≥19 to ≤75 years of age at the time of written informed consent
• Diagnosed record with gout, or ACR/EULAR 2015 score ≥8
• Able and willing to actively participate in TLC programme
• Signed ICF for voluntary study participation
• for randomization

• sUA level ≥7.0 mg/dL
• ACR/EULAR 2015 score ≥8

Exclusion criteria

• Medical history

Malignant tumor, Urolithiasis within 5 years, Hypersensitivity disease, Lesch-Nyhan syndrome, Hereditary problems, Ischemic heart disease, Prior or planned organ transplant recipient.

• Concurrent disease or laboratory test abnormality

Uncontrolled diabetes mellitus, Uncontrolled hypertension, Uncontrolled dyslipidemia, AST or ALT ≥2×ULN, total bilirubin ≥1.5×ULN, eGFR <30 mL/min/1.73m^2, Uncontrolled thyroid dysfunction, HIV, HBV or HCV positive, Drug and alcohol abuse, BMI ≥40 kg/m^2

• History of gout flare between 2 weeks before written informed consent and immediately before randomization
• Any cardiovascular abnormalities that might affect the study
• Prior or planned treatment with xanthine oxidase inhibitors, uricosuric agents, or uricolytic agents
• Prior or planned treatment with drugs acting on human uric acid transporter 1 or diuretics
• Prior or planned treatment with intravenous and oral high dose systemic corticosteroids, mercaptopurine, azathioprine, or theophylline
• Hypersensitivity to the IP (epaminurad or febuxostat)
• Pregnant or lactating woman.