A Multicenter, Randomized, Double-blind, Active-controlled Parallel-group Phase ii Clinical Study to Compare the Efficacy and Safety of SHR4640 Tablets Combined With Febuxostat Tablets at 40 mg/Day Versus Febuxostat Tablets With Dose Escalation in Treatment of Primary Gout and Hyperuricemia Subjects With Inadequate Control on 40 mg/Day Febuxostat
SHR4640 tablets is a highly selective and potent URAT1 inhibitors. The study is being conducted to evaluate the efficacy, and safety of SHR4640 tablet combined with 40 mg/d febuxostat tablet in reducing uric acid in subjects with primary gout and hyperuricemia The primary purpose of the study is to evaluate the efficacy and safety of the combination of SHR4640 and 40 mg/d febuxostat compared with 60 mg/d febuxostat in primary gout and hyperuricemia subjects with inadequate control on 40 mg/d febuxostat for 12 weeks.
• Voluntarily signed the informed consent, understood the procedures and methods of the study, and was willing to complete the study strictly in accordance with the clinical trial protocol;
• The screening age should be 18-75 years old (including both ends), male or female;
• Receive febuxostat at a stable dose of 40 mg/day for ≥6 weeks before randomization; have a fasting serum uric acid level ≥390 µmol/L at the first measurement, and a repeat fasting serum uric acid level ≥360 µmol/L after taking febuxostat 40 mg/day stably for ≥2 weeks during screening and run-in period,;
• Meet the gout classification criteria formulated by the American College of Rheumatology (ACR) in 1977 or the joint gout classification criteria formulated by the American College of Rheumatology and the European League Against Rheumatism (ACR/EULAR) in 2015;
• Body Mass Index (BMI) between 18 kg/m² and 35 kg/m².