A Randomized, Double-Blind, Double-Dummy, Multi-Center, Phase III Study Comparing the Efficacy and Safety of Tigulixostat (IBI128) and Febuxostat in Chinese Subjects With Gout
The primary purpose of this study is to compare the efficacy of Tigulixostat (IBI128) versus Febuxostat on the proportion of Chinese adults with gout achieving a serum uric acid (sUA) level \< 360 μmol/L at Week 24. The study also evaluates safety, gout attacks, kidney function, inflammation, and quality of life over 52 weeks of treatment. Approximately 600 eligible participants will be randomized to receive either Tigulixostat or Febuxostat.
⁃ Participants must meet all of the following criteria to be eligible for the study:
• Age ≥ 18 years, male or female.
• Body mass index (BMI) between 18 and 40 kg/m².
• Diagnosed with gout according to the 2015 ACR/EULAR classification criteria.
• Serum uric acid (sUA) at screening:
• ≥ 480 μmol/L for subjects without comorbidities;
• ≥ 420 μmol/L for subjects with at least one concurrent condition (e.g., ≥ 2 gout attacks/year, tophi, chronic gouty arthritis, hypertension, diabetes, dyslipidemia, age of onset \< 40 years).
• Voluntarily sign the informed consent form and agree to strictly follow the protocol requirements.