24-Week Recurrence Rate of Gout Following Firsekibart Treatment

Inclusion criteria

• Age 18 to 75 years (inclusive), male or female;
• Meet the 2015 ACR/EULAR Gout Classification Criteria;
• Two or more acute gout flares within a year;
• In the acute phase of a gout flare;
• Voluntarily signed the Informed Consent Form (ICF).

Exclusion criteria

• History of hypersensitivity to the study drug or similar classes of drugs;
• Pregnant or breastfeeding women;
• History of clinically significant diseases, including: Chronic congestive heart failure (NYHA Class IV); History of echocardiography-confirmed ejection fraction (EF) < 30%; Myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within 6 months; Coronary revascularization within 6 months; Severe arrhythmia requiring treatment with Class Ia or III antiarrhythmic drugs;History of sick sinus syndrome, Mobitz II and Complete Heart Block without a permanent pacemaker implanted; QTc interval≥480 ms on screening ECG ;
• Confirmed active tuberculosis infection;
• History of severe immunodeficiency, including positive human immunodeficiency virus (HIV) antibody, or other acquired or congenital immunodeficiency diseases;
• Presence of infection requiring systemic treatment within 7 days prior to screening;
• Laboratory abnormalities at screening as follows: White blood cellcount or absolute neutrophil count below the lower limit of normal at the study site; Platelet count ≤100×10^9/L; Total bilirubin > 1.5 times ULN (Upper Limit of Normal); AST/ALT > 3 times ULN; Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m²; Triglycerides > 5.7 mmol/L;
• Any other conditions that, in the opinion of the investigator, may affect the evaluation of efficacy or safety in this study.