Efficacy and Safety of Scheduled Versus As-Needed Firsekibart Administration for the Prevention of Gout Recurrence: A Multicenter, Open-Label, Randomized Controlled Trial

Exclusion Criteria

• •1. History of hypersensitivity to the study drug or similar classes of drugs;
• •2. Systemic treatment with corticosteroids, or use of colchicine/NSAIDs within 24 weeks prior to enrollment;
• •3. Confirmed active visceral bleeding, or severe bleeding tendency, or currently receiving anticoagulation therapy with heparin;
• •4. Confirmed secondary gout;
• •5. Confirmed or suspected rheumatoid arthritis, infectious/septic arthritis, or other conditions that may confound the assessment of affected joints (e.g., other joint pain including but not limited to neurological disorders, herpes zoster, etc.);
• •6. Presence of infection requiring systemic treatment within 7 days prior to screening;
• •7. Received live or live-attenuated vaccines within 3 months prior to screening, or planned vaccination with such vaccines during the study;
• •8. History of malignancy within 5 years prior to screening, except for adequately treated or excised cutaneous basal cell carcinoma or Stage I squamous cell carcinoma;
• •9. History of systemic irradiation or total lymphoid irradiation; history of stem cell therapy or any type of bone marrow transplantation; history of solid organ transplantation; or long-term systemic use of immunosuppressants;
• •10. History of severe immunodeficiency, including positive human immunodeficiency virus (HIV) antibody, or other acquired or congenital immunodeficiency diseases;
• •11. 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 ;
• •12. Confirmed active tuberculosis infection;
• •13. Receiving renal dialysis;
• •14. 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;
• •15. Pregnant or breastfeeding women;
• •16. Women of childbearing potential who refuse to use highly effective contraception during the study;
• •17. Use of any investigational drug or participation in other interventional clinical trials within 1 month prior to screening (participation in observational studies only is permitted);
• •18. History of drug and/or alcohol abuse or psychiatric disorders;
• •19. Any other conditions that, in the opinion of the investigator, may affect the evaluation of efficacy or safety in this study.