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

Inclusion criteria

• Age 18 to 75 years (inclusive), male or female;**
• Meet the 2015 ACR/EULAR Gout Classification Criteria;**
• Received initial treatment with Firsekibart 200 mg via subcutaneous injection for 24 weeks, and experienced no gout flares during this 24-week period;**
• Had≥2 gout flares within 1 year prior to the first administration of Firsekibart；
• Willing to comply with the protocol-defined urate-lowering therapy (ULT) during the study, meeting one of the following conditions:

• Patients currently receiving ULT with a stable regimen for≥14 days may continue their stable dosing; adjustments (including medication switch, dose reduction, or discontinuation) are permitted if the investigator assesses intolerance, poor efficacy, or achievement of target serum uric acid levels;

• For patients not on ULT or those on ULT but not stable for 14 days before enrollment, the investigator will decide whether to initiate ULT based on uric acid levels. In principle, allopurinol-naive patients should not be prescribed allopurinol in this study;
• Voluntarily signed the Informed Consent Form (ICF).

Exclusion criteria

• History of hypersensitivity to the study drug or similar classes of drugs;
• Systemic treatment with corticosteroids, or use of colchicine/NSAIDs within 24 weeks prior to enrollment;
• Confirmed active visceral bleeding, or severe bleeding tendency, or currently receiving anticoagulation therapy with heparin;
• Confirmed secondary gout;
• 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.);
• Presence of infection requiring systemic treatment within 7 days prior to screening;
• Received live or live-attenuated vaccines within 3 months prior to screening, or planned vaccination with such vaccines during the study;
• 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;
• 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;
• History of severe immunodeficiency, including positive human immunodeficiency virus (HIV) antibody, or other acquired or congenital immunodeficiency diseases;
• 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;
• Receiving renal dialysis;
• 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;

• Pregnant or breastfeeding women;
• Women of childbearing potential who refuse to use highly effective contraception during the study;
• 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);
• History of drug and/or alcohol abuse or psychiatric disorders;
• Any other conditions that, in the opinion of the investigator, may affect the evaluation of efficacy or safety in this study.