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

Обзор

Study Objective To compare the efficacy of continued scheduled dosing versus as-needed dosing in patients with acute gouty arthritis who remained recurrence-free after 24 weeks of treatment with Firsekibart. Primary Endpoint The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization. Secondary Endpoints The mean number of gout recurrences within 24 weeks after randomization;The duration of the first gout recurrence;The proportion of patients experiencing at least one gout recurrence within 12 weeks after randomization;Time to first gout recurrence after randomization;Patient treatment satisfaction at 24 weeks after randomization, assessed using a Likert scale. Study Design and Methods Patients with acute gouty arthritis who had received Firsekibart as initial treatment and experienced no recurrence during the first 24 weeks of treatment were eligible for enrollment and randomization in this study. Eligible patients were randomized to either a scheduled dosing group or an as-needed dosing group. In the scheduled dosing group, patients received study treatment immediately after enrollment. In the as-needed dosing group, patients entered an observation period after enrollment and received study treatment only in the event of recurrence. During the study, gout recurrence was recorded using patient diary cards. Telephone follow-up was conducted every 4 weeks to confirm recurrence status. On-site visits were performed at Weeks 12 and 24, as well as at the time of gout recurrence, for collection of efficacy-related assessments. Adverse events (AEs) and serious adverse events (SAEs) were followed until 12 weeks after the last dose of study drug. Treatment Arms Scheduled Dosing Group (Intervention Group): Firsekibart 200 mg was administered by subcutaneous injection on the day of randomization. As-Needed Dosing Group (Control Group): Patients were observed after randomization. If recurrence occurred, patients were required to return to the hospital within 4 days and receive Firsekibart 200 mg by subcutaneous injection.

Вмешательства

• Препарат Scheduled Firsekibart administration
  A 200 mg subcutaneous injection of Firsekibart will be administered on the day of randomization or the day of gout flare.
• Препарат As-Needed Firsekibart Administration
  Following randomization, patients will remain under continuous observation. In the event of recurrence, patients should return to the hospital within 4 days to receive a 200 mg subcutaneous injection of Firsekibart.

Первичные конечные точки

• The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization. [Срок оценки: 24 weeks after randomization]

Вторичные конечные точки (6)

• Mean number of gout flares over 24 weeks after randomization. [Срок оценки: 24 weeks after randomization]
• Time to resolution of the first gout flare [Срок оценки: 24 weeks after randomization.]
• Time to first gout flare [Срок оценки: 24 weeks after randomization]
• Proportion of patients with at least one gout flare [Срок оценки: 24 weeks after randomization]
• Patient treatment satisfaction scores [Срок оценки: 24 weeks after randomization]
• Incidence of adverse events and serious adverse events. [Срок оценки: 24 weeks after randomization]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 11 центров

• The Second Affiliated Hospital of Zhejiang Chinese Medical University — Ханчжоу
• The Second Affiliated Hospital Zhejiang University School of Medicine — Ханчжоу
• Zhejiang Provincial People's Hospital — Ханчжоу
• Fuzhou University Affiliated Provincial Hospital — Фучжоу
• Tongde Hospital of Zhejiang Province — Ханчжоу
• Zhejiang Hospital — Ханчжоу
• Changxin People's Hospital — Huzhou
• Jinhua Municipal Central Hospital — Jinhua
• … и ещё 3 центра

Идентификаторы

NCT: NCT07616531 · 20260160

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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