24-Week Recurrence Rate of Gout Following Firsekibart Treatment

Starting soon · Not applicable

Conditions studied: Gout Flare

In brief

Study Objective: To evaluate the 24-week recurrence rate and safety of Firsekibart in patients with acute gouty arthritis in a real-world clinical setting. Study Methods: This study utilizes a multicenter, prospective, observational, real-world study design. The study plans to enroll all cases that receive Firsekibart for the first time and meet the inclusion and exclusion criteria between March 1, 2026, and February 28, 2029, with a follow-up period of 24 weeks. This study will not intervene in clinical treatment regimens; it will solely record and analyze the diagnosis and treatment data that actually occur. Study Outcomes: Primary Outcome: The proportion of patients with at least one gout recurrence (flare) at 24 weeks.Secondary Outcomes: 1. Average number of gout recurrences over 24 weeks; 2. Time to the first gout recurrence; 3. Duration of the first gout recurrence; 4. Incidence of adverse events (AEs) and serious adverse events (SAEs).

Key facts

Study ID

NCT07625514

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

264

Starts

2026-05-07

Expected to finish

2029-08-28

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Fuzhou University Affiliated Provincial Hospital — Fuzhou, China
• The Second Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, China
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, China
• Tongde Hospital of Zhejiang Province — Hangzhou, China
• Zhejiang Hospital — Hangzhou, China
• Zhejiang Provincial People's Hospital — Hangzhou, China
• Changxin People's Hospital — Huzhou, China
• Jinhua Municipal Central Hospital — Jinhua, China
• Ningbo Medical Center Lihuili Hospital — Ningbo, China
• The First People's Hospital of Wenlin — Wenzhou, China
• The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, China

Full record on ClinicalTrials.gov

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