24-Week Recurrence Rate of Gout Following Firsekibart Treatment

ClinicalTrials.gov ID

NCT07625514

Lead Sponsor

Second Affiliated Hospital, Zhejiang University, School of MedicineOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

264Estimated

Last Update Posted

Jun 4, 2026Actual

Start Date

May 7, 2026Estimated

Primary Completion Date

Aug 28, 2029Estimated

Completion Date

Aug 28, 2029Estimated

Official Title

The 24-Week Recurrence Rate of Acute Gouty Arthritis in Patients Treated With Firsekibart: A Multicenter, Prospective, Real-World Study

Brief Summary

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).

• Gout Flare

• Firsekibart

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. History of hypersensitivity to the study drug or similar classes of drugs;
2. Pregnant or breastfeeding women;
3. 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 ;
4. Confirmed active tuberculosis infection;
5. History of severe immunodeficiency, including positive human immunodeficiency virus (HIV) antibody, or other acquired or congenital immunodeficiency diseases;
6. Presence of infection requiring systemic treatment within 7 days prior to screening;
7. 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;
8. Any other conditions that, in the opinion of the investigator, may affect the evaluation of efficacy or safety in this study.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Second Affiliated Hospital, Zhejiang University, School of MedicineOTHER

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