24-Week Recurrence Rate of Gout Following Firsekibart Treatment

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).

NCT Number	NCT07625514
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions	Gout Flare
Enrollment	264 participants
Start Date	2026-05-07
Primary Completion	2029-08-28 (estimated)
Study Completion	2029-08-28 (estimated)
Updated on ClinicalTrials.gov	2026-06-04