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24-Week Recurrence Rate of Gout Following Firsekibart Treatment

NCT07625514 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2026-06-04

No results posted yet for this study

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).

Conditions

  • Gout Flare

Interventions

DRUG

Firsekibart

A 200mg subcutaneous injection of firsekibart was administered within 12 hours of the onset of an acute gout flare.

Sponsors & Collaborators

  • Second Affiliated Hospital, Zhejiang University, School of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-07
Primary Completion
2029-08-28
Completion
2029-08-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07625514 on ClinicalTrials.gov