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24-Week Recurrence Rate of Gout Following Firsekibart Treatment

ConditionGout Flare
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Firsekibart

    Drug

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

Treatment groups

264 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of patients experiencing at least one gout recurrence within 24 weeks.

Time frame
From enrollment to the end of treatment at 24 weeks.

Secondary outcomes

1

Mean number of gout flares over 24 weeks.

Time frame
From enrollment to the end of treatment at 24 weeks
2

Time to resolution of the first gout flare

Time frame
From enrollment to the end of treatment at 24 weeks
3

Time to first gout recurrence

Time frame
From enrollment to the end of treatment at 24 weeks
4

Incidence of adverse events and serious adverse events.

Time frame
From enrollment to the end of treatment at 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: