Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2026-05-07
Last updated
2026-06-04
Condition(s) studied
Gout Flare
Investigational drug(s) / intervention(s)
Firsekibart
Firsekibart: A 200mg subcutaneous injection of firsekibart was administered within 12 hours of the onset of an acute gout flare.
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)
The proportion of patients experiencing at least one gout recurrence within 24 weeks. — From enrollment to the end of treatment at 24 weeks.
Trial sites (11)
Facility
City
Region
Status
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
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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