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Not yet recruiting NCT07625514

24-Week Recurrence Rate of Gout Following Firsekibart Treatment

No phase Interventional Gout Flare

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Firsekibart.
Who it may be relevant to
Registry conditions: Gout Flare. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • 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 outcome measures (4)
  • Mean number of gout flares over 24 weeks. [Time frame: From enrollment to the end of treatment at 24 weeks]
  • Time to resolution of the first gout flare [Time frame: From enrollment to the end of treatment at 24 weeks]
  • Time to first gout recurrence [Time frame: From enrollment to the end of treatment at 24 weeks]
  • Incidence of adverse events and serious adverse events. [Time frame: From enrollment to the end of treatment at 24 weeks]

Eligibility criteria

Inclusion criteria

  • 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;
  • Voluntarily signed the Informed Consent Form (ICF).

Exclusion criteria

  • 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;
  • History of severe immunodeficiency, including positive human immunodeficiency virus (HIV) antibody, or other acquired or congenital immunodeficiency diseases;
  • Presence of infection requiring systemic treatment within 7 days prior to screening;
  • 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;
  • Any other conditions that, in the opinion of the investigator, may affect the evaluation of efficacy or safety in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 11 centers
  • Fuzhou University Affiliated Provincial Hospital — Fuzhou
  • The Second Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou
  • The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou
  • Tongde Hospital of Zhejiang Province — Hangzhou
  • Zhejiang Hospital — Hangzhou
  • Zhejiang Provincial People's Hospital — Hangzhou
  • Changxin People's Hospital — Huzhou
  • Jinhua Municipal Central Hospital — Jinhua
  • … and 3 more centers

Identifiers

NCT: NCT07625514 · 2026-0160

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗