24-Week Recurrence Rate of Gout Following Firsekibart Treatment

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Gout Flare
• Intervention / Treatment: Drug: Firsekibart

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: 华香 吴; Phone Number: 0086-13757118395; Email: wuhx8855@zju.edu.cn

Study Locations

• China
  • Fuzhou, China
    • Fuzhou University Affiliated Provincial Hospital
    • Contact: Fei Gao; Phone Number: 0086-13665013469
  • Hangzhou, China
    • Zhejiang Provincial People's Hospital
    • Contact: Lijuan Wang; Phone Number: 0086-13567134447
  • Hangzhou, China
    • the Second Affiliated Hospital Zhejiang University School of Medicine
    • Contact: 华香 吴; Email: wuhx8855@zju.edu.cn
  • Hangzhou, China
    • Zhejiang Hospital
    • Contact: Fang Yuan; Phone Number: 0086-18072963566
  • Hangzhou, China
    • The Second Affiliated Hospital of Zhejiang Chinese Medical University
    • Contact: Kepeng Yang; Phone Number: 0086-17826873536; Email: ykp1029@126.com
  • Hangzhou, China
    • Tongde Hospital of Zhejiang Province
    • Contact: Qin Chen; Phone Number: 0086-15869192858
  • Huzhou, China
    • Changxin People's Hospital
    • Contact: Yingying Wang
  • Jinhua, China
    • Jinhua Municipal Central Hospital
    • Contact: Li Hua; Phone Number: 0086-13758992315
  • Ningbo, China
    • Ningbo Medical Center Lihuili Hospital
    • Contact: Li Zhou; Phone Number: 0086-13858287828
  • Wenzhou, China
    • The Second Affiliated Hospital of Wenzhou Medical University
    • Contact: Hong Wang; Phone Number: 0086-13957756514
  • Wenzhou, China
    • The First People's Hospital of Wenlin
    • Contact: Yongjun Cheng; Phone Number: 0086-13958633696

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Drug: Firsekibart; A 200mg subcutaneous injection of firsekibart was administered within 12 hours of the onset of an acute gout flare.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients experiencing at least one gout recurrence within 24 weeks.	From enrollment to the end of treatment at 24 weeks.

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean number of gout flares over 24 weeks.	From enrollment to the end of treatment at 24 weeks
Time to resolution of the first gout flare	From enrollment to the end of treatment at 24 weeks
Time to first gout recurrence	From enrollment to the end of treatment at 24 weeks
Incidence of adverse events and serious adverse events.	From enrollment to the end of treatment at 24 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): May 7, 2026
• Primary Completion (Estimated): August 28, 2029
• Study Completion (Estimated): August 28, 2029

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2026-0160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No