24-Week Recurrence Rate of Gout Following Firsekibart Treatment

NCT07625514 | Not Yet Recruiting

• 1 other identifier: 2026-0160
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 11

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  From enrollment to the end of treatment at 24 weeks.

Secondary Outcomes (4)

• 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

Study Arms (1)

Experimental group

EXPERIMENTAL

Drug: Firsekibart

Interventions

Firsekibart DRUG

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (11)

Fuzhou University Affiliated Provincial Hospital

Fuzhou, China

Location

The Second Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

Location

Tongde Hospital of Zhejiang Province

Hangzhou, China

Location

Zhejiang Hospital

Hangzhou, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

Changxin People's Hospital

Huzhou, China

Location

Jinhua Municipal Central Hospital

Jinhua, China

Location

Ningbo Medical Center Lihuili Hospital

Ningbo, China

Location

The First People's Hospital of Wenlin

Wenzhou, China

Location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Location

Central Study Contacts

华香 吴

CONTACT

0086-13757118395; wuhx8855@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 4, 2026
• Study Start: May 7, 2026
• Primary Completion (Estimated): August 28, 2029
• Study Completion (Estimated): August 28, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-04

Locations

CN (11)