Gout FlareNCT07625514
24-Week Recurrence Rate of Gout Following Firsekibart Treatment
A study testing Firsekibart in people with Gout Flare, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 11 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gout Flare
- What is being tested?
- Firsekibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 11 sitesChina
- Study dates
- 7 May 2026to 28 Aug 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites
Fuzhou University Affiliated Provincial Hospital
Fuzhou
Fei Gao, 0086-13665013469
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou
Kepeng Yang, 0086-17826873536, ykp1029@126.com
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
华香 吴, wuhx8855@zju.edu.cn
Tongde Hospital of Zhejiang Province
Hangzhou
Qin Chen, 0086-15869192858
Zhejiang Hospital
Hangzhou
Fang Yuan, 0086-18072963566
Zhejiang Provincial People's Hospital
Hangzhou
Lijuan Wang, 0086-13567134447
Changxin People's Hospital
Huzhou
Yingying Wang
Jinhua Municipal Central Hospital
Jinhua
Li Hua, 0086-13758992315
Ningbo Medical Center Lihuili Hospital
Ningbo
Li Zhou, 0086-13858287828
The First People's Hospital of Wenlin
Wenzhou
Yongjun Cheng, 0086-13958633696
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou
Hong Wang, 0086-13957756514
About this study
Official title: 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).
- Conditions
- Gout Flare
- Being tested
- Firsekibart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FirsekibartDrug
A 200mg subcutaneous injection of firsekibart was administered within 12 hours of the onset of an acute gout flare.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Firsekibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients experiencing at least one gout recurrence within 24 weeks.
Measured: From enrollment to the end of treatment at 24 weeks.
Secondary outcomes (4)
Mean number of gout flares over 24 weeks.
Measured: From enrollment to the end of treatment at 24 weeks
Time to resolution of the first gout flare
Measured: From enrollment to the end of treatment at 24 weeks
Time to first gout recurrence
Measured: From enrollment to the end of treatment at 24 weeks
Incidence of adverse events and serious adverse events.
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start7 May 2026 (estimated)
- Primary completion28 Aug 2029 (estimated)
- Study completion28 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout FlareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625514
- Sponsor's protocol ID
- 2026-0160
- Status last verified
- Apr 2026
- First submitted
- 24 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided