New study tests best way to use firsekibart to stop gout attacks
NCT ID NCT07616531
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether taking Firsekibart regularly (every 4 weeks) is better than using it only when a gout flare starts. It involves 118 adults who had no flares during 24 weeks of initial treatment. The goal is to see which approach prevents more gout attacks over the next 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Firsekibart (a drug injected under the skin)
- What this could lead to
- If successful, this could show that taking Firsekibart on a regular schedule is better than waiting for a flare to use it, helping prevent gout attacks.
- What could go wrong
- This is a small, early-stage trial with only 118 participants, so results may not apply to everyone. The drug may cause side effects, and the study is not yet recruiting.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 118 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 to 75 years (inclusive), male or female;\*\* 2. Meet the 2015 ACR/EULAR Gout Classification Criteria;\*\* 3. Received initial treatment with Firsekibart 200 mg via subcutaneous injection for 24 weeks, and experienced no gout flares during this 24-week period;\*\* 4. Had≥2 gout flares within 1 year prior to the first administration of Firsekibart; 5. Willing to comply with the protocol-defined urate-lowering therapy (ULT) during the study, meeting one of the following conditions: * Patients currently receiving ULT with a stable regimen for≥14 days may continue their stable dosing; adjustments (including medication switch, dose reduction, or discontinuation) are permitted if the investigator assesses intolerance, poor efficacy, or achievement of target serum uric acid levels; * For patients not on ULT or those on ULT but not stable for 14 days before enrollment, the investigator will decide whether to initiate ULT based on uric acid levels. In principle, allopurinol-naive patients should not be prescribed allopurinol in this study; 6. Voluntarily signed the Informed Consent Form (ICF). Exclusion Criteria: 1. History of hypersensitivity to the study drug or similar classes of drugs; 2. Systemic treatment with corticosteroids, or use of colchicine/NSAIDs within 24 weeks prior to enrollment; 3. Confirmed active visceral bleeding, or severe bleeding tendency, or currently receiving anticoagulation therapy with heparin; 4. Confirmed secondary gout; 5. Confirmed or suspected rheumatoid arthritis, infectious/septic arthritis, or other conditions that may confound the assessment of affected joints (e.g., other joint pain including but not limited to neurological disorders, herpes zoster, etc.); 6. Presence of infection requiring systemic treatment within 7 days prior to screening; 7. Received live or live-attenuated vaccines within 3 months prior to screening, or planned vaccination with such vaccines during the study; 8. History of malignancy within 5 years prior to screening, except for adequately treated or excised cutaneous basal cell carcinoma or Stage I squamous cell carcinoma; 9. History of systemic irradiation or total lymphoid irradiation; history of stem cell therapy or any type of bone marrow transplantation; history of solid organ transplantation; or long-term systemic use of immunosuppressants; 10. History of severe immunodeficiency, including positive human immunodeficiency virus (HIV) antibody, or other acquired or congenital immunodeficiency diseases; 11. 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 ; 12. Confirmed active tuberculosis infection; 13. Receiving renal dialysis; 14. 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; 15. Pregnant or breastfeeding women; 16. Women of childbearing potential who refuse to use highly effective contraception during the study; 17. Use of any investigational drug or participation in other interventional clinical trials within 1 month prior to screening (participation in observational studies only is permitted); 18. History of drug and/or alcohol abuse or psychiatric disorders; 19. Any other conditions that, in the opinion of the investigator, may affect the evaluation of efficacy or safety in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Changxin People's Hospital
Huzhou, China
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Fuzhou University Affiliated Provincial Hospital
Fuzhou, China
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Jinhua Municipal Central Hospital
Jinhua, China
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Ningbo Medical Center Lihuili Hospital
Ningbo, China
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The First People's Hospital of Wenlin
Wenzhou, China
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The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
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The Second Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China
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Tongde Hospital of Zhejiang Province
Hangzhou, China
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Zhejiang Hospital
Hangzhou, China
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Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
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