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New study tests best way to use firsekibart to stop gout attacks

NCT ID NCT07616531

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 118 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Changxin People's Hospital

    Huzhou, China

  • Fuzhou University Affiliated Provincial Hospital

    Fuzhou, China

  • Jinhua Municipal Central Hospital

    Jinhua, China

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, China

  • The First People's Hospital of Wenlin

    Wenzhou, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, China

  • The Second Affiliated Hospital of Zhejiang Chinese Medical University

    Hangzhou, Zhejiang, China

  • Tongde Hospital of Zhejiang Province

    Hangzhou, China

  • Zhejiang Hospital

    Hangzhou, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, China

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