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New drug firsekibart tested to stop painful gout attacks

NCT ID NCT07625514

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study will follow 264 adults with frequent gout flares to see how often attacks return within 24 weeks after starting firsekibart. Researchers will also track side effects and how quickly flares resolve. The goal is to understand if this medication helps control gout in everyday medical practice.

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 264 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

Aug 2029

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. 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.

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Conditions

The condition(s) this trial relates to.

gout

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gout flare

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, China

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, China

  • The Second Affiliated Hospital of Zhejiang Chinese Medical University

    Hangzhou, China

  • Tongde Hospital of Zhejiang Province

    Hangzhou, China

  • Zhejiang Hospital

    Hangzhou, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, China

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Other studies related to the condition(s) this trial covers.