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Efficacy and Safety of Scheduled Versus As-Needed Firsekibart Administration for the Prevention of Gout Recurrence: A Multicenter, Open-Label, Randomized Controlled Trial

24 mei 2026 bijgewerkt door: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Objective To compare the efficacy of continued scheduled dosing versus as-needed dosing in patients with acute gouty arthritis who remained recurrence-free after 24 weeks of treatment with Firsekibart.

Primary Endpoint The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization.

Secondary Endpoints The mean number of gout recurrences within 24 weeks after randomization;The duration of the first gout recurrence;The proportion of patients experiencing at least one gout recurrence within 12 weeks after randomization;Time to first gout recurrence after randomization;Patient treatment satisfaction at 24 weeks after randomization, assessed using a Likert scale.

Study Design and Methods Patients with acute gouty arthritis who had received Firsekibart as initial treatment and experienced no recurrence during the first 24 weeks of treatment were eligible for enrollment and randomization in this study. Eligible patients were randomized to either a scheduled dosing group or an as-needed dosing group.

In the scheduled dosing group, patients received study treatment immediately after enrollment. In the as-needed dosing group, patients entered an observation period after enrollment and received study treatment only in the event of recurrence.

During the study, gout recurrence was recorded using patient diary cards. Telephone follow-up was conducted every 4 weeks to confirm recurrence status. On-site visits were performed at Weeks 12 and 24, as well as at the time of gout recurrence, for collection of efficacy-related assessments. Adverse events (AEs) and serious adverse events (SAEs) were followed until 12 weeks after the last dose of study drug.

Treatment Arms Scheduled Dosing Group (Intervention Group): Firsekibart 200 mg was administered by subcutaneous injection on the day of randomization.

As-Needed Dosing Group (Control Group): Patients were observed after randomization. If recurrence occurred, patients were required to return to the hospital within 4 days and receive Firsekibart 200 mg by subcutaneous injection.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

118

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
      • Fuzhou, China
        • Fuzhou University Affiliated Provincial Hospital
        • Contact:
          • Fei Gao
          • Telefoonnummer: 0086-13665013469
      • Hangzhou, China
        • Zhejiang Hospital
        • Contact:
          • Fang Yuan
          • Telefoonnummer: 0086-18072963566
      • Hangzhou, China
        • Tongde Hospital of Zhejiang Province
        • Contact:
          • Qin Chen
      • Huzhou, China
        • Changxin People's Hospital
        • Contact:
          • Yingying Wang
          • Telefoonnummer: 0086-13705790575
      • Jinhua, China
        • Jinhua Municipal Central Hospital
        • Contact:
          • Li Hua
          • Telefoonnummer: 0086-13758992315
      • Ningbo, China
        • Ningbo Medical Center Lihuili Hospital
        • Contact:
          • Li Zhou
          • Telefoonnummer: 0086-13858287828
      • Wenzhou, China
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Hong Wang
          • Telefoonnummer: 0086-13957756514
      • Wenzhou, China
        • The First People's Hospital of Wenlin
        • Contact:
          • Yongjun Chen
          • Telefoonnummer: 0086-13958633696
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Provincial People's Hospital
        • Contact:
          • Lijuan Wang
          • Telefoonnummer: 0086-13567134447
      • Hangzhou, Zhejiang, China
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China
        • The Second Affiliated Hospital of Zhejiang Chinese Medical University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Regular dosing group
Geneesmiddel: Scheduled Firsekibart administration
A 200 mg subcutaneous injection of Firsekibart will be administered on the day of randomization or the day of gout flare.
Ander: On-demand dosing group
Geneesmiddel: As-Needed Firsekibart Administration
Following randomization, patients will remain under continuous observation. In the event of recurrence, patients should return to the hospital within 4 days to receive a 200 mg subcutaneous injection of Firsekibart.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization.
Tijdsspanne: 24 weeks after randomization
24 weeks after randomization

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Mean number of gout flares over 24 weeks after randomization.
Tijdsspanne: 24 weeks after randomization
24 weeks after randomization
Time to resolution of the first gout flare
Tijdsspanne: 24 weeks after randomization.
24 weeks after randomization.
Time to first gout flare
Tijdsspanne: 24 weeks after randomization
24 weeks after randomization
Proportion of patients with at least one gout flare
Tijdsspanne: 24 weeks after randomization
24 weeks after randomization
Patient treatment satisfaction scores
Tijdsspanne: 24 weeks after randomization
24 weeks after randomization
Incidence of adverse events and serious adverse events.
Tijdsspanne: 24 weeks after randomization
24 weeks after randomization

Andere uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change from baseline in CRP and hsCRP
Tijdsspanne: 24 weeks after randomization
24 weeks after randomization
Change from baseline in IL-6、IL-1β and TNF-α
Tijdsspanne: 24 weeks after randomization
24 weeks after randomization
Change from baseline in ESR
Tijdsspanne: 24 weeks after randomization
24 weeks after randomization
Percentage change from baseline in tophus diameter
Tijdsspanne: 24 weeks after randomization
24 weeks after randomization
change from baseline in serum urate
Tijdsspanne: 24 weeks after randomization
24 weeks after randomization
Pain VAS score at the first gout flare
Tijdsspanne: 24 weeks after randomization
24 weeks after randomization

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 mei 2026

Primaire voltooiing (Geschat)

28 februari 2029

Studie voltooiing (Geschat)

28 februari 2030

Studieregistratiedata

Eerst ingediend

24 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 mei 2026

Eerst geplaatst (Werkelijk)

1 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

24 mei 2026

Laatst geverifieerd

1 maart 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 20260160

Plan Individuele Deelnemersgegevens (IPD)

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ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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