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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

2026年5月24日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

118

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Regular dosing group
薬：Scheduled Firsekibart administration
A 200 mg subcutaneous injection of Firsekibart will be administered on the day of randomization or the day of gout flare.
他の：On-demand dosing group
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
時間枠
The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization.
時間枠：24 weeks after randomization
24 weeks after randomization

二次結果の測定

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

その他の成果指標

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Second Affiliated Hospital, School of Medicine, Zhejiang University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年5月1日

一次修了 (推定)

2029年2月28日

研究の完了 (推定)

2030年2月28日

試験登録日

最初に提出

2026年5月24日

QC基準を満たした最初の提出物

2026年5月24日

最初の投稿 (実際)

2026年6月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月1日

QC基準を満たした最後の更新が送信されました

2026年5月24日

最終確認日

2026年3月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 20260160

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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