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Ivarmacitinib for Refractory Behcet's Syndrome

2026年7月8日 更新者:Liu Tian

Efficacy and Safety of the Novel, Highly Selective JAK Inhibitor Ivarmacitinib in the Treatment of Behçet's Disease: A Multicenter Prospective Study

Behcet's syndrome (BS) is a multisystem autoimmune vasculitis. Current clinical treatment primarily includes glucocorticoids, immunosuppressants, and molecularly targeted drugs such as TNF-α and IL-6 inhibitors; however, some patients still respond poorly to existing treatment regimens. The JAK-STAT signaling pathway serves as a common downstream signaling pathway for various cytokines involved in the pathogenesis of Behcet's syndrome. Upon binding to their receptors, cytokines activate JAK kinases, which in turn phosphorylate STAT proteins to regulate the expression of inflammation-related genes. Therefore, blocking the JAK-STAT pathway can simultaneously inhibit the signal transduction of multiple pathogenic cytokines, thereby exerting anti-inflammatory effects. Consequently, Ivarmacitinib-a highly selective JAK1 inhibitor-holds promise for improving the prognosis and quality of life of patients with refractory Behçet's syndrome.

This is a multi-center, single-arm trial conducted to evaluate the safety and efficacy of Ivarmacitinib in Behçet's syndrome (BS) . Patients with refractory Behçet's syndrome were enrolled . Patients received Ivarmacitinib for up to 24 weeks, which was added to the glucocorticoid and immunosuppressants. The clinical manifestations, inflammatory indicators, imaging and treatment of patients were recorded by investigators during the follow up.

研究概览

地位

撤销

研究类型

介入性

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Beijing Municipality
      • Beijing、Beijing Municipality、中国
        • Department of Rheumatology and Immunology, Peking University People's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • ① Meets the 1990 ISG diagnostic criteria for Behçet's syndrome [9];

    • Aged 18-70 years; ③ Has shown an inadequate response to treatment after at least 6 months of therapy with glucocorticoids, at least two immunosuppressants, and/or biologics (including TNF-α inhibitors and IL-6 inhibitors);

      • Agrees to receive treatment with a new targeted therapy

Exclusion Criteria:

  • ① Patients with one or more other autoimmune diseases;

    • Patients who have undergone major surgery within 4 weeks prior to enrollment, or who are scheduled to undergo elective surgery during the study; ③ Patients with a confirmed acute or chronic active infection (e.g., bacterial, viral [such as EBV, CMV, HIV, or active hepatitis virus]) within 4 weeks prior to enrollment; ④ Patients with a current or past history of any malignancy;

      • Female patients who are pregnant or within 6 months postpartum;

        • Patients with severe liver failure (Child-Pugh Class C) or end-stage renal disease (dialysis-dependent).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Ivarmacitinib for the Treatment of Refractory Behçet's Disease
The specific regimen was 4 mg of Ivarmacitinib administered daily for 24 weeks. All patients will undergo 24 weeks of prospective follow-up.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
达到完全缓解和部分缓解的患者
大体时间:第 24 周
主要终点定义为整个队列中在第24周时实现完全缓解和部分缓解的患者比例(百分比)。
第 24 周

次要结果测量

结果测量
措施说明
大体时间
Changes of C-reactive protein
大体时间:Week 24
Blood samples were collected from all patients and the concentration of C-reactive protein (mg/L) were recorded.
Week 24
Changes of erythrocyte sedimentation rate
大体时间:week24
Blood samples were collected from all patients and the erythrocyte sedimentation rates (mm/h) were recorded.
week24
Changes of dosage of glucocorticoids from baseline.
大体时间:week 24
The dosage of glucocorticoids (mg/day) of all patients were recorded during the follow-up.
week 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2027年5月31日

研究完成 (估计的)

2027年5月31日

研究注册日期

首次提交

2026年5月31日

首先提交符合 QC 标准的

2026年6月7日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年7月10日

上次提交的符合 QC 标准的更新

2026年7月8日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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