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Empasiprubart 对成人皮肌炎患者的身体、血液水平、有效性和安全性的影响的研究 (empacific)

2026年11月2日 更新者：argenx

一项 2 期、随机、双盲、安慰剂对照、多中心研究，旨在评估 Empasiprubart 多剂量方案治疗成人皮肌炎的安全性、耐受性和有效性

This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM).

The study duration will be approximately 92 weeks for all participants. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either empasiprubart or placebo, respectively, during the treatment period (duration of 25 weeks). At the end of the treatment period, all the participants will enter a safety follow-up period (duration of 65 weeks).

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

3

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

  • 乔治亚州
      • Tbilisi、乔治亚州、0141
        • The First University Clinic of Tbilisi State Medical University
      • Tbilisi、乔治亚州、0167
        • Jerarsi Clinic
      • Tbilisi、乔治亚州、0179
        • Mtskheta street Clinic
      • Tbilisi、乔治亚州、0180
        • The First Medical Center
      • Tbilisi、乔治亚州、0159
        • Institute of Clinical Cardiology, Ltd
      • Tbilisi、乔治亚州、0102
        • V.Tsitlanadze Scientific Practical Reumatology Center
  • 希腊
      • Athens、希腊、12462
        • National and Kapodistrian University of Athens (NKUA) - University General Hospital Attikon
      • Athens、希腊、16121
        • Andreas Syggros Hospital of Skin and Venereal Diseases - University Dermatology and Venereology
      • Thessaloniki、希腊、56429
        • General Hospital of Thessaloniki Papageorgiou
  • 意大利
      • Pisa、意大利、56126
        • Azienda Ospedaliera Universitaria Pisana
      • Rome、意大利、00128
        • Fondazione Policlinico Universitario Campus Bio-Medico
  • 摩尔多瓦
      • Chisinau、摩尔多瓦、MD2025
        • Institute of Cardiology
      • Chisinau、摩尔多瓦、2025
        • Timofei Mosneaga Republican Clinical Hospital
  • 波兰
      • Bialystok、波兰、15707
        • Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
      • Poznan、波兰、61-397
        • Prywatna Praktyka Lekarska Prof. UM dr Hab. Med. Pawel Hrycaj
      • Wroclaw、波兰、50-556
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • 美国
    • California
      • Oceanside、California、美国、92056
        • Profound Research LLC
    • Florida
      • DeBary、Florida、美国、32713
        • Omega Research Debary, LLC
      • Gainesville、Florida、美国、32610
        • University of Florida Health (UF) - Endocrinology - Medical Specialties - Medical Plaza
      • Homestead、Florida、美国、33033
        • Homestead Associates in Research, Inc.
      • Margate、Florida、美国、33063
        • Life Clinical Trials
      • Miami、Florida、美国、33135
        • Advance Medical Research Center
      • Plantation、Florida、美国、33324
        • Integral Rheumatology and Immunology Specialists (IRIS)
      • Tamarac、Florida、美国、33321
        • D and H Tamarac Research, LLC Center
    • Ohio
      • Dayton、Ohio、美国、45324
        • Wright State Physicians Health Center
  • 西班牙
      • Barcelona、西班牙、08003
        • Parc de Salut Mar - Hospital del Mar
      • Seville、西班牙、41010
        • Hospital Quironsalud Infanta Luisa
      • Valladolid、西班牙、47012
        • Hospital Universitario Rio Hortega

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Is at least 18 years of age and the local legal age of consent for clinical studies when signing the Informed Consent Form
  • Is capable of providing signed informed consent and complying with protocol requirements
  • Agrees to use contraceptive measures consistent with local regulations and women of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before receiving the study drug
  • Has a clinical diagnosis of dermatomyositis or juvenile dermatomyositis. The diagnosis date for juvenile dermatomyositis should be ≤5 years before screening
  • Has active muscle disease associated with classic dermatomyositis or juvenile dermatomyositis at screening and before the first study drug adminisitration and at least 1 of the following: elevated levels of creatine kinase, aldolase, lactate dehydrogenase, aspartate aminotransaminase or alanine aminotransferase at screening; or electromyography ≤18 weeks before the first study drug administration; or an MRI depicting active muscle inflammation ≤18 weeks before the first study drug administration; or muscle biopsy demonstrating signs of active inflammation ≤18 weeks before the first study drug administration
  • Has at least mild skin disease at screening
  • Complies with the permitted background dermatomyositis treatment requirements at screening
  • Has had immunization with the first meningococcal, pneumococcal, and the single Haemophilus influenza type B vaccine ≥14 days before the first study drug administration

Exclusion Criteria:

  • Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of dermatomyositis or puts the participant at undue risk
  • Naïve to standard dermatomyositis treatment according to local recommendations
  • History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the first study drug administration. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological findings of prostate cancer
  • Clinically significant active infection that is not sufficiently resolved before the first study drug administration in the investigator's opinion
  • Positive serum test at screening for active infection with any of the following: Hepatitis B virus, Hepatitis C virus, HIV
  • Clinically significant disease, recent major surgery, or intention to have major surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
  • Current participation in another interventional clinical study
  • Known hypersensitivity to the study drug or any of its excipients
  • History (within 12 months before screening) of or current alcohol, drug, or medication abuse, as assessed by the investigator
  • Pregnant or lactating state or intending to become pregnant during the study
  • Previous participation in an empasiprubart clinical study with at least 1 dose of study drug received
  • Known complement component deficiency as assessed by the investigator
  • Change in dermatomyositis physical therapy or exercise program from ≤4 weeks before screening
  • Inflammatory or non-inflammatory myopathies other than dermatomyositis, such as drug-induced or endocrine-induced myositis, infective myositis, polymyositis, immune-mediated necrotizing myopathy, inclusion body myositis, overlap myositis, metabolic myopathies, or muscle dystrophies
  • Paraneoplastic dermatomyositis secondary to malignancy
  • Glucocorticoid-induced myopathy
  • Severe muscle damage
  • Extensive or severe calcinosis
  • Interstitial lung disease with at least 1 of the following: forced vital capacity (FVC) ≤60%; supplemental oxygen therapy; rapidly progressing uncontrolled interstitial lung disease; moderate or severe interstitial lung disease

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：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Empasiprubart

Patients receiving Empasiprubart IV
生物：Empasiprubart IV

Intravenous infusion with Empasiprubart IV

其他名称：
  • ARGX-117
安慰剂比较：Placebo

Patients receiving Placebo IV
其他：Placebo IV

Intravenous infusion with Placebo IV

研究衡量的是什么？

主要结果指标

结果测量
大体时间
不良事件 (AE) 的发生率
大体时间：长达 90 周
长达 90 周
由于不良事件 (AE) 而停止研究药品 (IMP) 的参与者的百分比
大体时间：长达 25 周
长达 25 周

次要结果测量

结果测量
措施说明
大体时间
Mean TIS
大体时间：Up to 25 weeks

The Total Improvement Score (TIS) assesses minimal, moderate, and major clinical response categorically or continuously using American College of Rheumatology and European League Against Rheumatism (ACR/EULAR) criteria.
Up to 25 weeks

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

argenx

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 (实际的)

2024年8月20日

初级完成 (估计的)

2026年11月1日

研究完成 (估计的)

2026年11月1日

研究注册日期

首次提交

2024年2月22日

首先提交符合 QC 标准的

2024年2月22日

首次发布 (实际的)

2024年2月29日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ARGX-117-2301
  • 2023-508337-14 (其他标识符：CTIS number)
  • 2023 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

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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