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A Phase 3 Evaluation of Sutacimig in Glanzmann Thrombasthenia (SOLARA)

2026年11月9日 更新者：Hemab ApS

SOLARA: A Phase 3 Study of the Efficacy and Safety of Sutacimig in Participants With Glanzmann Thrombasthenia

Glanzmann thrombasthenia (GT) is a serious inherited bleeding disorder. In GT, platelets, the blood cells that normally stick together at the site of an injury to stop bleeding, are unable to properly do so. As a result, bleeding does not stop as it should. Bleeding in GT often starts without warning, can happen frequently, and can be severe. It most commonly affects the nose, mouth and gums, gastrointestinal tract, and skin, and many women and girls with GT experience heavy menstrual bleeding. Over time, bleeding can lead to iron deficiency and anemia. Some bleeding episodes require emergency care, hospitalization, transfusion, or surgery, and some can be life-threatening.

Sutacimig is an investigational medicine given as an injection under the skin (subcutaneous injection). It is designed to help platelets work at the site of bleeding despite the underlying defect in GT. It is intended to be given regularly to help prevent bleeding (prophylaxis), rather than only to treat bleeding after it starts.

The purpose of this study is to find out whether sutacimig, given as prophylaxis, reduces the number of treated bleeding episodes in people with GT compared with no prophylaxis, and to evaluate its safety and tolerability.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

76

阶段

  • 第三阶段

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。

学习联系方式

学习地点

  • 美国
    • California
      • La Jolla、California、美国、92037
        • 招聘中
        • University of California San Diego (UC San Diego) Health - Jacobs Medical Center
      • Los Angeles、California、美国、90027
        • 招聘中
        • Children's Hospital Los Angeles
      • Sacramento、California、美国、95817
        • 招聘中
        • University of California Davis (UC Davis) Medical Center
      • San Francisco、California、美国、94143
        • 招聘中
        • University of California San Francisco (UCSF) Medical Center
    • Indiana
      • Indianapolis、Indiana、美国、46260
        • 招聘中
        • Innovative Hematology - Indiana Hemophilia & Thrombosis Center
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • 招聘中
        • M Health Fairview - University of Minnesota Medical Center
    • New York
      • New York、New York、美国、10065
        • 招聘中
        • New York-Presbyterian - Weill Cornell Medical Center
    • North Carolina
      • Durham、North Carolina、美国、27709
        • 招聘中
        • Science 37
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • Gulf States Hemophilia and Thrombophilia Center - Texas Medical Center

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

12年 至 70年 (孩子、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:

  • Has the ability to provide informed consent to participate in the clinical study before completing any study-related procedures, and has an understanding, ability, and willingness to comply with clinical study procedures and restrictions.

  • Adults 18 to 70 years.

  • Adolescents 12 to <18 years, dependent on geographical location.

  • Has clinical bleeding phenotype consistent with Glanzmann thrombasthenia (GT) and documentation of either diagnostic laboratory criteria (a) or (b) below:

    1. Abnormal platelet aggregometry AND flow cytometry
    2. A confirmed genetic mutation in ITGA2B or ITGB3.

  • Participants have experienced at least four treated bleeding events related to GT within the 12 months prior to Screening.

Exclusion Criteria:

  • Prior exposure to sutacimig.
  • History of clinically significant hypersensitivity associated with monoclonal antibody therapies.
  • Congenital or acquired bleeding disorders other than GT.
  • Medical condition (other than GT) that constitutes an increased risk of having uncontrolled bleeding events during the study or other conditions per Investigator discretion.
  • History of venous or arterial thromboembolic (TE) event or TE disease except for catheter-associated vein thrombosis.
  • Co-existing thrombophilia disorder.

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：Sutacimig

Participants will receive sutacimig 0.2 milligrams per kilogram (mg/kg) by subcutaneous injection once weekly for 48 weeks. Upon completion of the 48-week treatment period, participants will be offered the opportunity to transition to a separate open-label extension (OLE) study for continued assessment of the prophylactic treatment with sutacimig.
药品：Sutacimig

Sutacimig will be administered by subcutaneous injection.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Annualized Treated Bleed Rate (ATBR)
大体时间：From the first dose through Week 48
From the first dose through Week 48

次要结果测量

结果测量
大体时间
High-Intensity Annualized Treated Bleed Rate (Hi-ATBR)
大体时间：From the first dose through Week 48
From the first dose through Week 48
Annualized Treated Bleed Days (ATBD)
大体时间：From the first dose through Week 48
From the first dose through Week 48
Annualized Treated Bleed Rate (ATBR) by Bleeding Event Type
大体时间：From the first dose through Week 48
From the first dose through Week 48
Annualized Treated Bleed Rate (ATBR) by Bleeding Event Cause
大体时间：From the first dose through Week 48
From the first dose through Week 48
Percentage of Participants With Reductions in Annualized Treated Bleed Rate (ATBR)
大体时间：From the first dose through Week 48
From the first dose through Week 48
Percentage of Participants With Reductions in High-Intensity Annualized Treated Bleed Rate (Hi-ATBR)
大体时间：From the first dose through Week 48
From the first dose through Week 48
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
大体时间：From the first dose through Week 56
From the first dose through Week 56
Number of Participants With Physical Examination Abnormalities
大体时间：From the first dose through Week 56
From the first dose through Week 56
Number of Participants With Vital Sign Abnormalities
大体时间：From the first dose through Week 56
From the first dose through Week 56
Number of Participants With Clinical Laboratory Test Abnormalities
大体时间：From the first dose through Week 56
From the first dose through Week 56
Number of Participants With Anti-Drug Antibody (ADA) Development
大体时间：From the first dose through Week 56
From the first dose through Week 56
Number of Participants With Changes in Electrocardiogram (ECG) Parameters
大体时间：From the first dose through Week 56
From the first dose through Week 56
Plasma Concentration for Sutacimig
大体时间：Baseline through Week 56
Baseline through Week 56

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

Hemab ApS

调查人员

  • 研究主任：Medical Director、Hemab

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)

2026年10月27日

初级完成 (估计的)

2029年11月1日

研究完成 (估计的)

2030年1月1日

研究注册日期

首次提交

2026年11月9日

首先提交符合 QC 标准的

2026年11月9日

首次发布 (实际的)

2026年11月13日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月9日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HMB-001-103
  • U1111-1342-3293 (其他标识符：Universal Trial Number)

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

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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