Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia
2026年5月18日 更新者：Gliknik Inc.
Initial Safety and Efficacy, Sequential Group, Adaptive Dose Study of GL-2045 Subcutaneous Injection Repeat Doses in Patients With Immune Thrombocytopenia
The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP).
研究概览
详细说明
This is a Phase 1b, open-label, multiple subcutaneous (SC) injection dose study in participants with ITP. The specific aims of this study are to determine:
- The safety of the study drug when given to participants with ITP
- The effect of the study drug on safety blood tests and blood platelet counts
- How the study drug affects certain responses in the body such as severity of bleeding, levels of fatigue and health-related quality of life
- How much of the study drug gets into the bloodstream
- The body's immune response to the study drug
This information, together with pharmacokinetic (PK) data, will help to establish doses and dosing regimens suitable for use in future studies. The effects of GL-2045 on multiple biomarkers will also be investigated.
研究类型
介入性
注册 (估计的)
42
阶段
- 阶段1
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
- 姓名：Gliknik Clinical Trials Group
- 电话号码：410-665-0662
- 邮箱：gliknikclinicaltrialinquiries@gliknik.com
学习地点
-
-
-
Leeds、英国、LS11 9EH
- 招聘中
- Fortrea Clinical Research Unit Ltd
-
-
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
Key Inclusion Criteria:
- Male or female between 18 and 80 years of age with ITP or certain limited ITP conditions.
- Females must not be pregnant or lactating. Males and females of childbearing potential must agree to use contraception.
- A platelet count of 10 to 49 × 10^9/L at baseline.
- Study subjects must have prior response to corticosteroids or to intravenous immunoglobin (IVIg) documented by a consultant hematologist. Prior response to thrombopoietin receptor agonists is insufficient for eligibility.
- The subject may be on a stable dose of corticosteroids for the 3 months prior to study entry, limited to a daily dose of prednisone 10 mg or equivalent. No reductions or increases of steroids are allowed during the study.
Key Exclusion Criteria:
- Any serious adverse event (SAE) with prior IVIg dosing.
- Prior splenectomy within 1 year of randomization or planned splenectomy during the study period.
- Participants with grade 2 bleeding by World Health Organization (WHO) bleeding criteria in the 8 weeks prior to treatment.
- Abnormal organ function including liver and kidney.
- Any previous or current treatments prohibited by the protocol.
- Treatment within the last 4 weeks or intention to treat during the study with a thrombopoietin receptor agonist including romiplostim (Nplate®), eltrombopag (Revolade®), or avatrombopag (Doptelet®).
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：顺序分配
- 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：GL-2045
Participants will receive GL-2045 by SC injection during the treatment period. Cohort 1: Adaptive design cohort during which dose adjustment may occur. Up to 18 participants will be enrolled Cohort 2: Fixed-dose and dosing frequency testing 1 or 2 dose levels and dose regimens. Up to 24 participants will be enrolled |
Administrative route: SC injection
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Incidence, severity and type of adverse events and laboratory abnormalities
大体时间：Screening (Days -28 to -2) to Follow-up (Day 55)
|
Screening (Days -28 to -2) to Follow-up (Day 55)
|
|
Multiple measurements of change from baseline in platelet count
大体时间：Day -1 to Follow-up (Day 55)
|
Day -1 to Follow-up (Day 55)
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change from Baseline in Tumor Necrosis Factor-Alpha (TNF-α) Levels
大体时间：Day 1 to Follow-up (Day 55)
|
Day 1 to Follow-up (Day 55)
|
|
Change from Baseline in Classical Complement Pathway (CCP) Inhibition
大体时间：Day 1 to Follow-up (Day 55)
|
Day 1 to Follow-up (Day 55)
|
|
Changes in bleeding scale
大体时间：Day -1 to Follow-up (Day 55)
|
Day -1 to Follow-up (Day 55)
|
|
Changes from baseline in Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Questionnaire
大体时间：Day -1 to Follow-up (Day 55)
|
Day -1 to Follow-up (Day 55)
|
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Changes from baseline in FACIT-Thrombocytopenia 6 Questionnaire
大体时间：Day -1 to Follow-up (Day 55)
|
Day -1 to Follow-up (Day 55)
|
|
Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUCO-tlast)
大体时间：Day 1 to Follow-up (Day 55)
|
Day 1 to Follow-up (Day 55)
|
|
Maximum observed concentration (Cmax)
大体时间：Day 1 to Follow-up (Day 55)
|
Day 1 to Follow-up (Day 55)
|
|
Time of the maximum observed concentration (tmax)
大体时间：Day 1 to Follow-up (Day 55)
|
Day 1 to Follow-up (Day 55)
|
|
Incidence of immune response to drug
大体时间：Day 1 to Day 48
|
Day 1 to Day 48
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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
调查人员
- 首席研究员：Jim Bush, MBChB, PhD、Fortrea Clinical Research Unit Ltd.
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4月14日
初级完成 (估计的)
2027年12月6日
研究完成 (估计的)
2027年12月6日
研究注册日期
首次提交
2026年4月29日
首先提交符合 QC 标准的
2026年5月18日
首次发布 (实际的)
2026年5月26日
研究记录更新
最后更新发布 (实际的)
2026年5月26日
上次提交的符合 QC 标准的更新
2026年5月18日
最后验证
2026年5月1日
更多信息
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.