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高 ERE 嗜酸性粒细胞综合征 (SPHERE) 儿科研究 (SPHERE)

2026年7月1日 更新者：GlaxoSmithKline

一项为期 52 周、开放标签、单臂研究，旨在调查 Mepolizumab SC 在 6 至 17 岁患有嗜酸性粒细胞增多综合征的参与者中的疗效和安全性

本研究的目的是调查美泊利单抗对接受标准护理 (SoC) 治疗的嗜酸性粒细胞增多综合征 (HES) 儿童和青少年的疗效和安全性。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

16

阶段

  • 第三阶段

扩展访问

不再可用 查看扩展访问记录。

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

  • 以色列
      • Petah Tikva、以色列、49202
        • GSK Investigational Site
  • 土耳其（türkiye）
      • Ankara、土耳其（türkiye）、6230
        • GSK Investigational Site
      • Izmir、土耳其（türkiye）、35100
        • GSK Investigational Site
      • Kayseri、土耳其（türkiye）、38039
        • GSK Investigational Site
  • 巴西
      • Sorocaba、巴西、18040-425
        • GSK Investigational Site
      • São Paulo、巴西、05410-002
        • GSK Investigational Site
  • 美国
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • GSK Investigational Site
    • Ohio
      • Cincinnati、Ohio、美国、45229
        • GSK Investigational Site
      • Cleveland、Ohio、美国、44106
        • GSK Investigational Site
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • GSK Investigational Site
  • 荷兰
      • Rotterdam、荷兰、3015 CE
        • GSK Investigational Site
  • 阿根廷
      • Buenos Aires、阿根廷、1888
        • GSK Investigational Site
      • Buenos Aires、阿根廷、C1028AAP
        • GSK Investigational Site
      • Quilmes、阿根廷、1878
        • GSK Investigational Site

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

6年 至 17年 (孩子)

接受健康志愿者

不

描述

纳入标准：

  • 参加者在筛选时必须年满 6 至 17 岁（访问 1）。
  • 在入组前至少 6 个月被诊断患有 HES 的参与者（访问 2）。
  • 在筛选前的过去 12 个月内有 2 次或更多次 HES 发作的病史（访视 1）。
  • 筛选时，参与者的血液嗜酸性粒细胞计数必须 >=1000 个细胞/微升 (/mcL)。
  • 参与者必须在首次服用美泊利单抗之前的 4 周内接受稳定剂量的 HES 治疗（访问 2）
  • 男性和/或女性
  • 签署书面知情同意书

排除标准：

  • 危及生命的 HES 或危及生命的 HES 合并症
  • 其他可能影响参与者安全的并发医疗状况
  • 意义不明的嗜酸性粒细胞增多
  • 融合酪氨酸激酶基因易位 [FIP1L1- 血小板衍生生长因子受体 (PDGFRα) (F/P)] 阳性
  • 嗜酸性肉芽肿性多血管炎（EGPA）的临床诊断
  • 患有需要全身治疗的慢性或持续活动性感染的参与者，以及在入组前 4 周内因病毒、细菌和真菌引起的具有临床意义的感染的参与者（访问 2）
  • 入组前 6 个月内已存在寄生虫感染的参与者（访问 2）
  • 患有已知免疫缺陷的参与者（例如 人类免疫缺陷病毒 [HIV]），除了使用 OCS 或针对 HES 采取的其他疗法所解释的以外
  • 在筛选（访问 1）之前有任何临床显着心脏损伤记录的参与者，研究者认为这会影响参与者在研究期间的参与
  • 有淋巴瘤病史或目前有淋巴瘤病史的参与者，目前患有恶性肿瘤或既往有癌症缓解史且在筛选前缓解少于 12 个月的参与者（访问 1）
  • 根据临床反应或血液嗜酸性粒细胞计数对 OCS 无反应的参与者。
  • 在入组前 4 个月内曾接受美泊利单抗治疗的参与者（访问 2）
  • 在入组前 4 周内接受非口服全身性皮质类固醇的参与者（访视 2）。
  • 在入组后 30 天或 5 个半衰期（以较长者为准）内接受过任何其他单克隆抗体的参与者（访视 2）。
  • 在过去 30 天内或 5 个药物半衰期（以较长者为准）之前接受过研究药物（生物或非生物）治疗的参与者（访问 2）。
  • 使用未获得有限、加速或完全授权/批准且仅作为临床试验的一部分使用的候选冠状病毒病 2019 (COVID-19) 疫苗。
  • 目前正在参加任何其他介入性临床研究的参与者
  • 对任何单克隆抗体（包括美泊利单抗）有过敏史的参与者。
  • 根据研究者的判断，在筛选（访问 1）时收集的样本的血液学、生化或尿液分析筛选存在临床显着异常的证据，这可能会使参与研究的参与者的安全处于危险之中

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：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：Mepolizumab 100 mg SC
Participants in the age group of 6 to 11 years with body weight less than (<) 40 kilogram (kg) received Mepolizumab 100 milligram (mg) subcutaneous (SC) injection every 4 weeks over a treatment period of 52 weeks.
药品：Mepolizumab
Mepolizumab was provided in pre-filled safety syringe
实验性的：Mepolizumab 300 mg SC
Participants in the age group of 12 to 17 years received Mepolizumab 300 mg SC injection every 4 weeks over a treatment period of 52 weeks.
药品：Mepolizumab
Mepolizumab was provided in pre-filled safety syringe
实验性的：Mepolizumab 200/100 mg SC
A participant in the age group of 6 to 11 years with body weight greater than or equal to (>=) 40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was reduced to 100 mg SC injection every 4 weeks as body weight of the participant reduced to less than (<) 40 kg over a treatment period of 52 weeks.
药品：Mepolizumab
Mepolizumab was provided in pre-filled safety syringe
实验性的：Mepolizumab 200/300 mg SC
A participant in the age group of 6 to 11 years with body weight >=40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was increased to 300 mg SC injection every 4 weeks as age of the participant increased to the age group of 12 to 17 years over a treatment period of 52 weeks.
药品：Mepolizumab
Mepolizumab was provided in pre-filled safety syringe

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
Number of Participants Who Experienced HES Flares Over the 52-Week Study Treatment Period
大体时间：Up to Week 52
A HES flare is defined as a HES related clinical manifestation based on a physician-documented change in clinical signs or symptoms (worsening symptoms and/or elevated blood eosinophil level) which resulted in need for either: an increase from the most recent dose in the maintenance Oral Corticosteroid (OCS) dose (prednisone/prednisolone equivalent) by at least 10 mg per day for 5 days or an increase in or addition of any immunosuppressive and/or cytotoxic HES therapy from/to the most recent dose of HES therapy. Data is presented by the number of HES flares (0, 1, 2, 3 ,4 and >=5) in the participants.
Up to Week 52

次要结果测量

结果测量
措施说明
大体时间
Change in Mean Daily Oral Corticosteroids (OCS) Dose (Prednisone/Prednisolone or Equivalent) for Each 4-week Period From Weeks 0-4 to Weeks 48-52
大体时间：Baseline (Weeks 0-4), Weeks 4-8, Weeks 8-12, Weeks 12-16, Weeks 16-20, Weeks 20-24, Weeks 24-28, Weeks 28-32, Weeks 32-36, Weeks 36-40, Weeks 40-44, Weeks 44-48 and Weeks 48-52
The mean daily OCS (prednisone or equivalent) dose for each 4-week period from Weeks 0-4 to Weeks 48-52 for each participant were calculated as the sum of the daily doses of OCS during each 4-week period divided by the total number of days. The change in the mean daily OCS dose for each 4-week period from Weeks 0-4 to Weeks 48-52 was calculated for each participant as the mean daily OCS dose for Weeks 48-52 minus the mean daily OCS dose for Weeks 0-4. Baseline value was derived as the sum of the daily doses of OCS during first 4 weeks following the initiation of mepolizumab treatment (Weeks 0-4) divided by total number of days. Change from Baseline was calculated as post-Baseline value minus Baseline Value.
Baseline (Weeks 0-4), Weeks 4-8, Weeks 8-12, Weeks 12-16, Weeks 16-20, Weeks 20-24, Weeks 24-28, Weeks 28-32, Weeks 32-36, Weeks 36-40, Weeks 40-44, Weeks 44-48 and Weeks 48-52
Number of Participants With Reduction of >=50 Percentage (%) in Mean Daily OCS Dose (Prednisone/Prednisolone or Equivalent) for Each 4-week Period From Weeks 0-4 to Weeks 48-52
大体时间：Baseline (Weeks 0-4), Weeks 4-8, Weeks 8-12, Weeks 12-16, Weeks 16-20, Weeks 20-24, Weeks 24-28, Weeks 28-32, Weeks 32-36, Weeks 36-40, Weeks 40-44, Weeks 44-48 and Weeks 48-52
The mean daily OCS (prednisone or equivalent) dose for each 4-week period from Weeks 0-4 to Weeks 48-52 for each participant were calculated as the sum of the daily doses of OCS during each period divided by the total number of days. For each 4-week period, a reduction of 50% or more in mean OCS dose was defined as (mean OCS dose at each 4-week period minus mean OCS dose during Weeks 0-4) divided by (mean OCS dose during Weeks 0-4) multiplied by 100 was <= -50. Baseline value was derived as the sum of the daily doses of OCS during first 4 weeks following the initiation of mepolizumab treatment (Weeks 0-4) divided by total number of days.
Baseline (Weeks 0-4), Weeks 4-8, Weeks 8-12, Weeks 12-16, Weeks 16-20, Weeks 20-24, Weeks 24-28, Weeks 28-32, Weeks 32-36, Weeks 36-40, Weeks 40-44, Weeks 44-48 and Weeks 48-52
Number of Participants With a Mean Daily OCS Dose (Prednisone/Prednisolone or Equivalent) of Less Than or Equal to (<=) 7.5 Milligrams (mg) During Weeks 48-52 in Subpopulation of Participants That Were Taking OCS at Baseline
大体时间：Weeks 48-52
The mean daily OCS (prednisone or equivalent) dose for Weeks 48-52 for each participant were calculated as the sum of the daily doses of OCS during this period divided by the total number of days. Number of participants with a mean daily OCS dose (prednisone/prednisolone or equivalent) of <=7.5 mg during period of Weeks 48-52 in subpopulation of participants that were taking OCS at Baseline has been presented.
Weeks 48-52
Number of Participants With a Mean Daily OCS Dose (Prednisone/Prednisolone or Equivalent) of <=7.5 mg During Weeks 48-52 in Overall Population
大体时间：Weeks 48-52
The mean daily OCS (prednisone or equivalent) dose for Weeks 48-52 for each participant were calculated as the sum of the daily doses of OCS during this period divided by the total number of days. Number of participants with a mean daily OCS dose (prednisone/prednisolone or equivalent) of <=7.5 mg during period of Weeks 48-52 in overall population has been presented.
Weeks 48-52
Change From Baseline in Fatigue Severity Based on Weekly Average Score of Brief Fatigue Inventory (BFI) Item 3 (Worst Level of Fatigue During Past 24 Hours) for Week 52 for Participants in the Age Group of 12 to 17 Years
大体时间：Baseline (Week 0) and Week 52
The BFI is a self-administered questionnaire developed to assess fatigue severity. The BFI has 9 items. BFI- Item 3 assesses the worst level of fatigue during the past 24 hours. Participants report their worst level of fatigue daily, for the previous 24 hours, using a numerical rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine). The weekly average score of BFI item 3 was defined as the mean of the observed daily assessments over the 7-day period. The weekly average score of BFI item 3 ranges from 0 to 10, higher score indicates worst outcome. BFI Item 3 was assessed in the participants with the age group of 12 to 17 years at study entry. Baseline was defined as the mean of the 7 daily assessments of BFI item 3 up to but not including the date of first dose of study treatment. Change from Baseline was calculated as post-Baseline value minus Baseline Value.
Baseline (Week 0) and Week 52
Number of Participants With Any Time Post-Baseline Positive Anti-mepolizumab Antibodies (ADA)
大体时间：Up to Week 52
Serum samples were collected for the determination of anti-mepolizumab antibodies (ADA) using a validated electro-chemiluminescent immunoassay. The assay involved screening, confirmation and titration assays. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample and were also further characterized in the Neutralizing antibody (Nab) assay. A participant was considered positive ADA if they had at least one positive any time post-Baseline ADA result.
Up to Week 52
Number of Participants With Any Time Post-Baseline Positive Neutralizing Antibodies (NAb)
大体时间：Up to Week 52
Blood samples were collected for the determination of positive neutralizing antibodies. NAb test was to be carried out on samples that were positive in the confirmatory binding antibody assay. A participant was to be considered positive for NAb if they had at least one positive any time post-Baseline neutralizing antibody result.
Up to Week 52
Ratio to Baseline in Blood Eosinophil Count
大体时间：Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Blood samples were collected to measure eosinophil count. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Baseline was defined as the latest blood eosinophil value measured by the central laboratory prior to the first dose of study treatment.
Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Plasma Concentrations of Mepolizumab
大体时间：Pre-dose at Weeks 4 and 24; Week 52
Blood samples were collected at the indicated time points for pharmacokinetic analysis of Mepolizumab.
Pre-dose at Weeks 4 and 24; Week 52

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

GlaxoSmithKline

调查人员

  • 研究主任：GSK Clinical Trials、GlaxoSmithKline

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)

2022年7月14日

初级完成 (实际的)

2025年10月28日

研究完成 (实际的)

2025年10月28日

研究注册日期

首次提交

2021年7月7日

首先提交符合 QC 标准的

2021年7月7日

首次发布 (实际的)

2021年7月16日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年7月1日

最后验证

2026年7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

  • 215360

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

本研究的 IPD 将通过临床研究数据请求网站提供。

IPD 共享时间框架

IPD 将在发布主要终点、关键次要终点和研究安全数据的结果后 6 个月内提供。

IPD 共享访问标准

在提交研究提案并获得独立审查小组的批准以及数据共享协议到位后，才提供访问权限。 最初提供 12 个月的访问权限，但在有正当理由的情况下可以再延长 12 个月。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

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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