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评估幼年型银屑病关节炎 (JPsA) 儿科参与者静脉注射 (i.v.) Secukinumab 长达 6 年的药代动力学 (PK)、安全性和耐受性的研究。

2026年11月6日 更新者：Novartis Pharmaceuticals

一项开放标签、多中心研究，旨在评估幼年型银屑病关节炎儿科参与者静脉注射苏金单抗长达 6 年的药代动力学、安全性和耐受性

The purpose of this study is to determine the PK, safety and tolerability of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a multicenter, open-label study with an optional treatment extension period to evaluate pharmacokinetics, safety and tolerability (up to 6 years) of i.v. secukinumab in pediatric patients with JPsA.

研究类型

介入性

注册 (估计的)

20

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

研究联系人备份

  • 姓名：Novartis Pharmaceuticals

学习地点

  • 美国
    • California
      • Loma Linda、California、美国、92354
        • 招聘中
        • Loma Linda University Health
        • 接触：
        • 首席研究员：
          • Wendy De La Pena
    • Florida
      • Gainesville、Florida、美国、32610-8068
        • 招聘中
        • University of Florida
        • 首席研究员：
          • Christian Oliveros
        • 接触：
    • Illinois
      • Chicago、Illinois、美国、60611
        • 招聘中
        • Ann and Robert H Lurie Childs Hosp
        • 首席研究员：
          • Pooja Patel
        • 接触：
    • New York
      • New York、New York、美国、10032
        • 招聘中
        • Col Uni Med Center New York Presby
        • 接触：
        • 首席研究员：
          • Lisa Imundo
    • North Carolina
      • Charlotte、North Carolina、美国、28203
        • 招聘中
        • Levine Childrens Hospital
        • 首席研究员：
          • Sheetal Vora
        • 接触：
    • Ohio
      • Cincinnati、Ohio、美国、45229
        • 招聘中
        • Cincinnati Childrens Hospital
        • 首席研究员：
          • Hermine Brunner
        • 接触：
      • Cleveland、Ohio、美国、44106-5028
        • 招聘中
        • Univ Hosp Cleveland Medical Center
        • 首席研究员：
          • Ezequiel Borgia
        • 接触：
    • Oregon
      • Portland、Oregon、美国、97232
        • 招聘中
        • Legacy Emanuel Research Hosp Portland
        • 首席研究员：
          • Daniel Joseph Kingsbury
        • 接触：
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15224
        • 招聘中
        • Childrens Hosp Pittsburgh UPMC
        • 首席研究员：
          • Margalit Rosenkranz
        • 接触：
    • Texas
      • El Paso、Texas、美国、79902
        • 招聘中
        • Texas Arthritis Center
        • 首席研究员：
          • Sanjay Chabra
        • 接触：
    • Utah
      • Salt Lake City、Utah、美国、84113
        • 招聘中
        • University of Utah
        • 接触：
        • 首席研究员：
          • Peter Chiraseveenuprapund

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

2年 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Key Inclusion Criteria:

  • Participants parent's or legal representative(s) written informed consent and child's assent, if appropriate, must be obtained before any study related activity or assessment is performed. Of note, if the participant reaches age of consent (as per local law) during the study, they will also need to sign the corresponding study ICF (Informed Consent Form).

  • Males and females ≥2 years old to <18 years old at the time of screening.

  • Confirmed diagnosis of JPsA according to the modified International League of Associations for Rheumatology (ILAR) classification criteria that must have occurred at least 6 months prior to screening.

  • Active JPsA disease defined as ≥3 active joints (swollen or if not swollen must be both tender and limited range of motion) at baseline (BSL).

  • Inadequate response (≥1 month) or intolerance to ≥1 Non-Steroidal Anti-Inflammatory Drug (NSAID) at screening.

  • Inadequate response (≥2 months) or intolerance to ≥ 1 Disease Modifying Anti-Rheumatic Drug (DMARD) at screening.

  • Concomitant use of the following second-line agents such as disease-modifying and/or immunosuppressive drugs to treat the JPsA will be allowed:

    • Stable dose of methotrexate (MTX) (maximum of 20 mg/ m2 BSA/ week) for at least 4 weeks prior to the BSL visit, with folic/folinic acid supplementation (according to standard medical practice of the center).
    • Stable dose of an oral corticosteroid (CS) at a prednisone equivalent dose of <0.2 mg/kg/day or up to 10 mg/day maximum, whichever is less, for at least 7 days prior to BSL.
    • Stable dose of no more than one NSAID for at least 1 week prior to BSL.

Key Exclusion Criteria:

  • Participants with body weight less than 10 kg at screening.
  • Use of other investigational drugs within 4 weeks or 5 half-lives of BSL, or until the expected pharmacodynamic effect has returned to BSL, whichever is longer.
  • History of hypersensitivity to study drug or its excipients or to drugs of similar chemical classes.
  • Participants with active inflammatory bowel disease or active uveitis at screening or BSL.
  • Fulfilling diagnostic criteria for any International League of Associations for Rheumatology (ILAR ) juvenile idiopathic arthritis (JIA) category other than JPsA at BSL.
  • Participants treated with prohibited medication
  • Participants taking any non-biologic DMARD at screening except for MTX.
  • Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.

Other inclusion/exclusion criteria may apply

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：Secukinumab

Secukinumab administered intravenously in pediatric participants with JPsA
生物：Secukinumab

Intravenous secukinumab

其他名称：
  • AIN457

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
Maximum concentration on Day 1
大体时间：Pre-infusion and end of infusion (EOI) at Day 1

Maximum concentration of secukinumab on Day 1
Pre-infusion and end of infusion (EOI) at Day 1
Maximum concentration at steady-state (Cmax, ss)
大体时间：Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365

Maximum concentration at steady-state.
Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
Minimum concentration at steady-state (Cmin, ss)
大体时间：Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365

Minimum concentration at steady-state
Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
Area under the concentration-time curve at steady-state (AUCtau, ss)
大体时间：Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365

Area under the concentration-time curve at steady-state during a dosing interval
Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
Average concentration at steady-state (Cavg,ss)
大体时间：Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365

Average concentration at steady-state
Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365

次要结果测量

结果测量
措施说明
大体时间
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Up to Week 20

Number of participants with AEs and SAEs as a measure of safety and tolerability
Up to Week 20
Number of participants with clinically significant changes in clinical laboratory measures and vital signs.
大体时间：Up to Week 20

Number of participants with clinically significant changes in clinical laboratory measures and vital signs as a measure of safety and tolerability
Up to Week 20

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

Novartis Pharmaceuticals

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)

2025年9月24日

初级完成 (估计的)

2029年10月31日

研究完成 (估计的)

2031年3月11日

研究注册日期

首次提交

2024年12月20日

首先提交符合 QC 标准的

2024年12月20日

首次发布 (实际的)

2024年12月27日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月6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

  • CAIN457G22101

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

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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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