此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

对患有慢性炎症性脱髓鞘性多利吡啶肌病（CIDP）的成年人的TAK-411研究 (CASCA)

2026年10月30日 更新者：Takeda

第2阶段的开放标签，概念验证研究，以研究TAK-411在患有慢性炎症性脱髓鞘性多吡啶肌病变的成年受试者中的功效，安全性和耐受性（CASCA研究）

CIDP is an autoimmune disease. This means that the body's germ fighting (immune) system attacks itself. In CIDP, the immune system attacks the protective covering around the nerves called myelin. Over time, these nerves lose their ability to send signals to the muscles in the body. This leads to muscle weakness and loss of sensation in arms and legs among other symptoms. Participants with CIDP can be treated with a protein called immunoglobulin (or IG).

TAK-411 is a special type of immune globulin G (hsIgG) that has been chemically changed. It is made from IG that comes from human plasma. This study will test if TAK-411 can decrease inflammation and improve symptoms of CIDP.

The main aim of this study is to check how TAK-411 affects the physical functioning of adults with CIDP when compared with results of the placebo group of a historical trial.

Participants may be treated with TAK-411 for up to 1 year (51 weeks) and will be followed up for 3 weeks after last dose.

During the study, participants may visit their study clinic up to approximately 21 times.

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)

36

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。

学习联系方式

学习地点

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4Z6
        • 招聘中
        • University of Calgary
        • 接触：
        • 首席研究员：
          • Christopher White
    • Ontario
      • Toronto、Ontario、加拿大、M5G 2C4
        • 招聘中
        • University Health Network
        • 接触：
        • 首席研究员：
          • Hans Katzberg
  • 哥伦比亚
      • Bogotá、哥伦比亚、111711
      • Bucaramanga、哥伦比亚、680001
        • 招聘中
        • Fundacion Oftalmologica de Santander - FOSCAL
        • 接触：
        • 首席研究员：
          • Ivan Peña
    • Antioquia
      • Medellín、Antioquia、哥伦比亚、50021
        • 招聘中
        • Neuro ClinicaS.A.S
        • 接触：
        • 首席研究员：
          • Juan Marcos Solano Atehortua
    • D.C.
      • Bogotá、D.C.、哥伦比亚
        • 招聘中
        • Hospital Universitario San Ignacio
        • 接触：
        • 首席研究员：
          • Alba Lucia Marentes Cubillos
    • Valle del Cauca Department
      • Cali、Valle del Cauca Department、哥伦比亚、760032
        • 招聘中
        • Fundacion Valle del Lili
        • 接触：
        • 首席研究员：
          • Francisco Arias Mora
  • 美国
    • California
      • La Jolla、California、美国、92093
        • 招聘中
        • University of California San Diego
        • 接触：
        • 首席研究员：
          • Dominic Ferrey
      • San Francisco、California、美国、94109
        • 招聘中
        • California Pacific Medical Center
        • 接触：
        • 首席研究员：
          • Liberty Jenkins
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20017
        • 招聘中
        • MedStar Georgetown University Hospital
        • 接触：
        • 首席研究员：
          • Noushin Jazebi
    • Florida
      • Jacksonville、Florida、美国、32209
        • 招聘中
        • UF Health Neurology - Jacksonville
        • 接触：
        • 首席研究员：
          • Michael Pulley
      • Miami、Florida、美国、33133
        • 招聘中
        • Visionary Investigators Network
        • 首席研究员：
          • Andrew Lerman
        • 接触：
      • Rockledge、Florida、美国、32955
        • 招聘中
        • Knight Neurology
        • 首席研究员：
          • Vaibhav Shah
        • 接触：
      • Tampa、Florida、美国、33612
        • 招聘中
        • University of South Florida
        • 首席研究员：
          • Kathleen Murray
        • 接触：
    • Georgia
      • Atlanta、Georgia、美国、30322
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • 招聘中
        • Beth Israel Deaconess Medical Center
        • 首席研究员：
          • Fernanda Wajnsztajn Yungher
        • 接触：
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • 招聘中
        • Mayo Clinic Rochester
        • 接触：
        • 首席研究员：
          • Marcus Pinto
    • Missouri
      • Columbia、Missouri、美国、65212-0001
        • 招聘中
        • The Curators of the University of Missouri on behalf of University of Missouri Health Care
        • 首席研究员：
          • William Arnold
        • 接触：
      • St Louis、Missouri、美国、63110
        • 招聘中
        • The Washington University
        • 接触：
        • 首席研究员：
          • Charles Roach
    • North Carolina
      • Raleigh、North Carolina、美国、27607
        • 招聘中
        • Velocity Clinical Research - Raleigh
        • 首席研究员：
          • Timothy Ryan
        • 接触：
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • 招聘中
        • Penn Blood Disorders Program - Hospital of The University of Pennsylvania
        • 首席研究员：
          • Chafic Karam
        • 接触：
    • Washington
      • Seattle、Washington、美国、98195
        • 招聘中
        • University of Washington
        • 接触：
        • 首席研究员：
          • Michael Weiss

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

Key Inclusion Criteria

  1. The participant is at least 18 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).

  2. The participant has a body weight of less than or equal to (<=) 150 kilogram (kg).

  3. The participant has a documented diagnosis of typical CIDP, as confirmed by a neurologist specializing/experienced in neuromuscular diseases and consistent with the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021 criteria.

  4. The participant has responded to IgG treatment in the past (documented partial or complete resolution of neurological symptoms and deficits).

  5. The participant has had disease activation within 24 months before screening, as documented in medical records and in the opinion of the investigator, defined as one of the following:

    1. Clinically meaningful deterioration of symptoms on interruption or dose reduction of IgG treatment.
    2. Clinically meaningful deterioration of symptoms requiring IgG treatment dose increase with subsequent clinical improvement.
    3. Clinically meaningful deterioration of symptoms at the end of IgG treatment dose interval with improvement after next dose administration.

  6. The participant is on a stable dose of immunoglobulin treatment intravenously (IGIV) treatment, (within the dose range of 0.4 to 2.4 grams per kilogram [g/kg] every 2 to 6 weeks [inclusive]). A stable dose is defined as no change greater than 10 percentage (%) in frequency or dose of IGIV therapy within the 3 months before and throughout screening.

  7. The participant has an INCAT score between 0 and 7 (inclusive) at screening.

Key Exclusion Criteria

  1. The participant has a documented diagnosis of a CIDP variant per EAN/PNS 2021 criteria.

  2. The participant has any neuropathy of other causes, including the following:

    1. Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy, Charcot-Marie-Tooth disease, and hereditary sensory and autonomic neuropathies.
    2. Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria, systemic lupus erythematosus, POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) syndrome, osteosclerotic myeloma, diabetic and nondiabetic lumbosacral radiculoplexus neuropathy, lymphoma, amyloidosis.
    3. Multifocal motor neuropathy.
    4. Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy.
    5. Diabetic peripheral neuropathy.

  3. The participant has any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or that may interfere with assessment of CIDP or outcome measures, including (but not limited to) multiple sclerosis, arthritis, stroke, and Parkinson's disease.

  4. The participant is required to take or has taken either of the following for treatment of CIDP:

    1. Immunomodulatory/immunosuppressive agents (except IGIV) that include, but are not limited to, complement inhibitors, efgartigimod, and chemotherapeutic drugs, within 3 months or 5 half-lives, whichever is longer, of screening.
    2. B-cell affecting biologics (e.g. rituximab) within 6 months of screening.

    Note: Participants on a long-term, stable dosing regimen of certain immunomodulatory agents (eg, hydroxychloroquine) for any disease other than CIDP may be eligible, provided the dose regimen has been stable for 3 months before screening and is expected to remain stable throughout the study.

  5. The participant has undergone plasma exchange within 3 months of screening.

  6. The participant has a history of malignancy with less than 2 years of complete remission before screening, or active malignancy requiring chemotherapy and/or radiotherapy.

    Note: Participants with adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or stable prostate cancer not requiring treatment are eligible.

  7. The participant has experienced deep vein thrombosis or arterial thromboembolic events (example, cerebrovascular accident, pulmonary embolism) within 12 months of screening.

  8. The participant has any medical condition, laboratory finding, or physical examination finding that precludes participation or with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the study or place the participant at undue medical risk.

  9. The participant has participated in another clinical study involving an IP or investigational device within 30 days before screening or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.

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：TAK-411

Participants will receive TAK-411 400 milligrams per kilogram (mg/kg), IV infusion as an induction dose on Day 1 of initial treatment period. The induction dose may be repeated once after 3 weeks if participants exhibit no clinical change. Thereafter, participants will receive TAK-411 200 mg/kg, IV infusion every 3 weeks for a total of 24 weeks (initial treatment period), followed by an optional additional 27 weeks (extended treatment period).
生物：TAK-411

TAK-411 IV infusion.

其他名称：
  • 高溶解的免疫球蛋白G

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 With Improvement in Functional Ability at Week 24
大体时间：At Week 24

Improvement in functional ability is defined as decrease of >=1 point in INCAT score at Week 24 compared with baseline (last assessment before first investigational product [IP] administration on Day 1). INCAT disability scale consists of upper and lower extremity components, which are scored based on a participant's level of impairment/disability in their arms and legs, respectively. Each component is scored from 0 to 5 points, which are summed for an overall INCAT disability score ranging from 0 to 10 points, where a score of 0 indicates no signs of disability (example, no upper limb problems and walking not affected) and a score of 10 indicates most severe disability (example, inability to move either arm for any purposeful movement and restricted to a wheelchair, unable to stand and walk a few steps with help). Adjusted INCAT disability score remains identical to INCAT disability score, except that changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded.
At Week 24

次要结果测量

结果测量
措施说明
大体时间
患有治疗效果不良事件（TEAE）的参与者数量
大体时间：从学习开始，药物管理到54周
从学习开始，药物管理到54周
由于TAK-411相关的茶水，输液中断，中断和输液率的参与者数量降低
大体时间：从学习开始，药物管理到54周
从学习开始，药物管理到54周
抗宿主细胞蛋白（HCP），β-1,4-半乳糖基转移酶（B4GALT1）和alpha-2,6-溶解酶（ST6GAL1）的参与者数量
大体时间：最多54周
最多54周
Number of Participants With Improvement in Functional Ability at Weeks 12 and 54
大体时间：At 12 and 54 weeks

Improvement in functional ability is defined as decrease of >=1 point in the adjusted INCAT score at 12 and 54 weeks compared with baseline (last assessment before first IP administration on Day 1). INCAT disability scale consists of upper and lower extremity components, which are scored based on a participant's level of impairment/disability in their arms and legs, respectively. Each component is scored from 0 to 5 points, which are summed for an overall INCAT disability score ranging from 0 to 10 points, where a score of 0 indicates no signs of disability (example, no upper limb problems and walking not affected) and a score of 10 indicates most severe disability (example, inability to move either arm for any purposeful movement and restricted to a wheelchair, unable to stand and walk a few steps with help). Adjusted INCAT disability score remains identical to INCAT disability score, except that changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded.
At 12 and 54 weeks
Change From Baseline in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score
大体时间：Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks

INCAT disability scale consists of upper and lower extremity components, which are scored based on a participant's level of impairment/disability in their arms and legs, respectively. Each component is scored from 0 to 5 points, which are summed for an overall INCAT disability score ranging from 0 to 10 points, where a score of 0 indicates no signs of disability (example, no upper limb problems and walking not affected) and a score of 10 indicates most severe disability (example, inability to move either arm for any purposeful movement and restricted to a wheelchair, unable to stand and walk a few steps with help). Adjusted INCAT disability score remains identical to INCAT disability score, except that changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded.
Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks
Change From Screening in the Adjusted INCAT Score
大体时间：Screening, at 12, 24 and 54 weeks

INCAT disability scale consists of upper and lower extremity components, which are scored based on a participant's level of impairment/disability in their arms and legs, respectively. Each component is scored from 0 to 5 points, which are summed for an overall INCAT disability score ranging from 0 to 10 points, where a score of 0 indicates no signs of disability (example, no upper limb problems and walking not affected) and a score of 10 indicates most severe disability (example, inability to move either arm for any purposeful movement and restricted to a wheelchair, unable to stand and walk a few steps with help). Adjusted INCAT disability score remains identical to INCAT disability score, except that changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded.
Screening, at 12, 24 and 54 weeks
Number of Participants With Improvement in Functional Ability on Inflammatory Rasch-built Overall Disability Scale (I-RODS) Score
大体时间：At 12, 24 and 54 weeks

Improvement in functional ability defined as increase of greater than or equal to (>=) 4 points in the raw summed I-RODS score at 12, 24, and 54 weeks compared with baseline. I-RODS is a validated, participants-reported, linearly weighted overall disability scale that was specifically designed to capture current activity and social participation limitations in participants with immune-mediated peripheral neuropathies including CIDP. I-RODS comprises 24 items for which participants are asked to rate their functioning related to a variety of everyday tasks at the moment of completion. The participant assigns a score between 0 and 2 to each item as follows:0 (impossible to perform),1 (performed with difficulty), 2 (easily performed) with a lower score indicating more severe activity and social participation limitations. A total I-RODS score of 0 (complete disability) to 48 (no disability) is tabulated by totalling the 24-item responses where higher score represents better outcomes.
At 12, 24 and 54 weeks
Change From Baseline in I-RODS Score
大体时间：Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks

The I-RODS is a validated, participants-reported, linearly weighted overall disability scale that was specifically designed to capture current activity and social participation limitations in participants with immune-mediated peripheral neuropathies including CIDP. The I-RODS comprises 24 items for which participants are asked to rate their functioning related to a variety of everyday tasks at the moment of completion. The participant assigns a score between 0 and 2 to each item as follows: 0 (impossible to perform), 1 (performed with difficulty), 2 (easily performed) with a lower score indicating more severe activity and social participation limitations. A total I-RODS score of 0 (complete disability) to 48 (no disability) is tabulated by totalling the 24-item responses where higher score represents better outcomes.
Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks
Change From Screening in I-RODS Score
大体时间：Screening, at 12, 24 and 54 weeks

The I-RODS is a validated, participants-reported, linearly weighted overall disability scale that was specifically designed to capture current activity and social participation limitations in participants with immune-mediated peripheral neuropathies including CIDP. The I-RODS comprises 24 items for which participants are asked to rate their functioning related to a variety of everyday tasks at the moment of completion. The participant assigns a score between 0 and 2 to each item as follows: 0 (impossible to perform), 1 (performed with difficulty), 2 (easily performed) with a lower score indicating more severe activity and social participation limitations. A total I-RODS score of 0 (complete disability) to 48 (no disability) is tabulated by totalling the 24-item responses where higher score represents better outcomes.
Screening, at 12, 24 and 54 weeks
Change From Baseline in Medical Research Council Sum Score (MRC-SS)
大体时间：Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks

The MRC-SS is used clinician-reported measure of muscle strength. Assessments are conducted bilaterally on six muscle groups: upper arm abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and foot dorsal flexors. Each muscle is rated from 0 to 5, where 0 indicates no visible contraction and 5 indicates normal strength. The scores are summed to obtain the MRC-SS, which ranges from 0 (quadriplegic) to 60 (normal strength).
Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks
Change From Screening in MRC-SS
大体时间：Screening, at 12, 24 and 54 weeks

The MRC-SS is used clinician-reported measure of muscle strength. Assessments are conducted bilaterally on six muscle groups: upper arm abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and foot dorsal flexors. Each muscle is rated from 0 to 5, where 0 indicates no visible contraction and 5 indicates normal strength. The scores are summed to obtain the MRC-SS, which ranges from 0 (quadriplegic) to 60 (normal strength).
Screening, at 12, 24 and 54 weeks
Change From Baseline in Bilateral Hand Grip Strength
大体时间：Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks

Bilateral hand grip strength assessments will be performed by prescribing physicians or qualified designees using the Martin Vigorimeter, measuring strength in kilopascals (kPa) ranging from 0 to 160 kPa.
Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks
Change From Screening in Bilateral Grip Strength
大体时间：Screening, at 12, 24 and 54 weeks

Bilateral hand grip strength assessments will be performed by prescribing physicians or qualified designees using the Martin Vigorimeter, measuring strength in kPa ranging from 0 to 160 kPa.
Screening, at 12, 24 and 54 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

Takeda

调查人员

  • 研究主任：Study Director、Takeda

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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5月14日

初级完成 (估计的)

2027年12月2日

研究完成 (估计的)

2028年6月8日

研究注册日期

首次提交

2025年1月23日

首先提交符合 QC 标准的

2025年1月23日

首次发布 (实际的)

2025年1月29日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月30日

最后验证

2026年10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

  • TAK-411-2001

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

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD 共享访问标准

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

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.

订阅