이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

만성 염증성 탈수성 탈수성 탈수성 폴리 르디 쿨론 뉴로 병증이있는 성인의 TAK-411에 대한 연구 (CIDP) (CASCA)

2026년 10월 30일 업데이트: Takeda

만성 염증성 탈수성 탈수성 다이 니 엘리 엘리 엘린 링 폴리 르디 쿨론 뉴로 병증이있는 성인 대상체에서 TAK-411의 효능, 안전성 및 내약성을 조사하기위한 2 상, 개방형 개념, 개념 증명 연구 (CASCA 연구).

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

36

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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).
생물학적: TAK-411

TAK-411 IV infusion.

다른 이름들:
  • Hypersiallated 면역 글로불린 G.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Improvement in Functional Ability at Week 24
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
치료 부작용을 가진 참가자 수 (TEAES)
기간: 연구 시작부터 최대 54 주까지
연구 시작부터 최대 54 주까지
TAK-411 관련 차로 인한 주입 중단, 중단 및 주입 속도 감소가있는 참가자 수
기간: 연구 시작부터 최대 54 주까지
연구 시작부터 최대 54 주까지
숙주 세포 단백질에 대한 항체를 가진 참가자 수 (HCP), 베타 -1,4- 갈 락토 실 트랜스퍼 라제 (B4Galt1) 및 알파 -2,6- 시아일 트랜스퍼 라제 (ST6GAL1)
기간: 최대 54 주
최대 54 주
Number of Participants With Improvement in Functional Ability at Weeks 12 and 54
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Takeda

수사관

  • 연구 책임자: Study Director, Takeda

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 5월 14일

기본 완료 (추정된)

2027년 12월 2일

연구 완료 (추정된)

2028년 6월 8일

연구 등록 날짜

최초 제출

2025년 1월 23일

QC 기준을 충족하는 최초 제출

2025년 1월 23일

처음 게시됨 (실제)

2025년 1월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 30일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TAK-411-2001

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다