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Studie TAK-411 u dospělých s chronickou zánětlivou demyelinizační polyradikuloneuropatií (CIDP) (CASCA)

30. října 2026 aktualizováno: Takeda

Fáze 2, otevřená značka, studie důkazu konceptu pro zkoumání účinnosti, bezpečnosti a snášenlivosti TAK-411 u dospělých subjektů s chronickou zánětlivou demyelinizační polyradikuloneuropatií (studie CASCA)

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

36

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 4Z6
        • Nábor
        • University of Calgary
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Christopher White
    • Ontario
      • Toronto, Ontario, Kanada, M5G 2C4
        • Nábor
        • University Health Network
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Hans Katzberg
  • Kolumbie
      • Bogotá, Kolumbie, 111711
      • Bucaramanga, Kolumbie, 680001
        • Nábor
        • Fundacion Oftalmologica de Santander - FOSCAL
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Ivan Peña
    • Antioquia
      • Medellín, Antioquia, Kolumbie, 50021
        • Nábor
        • Neuro ClinicaS.A.S
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Juan Marcos Solano Atehortua
    • D.C.
      • Bogotá, D.C., Kolumbie
        • Nábor
        • Hospital Universitario San Ignacio
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Alba Lucia Marentes Cubillos
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Kolumbie, 760032
        • Nábor
        • Fundacion Valle del Lili
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Francisco Arias Mora
  • Spojené státy
    • California
      • La Jolla, California, Spojené státy, 92093
        • Nábor
        • University of California San Diego
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Dominic Ferrey
      • San Francisco, California, Spojené státy, 94109
        • Nábor
        • California Pacific Medical Center
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Liberty Jenkins
    • District of Columbia
      • Washington D.C., District of Columbia, Spojené státy, 20017
        • Nábor
        • MedStar Georgetown University Hospital
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Noushin Jazebi
    • Florida
      • Jacksonville, Florida, Spojené státy, 32209
        • Nábor
        • UF Health Neurology - Jacksonville
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Michael Pulley
      • Miami, Florida, Spojené státy, 33133
        • Nábor
        • Visionary Investigators Network
        • Vrchní vyšetřovatel:
          • Andrew Lerman
        • Kontakt:
      • Rockledge, Florida, Spojené státy, 32955
        • Nábor
        • Knight Neurology
        • Vrchní vyšetřovatel:
          • Vaibhav Shah
        • Kontakt:
      • Tampa, Florida, Spojené státy, 33612
        • Nábor
        • University of South Florida
        • Vrchní vyšetřovatel:
          • Kathleen Murray
        • Kontakt:
    • Georgia
      • Atlanta, Georgia, Spojené státy, 30322
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02215
        • Nábor
        • Beth Israel Deaconess Medical Center
        • Vrchní vyšetřovatel:
          • Fernanda Wajnsztajn Yungher
        • Kontakt:
    • Minnesota
      • Rochester, Minnesota, Spojené státy, 55905
        • Nábor
        • Mayo Clinic Rochester
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Marcus Pinto
    • Missouri
      • Columbia, Missouri, Spojené státy, 65212-0001
        • Nábor
        • The Curators of the University of Missouri on behalf of University of Missouri Health Care
        • Vrchní vyšetřovatel:
          • William Arnold
        • Kontakt:
      • St Louis, Missouri, Spojené státy, 63110
        • Nábor
        • The Washington University
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Charles Roach
    • North Carolina
      • Raleigh, North Carolina, Spojené státy, 27607
        • Nábor
        • Velocity Clinical Research - Raleigh
        • Vrchní vyšetřovatel:
          • Timothy Ryan
        • Kontakt:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Spojené státy, 19104
        • Nábor
        • Penn Blood Disorders Program - Hospital of The University of Pennsylvania
        • Vrchní vyšetřovatel:
          • Chafic Karam
        • Kontakt:
    • Washington
      • Seattle, Washington, Spojené státy, 98195
        • Nábor
        • University of Washington
        • Kontakt:
          • Site Contact
          • Telefonní číslo: 206-598-7688
          • E-mail: mdweiss@uw.edu
        • Vrchní vyšetřovatel:
          • Michael Weiss

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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).
Biologický: TAK-411

TAK-411 IV infusion.

Ostatní jména:
  • Hypersialylovaný imunitní globulin G

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Improvement in Functional Ability at Week 24
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Počet účastníků s nepříznivými událostmi ve vývoji léčby (čaje)
Časové okno: Od začátku studijního léčiva do 54 týdnů
Od začátku studijního léčiva do 54 týdnů
Počet účastníků s přerušením infuze, přerušením a snížením míry infuze v důsledku čaje souvisejících s TAK-411
Časové okno: Od začátku studijního léčiva do 54 týdnů
Od začátku studijního léčiva do 54 týdnů
Počet účastníků s protilátkami proti proteinům hostitelských buněk (HCP), beta-1,4-galaktosyltransferázy (B4galt1) a alfa-2,6-sialyltransferázy (ST6GAL1)
Časové okno: Až 54 týdnů
Až 54 týdnů
Number of Participants With Improvement in Functional Ability at Weeks 12 and 54
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Takeda

Vyšetřovatelé

  • Ředitel studie: Study Director, Takeda

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

14. května 2025

Primární dokončení (Odhadovaný)

2. prosince 2027

Dokončení studie (Odhadovaný)

8. června 2028

Termíny zápisu do studia

První předloženo

23. ledna 2025

První předloženo, které splnilo kritéria kontroly kvality

23. ledna 2025

První zveřejněno (Aktuální)

29. ledna 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. října 2026

Naposledy ověřeno

1. října 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • TAK-411-2001

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Kritéria přístupu pro sdílení IPD

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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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