TAK-411-2001 (CASCA)

Evaluating the Effects of an Investigational Medication on CIDP

Recruiting
18 years or above
All
Phase 2
36 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
  • Age: 18 years or above
  • Gender: All

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.

This study investigates chronic inflammatory demyelinating polyneuropathy (CIDP).

The study evaluates the effects of an investigational medication on the physical functioning of adults with CIDP.

  • Who can participate: Adults aged 18 and older with a body weight of 150 kg or less and a confirmed diagnosis of typical CIDP may participate. Participants must have responded to IgG treatment in the past and have had disease activation within 24 months before screening.
  • Study details: Participants may receive the investigational medication, which is compared to results from a historical trial's placebo group. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
  • Study timelines and visits: The study will last 51 weeks. The study requires 21 visits.
Updated on 23 Apr 2026. Study ID: 25-0301

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