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New hope for CIDP: modified immune protein enters human testing

NCT ID NCT06798012

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 study is testing TAK-411, a specially modified immune globulin, in 36 adults with CIDP, an autoimmune disease that attacks nerve insulation and causes muscle weakness. The main goal is to see if TAK-411 improves physical function over 24 weeks compared to historical placebo data. Participants receive infusions for up to a year and are followed for three more weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TAK-411 (a modified immune globulin made from human plasma)
What this could lead to
If successful, TAK-411 could offer a new treatment option to improve physical function and reduce disability in people with CIDP.
What could go wrong
This is an early Phase 2 proof-of-concept study with only 36 participants, so results may not apply to everyone. The trial is open-label, meaning both patients and doctors know the treatment, which can bias results.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic inflammatory demyelinating polyradiculoneuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    20 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • California Pacific Medical Center

    RECRUITING

    San Francisco, California, 94109, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Fundacion Oftalmologica de Santander - FOSCAL

    NOT_YET_RECRUITING

    Bucaramanga, 680001, Colombia

  • Fundacion Valle del Lili

    NOT_YET_RECRUITING

    Cali, Valle del Cauca Department, 760032, Colombia

  • Hospital Universitario San Ignacio

    NOT_YET_RECRUITING

    Bogotá, D.C., Colombia

  • Houston Methodist Research Institute

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Neuro ClinicaS.A.S

    NOT_YET_RECRUITING

    Medellín, Antioquia, 50021, Colombia

  • Penn Blood Disorders Program - Hospital of The University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • The Curators of the University of Missouri on behalf of University of Missouri Health Care

    RECRUITING

    Columbia, Missouri, 65212-0001, United States

  • The Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

  • UF Health Neurology - Jacksonville

    RECRUITING

    Jacksonville, Florida, 32209, United States

  • Universidad del Rosario

    NOT_YET_RECRUITING

    Bogotá, 111711, Colombia

  • University Health Network

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • University of Calgary

    NOT_YET_RECRUITING

    Calgary, Alberta, T2N 4Z6, Canada

  • University of California San Diego

    RECRUITING

    La Jolla, California, 92093, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33612, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • Visionary Investigators Network

    RECRUITING

    Miami, Florida, 33133, United States

    Contact Email: •••••@•••••

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