Recruiting
Phase 2

TAK-411

Sponsor:

Takeda

Code:

NCT06798012

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TAK-411

Study Details

Brief summary:

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.

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Study ID

NCT06798012

Start date

May 14, 2025

Status verified date

Apr, 2026

Completion date

Jun 8, 2028

Anticipated

Primary completion date

Dec 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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).

Interventions

TAK-411

TAK-411 IV infusion.

Primary outcome measure

  • Number of Participants With Improvement in Functional Ability at Week 24 [ Time Frame: At Week 24 ]

Central Contacts and Locations

Central contacts

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Principal Investigator:

Dominic Ferrey

California Pacific Medical Center

Recruiting

San Francisco, California, United States, 94109

Contacts

Principal Investigator:

Liberty Jenkins

UF Health Neurology - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Principal Investigator:

Michael Pulley

Visionary Investigators Network

Recruiting

Miami, Florida, United States, 33133

Contacts

Principal Investigator:

Andrew Lerman

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

Kathleen Murray

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Principal Investigator:

Christina Nicole Fournier

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Fernanda Wajnsztajn Yungher

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Marcus Pinto

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

Recruiting

Columbia, Missouri, United States, 65212-0001

Contacts

Principal Investigator:

William Arnold

The Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Charles Roach

Penn Blood Disorders Program - Hospital of The University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Chafic Karam

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Principal Investigator:

Michael Weiss

More Information

Sponsor

Takeda

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Drug Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Takeda on 2026-04-23.