A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

NCT06798012 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TAK-411-2001
• Study Type: interventional
• Target: 36
• Locations: 3 countries
• Sites: 20

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)

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Improvement in Functional Ability 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

Secondary Outcomes (13)

• Number of Participants With Improvement in Functional Ability at Weeks 12 and 54

  At 12 and 54 weeks

• Change From Baseline in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score

  Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks

• Change From Screening in the Adjusted INCAT Score

  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

  At 12, 24 and 54 weeks

• Change From Baseline in I-RODS Score

  Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks

Study Arms (1)

TAK-411

EXPERIMENTAL

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).

Biological: TAK-411

Interventions

TAK-411 BIOLOGICAL

TAK-411 IV infusion.

Also known as: Hypersialylated Immune Globulin G

TAK-411

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant is at least 18 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
• The participant has a body weight of less than or equal to (\<=) 150 kilogram (kg).
• 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.
• The participant has responded to IgG treatment in the past (documented partial or complete resolution of neurological symptoms and deficits).
• 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:
• Clinically meaningful deterioration of symptoms on interruption or dose reduction of IgG treatment.
• Clinically meaningful deterioration of symptoms requiring IgG treatment dose increase with subsequent clinical improvement.
• Clinically meaningful deterioration of symptoms at the end of IgG treatment dose interval with improvement after next dose administration.
• 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.
• The participant has an INCAT score between 0 and 7 (inclusive) at screening.

You may not qualify if:

• The participant has a documented diagnosis of a CIDP variant per EAN/PNS 2021 criteria.
• The participant has any neuropathy of other causes, including the following:
• Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy, Charcot-Marie-Tooth disease, and hereditary sensory and autonomic neuropathies.
• 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.
• Multifocal motor neuropathy.
• Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy.
• Diabetic peripheral neuropathy.
• 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.
• The participant is required to take or has taken either of the following for treatment of CIDP:
• 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.
• 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.
• The participant has undergone plasma exchange within 3 months of screening.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (20)

University of California San Diego

La Jolla, California, 92093, United States

RECRUITING

California Pacific Medical Center

San Francisco, California, 94109, United States

RECRUITING

UF Health Neurology - Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

Visionary Investigators Network

Miami, Florida, 33133, United States

RECRUITING

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

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

Columbia, Missouri, 65212-0001, United States

RECRUITING

The Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Penn Blood Disorders Program - Hospital of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Houston Methodist Research Institute

Houston, Texas, 77030, United States

NOT YET RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

NOT YET RECRUITING

University Health Network

Toronto, Ontario, M5G 2C4, Canada

NOT YET RECRUITING

Neuro ClinicaS.A.S

Medellín, Antioquia, 50021, Colombia

NOT YET RECRUITING

Hospital Universitario San Ignacio

Bogotá, D.C., Colombia

NOT YET RECRUITING

Fundacion Valle del Lili

Cali, Valle del Cauca Department, 760032, Colombia

NOT YET RECRUITING

Universidad del Rosario

Bogotá, 111711, Colombia

NOT YET RECRUITING

Fundacion Oftalmologica de Santander - FOSCAL

Bucaramanga, 680001, Colombia

NOT YET RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): December 2, 2027
• Study Completion (Estimated): June 8, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: 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.

Locations

US (13); CO (5); CA (2)