Actively Recruiting
A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Led by Takeda · Updated on 2026-04-23
36
Participants Needed
20
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age at the time of informed consent
- Body weight less than or equal to 150 kilograms
- Documented diagnosis of typical CIDP confirmed by a neurologist experienced in neuromuscular diseases consistent with EAN/PNS 2021 criteria
- Previous response to immunoglobulin treatment with partial or complete symptom resolution
- Disease activation within 24 months before screening as shown by meaningful symptom deterioration requiring immunoglobulin dose changes or interruption
- Stable dose of intravenous immunoglobulin treatment between 0.4 to 2.4 g/kg every 2 to 6 weeks without more than 10% change in dose or frequency for at least 3 months before and during screening
- INCAT score between 0 and 7 inclusive at screening
You will not qualify if you...
- Diagnosis of a CIDP variant according to EAN/PNS 2021 criteria
- Neuropathies caused by other conditions such as hereditary neuropathies, infections, systemic diseases, multifocal motor neuropathy, drug- or toxin-induced neuropathy, and diabetic peripheral neuropathy
- Chronic or debilitating diseases or central nervous disorders causing neurological symptoms or interfering with CIDP assessment, including multiple sclerosis, arthritis, stroke, and Parkinson's disease
- Use of immunomodulatory or immunosuppressive agents (except intravenous immunoglobulin) within 3 months or 5 half-lives before screening
- Use of B-cell affecting biologics (e.g., rituximab) within 6 months before screening
- Plasma exchange within 3 months before screening
- History of malignancy with less than 2 years complete remission or active malignancy needing chemotherapy or radiotherapy
- Deep vein thrombosis or arterial thromboembolic events within 12 months before screening
- Any medical condition, laboratory, or physical finding that may interfere with study participation or pose medical risk
- Participation in another clinical trial involving investigational products or devices within 30 days before screening or planned during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
University of California San Diego
La Jolla, California, United States, 92093
Actively Recruiting
2
California Pacific Medical Center
San Francisco, California, United States, 94109
Actively Recruiting
3
UF Health Neurology - Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
4
Visionary Investigators Network
Miami, Florida, United States, 33133
Actively Recruiting
5
University of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
6
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
The Curators of the University of Missouri on behalf of University of Missouri Health Care
Columbia, Missouri, United States, 65212-0001
Actively Recruiting
10
The Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
11
Penn Blood Disorders Program - Hospital of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
Houston Methodist Research Institute
Houston, Texas, United States, 77030
Not Yet Recruiting
13
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
14
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
Not Yet Recruiting
15
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Not Yet Recruiting
16
Neuro ClinicaS.A.S
Medellín, Antioquia, Colombia, 50021
Not Yet Recruiting
17
Hospital Universitario San Ignacio
Bogotá, D.C., Colombia
Not Yet Recruiting
18
Fundacion Valle del Lili
Cali, Valle del Cauca Department, Colombia, 760032
Not Yet Recruiting
19
Universidad del Rosario
Bogotá, Colombia, 111711
Not Yet Recruiting
20
Fundacion Oftalmologica de Santander - FOSCAL
Bucaramanga, Colombia, 680001
Not Yet Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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