NCT06798012RecruitingPhase 2
A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
A Phase 2, Open-label, Proof-of-Concept Study to Investigate the Efficacy, Safety, and Tolerability of TAK-411 in Adult Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (The CASCA Study)
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 23 Jan 2025
- Start date
- 14 May 2025
- Primary completion date
- 2 Dec 2027
- Lead sponsor
- Takeda
- NCT number
- NCT06798012
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 36
- From 14 May 2025 to the primary completion date, 2 Dec 2027
- 22 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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.
Other illness
- 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 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.
- The participant has experienced deep vein thrombosis or arterial thromboembolic events (example, cerebrovascular accident, pulmonary embolism) within 12 months of screening.
Lab values
- 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.
Other
- The participant has a documented diagnosis of a CIDP variant per EAN/PNS 2021 criteria.
- The participant has undergone plasma exchange within 3 months of screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Hospital Universitario San Ignacio Coordinator of this site? Confirm its status | Bogotá | Colombia | Recruiting |
| Universidad del Rosario Coordinator of this site? Confirm its status | Bogotá | Colombia | Recruiting |
| Fundacion Oftalmologica de Santander - FOSCAL Coordinator of this site? Confirm its status | Bucaramanga | Colombia | Recruiting |
| Fundación Valle del Lili Coordinator of this site? Confirm its status | Cali | Colombia | Recruiting |
| Neuro ClinicaS.A.S Coordinator of this site? Confirm its status | Medellín | Colombia | Recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| The Curators of the University of Missouri on behalf of University of Missouri Health Care Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| UF Health Neurology - Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| Visionary Investigators Network Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Penn Blood Disorders Program - Hospital of The University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Velocity Clinical Research - Raleigh Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Knight Neurology Coordinator of this site? Confirm its status | Rockledge | United States | Recruiting |
| California Pacific Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| The Washington University Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| MedStar Georgetown University Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.