Last updated 45 days ago
A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
36 patients around the world
Available in Colombia, United States
Takeda
5Research sites
36Patients around the world
This study is for people with
Polyneuropathy
Chronic inflammatory demyelinating polyneuropathy - CIDP
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 18 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, defined as no change greater than 10 percentage (%) in frequency or dose of IGIV therapy within the 12 weeks before and throughout screening within the dose range of 0.4 to 2.4 grams per kilogram (g/kg) every 2 to 6 weeks (inclusive).The participant has an INCAT score greater than 2 at screening.
- 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 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 multiple sclerosis, arthritis, stroke, and Parkinson's disease.The participant is required to take or has taken immunomodulatory/immunosuppressive agents that include, but are not limited to, complement inhibitors, rituximab, efgartigimod, and chemotherapeutic drugs, within 6 months of screening.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.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 within 12 months of screening.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.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.
Sites
Neuro Clínica IPS
Clínica Reina Sofia
Hospital Universitario San Ignacio - Bogotá
Fundación Oftalmológica de Santander FOSCAL
Fundación Valle del Lili
StudyCASCA
SponsorTakeda
Study typeInterventional
Conditions
Chronic inflammatory demyelinating polyneuropathy - CIDP
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06798012
