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New treatment option for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Official title A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
ClinicalTrials.gov ID: NCT06798012
What this study is testing
What is TAK-411?
TAK-411 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic inflammatory demyelinating polyradiculoneuropathy (cidp).
Also referred to as Hypersialylated Immune Globulin G.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- CIDP is an autoimmune disease. This means that the body's germ fighting (immune) system attacks itself.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key 1. 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...
- 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...
You likely can't join 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...
- Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria, systemic...
- Multifocal motor neuropathy.
- Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy.
See the full eligibility criteria
- Key 1. 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...
- 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...
- The participant has an INCAT score between 0 and 7 (inclusive) at screening. Key
- 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...
- 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)...
- 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...
- 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...
- 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...
- The participant has experienced deep vein thrombosis or arterial thromboembolic events (example, cerebrovascular accident, pulmonary embolism) 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 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...
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- San Francisco, California, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Columbia, Missouri, United States
- St Louis, Missouri, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Calgary, Alberta, Canada
- Toronto, Ontario, Canada
- Medellín, Antioquia, Colombia
- Bogotá, D.C., Colombia
- Cali, Valle del Cauca Department, Colombia
- Bogotá, Colombia
- Bucaramanga, Colombia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; San Francisco, California, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.