Chronic Inflammatory Demyelinating Polyradiculoneuropathy study: TAK-411
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 IV infusion 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
- The study wants to find out if TAK‑411 can reduce inflammation and improve physical function in people with CIDP compared with a historical placebo group.
- Who it's for
- Adults who have been diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
- What's involved
- Participants receive TAK‑411 (or a placebo) for up to 51 weeks and go to the study clinic about 21 times for visits and tests.
- Time commitment
- The study lasts up to 51 weeks of treatment plus a 3‑week follow‑up, with roughly 21 clinic visits.
- 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).
- Clinically meaningful deterioration of symptoms on interruption or dose reduction of IgG treatment.
You likely can't join if
- The participant has a documented diagnosis of a CIDP variant per EAN/PNS 2021 criteria.
- 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.
- Diabetic 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).
- 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]).
- 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.
- 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)...
- 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.
- 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 is enrolling
- La Jolla, California, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Rockledge, 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
- Raleigh, North Carolina, United States
- Philadelphia, Pennsylvania, 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
+ 2 more site(s).
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, but 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?
This study is enrolling now at La Jolla, California, United States; San Francisco, California, United States; Washington D.C., District of Columbia, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Rockledge, Florida, United States and 16 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.