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Testing TAK-411 for treating CIDP in adults

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)

Phase 2 Interventional Takeda · NCT06798012

This study is testing a new treatment called TAK-411 to see if it can help adults with CIDP feel better and improve their physical abilities.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment36 (estimated)
Ages18 Years and up
SexAll
SponsorTakeda Industry-sponsored
Drugs / interventionsrituximab, chemotherapy
Locations20 sites (La Jolla, California and 19 other locations)
Trial IDNCT06798012 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of TAK-411, a modified immune globulin G, on adults diagnosed with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). The study aims to determine whether TAK-411 can reduce inflammation and improve physical functioning compared to a historical placebo group. Participants will receive treatment for up to 51 weeks and will be monitored for an additional 3 weeks post-treatment. The trial includes adults who have previously responded to immunoglobulin therapy and have experienced recent disease activation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a documented diagnosis of typical CIDP who have previously responded to immunoglobulin treatment.

Not a fit: Patients who have not responded to immunoglobulin treatments in the past or have not experienced recent disease activation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from CIDP by alleviating symptoms and enhancing physical function.

How similar studies have performed: Previous studies on immunoglobulin therapies for CIDP have shown positive outcomes, suggesting that this approach may be promising.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria

1. The participant is at least 18 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
2. The participant has a body weight of less than or equal to (\<=) 150 kilogram (kg).
3. 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.
4. The participant has responded to IgG treatment in the past (documented partial or complete resolution of neurological symptoms and deficits).
5. 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:

   1. Clinically meaningful deterioration of symptoms on interruption or dose reduction of IgG treatment.
   2. Clinically meaningful deterioration of symptoms requiring IgG treatment dose increase with subsequent clinical improvement.
   3. Clinically meaningful deterioration of symptoms at the end of IgG treatment dose interval with improvement after next dose administration.
6. 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.
7. The participant has an INCAT score between 0 and 7 (inclusive) at screening.

Key Exclusion Criteria

1. The participant has a documented diagnosis of a CIDP variant per EAN/PNS 2021 criteria.
2. The participant has any neuropathy of other causes, including the following:

   1. Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy, Charcot-Marie-Tooth disease, and hereditary sensory and autonomic neuropathies.
   2. 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.
   3. Multifocal motor neuropathy.
   4. Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy.
   5. Diabetic peripheral neuropathy.
3. 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.
4. The participant is required to take or has taken either of the following for treatment of CIDP:

   1. 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.
   2. 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.
5. The participant has undergone plasma exchange within 3 months of screening.
6. 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.
7. The participant has experienced deep vein thrombosis or arterial thromboembolic events (example, cerebrovascular accident, pulmonary embolism) within 12 months of screening.
8. 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.
9. 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.

Where this trial is running

La Jolla, California and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Inflammatory Demyelinating PolyradiculoneuropathyDrug Therapy
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.