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TAK-411 · 1 trial · 1 indication
Improvement in functional ability is defined as decrease of \>=1 point in INCAT score at Week 24 compared with baseline (last assessment before first investigational product \[IP\] administration on Day 1). INCAT disability scale consists of upper and lower extremity components, which are scored based on a participant's level of impairment/disability in their arms and legs, respectively. Each component is scored from 0 to 5 points, which are summed for an overall INCAT disability score ranging from 0 to 10 points, where a score of 0 indicates no signs of disability (example, no upper limb problems and walking not affected) and a score of 10 indicates most severe disability (example, inability to move either arm for any purposeful movement and restricted to a wheelchair, unable to stand and walk a few steps with help). Adjusted INCAT disability score remains identical to INCAT disability score, except that changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded.
| Arm | Type | Description |
|---|---|---|
| TAK-411 | EXPERIMENTAL | Participants will receive TAK-411 400 milligrams per kilogram (mg/kg), IV infusion as an induction dose on Day 1 of initial treatment period. The induction dose may be repeated once after 3 weeks if participants exhibit no clinical change. Thereafter, participants will receive TAK-411 200 mg/kg, IV infusion every 3 weeks for a total of 24 weeks (initial treatment period), followed by an optional additional 27 weeks (extended treatment period). |
| Name | Type | Description |
|---|---|---|
| TAK-411 | BIOLOGICAL | TAK-411 IV infusion. |
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 confirme...
TAK-411 is an investigational monoclonal antibody being studied for the treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), a neurological disorder. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
TAK-411 is being developed by Takeda Pharmaceutical Company Limited, a biopharmaceutical company traded on the stock exchange under the ticker symbol TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with CIDP.
TAK-411 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The ongoing Phase 2 trial is recruiting participants to further assess its potential as a treatment for CIDP.
TAK-411 is being evaluated in a Phase 2 clinical trial with the identifier NCT06798012, titled 'A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)'. This trial is currently recruiting participants in the United States, Canada, and Colombia, with an enrollment target of 36 adults aged 18 years and older.
Yes, TAK-411 is a monoclonal antibody, a type of biologic drug designed to target specific proteins in the body. It is being investigated for its potential role in treating Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), a condition affecting the peripheral nervous system.