A Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of TAK-771 for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) in Japanese Subjects

ishizawa Atsushi0 sites26 target enrollmentOctober 14, 2021

ConditionsChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MM

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MM
Sponsor: ishizawa Atsushi
Enrollment: 26
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 14, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

ishizawa Atsushi

Eligibility Criteria

Inclusion Criteria

•1\. Be a Japanese person.
•2\. The participant is male or female \>\=18 years old at the time of screening.
•3\. Participant has a documented diagnosis of definite or probable CIDP (focal atypical CIDP and pure sensory atypical CIDP will be excluded) or definite or probable MMN, as confirmed by a neurologist specializing/experienced in neuromuscular diseases to be consistent with the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) 2010 criteria.
•4\. Participant has responded to IgG treatment in the past (partial or complete resolution of neurological symptoms and deficits), and must currently be on stable doses of intravenous immunoglobulin(IVIG) treatment within the dose range equivalent to a cumulative monthly dose of 0\.4 to 2\.4 g/kg BW (inclusive) administered intravenously for at least 12 weeks prior to screening. The dosing interval of IVIG treatment must be between 2 and 6 weeks (inclusive). Variations in the dosing interval of up to plus/minus 7 days or monthly dose amount of up to \+or\-20% between participant's pre\-study IgG infusions are within acceptable limits.
•5\. CIDP participants only \- INCAT disability score between 0 and 7 (inclusive). Participants with INCAT scores of 0, 1 (whether from upper or lower extremities), or 2 (if at least 1 point is from an upper extremity) at screening and/or baseline will be required to have a history of significant disability as defined by an INCAT disability score of 2 (must be exclusively from the lower extremities) or greater documented in the medical record. Participants will be eligible if one of the below eligibility criteria are met:
•a. Screening and Baseline INCAT disability score between 3 and 7 inclusive.
•b. Screening and/or Baseline INCAT disability score of 2 (both points are from lower extremities)
•c. Screening and/or Baseline INCAT disability score of 2 (both points are not from lower extremities) AND has at least a score of 2 or greater documented in the medical record prior to screening. If a score was greater than 2 documented in the medical record prior to screening at least 2 points must be from lower extremities.
•d. Screening and/or Baseline INCAT disability score of 0 or 1 AND has at least a score of 2 or greater (both from lower extremities) documented in the medical record prior to screening, at least 2 points must be from lower extremities.
•6\. If female of childbearing potential, the participant must have a negative pregnancy test at screening and agree to employ a highly effective contraceptive measure throughout the course of the study and for at least 30 days after the last administration of IP.

Exclusion Criteria

•CIDP patients
•1\. Participants with focal atypical CIDP or pure sensory atypical CIDP or multifocal acquired demyelinating sensory and motor neuropathy (MADASAM).
•2\. Participants with any neuropathy of other causes, including:
•a. Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (HSMN) (Charcot\-Marie\-Tooth \[CMT] disease), and hereditary sensory and autonomic neuropathies (HSANs).
•b. 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 non\-diabetic lumbosacral radiculoplexus neuropathy, lymphoma, and amyloidosis.
•c. Multifocal motor neuropathy (MMN).
•d. Drug\-, biologic\-, chemotherapy\-, or toxin\-induced peripheral neuropathy.
•MMN patients
•3\. Participant with other neuropathies (eg, diabetic, lead, porphyric or vasculitic neuropathy, chronic inflammatory demyelinating polyradiculoneuropathy, Lyme neuroborreliosis, post radiation neuropathy, hereditary neuropathy with liability to pressure palsies, CMT neuropathies, meningeal carcinomatosis).
•CIDP/MMN Patients