A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN)

NCT05084053 | Active Not Recruiting Phase 3 Results

• 2 other identifiers: TAK-771-3002jRCT2051210110
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 23

Brief Summary

The main aim of the study is to check for side effects from TAK-771, and to check how well TAK-771 controls symptoms in Japanese participants with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) The participants will be treated with TAK-771 for 45 months as a maximum. There will be many clinic visits. The number of visits will depend on the infusion cycles of study drug (every 2, 3, or 4 weeks).

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP); Multifocal Motor Neuropathy (MMN)

Outcome Measures

Primary Outcomes (2)

• Epoch 1: Percentage of Participants With CIDP Who Experienced Relapse

  Relapse was defined as worsening of functional disability defined as an increase of \>=1 point relative to the pre-subcutaneous (pre-SC) treatment baseline score in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability scale was the most widely used assessment tool to measure the functional activity level of participants with CIDP. The INCAT disability scale consisted of upper and lower extremity components, with a maximum of 5 points for the upper extremities (arm disability) and a maximum of 5 points for the lower extremities (leg disability), which were summed for an overall INCAT disability score ranging from 0 to 10 points, where 0 was normal and 10 was severely incapacitated. An adjusted INCAT disability score was the same as the INCAT disability score, with the only exception in the exclusion of changes from 0 (normal) to 1 (minor symptoms) (or vice versa) in upper limb function.

  Epoch 1: Baseline up to 6 months

• Epoch 1: Change From Baseline in Maximum Grip Strength in the More Affected Hand in Participants With MMN

  The Martin Vigorimeter was used to assess grip strength in both hands. The instrument consisted of a compressible rubber ball that was connected to a manometer. When the rubber ball was squeezed, the force of compression was measured in kilopascal (kPa) ranging from 0 to 160 kPa.

  Epoch 1: Baseline up to 6 months

Secondary Outcomes (18)

• Epoch 1 and 2 (6 Months): Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

• Epoch 1 and 2 (6 Months): Number of Participants With Serious Adverse Events (SAEs)

  Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

• Epoch 1 and 2 (6 Months): Number of Participants With Related SAEs and TEAEs

  Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

• Epoch 1 and 2 (6 Months): Number of Participants With Serious and Non-serious Adverse Reactions (ARs) Plus Suspected ARs

  Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

• Epoch 1 and 2 (6 Months): Number of Participants With SAEs and/or TEAEs Associated With Infusions

  Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

Study Arms (2)

Cohort 1: TAK-771 for CIDP Participants

EXPERIMENTAL

TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 2, 3, or 4 weeks.

Drug: TAK-771

Cohort 2: TAK-771 for MMN Participants

EXPERIMENTAL

TAK-771 includes IGI 10% and rHuPH20. Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 2, 3, or 4 weeks.

Drug: TAK-771

Interventions

TAK-771 DRUG

Intervention description; Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20)

Also known as: Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

Cohort 1: TAK-771 for CIDP Participants; Cohort 2: TAK-771 for MMN Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be a Japanese person.
• The participant is male or female \>=18 years old at the time of screening.
• 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.
• 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 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 intravenous immunoglobulin (IVIG) treatment must be between 2 and 6 weeks (inclusive). Variations in the dosing interval of up to ±7 days or monthly dose amount of up to +or-20% between participant's pre-study IgG infusions are within acceptable limits.
• 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:
• Screening and Baseline INCAT disability score between 3 and 7 inclusive.
• Screening and/or Baseline INCAT disability score of 2 (both points are from lower extremities)
• 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.
• 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.
• 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.
• The participant is willing and able to sign an Informed Consent Form (ICF).
• The participant is willing and able to comply with the requirements of the protocol.

You may not qualify if:

• Participants with focal atypical CIDP or pure sensory atypical CIDP or multifocal acquired demyelinating sensory and motor neuropathy (MADASAM).
• Participants with any neuropathy of other causes, including:
• Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (HSMN) (Charcot-Marie-Tooth \[CMT\] disease), and hereditary sensory and autonomic neuropathies (HSANs).
• 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.
• Multifocal motor neuropathy (MMN).
• Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy. MMN patients
• 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
• Participant with immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with high titer antibodies to myelin-associated glycoprotein.
• Participant with presence of prominent sphincter disturbance.
• Participant with any central demyelinating disorders such as multiple sclerosis.
• Participant with any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or may interfere with assessment of endpoint measures, including (but not limited to) arthritis, stroke, Parkinson's disease, and diabetic peripheral neuropathy.
• (Participants with clinically diagnosed diabetes mellitus who do not have diabetic peripheral neuropathy and who have adequate glycemic control with hemoglobin A1c \[HbA1c\] level of \<7.5% at screening will be eligible for the study, provided the electrodiagnostic criteria are consistent with the diagnosis of a definite or probable CIDP consistent with the EFNS/PNS 2010 criteria and the participant agrees to maintain adequate glycemic control.)
• Participant with congestive heart failure (New York Heart Association \[NYHA\] class III/IV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension (defined as diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>160 mmHg).
• Participant with a history of deep vein thrombosis or thromboembolic events (eg, cerebrovascular accident, pulmonary embolism) within 12 months prior to screening.

Sponsors & Collaborators

• Takeda: lead

Study Sites (23)

Aichi Medical University Hospital

Nagakute, Aichi-ken, Japan

Location

Chubu Rosai Hospital

Nagoya, Aichi-ken, Japan

Location

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Location

Chiba University Hospital

Chiba, Chiba, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Location

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Location

Asahikawa Medical Center

Asahikawa, Hokkaido, Japan

Location

Kansai Rosai Hospital

Amagasaki, Hyōgo, Japan

Location

Hyogo College of Medicine Hospital

Nishinomiya, Hyōgo, Japan

Location

St.Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan

Location

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Location

Tohoku Medical and Pharmaceutical University Hospital

Sendai, Miyagi, Japan

Location

Nara Medical University Hospital

Kashihara, Nara, Japan

Location

Higashimatsuyama Municipal Hospital

Higashi-Matsuyama, Saitama, Japan

Location

Shiga University of Medical Science Hospital

Ōtsu, Shiga, Japan

Location

Tokushima University Hospital

Tokushima, Tokushima, Japan

Location

Tokushima National Hospital

Yoshinogawa, Tokushima, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Location

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Location

Toho University Omori Medical Center

Ōta-ku, Tokyo, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Location

Toyama University Hospital

Toyama, Toyama, Japan

Location

Yamaguchi University Hospital

Ube, Yamaguchi, Japan

Location

Related Links

• To obtain more information on the study, click here/on this link.

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: October 19, 2021
• Study Start: January 19, 2022
• Primary Completion: March 5, 2024
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 26, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (23)