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

Primary Purpose

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

Status
Active
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
TAK-771
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.
  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:

    1. Screening and Baseline INCAT disability score between 3 and 7 inclusive.
    2. Screening and/or Baseline INCAT disability score of 2 (both points are from lower extremities)
    3. 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.
    4. 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.
  7. The participant is willing and able to sign an Informed Consent Form (ICF).
  8. The participant is willing and able to comply with the requirements of the protocol.

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:

    1. Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (HSMN) (Charcot-Marie-Tooth [CMT] disease), and hereditary sensory and autonomic neuropathies (HSANs).
    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 non-diabetic lumbosacral radiculoplexus neuropathy, lymphoma, and amyloidosis.
    3. Multifocal motor neuropathy (MMN).
    4. 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

  4. Participant with immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with high titer antibodies to myelin-associated glycoprotein.
  5. Participant with presence of prominent sphincter disturbance.
  6. Participant with any central demyelinating disorders such as multiple sclerosis.
  7. 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.)

  8. 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).
  9. Participant with a history of deep vein thrombosis or thromboembolic events (eg, cerebrovascular accident, pulmonary embolism) within 12 months prior to screening.
  10. Participant with condition(s) which could alter protein catabolism and/or IgG utilization (eg, protein-losing enteropathies, nephrotic syndrome).
  11. Participant with a known history of chronic kidney disease, or glomerular filtration rate of <60 mL/min/1.73m^2 estimated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at the time of screening.
  12. Participant with active malignancy requiring chemotherapy and/or radiotherapy, or history of malignancy with less than 2 years of complete remission prior to screening. Exceptions to this exclusion are: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment.
  13. Participant with clinically significant anemia that precludes repeated blood sampling during the study, or hemoglobin (Hgb) level of <10.0 g/dL at the time of screening.
  14. Participant with a known history of hypersensitivity or ARs such as urticaria, breathing difficulty, severe hypotension, or anaphylaxis following administration of human blood products such as human IgG, albumin, or other blood components.

    (Clinically non-significant skin reactions, as per the investigator's and the sponsor medical monitor's discretion, do not meet this exclusion criterion. Clinically non-significant skin reactions may include local reactions to injection such as injection site's itching, redness, erythema, or swelling.)

  15. Participant has a known allergy to hyaluronidase of human (including recombinant human hyaluronidase) or animal origin such as bee or wasp venom.
  16. Participant with immunoglobulin A (IgA) deficiency and antibodies against IgA and a history of hypersensitivity.
  17. Participant with an abnormal laboratory values at screening meeting any one of the following criteria:

    1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN).
    2. Platelet count <100,000 cells/microL.
    3. Absolute neutrophil count (ANC) <1000 cells/microL.
  18. Participant has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAG), polymerase chain reaction (PCR) for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1/2.
  19. Participant has received or is currently receiving treatment with immunomodulatory/immunosuppressive agents within 6 months prior to screening.
  20. Participant has received or is currently receiving treatment with any corticosteroids dose within 8 weeks prior to screening, regardless of indication.
  21. Participant has undergone PE within 3 months prior to screening.
  22. Participant has any disorder or condition that in the investigator's judgment may impede the participant's participation in the study, pose increased risk to the participant, or confound the results of the study.
  23. Participant is nursing or intends to begin nursing during the course of the study.
  24. Participant has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment, or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
  25. Participant is a family member or employee of the investigator.
  26. Participants with known acquired or inherited thrombophilic disorders. These will include the specific types of acquired or inherited thrombophilic disorders that could put participants at risk of developing thrombotic events. Examples include a. Hereditary thrombophilia: i. Factor V Leiden mutation. ii. Prothrombin 20210A mutation. iii. Protein C deficiency. iv. Protein S deficiency. v. Anti-thrombin deficiency. b. Acquired thrombophilia: i. Anti-phospholipid antibody syndrome. ii. Activated protein C Resistance acquired. iii. Homocystinemia.

Sites / Locations

  • Aichi Medical University Hospital
  • Chubu Rosai Hospital
  • Fujita Health University Hospital
  • Asahikawa Medical Center
  • Kansai Rosai Hospital
  • Hyogo College of Medicine Hospital
  • Kanazawa Medical University Hospital
  • St.Marianna University School of Medicine Hospital
  • Tohoku Medical and Pharmaceutical University Hospital
  • Nara Medical University Hospital
  • Saitama Medical Center
  • Shiga University of Medical Science Hospital
  • Tokushima National Hospital
  • Juntendo University Hospital
  • National Center of Neurology and Psychiatry
  • Toho University Omori Medical Center
  • Tokyo Women's Medical University Hospital
  • Yamaguchi University Hospital
  • Chiba University Hospital
  • Kyushu University Hospital
  • Hiroshima University Hospital
  • Kumamoto University Hospital
  • Higashimatsuyama Municipal Hospital
  • Tokushima University Hospital
  • Toyama University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1: TAK-771 for CIDP Participants

Cohort 2: TAK-771 for MMN Participants

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants with CIDP who Experienced Relapse in Epoch 1
Relapse is 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 is the most widely used assessment tool to measure the functional activity level of patients with CIDP. The INCAT disability scale consists 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 are summed for an overall INCAT disability score ranging from 0 to 10 points, where 0 is normal and 10 is severely incapacitated. An adjusted INCAT disability score is 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.
Change in Maximum Grip Strength in the More Affected Hand in Epoch 1 for Participants with MMN
Change in maximum grip strength in the more affected hand in Epoch 1 for participants with MMN will be reported. Per baseline measurement point, investigators will judge which of both hands is more affected.

Secondary Outcome Measures

Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with Serious and Nonserious Adverse Reactions (ARs) plus Suspected ARs
Number of Participants with SAEs Associated with Infusions
Number of Participants with TEAEs Associated with Infusions
Number of Participants with AEs Temporally Associated with Infusions
AEs temporally associated with infusions defined as AEs occurring during or within 72 hours after completion of an infusion.
Number of Participants with Serious and Nonserious ARs plus Suspected ARs Associated with Infusions
Number of Participants with Treatment-emergent Systemic AEs Associated with Infusions
Number of Participants with Treatment-emergent Local Infusion Site Reactions Associated with Infusions
Number of Infusions for which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped due to Intolerability and/or AEs
Number of Participants who Have Positive Titer (>=160) Binding Antibodies, or Neutralizing Antibodies, to rHuPH20
Percentage of Participants with CIDP who Experienced Worsening in Epoch 1
Worsening defined as a >=8 kilo Pascal (kPa) decrease in the hand grip strength in the more affected hand) OR >=4 points decrease in Rasch Built Overall Disability Scale (R-ODS) relative to the pre-SC treatment baseline score at 2 consecutive time points. The R-ODS is a patient self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in patients with immune-mediated peripheral neuropathies including CIDP. The R-ODS is comprised of 24 items for which participants are asked to rate their functioning (ie, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion.
Time to Relapse in Participants with CIDP
Time to relapse is defined as time from the date of the first SC administration of TAK-771 to the date of relapse.
Change from Baseline in R-ODS Score in Epoch 1 for Participants with CIDP
The R-ODS is a patient self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in patients with immune-mediated peripheral neuropathies including CIDP. The R-ODS is comprised of 24 items for which participants are asked to rate their functioning (ie, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion.
Change from Baseline in an Average of Handgrip Strength of Both Hands in Epoch 1 for Participants with CIDP
Medical Research Council (MRC) Sum Score in Epoch 1 for Participants with MMN
The MRC sum score will serve as a measure of muscle strength. The following muscles on each side of the body are examined and the strength of each muscle is rated according to the MRC scale: deltoids, biceps, wrist extensors, iliopsoas, quadriceps, and anterior tibialis. The MRC scale ranges from 0 to 5, where: 0 = no visible contraction; 1 = visible contraction without movement of the limb; 2 = movement of the limb but not against gravity; 3 = movement against gravity over (almost) the full range; 4 = movement against gravity and resistance; and, 5 = normal. All scores from both left and right side of the body are summed to obtain the MRC sum score. The MRC sum score ranges from 0 (paralysis) to 60 (normal strength).
Guy's Neurological Disability Scale (GNDS) in Upper Limb and Lower Limb Categories in Epoch 1 for Participants with MMN
Guy's Neurological Disability Scale is a questionnaire which consists of 12 separate categories (4 to 8 questions per category). The categories include: cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and others. In the current study, only 2 categories; upper limb function and the lower limb function will be used for assessment of the disability of participants with MMN. The severity of each subscale is graded from 0 (normal function) to 5 (total loss of function) based according to severity and impact on the individual.
Change from Baseline in an Average of Handgrip Strength of Both Hands in Epoch 1 for Participants with MMN

Full Information

First Posted
October 10, 2021
Last Updated
August 29, 2023
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT05084053
Brief Title
A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), Multifocal Motor Neuropathy (MMN)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: TAK-771 for CIDP Participants
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2: TAK-771 for MMN Participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TAK-771
Other Intervention Name(s)
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
Intervention Description
Intervention description; Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20)
Primary Outcome Measure Information:
Title
Percentage of Participants with CIDP who Experienced Relapse in Epoch 1
Description
Relapse is 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 is the most widely used assessment tool to measure the functional activity level of patients with CIDP. The INCAT disability scale consists 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 are summed for an overall INCAT disability score ranging from 0 to 10 points, where 0 is normal and 10 is severely incapacitated. An adjusted INCAT disability score is 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.
Time Frame
6 Months
Title
Change in Maximum Grip Strength in the More Affected Hand in Epoch 1 for Participants with MMN
Description
Change in maximum grip strength in the more affected hand in Epoch 1 for participants with MMN will be reported. Per baseline measurement point, investigators will judge which of both hands is more affected.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame
45 Months
Title
Number of Participants with Serious Adverse Events (SAEs)
Time Frame
45 Months
Title
Number of Participants with Serious and Nonserious Adverse Reactions (ARs) plus Suspected ARs
Time Frame
45 Months
Title
Number of Participants with SAEs Associated with Infusions
Time Frame
45 Months
Title
Number of Participants with TEAEs Associated with Infusions
Time Frame
45 Months
Title
Number of Participants with AEs Temporally Associated with Infusions
Description
AEs temporally associated with infusions defined as AEs occurring during or within 72 hours after completion of an infusion.
Time Frame
45 Months
Title
Number of Participants with Serious and Nonserious ARs plus Suspected ARs Associated with Infusions
Time Frame
45 Months
Title
Number of Participants with Treatment-emergent Systemic AEs Associated with Infusions
Time Frame
45 Months
Title
Number of Participants with Treatment-emergent Local Infusion Site Reactions Associated with Infusions
Time Frame
45 Months
Title
Number of Infusions for which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped due to Intolerability and/or AEs
Time Frame
45 Months
Title
Number of Participants who Have Positive Titer (>=160) Binding Antibodies, or Neutralizing Antibodies, to rHuPH20
Time Frame
45 Months
Title
Percentage of Participants with CIDP who Experienced Worsening in Epoch 1
Description
Worsening defined as a >=8 kilo Pascal (kPa) decrease in the hand grip strength in the more affected hand) OR >=4 points decrease in Rasch Built Overall Disability Scale (R-ODS) relative to the pre-SC treatment baseline score at 2 consecutive time points. The R-ODS is a patient self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in patients with immune-mediated peripheral neuropathies including CIDP. The R-ODS is comprised of 24 items for which participants are asked to rate their functioning (ie, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion.
Time Frame
6 Months
Title
Time to Relapse in Participants with CIDP
Description
Time to relapse is defined as time from the date of the first SC administration of TAK-771 to the date of relapse.
Time Frame
45 Months
Title
Change from Baseline in R-ODS Score in Epoch 1 for Participants with CIDP
Description
The R-ODS is a patient self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in patients with immune-mediated peripheral neuropathies including CIDP. The R-ODS is comprised of 24 items for which participants are asked to rate their functioning (ie, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion.
Time Frame
6 Months
Title
Change from Baseline in an Average of Handgrip Strength of Both Hands in Epoch 1 for Participants with CIDP
Time Frame
6 Months
Title
Medical Research Council (MRC) Sum Score in Epoch 1 for Participants with MMN
Description
The MRC sum score will serve as a measure of muscle strength. The following muscles on each side of the body are examined and the strength of each muscle is rated according to the MRC scale: deltoids, biceps, wrist extensors, iliopsoas, quadriceps, and anterior tibialis. The MRC scale ranges from 0 to 5, where: 0 = no visible contraction; 1 = visible contraction without movement of the limb; 2 = movement of the limb but not against gravity; 3 = movement against gravity over (almost) the full range; 4 = movement against gravity and resistance; and, 5 = normal. All scores from both left and right side of the body are summed to obtain the MRC sum score. The MRC sum score ranges from 0 (paralysis) to 60 (normal strength).
Time Frame
6 Months
Title
Guy's Neurological Disability Scale (GNDS) in Upper Limb and Lower Limb Categories in Epoch 1 for Participants with MMN
Description
Guy's Neurological Disability Scale is a questionnaire which consists of 12 separate categories (4 to 8 questions per category). The categories include: cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and others. In the current study, only 2 categories; upper limb function and the lower limb function will be used for assessment of the disability of participants with MMN. The severity of each subscale is graded from 0 (normal function) to 5 (total loss of function) based according to severity and impact on the individual.
Time Frame
6 Months
Title
Change from Baseline in an Average of Handgrip Strength of Both Hands in Epoch 1 for Participants with MMN
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 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. Exclusion Criteria CIDP patients 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. Participant with condition(s) which could alter protein catabolism and/or IgG utilization (eg, protein-losing enteropathies, nephrotic syndrome). Participant with a known history of chronic kidney disease, or glomerular filtration rate of <60 mL/min/1.73m^2 estimated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at the time of screening. Participant with active malignancy requiring chemotherapy and/or radiotherapy, or history of malignancy with less than 2 years of complete remission prior to screening. Exceptions to this exclusion are: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment. Participant with clinically significant anemia that precludes repeated blood sampling during the study, or hemoglobin (Hgb) level of <10.0 g/dL at the time of screening. Participant with a known history of hypersensitivity or ARs such as urticaria, breathing difficulty, severe hypotension, or anaphylaxis following administration of human blood products such as human IgG, albumin, or other blood components. (Clinically non-significant skin reactions, as per the investigator's and the sponsor medical monitor's discretion, do not meet this exclusion criterion. Clinically non-significant skin reactions may include local reactions to injection such as injection site's itching, redness, erythema, or swelling.) Participant has a known allergy to hyaluronidase of human (including recombinant human hyaluronidase) or animal origin such as bee or wasp venom. Participant with immunoglobulin A (IgA) deficiency and antibodies against IgA and a history of hypersensitivity. Participant with an abnormal laboratory values at screening meeting any one of the following criteria: Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN). Platelet count <100,000 cells/microL. Absolute neutrophil count (ANC) <1000 cells/microL. Participant has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAG), polymerase chain reaction (PCR) for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1/2. Participant has received or is currently receiving treatment with immunomodulatory/immunosuppressive agents within 6 months prior to screening. Participant has received or is currently receiving treatment with any corticosteroids dose within 8 weeks prior to screening, regardless of indication. Participant has undergone PE within 3 months prior to screening. Participant has any disorder or condition that in the investigator's judgment may impede the participant's participation in the study, pose increased risk to the participant, or confound the results of the study. Participant is nursing or intends to begin nursing during the course of the study. Participant has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment, or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study. Participant is a family member or employee of the investigator. Participants with known acquired or inherited thrombophilic disorders. These will include the specific types of acquired or inherited thrombophilic disorders that could put participants at risk of developing thrombotic events. Examples include a. Hereditary thrombophilia: i. Factor V Leiden mutation. ii. Prothrombin 20210A mutation. iii. Protein C deficiency. iv. Protein S deficiency. v. Anti-thrombin deficiency. b. Acquired thrombophilia: i. Anti-phospholipid antibody syndrome. ii. Activated protein C Resistance acquired. iii. Homocystinemia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Aichi Medical University Hospital
City
Nagakute
State/Province
Aichi
Country
Japan
Facility Name
Chubu Rosai Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake
State/Province
Aichi
Country
Japan
Facility Name
Asahikawa Medical Center
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Kansai Rosai Hospital
City
Amagasaki
State/Province
Hyogo
Country
Japan
Facility Name
Hyogo College of Medicine Hospital
City
Nishinomiya
State/Province
Hyogo
Country
Japan
Facility Name
Kanazawa Medical University Hospital
City
Kahoku
State/Province
Ishikawa
Country
Japan
Facility Name
St.Marianna University School of Medicine Hospital
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Tohoku Medical and Pharmaceutical University Hospital
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara
State/Province
Nara
Country
Japan
Facility Name
Saitama Medical Center
City
Kawagoe
State/Province
Saitama
Country
Japan
Facility Name
Shiga University of Medical Science Hospital
City
Otsu
State/Province
Shiga
Country
Japan
Facility Name
Tokushima National Hospital
City
Yoshinogawa
State/Province
Tokushima
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
National Center of Neurology and Psychiatry
City
Kodaira
State/Province
Tokyo
Country
Japan
Facility Name
Toho University Omori Medical Center
City
Ota-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube
State/Province
Yamaguchi
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
Country
Japan
Facility Name
Higashimatsuyama Municipal Hospital
City
Saitama
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
Country
Japan
Facility Name
Toyama University Hospital
City
Toyama
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be reidentified (due to the limited number of study participants/study sites).
Links:
URL
https://clinicaltrials.takeda.com/study-detail/616f8da3eb0e19002afd68f8
Description
To obtain more information on the study, click here/on this link.

Learn more about this trial

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

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