| Eligibility |
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.
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