The main goal of the study is to find out whether XEMBIFY, given once a week under the skin, provides similar levels of immunoglobulin G in the blood over time as Gamunex-C, which is given into a vein once every 3 weeks in people with CIDP.
Participants with CIDP will first have up to 28 days of screening to make sure they can join the study. Those who qualify will then start a 19-week treatment period with Gamunex-C. During this period, they will receive Gamunex-C through a vein once every 3 weeks, for a total of 7 doses. Approximately, one week after their last Gamunex-C dose, they will begin a 16-week treatment period with XEMBIFY under the skin, once a week for a total of 16 doses. Blood samples will be collected during both treatment periods to measure IgG level in the blood.
Have typical CIDP or a CIDP variant according to the 2021 criteria established by the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS). The level of diagnostic certainty may be CIDP or possible CIDP.
Participants ≤ 90 kg in body weight and requiring an IGIV dose equivalent to 0.3-1.0 g/kg every three weeks (Q3W) inclusive and between 20-90 g of IGIV Q3W inclusive.
Clinically stable on IGIV, defined as no recent change in CIDP treatment or experienced a CIDP relapse requiring treatment, within 12 weeks prior to Screening and through baseline visit.
Diagnosis of polyneuropathy of any other cause (including multifocal motor neuropathy; monoclonal gammopathy of uncertain significance with anti-myelin-associated glycoprotein IgM antibodies; hereditary demyelinating neuropathy; polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes syndrome; lumbosacral radiculoplexus neuropathy; polyneuropathy associated with diabetes mellitus; polyneuropathy associated with systemic illnesses; or drug or toxin induced polyneuropathy).
current malignancy or history of allogeneic bone marrow/stem cell transplant,
cardiac insufficiency (New York Heart Association classes III/IV), cardiomyopathy, significant cardiac arrhythmia requiring treatment, unstable or advanced ischemic heart disease, congestive heart failure or severe hypertension
chronic kidney disease stage IV or V
Sequential
Gamunex-C
Biological/VaccineImmune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (IGIV-C 10%)
Xembify
Biological/VaccineImmune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%)
AUC in the IV Phase: Steady-state area under the concentration-time curve (AUC) of total IgG over a 3-week intravenous dosing interval (τ) (i.e., AUC(0-21days) in participants with CIDP
AUC in the SC Phase: Steady-state AUC of total IgG over a weekly SC dosing interval (τ) (i.e., AUC(0-7days)) in participants with CIDP
Steady-state mean trough (pre-dose) concentration of total IgG following IV administration of Gamunex-C 10% every 3 weeks SC administration of Xembify 20% once weekly
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