A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - Phase III Efficacy, Safety, and Tolerability Study of HyQvia and KIOVIG in CIDP

Baxalta Innovations GmbH0 sites232 target enrollmentOctober 6, 2015

Overview

No summary available.

Registry

who.int

Start Date

October 6, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Males or females of age \=18 to \=80 years old at the time of screening.
•2\. Subject has a documented diagnosis of definite or probable CIDP (focal atypical CIDP and pure sensory atypical CIDP will be excluded).
•3\. Subject has responded to IgG treatment in the past, and must currently be on stable doses of IGIV treatment within the dose range equivalent to a cumulative monthly dose of 0\.5 to 2\.4 g/kg BW (inclusive) administered intravenously for at least 3 months prior to screening. The dosing interval of IGIV treatment must be between 2 to 6 weeks (inclusive).
•4\. INCAT disability score between 0 to 7 (inclusive). Subjects 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 within 24 months prior to screening.
•5\. If female of childbearing potential, the subject 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 investigational product.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 197
•F.1\.3 Elderly (\>\=65 years) yes

•1\. Subjects with focal atypical CIDP or pure sensory atypical CIDP.
•2\. Any neuropathy of other causes, including:
•a. Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (Charcot\-Marie\-Tooth \[CMT] disease), and hereditary sensory and autonomic neuropathies.
•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
•d. Drug\-, biologic\-, chemotherapy\-, or toxin\-induced peripheral neuropathy
•3\. Immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with high titre antibodies to myelin\-associated glycoprotein.
•4\. Presence of prominent sphincter disturbance.
•5\. Any central demyelinating disorders such as multiple sclerosis.
•6\. Any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or may interfere with assessment of CIDP or outcome measures, including (but not limited to) arthritis, stroke, and Parkinson’s disease and diabetic peripheral neuropathy.