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 enrollmentMay 3, 2017

ConditionsChronic inflammatory demyelinating polyradiculoneuropathy MedDRA version: 20.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

DrugsHyQvia 100 mg/ml solution for infusion for subcutaneous use KIOVIG 100 mg/ml solution for infusion

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic inflammatory demyelinating polyradiculoneuropathy
Sponsor: Baxalta Innovations GmbH
Enrollment: 232
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 3, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Baxalta Innovations GmbH

Eligibility Criteria

Inclusion Criteria

•1\. Males or females of age \=18 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, (partial or complete resolution of neurological symptoms and deficits), and must currently be on stable doses of IGIV 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 IGIV treatment must be between 2 to 6 weeks (inclusive). Variations in the dosing interval of up to ±7 days or monthly dose amount of up to ±20% between subject's pre study IgG infusions are within acceptable limits.
•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 documented in the medical record. Subjects will be eligible if one of the below eligibility criteria are met:
•a. Screening and Baseline INCAT disability score of between 3 and 7 inclusive.
•b. Screening and/or Baseline INCAT disability score of 2 (both points are from lower extremities)
•c. Screening and/or Baseline INCAT disability score of 2 (both points are from lower extremities) AND has at least a score of 2 or greater documented in the clinical 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.
•d. Screening and/or Baseline INCAT disability score of 0 and 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.
•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.
•6\. Subject is willing and able to sign an Informed Consent Form (ICF).

Exclusion Criteria

•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), multifocal acquired demyelinating sensory and motor neuropathy (MADSAM), 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.