Last updated on November 2018

Phase III Efficacy Safety and Tolerability Study of HYQVIA/HyQvia and GAMMAGARD LIQUID/KIOVIG in CIDP

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic inflammatory demyelinating polyradiculoneuropathy
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Documented diagnosis of definite or probable Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) (focal atypical CIDP and pure sensory atypical CIDP will be excluded) consistent with European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) 2010 criteria.
  2. 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 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 and 6 weeks (inclusive). Variations in the dosing interval of up to 7 days or monthly dose amount of up to 20% between participant's pre-study Immunoglobulin G (IgG) infusions are within acceptable limits
  3. INCAT disability score between 0 and 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.
  4. 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 investigational product.
  5. Participant is willing and able to sign an Informed Consent Form (ICF).
  6. Participant is willing and able to comply with the requirements of the protocol.

Exclusion Criteria:

  1. Focal atypical CIDP or pure sensory atypical CIDP.
  2. Any neuropathy of other causes, including:
  3. Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (HSMN) (Charcot-Marie-Tooth [CMT] disease), multifocal acquired demyelinating sensory and motor neuropathy (MADSAM), and hereditary sensory and autonomic neuropathies (HSANs)
  4. 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
  5. Multifocal motor neuropathy (MMN)
  6. Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy
  7. Immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with high titer antibodies to myelin-associated glycoprotein
  8. Prominent sphincter disturbance.
  9. Central demyelinating disorders (eg, multiple sclerosis).
  10. Any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or may interfere with assessment of CIDP or outcome measures (eg, arthritis, stroke, Parkinson's disease, and diabetic peripheral neuropathy) (Participants with clinically diagnosed diabetes mellitus who do not have diabetic peripheral neuropathy, who have adequate glycemic control with Hemoglobin A1C; also known as glycosylated or glycated hemoglobin (HbA1C) of <7.5% at screening, and who agree to maintain adequate glycemic control during the study are allowed.)
  11. Congestive heart failure (New York Heart Association (NYHA) Class III/IV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension (ie, diastolic blood pressure >100 mmHg and/or systolic blood pressure >160 mmHg).
  12. History of deep vein thrombosis or thromboembolic events (eg, cerebrovascular accident, pulmonary embolism) in the past 12 months.
  13. Condition(s) which could alter protein catabolism and/or IgG utilization (eg, protein-losing enteropathies, nephrotic syndrome).
  14. Known history of chronic kidney disease, or glomerular filtration rate (GFR) of <60 mL/min/1.73m^2 estimated based on CKD-EPI equation (2009).
  15. 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 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.
  16. Clinically significant anemia or hemoglobin (Hgb) level of <10.0 g/dL at screening.
  17. Hypersensitivity or adverse reactions (eg, urticaria, breathing difficulty, severe hypotension, or anaphylaxis) to human blood products such as human IgG, albumin, or other blood components.
  18. Known allergy to hyaluronidase of human (including recombinant human hyaluronidase) or animal origin (such as bee or wasp venom).
  19. Known history of or immunoglobulin A (IgA) deficiency (<8 mg/dL) at screening.
  20. Abnormal laboratory values at screening:
  21. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5x upper limit of normal (ULN)
  22. Platelet count <100,000 cells/L
  23. Absolute neutrophil count (ANC) <1000 cells/L
  24. Ongoing/active infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) Type 1/2 infection.
  25. The participant has received or is currently receiving treatment with immunomodulatory/ immunosuppressive agents within 6 months prior to screening.
  26. Participant has received or is currently receiving treatment with corticosteroids within 3 months prior to screening. The following exceptions for prednisolone or its equivalent are allowed: stable dosages of low-dose systemic corticosteroids (10 mg prednisolone/day or its equivalent) and non-systemic corticosteroids (eg, topical, ophthalmic, or inhaled glucocorticoids). In addition and for the purpose of treating AE or non-CIDP intercurrent disease, a single corticosteroid dose >10 mg prednisolone or a single short term course of to 7 days (such as Methylprednisolone Dose Pack) within 3 months prior to screening is allowed.
  27. Participant has undergone plasma exchange within 3 months prior to screening.
  28. The 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.
  29. The participant is nursing or intends to begin nursing during the course of the study.
  30. Participation in another clinical study involving an investigational product and/or device within 30 days prior to enrollment, or planned participation in another clinical study during the course of this study.
  31. The participant is a family member or employee of the investigator.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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