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

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ClinicalTrials.gov Identifier: NCT02549170
Recruitment Status : Recruiting
First Posted : September 15, 2015
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

September 11, 2015
September 15, 2015
May 18, 2018
December 15, 2015
March 31, 2022   (Final data collection date for primary outcome measure)
  • Epoch 1: Relapse rate (proportion of participants who experience a worsening of functional disability) [ Time Frame: Screening; Pre-SC Baseline; AND participants on: 1) Q2W: week 15 & 27; End of Epoch 1 (EOE1); Unscheduled relapse visit assessment (UV); & if early termination occurs (ET). 2) Q3W: week 14 & 26; EOE1; UV; and ET. 3) Q4W: week 16 & 28; EOE1; UV; and ET. ]
    Worsening of functional disability defined as an increase of ≥1 point relative to the pre- subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale.
  • Epoch 2: Responder rate (proportion of participants with clinically meaningful improvement in functional ability) [ Time Frame: Epoch 2: Pre-IV Baseline and every 3 weeks through end of Epoch 2 (6 months) ]
    Clinically meaningful improvement in functional ability defined as a decrease of ≥1 point in the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score at the completion of the intravenous (IV) treatment period [6 months] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score
Same as current
Complete list of historical versions of study NCT02549170 on ClinicalTrials.gov Archive Site
  • Epoch 1: Time to relapse [ Time Frame: Throughout Epoch 1, up to 6 months ]
    Defined as time from the date of the first SC administration of HYQVIA/HyQvia or placebo with rHuPH20 to the date of relapse
  • Epoch 1: Change from pre-subcutaneous (SC) treatment baseline in Rasch-built Overall Disability Scale (R-ODS) score [ Time Frame: Pre-subcutaneous (SC) treatment baseline, then weekly through Epoch 1 (up to 6 months); Unscheduled relapse visit assessment; & if early termination occurs. ]
    The Rasch-Built Overall Disability Scale (R-ODS) is a patient self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in patients with immune-mediated peripheral neuropathies including chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The R-ODS is comprised of 24 items for which subjects are asked to rate their functioning (ie, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion.
  • Epoch 1: Number of participants experiencing any treatment-emergent serious and/or non-serious adverse events (SAEs and/or AEs), regardless of causality [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of participants experiencing causally related serious and/or non-serious adverse events (SAEs and/or AEs) [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of participants with serious and/or non-serious adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions associated with treatment-emergent serious and/or non-serious adverse events (SAEs and/or AEs), regardless of causality [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions associated with causally related serious and/or non-serious adverse events (SAEs and/or AEs) [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions temporally associated with adverse events (AEs) [ Time Frame: During an infusion or within 72 hours after completion of an infusion ]
    AEs occurring during an infusion or within 72 hours after completion of an infusion
  • Epoch 1: Number of infusions associated with serious and/or non-serious adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions associated with treatment-emergent systemic adverse events (AEs) [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions associated with treatment-emergent local infusion site reactions [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or adverse events (AEs) [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per infusion [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per participant [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per participant-year [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per infusion [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per participant [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per participant-year [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per infusion [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per participant [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per participant-year [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of participants who develop binding and/or neutralizing antibodies to Recombinant human hyaluronidase (rHuPH20) [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 2: Number of participants experiencing any treatment-emergent serious and/or non-serious adverse events (SAEs and/or AEs), regardless of causality [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of participants experiencing causally related serious and/or non-serious adverse events (SAEs and/or AEs) [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of participants with serious and/or non-serious adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions associated with treatment-emergent serious and/or non-serious adverse events (SAEs and/or AEs), regardless of causality [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions associated with causally related serious and/or non-serious adverse events (SAEs and/or AEs) [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions temporally associated with adverse events (AEs) [ Time Frame: During an infusion or within 72 hours after completion of an infusion ]
    AEs occurring during an infusion or within 72 hours after completion of an infusion
  • Epoch 2: Number of infusions associated with serious and/or non-serious adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions associated with treatment-emergent systemic adverse events (AEs) [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions associated with treatment-emergent local infusion site reactions [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or adverse events (AEs) [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per infusion [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per participant [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per participant-year [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per infusion [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per participant [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per participant-year [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per infusion [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per participant [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per participant-year [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 1: Proportion of participants who experience a worsening of functional disability [ Time Frame: Throughout Epoch 1, up to 6 months ]
    Defined as one or more of the following: an increase of ≥1 point relative to the pre-subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) scores; who experience chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) worsening (defined as a ≥8 kilo Pascal (kPa) decrease in the hand grip strength in the more affected hand); ≥4 points decrease in Rasch-built Overall Disability Scale (R-ODS) relative to the pre-SC treatment baseline score (at the time of withdrawal from the SC treatment period)
  • Epoch 2: Proportion of participants with clinically meaningful improvement in functional ability [ Time Frame: Throughout Epoch 2, up to 6 months ]
    Defined as one or more of the following: a decrease of ≥1 point in the adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) score at 2 consecutive time points; who experience chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) improvement (defined as ≥8 kilo Pascal (kPa) increase in hand grip strength in the more affected hand; ≥4 points increase in Rasch-built Overall Disability Scale (R-ODS)) at the completion of the intravenous (IV) treatment period [6 months] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score
  • Epoch 1: Time to relapse [ Time Frame: Throughout Epoch 1, up to 6 months ]
    Defined as time from the date of the first SC administration of HYQVIA/HyQvia or placebo with rHuPH20 to the date of relapse
  • Epoch 1: Change from pre-subcutaneous (SC) treatment baseline in Rasch-built Overall Disability Scale (R-ODS) score [ Time Frame: Pre-subcutaneous (SC) treatment baseline, then weekly through Epoch 1 (up to 6 months); Unscheduled relapse visit assessment; & if early termination occurs. ]
    The Rasch-Built Overall Disability Scale (R-ODS) is a patient self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in patients with immune-mediated peripheral neuropathies including chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The R-ODS is comprised of 24 items for which subjects are asked to rate their functioning (ie, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion.
  • Epoch 1: Number of participants experiencing any treatment-emergent serious and/or non-serious adverse events (SAEs and/or AEs), regardless of causality [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of participants experiencing causally related serious and/or non-serious adverse events (SAEs and/or AEs) [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of participants with serious and/or non-serious adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions associated with treatment-emergent serious and/or non-serious adverse events (SAEs and/or AEs), regardless of causality [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions associated with causally related serious and/or non-serious adverse events (SAEs and/or AEs) [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions temporally associated with adverse events (AEs) [ Time Frame: During an infusion or within 72 hours after completion of an infusion ]
    AEs occurring during an infusion or within 72 hours after completion of an infusion
  • Epoch 1: Number of infusions associated with serious and/or non-serious adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions associated with treatment-emergent systemic adverse events (AEs) [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions associated with treatment-emergent local infusion site reactions [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or adverse events (AEs) [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per infusion [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per participant [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per participant-year [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per infusion [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per participant [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per participant-year [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per infusion [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per participant [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per participant-year [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of participants who develop binding and/or neutralizing antibodies to Recombinant human hyaluronidase (rHuPH20) [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 2: Number of participants experiencing any treatment-emergent serious and/or non-serious adverse events (SAEs and/or AEs), regardless of causality [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of participants experiencing causally related serious and/or non-serious adverse events (SAEs and/or AEs) [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of participants with serious and/or non-serious adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions associated with treatment-emergent serious and/or non-serious adverse events (SAEs and/or AEs), regardless of causality [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions associated with causally related serious and/or non-serious adverse events (SAEs and/or AEs) [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions temporally associated with adverse events (AEs) [ Time Frame: During an infusion or within 72 hours after completion of an infusion ]
    AEs occurring during an infusion or within 72 hours after completion of an infusion
  • Epoch 2: Number of infusions associated with serious and/or non-serious adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions associated with treatment-emergent systemic adverse events (AEs) [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions associated with treatment-emergent local infusion site reactions [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or adverse events (AEs) [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per infusion [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per participant [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per participant-year [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per infusion [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per participant [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per participant-year [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per infusion [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per participant [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per participant-year [ Time Frame: Throughout Epoch 2, up to 6 months ]
Not Provided
Not Provided
 
Phase III Efficacy, Safety, and Tolerability Study of HYQVIA/HyQvia and GAMMAGARD LIQUID/KIOVIG in CIDP
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)
This is a Phase III, prospective, multicenter study with two study parts (epochs) to evaluate the efficacy, safety, and tolerability of HYQVIA/HyQvia (IGI, 10% with recombinant human hyaluronidase (rHuPH20) administered subcutaneously) for maintenance therapy to prevent relapse (Epoch 1) and GAMMAGARD LIQUID/KIOVIG (immunoglobulin G intravenous (IGIV) 10% administered intravenously) for the treatment of CIDP (Epoch 2). This study will enroll adult subjects with a confirmed diagnosis of CIDP and who have remained on a stable dosing regimen (monthly equivalent dose of 0.4 to 2.4 g/kg body weight (BW) with a dosing interval of 2 to 6 weeks) of IGIV therapy for at least 12 weeks prior to screening. In this double-blind, placebo-controlled phase of the study (Epoch 1), eligible subjects will be randomized in a 1:1 ratio to receive either HYQVIA/HyQvia or 0.25% albumin placebo solution with rHuPH20 every two, three, or four weeks in a double-blind fashion for a period of 6 months or until relapse. Subjects who relapse during Epoch 1 will enter Epoch 2 to receive IGIV treatment for a period of 6 months.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
  • Biological: HYQVIA
    Dosing regimen for HYQVIA/HyQvia will be the same as the participant's pre-randomization monthly equivalent IgG dose when administered every 2, 3, or 4 weeks.
    Other Names:
    • IGI
    • 10% with rHuPH20
    • Immune Globulin Infusion 10% (Human) (IGI
    • 10%) with recombinant human hyaluronidase (rHuPH20)
  • Biological: 0.25% albumin placebo solution with rHuPH20
    Dosing regimen for placebo treatment will be the same as the participant's pre-randomization monthly equivalent IgG infusion volume when administered every 2, 3, or 4 weeks.
  • Biological: IGIV
    IGIV treatment will consist of an induction dose of 2 g/kg, followed by maintenance infusions at the same monthly dose as the participant's pre-randomization IgG dose, every 3 weeks.
    Other Names:
    • Immune Globulin Infusion (Human)
    • 10% Solution
    • KIOVIG
    • IVIg
    • Approved IGIV product for US sites
    • GAMMAGARD LIQUID
    • Intravenous immunoglobulin G
  • Experimental: Epoch 1: HYQVIA/HyQvia
    HYQVIA/HyQvia contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20)
    Intervention: Biological: HYQVIA
  • Placebo Comparator: Epoch 1: Placebo with rHuPH20
    Placebo treatment consists of a placebo solution (0.25% human albumin in Lactated Ringer's solution) and rHuPH20
    Intervention: Biological: 0.25% albumin placebo solution with rHuPH20
  • Experimental: Epoch 2: IGIV
    Intravenous immunoglobulin G treatment
    Intervention: Biological: IGIV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
232
Same as current
March 31, 2022
March 31, 2022   (Final data collection date for primary outcome measure)

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:

    1. 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)
    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
  3. Immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with high titer antibodies to myelin-associated glycoprotein
  4. Prominent sphincter disturbance.
  5. Central demyelinating disorders (eg, 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 (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.)
  7. 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).
  8. History of deep vein thrombosis or thromboembolic events (eg, cerebrovascular accident, pulmonary embolism) in the past 12 months.
  9. Condition(s) which could alter protein catabolism and/or IgG utilization (eg, protein-losing enteropathies, nephrotic syndrome).
  10. 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).
  11. 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.
  12. Clinically significant anemia or hemoglobin (Hgb) level of <10.0 g/dL at screening.
  13. 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.
  14. Known allergy to hyaluronidase of human (including recombinant human hyaluronidase) or animal origin (such as bee or wasp venom).
  15. Known history of or immunoglobulin A (IgA) deficiency (<8 mg/dL) at screening.
  16. Abnormal laboratory values at screening:

    1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5x upper limit of normal (ULN)
    2. Platelet count <100,000 cells/µL
    3. Absolute neutrophil count (ANC) <1000 cells/µL
  17. 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.
  18. The participant has received or is currently receiving treatment with immunomodulatory/ immunosuppressive agents within 6 months prior to screening.
  19. 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.
  20. Participant has undergone plasma exchange within 3 months prior to screening.
  21. 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.
  22. The participant is nursing or intends to begin nursing during the course of the study.
  23. 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.
  24. The participant is a family member or employee of the investigator.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Andras Nagy 617-588-8362 andras.nagy@shire.com
Austria,   Canada,   Colombia,   Czechia,   Denmark,   France,   Germany,   Greece,   Israel,   Italy,   Norway,   Poland,   Serbia,   Slovakia,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
Czech Republic
 
NCT02549170
161403
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Shire ( Baxalta now part of Shire )
Baxalta now part of Shire
Not Provided
Study Director: Steve Glyman, MD Shire
Shire
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP