Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)
Condition: Chronic Inflammatory Demyelinating Polyneuropathy; Polyradiculoneuropathy
MeSH terms: Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Polyradiculoneuropathy
Intervention: IgPro20 (low dose); Placebo; IgPro10; IgPro20 (high dose)
Intervention description: 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization:
0.2 g/kg body weight (low dose arm); 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.; 10% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during Restabilization Period of the study and/or as Rescue Therapy during SC Treatment Period for subjects with a CIDP relapse.; 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization:
0.4 g/kg body weight (high dose arm)
Intervention MeSH terms: Immunoglobulin G
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a prospective, multicenter, randomized, double-blind, placebo-controlled,
      parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20
      compared with placebo for maintenance treatment of patients with CIDP.

      Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks
      before screening will be assessed during 4 separate study periods. Patients first undergo a
      Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for
      ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be
      administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients
      with improved and maintained adjusted inflammatory neuropathy cause and treatment scale
      (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the
      study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly
      infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo.

      The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the
      Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical
      Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and
      electrophysiological evaluations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Definite or probable CIDP according to the European Federation of Neurological
             Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.

          -  An IVIG treatment during the last 8 weeks prior to enrollment.

          -  Age ≥18 years.

          -  Written informed consent for study participation obtained before undergoing any
             study-specific procedures.

        Exclusion Criteria:

          -  Any polyneuropathy of other causes

          -  Any other disease (mainly neurological or chronic orthopedic) that has caused
             neurological symptoms or may interfere with treatment or outcome assessments

          -  Severe diseases and conditions that are likely to interfere with evaluation of the
             study product or satisfactory conduct of the study

          -  History of thrombotic episodes within the 2 years prior to enrolment

          -  Known allergic or other severe reactions to blood products including intolerability to
             previous IVIG