Clinical Trial: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglob

Brief 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.


Detailed Summary:
Sponsor: CSL Behring

Current Primary Outcome: Percentage (%) of subjects who relapse or are withdrawn for any other reason during the SC treatment period [ Time Frame: 24 weeks ]

Relapse is defined as an increase of at least 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score).


Original Primary Outcome: Percentage (%) of subjects who relapse during the SC treatment period [ Time Frame: 24 weeks ]

Relapse is defined as an increase of at least 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score).


Current Secondary Outcome:

  • Change in mean Inflammatory Neuropathy Cause and Treatment (INCAT) scores during the SC treatment period [ Time Frame: At baseline and at all visits during the 25-week SC Treatment Period ]
  • Change in mean maximum grip strength scores during the SC treatment period [ Time Frame: At baseline and at all visits during the 25-week SC Treatment Period ]
  • Change in mean Medical Research Council (MRC) sum scores during the SC treatment period [ Time Frame: At baseline and at all visits during the 25-week SC Treatment Period ]
  • Time to CIDP relapse or withdrawal due to any other reason [ Time Frame: up to 24 weeks ]
  • Rate of adverse events per SC infusion [ Time Frame: 24 weeks ]
  • Number of subjects with adverse events during the SC Treatment Period [ Time Frame: 24 weeks ]
  • Percentage of subjects with adverse events during the SC Treatment Period [ Time Frame: 24 weeks ]
  • Change in mean Rasch-built Overall Disability Scale (R-ODS) scores during the SC Treatment Period [ Time Frame: At baseline and at all visits during the 25-week SC Treatment Period ]
  • Time to improvement on IgPro10 Re-stabilization Therapy [ Time Frame: Up to 12 weeks ]
    Improvement is defined as: an INCAT score decrease by 1 point (except for the decrease from 1 to 0 in the upper limb score), R-ODS improvement by at least 4 points, or Mean Grip strength improvement by at least 8 kPa in one hand.
  • Change in mean grip strength during IgPro10 Re-stabilization Therapy [ Time Frame: During IgPro10 Re-stabilization Therapy, up to 12 weeks ]
  • Change in MRC sum score during IgPro10 Re-stabilization Therapy [ Time Frame: During IgPro10 Re-stabilization Therapy, up to 12 weeks ]
  • Change in R-ODS during IgPro10 Re-stabilization Therapy [ Time Frame: During IgPro10 Re-stabilization Therapy, up to 12 weeks ]
  • Change in INCAT during IgPro10 Re-stabilization Therapy [ Time Frame: During IgPro10 Re-stabilization Therapy, up to 12 weeks ]
  • Change in mean grip strength during IgPro10 Rescue Therapy [ Time Frame: During IgPro10 Rescue Therapy, up to 12 weeks ]
  • Change in MRC sum score during IgPro10 Rescue Therapy [ Time Frame: During IgPro10 Rescue Therapy, up to 12 weeks ]
  • Change in R-ODS during IgPro10 Rescue Therapy [ Time Frame: During IgPro10 Rescue Therapy, up to 12 weeks ]
  • Change in INCAT during IgPro10 Rescue Therapy [ Time Frame: During IgPro10 Rescue Therapy, up to 12 weeks ]
  • Time to improvement after CIDP relapse in the SC Treatment Period [ Time Frame: Up to 24 weeks ]
    Improvement is defined as a decrease in INCAT score (except for the decrease from 1 to 0 in the upper limb score) back to or below the baseline score
  • Time to improvement after CIDP relapse during IgPro10 Rescue Therapy [ Time Frame: Up to 12 weeks ]
    Improvement is defined as a decrease in INCAT score (except for the decrease from 1 to 0 in the upper limb score) back to or below the baseline score
  • Rate of adverse events per IgPro10 infusion [ Time Frame: 24 weeks ]
  • Number of subjects with adverse events - IgPro10 [ Time Frame: Up to 13 weeks ]
    During IgPro10 Re-stabilization or Rescue Therapy
  • Percentage of subjects with adverse events - IgPro10 [ Time Frame: Up to 13 weeks ]
    During IgPro10 Re-stabilization or Rescue Therapy


Original Secondary Outcome:

  • Change in mean Inflammatory Neuropathy Cause and Treatment (INCAT) scores during the SC treatment period [ Time Frame: SC week 1, SC week 25 ]
  • Change in mean maximum grip strength scores during the SC treatment period [ Time Frame: SC week 1, SC week 25 ]
  • Change in mean Medical Research Council (MRC) sum scores during the SC treatment period [ Time Frame: SC week 1, SC week 25 ]
  • Time to CIDP relapse [ Time Frame: up to 24 weeks ]
  • Rate of adverse events per SC infusion [ Time Frame: 24 weeks ]
  • Number of subjects with adverse events during the SC Treatment Period [ Time Frame: 24 weeks ]
  • Percentage of subjects with adverse events during the SC Treatment Period [ Time Frame: 24 weeks ]


Information By: CSL Behring

Dates:
Date Received: March 1, 2012
Date Started: March 2012
Date Completion:
Last Updated: December 16, 2016
Last Verified: December 2016