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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by CSL Behring
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01545076
First received: March 1, 2012
Last updated: July 14, 2014
Last verified: July 2014

March 1, 2012
July 14, 2014
March 2012
November 2015   (final data collection date for primary outcome measure)
Percentage (%) of subjects who relapse during the SC treatment period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01545076 on ClinicalTrials.gov Archive Site
  • Change in mean Inflammatory Neuropathy Cause and Treatment (INCAT) scores during the SC treatment period [ Time Frame: SC week 1, SC week 25 ] [ Designated as safety issue: No ]
  • Change in mean maximum grip strength scores during the SC treatment period [ Time Frame: SC week 1, SC week 25 ] [ Designated as safety issue: No ]
  • Change in mean Medical Research Council (MRC) sum scores during the SC treatment period [ Time Frame: SC week 1, SC week 25 ] [ Designated as safety issue: No ]
  • Time to CIDP relapse or withdrawal due to any other reason [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Rate of adverse events per SC infusion [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with adverse events during the SC Treatment Period [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with adverse events during the SC Treatment Period [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Change in mean Rasch-built Overall Disability Scale (R-ODS) scores during the SC Treatment Period [ Time Frame: SC week 1, SC week 25 ] [ Designated as safety issue: No ]
  • Time to improvement on IgPro10 Re-stabilization Therapy [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Improvement is defined as: an INCAT score decrease by 1 point, 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: Before and at the end of IgPro10 Re-stabilization Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in MRC sum score during IgPro10 Re-stabilization Therapy [ Time Frame: Before and at the end of IgPro10 Re-stabilization Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in R-ODS during IgPro10 Re-stabilization Therapy [ Time Frame: Before and at the end of IgPro10 Re-stabilization Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in INCAT during IgPro10 Re-stabilization Therapy [ Time Frame: Before and at the end of IgPro10 Re-stabilization Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in mean grip strength during IgPro10 Rescue Therapy [ Time Frame: Before and at the end of IgPro10 Rescue Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in MRC sum score during IgPro10 Rescue Therapy [ Time Frame: Before and at the end of IgPro10 Rescue Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in R-ODS during IgPro10 Rescue Therapy [ Time Frame: Before and at the end of IgPro10 Rescue Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in INCAT during IgPro10 Rescue Therapy [ Time Frame: Before and at the end of IgPro10 Rescue Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Time to improvement after CIDP relapse in the SC Treatment Period [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    Improvement is defined as a decrease in INCAT score back to or below the baseline score
  • Time to improvement after CIDP relapse during IgPro10 Rescue Therapy [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Improvement is defined as a decrease in INCAT score back to or below the baseline score
  • Rate of adverse events per IgPro10 infusion [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with adverse events - IgPro10 [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: Yes ]
    During IgPro10 Re-stabilization or Rescue Therapy
  • Percentage of subjects with adverse events - IgPro10 [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: Yes ]
    During IgPro10 Re-stabilization or Rescue Therapy
  • Change in mean Inflammatory Neuropathy Cause and Treatment (INCAT) scores during the SC treatment period [ Time Frame: SC week 1, SC week 25 ] [ Designated as safety issue: No ]
  • Change in mean maximum grip strength scores during the SC treatment period [ Time Frame: SC week 1, SC week 25 ] [ Designated as safety issue: No ]
  • Change in mean Medical Research Council (MRC) sum scores during the SC treatment period [ Time Frame: SC week 1, SC week 25 ] [ Designated as safety issue: No ]
  • Time to CIDP relapse [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Rate of adverse events per SC infusion [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with adverse events during the SC Treatment Period [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with adverse events during the SC Treatment Period [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)
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 Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study

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 on intravenous immunoglobulin (IVIG) maintenance therapy enrolled in the study will be assessed during 3 separate study periods. Patients first undergo 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Inflammatory Demyelinating Polyneuropathy
  • Polyradiculoneuropathy
  • Biological: IgPro20

    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)

    0.4 g/kg body weight (high dose arm)

    Other Name: Hizentra
  • Biological: Placebo
    2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
  • Biological: IgPro10
    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 IgPro20 Phase for subjects with a CIDP relapse.
  • Experimental: IgPro20 low dose
    Interventions:
    • Biological: IgPro20
    • Biological: IgPro10
  • Experimental: IgPro20 high dose
    Interventions:
    • Biological: IgPro20
    • Biological: IgPro10
  • Placebo Comparator: Placebo
    Interventions:
    • Biological: Placebo
    • Biological: IgPro10
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
November 2015
November 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.
  • Repeated treatment with IVIG (≥ 4 infusions) within the last 9 months prior to enrollment.
  • 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
Both
18 Years and older
No
Contact: Use Central Contact clinicaltrials@cslbehring.com
Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Finland,   France,   Germany,   Israel,   Italy,   Japan,   Netherlands,   Spain,   United Kingdom,   United States
 
NCT01545076
IgPro20_3003
Yes
CSL Behring
CSL Behring
ICON Clinical Research
Principal Investigator: Prof. Dr. Ivo N. van Schaik Academic Medical Center, University of Amsterdam
CSL Behring
July 2014

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