Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT02027701
First received: January 3, 2014
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The purpose of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with regard to safety and efficacy.

Subjects who have participated in the subcutaneous (SC) Treatment Period of Study IgPro20_3003 (NCT01545076) will have the option to receive open-label high-dose IgPro20 (0.4 g/kg bodyweight [bw]) weekly for 24 weeks. After this period, the IgPro20 dose will be reduced to low-dose IgPro20 (0.2 g/kg bw) weekly for 24 weeks. Subjects relapsing on high-dose IgPro20 will either remain on high dose or be discontinued, depending on investigator's judgment. Subjects relapsing on low-dose IgPro20 will either return to high-dose IgPro20 immediately or be discontinued, depending on investigator's judgment. Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.

The treatment duration will be up to 48 weeks, followed by a completion visit (week 49) and a follow-up phone call (week 53).


Condition Intervention Phase
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Biological: IgPro20
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of IgPro20 in Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Subjects Completing Study IgPro20_3003

Resource links provided by NLM:


Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • Overall rate of adverse events (AEs) per infusion - high-dose IgPro20 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
    Overall rate of AEs per infusion during high-dose IgPro20 treatment


Secondary Outcome Measures:
  • Rate of adverse events (AEs) per infusion by severity, causality, and seriousness - high-dose IgPro20 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with adverse events (AEs) - high-dose IgPro20 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
    Percentage of subjects with AEs, overall and by severity, causality and seriousness, during high-dose IgPro20 treatment.

  • Rate of adverse events (AEs) per infusion - low-dose IgPro20 [ Time Frame: Up to 28 weeks ] [ Designated as safety issue: Yes ]
    Rate of AEs per infusion, overall and by severity, causality and seriousness, during low-dose IgPro20 treatment

  • Percentage of subjects with adverse events (AEs) - low-dose IgPro20 [ Time Frame: Up to 28 weeks ] [ Designated as safety issue: Yes ]
    Percentage of subjects with AEs, overall and by severity, causality and seriousness, during low-dose IgPro20 treatment

  • Total Inflammatory Neuropathy Cause and Treatment (INCAT) score at all study visits [ Time Frame: Up to 49 weeks (baseline [Week 1], Weeks 2, 9, 17, 25, 33, 41, and at completion visit) ] [ Designated as safety issue: No ]
  • Time to first CIDP relapse [ Time Frame: Up to 49 weeks ] [ Designated as safety issue: No ]
    Time to first CIDP relapse based on adjusted INCAT score, using the Kaplan-Meier estimator. 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 only).


Estimated Enrollment: 70
Study Start Date: July 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IgPro20
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: for 24 weeks at 0.4 g/kg bw (high-dose IgPro20), then for 24 weeks at 0.2 g/kg bw (low-dose IgPro20). Subjects who experience CIDP relapse on high-dose IgPro20 will either continue on high-dose IgPro20 until week 48 or are withdrawn, according to investigator's judgment. Subjects who experience CIDP relapse on low-dose IgPro20 will return to high-dose IgPro20 immediately and will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment.
Biological: IgPro20

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects having participated in the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076).
  • Written informed consent for study participation obtained before undergoing any study-specific procedures.
  • If treatment for CIDP is required, it has to include Immunoglobulin G (IgGs).
  • Subjects who completed study IgPro20_3003 before study IgPro20_3004 study was open for enrollment at the site must be enrolled no later than 8 weeks after study IgPro20_3004 is open for enrollment at the site.
  • Subjects who completed study IgPro20_3003 after study IgPro20_3004 study was open for enrollment at the site must be enrolled no later than 8 weeks after the completion visit of study IgPro20_3003.

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 (normal human immunoglobulin for intravenous administration) and/or SCIG (subcutaneous immunoglobulin)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02027701

Locations
United States, North Carolina
The Neurologic Insitute
Charlotte, North Carolina, United States, 28210
Japan
Nagoya University Hospital
Nagoya, Japan, 466-8560
Sponsors and Collaborators
CSL Behring
Investigators
Principal Investigator: Prof. Dr. Ivo N. van Schaik Academic Medical Center, University of Amsterdam
  More Information

No publications provided

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT02027701     History of Changes
Other Study ID Numbers: IgPro20_3004, 2013-004157-24
Study First Received: January 3, 2014
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Demyelinating Diseases
Polyradiculoneuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014