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: July 2, 2015
Last verified: July 2015
  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 completed subcutaneous (SC) Week 25 or were successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076) will have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight [bw]) weekly for up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose IgPro20 (0.4 g/kg) 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 If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.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).


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 [ Time Frame: Up to 49 weeks ] [ Designated as safety issue: Yes ]
    Overall rate of AEs per infusion during IgPro20 treatment


Secondary Outcome Measures:
  • Rate of adverse events (AEs) per infusion by severity, causality, and seriousness [ Time Frame: Up to 49 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with AEs, overall and by severity, causality and seriousness [ Time Frame: Up to 49 weeks ] [ Designated as safety issue: Yes ]
  • Rate of adverse events (AEs) per infusion by severity, causality, and seriousness by IgPro20 dose level [ Time Frame: Up to 49 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with adverse events (AEs) by severity, causality, and seriousness by IgPro20 dose level [ Time Frame: Up to 49 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in total adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) score [ Time Frame: Up to 49 weeks (baseline [Week 1], Weeks 2, 9, 25, 33, 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).

  • Change from baseline in Medical Research Council (MRC) score [ Time Frame: Up to 49 weeks (baseline [Week 1], Weeks 2, 9, 25, 33, and at completion visit) ] [ Designated as safety issue: No ]
  • Change from baseline in Rasch-built Overall Disability Scale (R-ODS) [ Time Frame: Up to 49 weeks (baseline [Week 1], Weeks 2, 9, 25, 33, and at completion visit) ] [ Designated as safety issue: No ]
  • Change from baseline in mean grip strength [ Time Frame: Up to 49 weeks (baseline [Week 1], Weeks 2, 9, 25, 33, and at completion visit) ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 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: 0.2 g/kg bw (low-dose IgPro20) for up to 48 weeks. Subjects who experience CIDP relapse on 0.2 g/kg IgPro20 will have an increase to 0.4 g/kg 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 completed the pivotal study IgPro20_3003 (SC Week 25) or successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076).
  • Written informed consent for study participation obtained before undergoing any study-specific procedures.

Exclusion Criteria:

  • Subject is unable to directly transition from study IgPro20_3003.
  • New medical condition and/or social behavior (ie, alcohol, drug, or medication abuse) during participation in study IgPro20_3003 that in the judgment of the investigator could increase risk to the subject, interfere with the evaluation of investigational medicinal product, and/or conduct of the study.
  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, Alabama
Site Reference 8400181
Birmingham, Alabama, United States, 35294-0017
United States, California
Site Reference 8400167
Los Angeles, California, United States, 90033
United States, Kansas
Site Reference 8400166
Kansas City, Kansas, United States, 66160
United States, New York
Site Reference 8400169
New York, New York, United States, 10021
United States, North Carolina
Site Reference 8400182
Charlotte, North Carolina, United States, 28210
Australia, Victoria
Site Reference 0360011
Fitzroy, Victoria, Australia, 3065
Canada, Quebec
Site Reference 1240007
Greenfield Park, Quebec, Canada, J4V2J2
Finland
Site Reference 2460002
Helsinki, Finland, 00290
Germany
Site Reference 2760052
Essen, Nordrhein-Westfalen, Germany, 45117
Site Reference 2760069
Berlin, Germany, 10117
Site Reference 2760072
Berlin, Germany, 12200
Site Reference 2760049
Bochum, Germany, 44791
Site Reference 2760055
Leipzig, Germany, DE04103
Site Reference 2760047
Potsdam, Germany, 14471
Italy
Site Reference 3800031
Milano, Italy, 20133
Japan
Site Reference 3920061
Sagamihara, Kanagawa, Japan, 228-8555
Site Reference 3920040
Nagoya, Japan, 466-8560
Netherlands
Site Reference 5280001
Amsterdam, Netherlands, 1105
Spain
Site Reference 7240010
Hospitalet de Llobregat, Barcelona, Spain, 08907
Site Reference 7240011
Barcelona, Spain, 08035
United Kingdom
Site Reference 8260019
London, United Kingdom, WC1N 3BG
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: July 2, 2015
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency
Germany: Paul-Ehrlich-Institut
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Finland: Finnish National Agency for Medicines
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

ClinicalTrials.gov processed this record on July 30, 2015