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
  Purpose

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.


Condition Intervention Phase
Chronic Inflammatory Demyelinating Polyneuropathy
Polyradiculoneuropathy
Biological: IgPro20
Biological: Placebo
Biological: IgPro10
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study

Resource links provided by NLM:


Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 350
Study Start Date: March 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IgPro20 low dose 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: 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 high dose 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: 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.
Placebo Comparator: Placebo 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.

  Eligibility

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

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
  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: NCT01545076

Contacts
Contact: Use Central Contact clinicaltrials@cslbehring.com

  Hide Study Locations
Locations
United States, Alabama
Site reference 8400181 Recruiting
Birmingham, Alabama, United States, 35233
United States, Arizona
Site reference 8400172 Withdrawn
Phoenix, Arizona, United States, 85018
Site reference 8400173 Recruiting
Phoenix, Arizona, United States, 85013
United States, California
Site reference 8400167 Recruiting
Los Angeles, California, United States, 90033
Site reference 8400170 Recruiting
Orange, California, United States, 92868
United States, Colorado
Site reference 8400077 Recruiting
Centennial, Colorado, United States, 80112
United States, Florida
Site reference 8400165 Withdrawn
Jacksonville, Florida, United States, 32209
Site reference 8400214 Recruiting
Miami, Florida, United States, 33136
United States, Illinois
Site reference 8400162 Recruiting
Chicago, Illinois, United States, 60611
United States, Indiana
Site Reference 8400215 Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
Site reference 8400166 Recruiting
Kansas City, Kansas, United States, 66160
United States, Minnesota
Site Reference 8400247 Recruiting
Minneapolis, Minnesota, United States, 55454
United States, New York
Site reference 8400207 Recruiting
New York, New York, United States, 10032
Site reference 8400169 Recruiting
New York, New York, United States, 10021
Site reference 8400179 Recruiting
New York, New York, United States, 10021
United States, North Carolina
Site reference 8400182 Recruiting
Charlotte, North Carolina, United States, 28204
United States, Ohio
Site reference 8400178 Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Site reference 8400217 Recruiting
Oklahoma, Oklahoma, United States, 73104
United States, Tennessee
Site Reference 8400177 Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Site reference 8400164 Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Site Reference 8400268 Recruiting
Charlottesville, Virginia, United States, 22908
Australia, Queensland
Site Reference 0360017 Recruiting
Herston, Queensland, Australia, 4029
Australia, Victoria
Site reference 0360011 Recruiting
Fitzroy, Victoria, Australia
Australia
Site reference 0360008 Recruiting
Southport, Australia
Site reference 0360016 Recruiting
Sydney, Australia
Austria
Site reference 0400009 Withdrawn
Innsbruck, Austria
Site reference 0400010 Withdrawn
Senftenberg, Austria
Belgium
Site reference 0560003 Recruiting
Leuven, Belgium
Canada
Site reference 1240008 Withdrawn
Calgary, Canada
Site reference 1240006 Recruiting
Edmonton, Canada
Site reference 1240010 Recruiting
Montreal, Canada
Site reference 1240007 Recruiting
Quebec, Canada
Site reference 1240009 Recruiting
Toronto, Canada
Czech Republic
Site reference 2030009 Recruiting
Hradec Kralove, Czech Republic
Site reference 2030002 Recruiting
Hradec Kralove, Czech Republic
Site reference 2030003 Recruiting
Prague, Czech Republic
Finland
Site reference 2460002 Recruiting
Helsinki, Finland
Site reference 2460004 Recruiting
Tampere, Finland
France
Site reference 2500024 Recruiting
Clermont-Ferrand, France
Site reference 2500013 Recruiting
Marseille, France
Site reference 2500021 Withdrawn
Nancy, France
Site reference 2500022 Recruiting
Nice, France
Site reference 2500023 Withdrawn
Paris, France
Site reference 2500019 Recruiting
Pessac, France
Germany
Site reference 2760069 Recruiting
Berlin, Germany
Site reference 2760072 Recruiting
Berlin, Germany
Site reference 2760048 Recruiting
Berlin, Germany
Site reference 2760049 Recruiting
Bochum, Germany
Site reference 2760075 Recruiting
Duesseldorf, Germany
Site reference 2760052 Recruiting
Essen, Germany
Site Reference 2760094 Enrolling by invitation
Essen, Germany, 45122
Site reference 2760053 Recruiting
Goettingen, Germany
Site reference 2760036 Recruiting
Goettingen, Germany
Site reference 2760054 Recruiting
Hannover, Germany
Site reference 2760080 Recruiting
Koeln, Germany
Site reference 2760055 Recruiting
Leipzig, Germany
Site reference 2760073 Recruiting
Marburg, Germany
Site reference 2760057 Withdrawn
Muenster, Germany
Site reference 2760047 Recruiting
Potsdam, Germany
Site reference 2760039 Recruiting
Wuerzburg, Germany
Israel
Site reference 3760005 Recruiting
Haifa, Israel
Site reference 3760006 Recruiting
Kfar Saba, Israel
Site reference 3760002 Recruiting
Tel Aviv, Israel
Italy
Site reference 3800026 Recruiting
Chieti, Italy
Site reference 3800027 Recruiting
Firenze, Italy
Site reference 3800028 Recruiting
Genova, Italy
Site reference 3800029 Withdrawn
La Spezia, Italy
Site reference 3800031 Recruiting
Milano, Italy
Site reference 3800032 Recruiting
Milano, Italy
Site reference 3800041 Recruiting
Monza, Italy
Site reference 3800034 Recruiting
Novara, Italy
Site reference 3800036 Recruiting
Roma, Italy
Site reference 3800035 Recruiting
Roma, Italy
Site reference 3800030 Recruiting
Rozzano (Milano), Italy
Site reference 3800037 Recruiting
Torino, Italy
Japan
Site reference 3920040 Recruiting
Aichi, Japan
Site reference 3920042 Recruiting
Aomori, Japan
Site Reference 3920040 Recruiting
Aomori, Japan, 030-8553
Site Reference 3920042 Recruiting
Aomori, Japan, 030-8553
Site reference 3920038 Recruiting
Chiba, Japan
Site reference 3920061 Recruiting
Kanagawa, Japan
Site reference 3920045 Recruiting
Matsumoto, Japan
Site reference 3920058 Recruiting
Osaka, Japan
Site reference 3920037 Recruiting
Saitama, Japan
Site reference 3920034 Recruiting
Tokushima, Japan
Site reference 3920032 Recruiting
Tokyo, Japan
Site Reference 3920062 Recruiting
Tokyo, Japan, 187-8551
Site Reference 3920065 Recruiting
Tokyo, Japan, 113-8431
Site reference 3920035 Recruiting
Yamaguchi, Japan
Netherlands
Site reference 5280001 Recruiting
Amsterdam, Netherlands
Site reference 5280005 Recruiting
Maastricht, Netherlands
Site reference 5280004 Recruiting
Utrecht, Netherlands
Spain
Site reference 7240011 Recruiting
Barcelona, Spain
Site reference 7240010 Recruiting
Barcelona, Spain
Site reference 7240014 Recruiting
Madrid, Spain
Site reference 7240013 Recruiting
Madrid, Spain
Site reference 7240016 Recruiting
Sevilla, Spain
Site reference 7240017 Recruiting
Valencia, Spain
United Kingdom
Site reference 8260019 Recruiting
London, United Kingdom
Site Reference 8260032 Recruiting
Manchester, United Kingdom, M6 8HD
Sponsors and Collaborators
CSL Behring
ICON Clinical Research
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: NCT01545076     History of Changes
Other Study ID Numbers: IgPro20_3003
Study First Received: March 1, 2012
Last Updated: July 14, 2014
Health Authority: Australia: Human Research Ethics Committee
Austria: Austrian Medicines and Medical Devices Agency
Belgium: Ministry of Social Affairs, Public Health and the Environment
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Finland: Ministry of Social Affairs and Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014