Clinical trial NCT02027701: Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2014-01-06
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.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).


Eligibility 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.

Primary outcomes:
measure: Number of Adverse Events (AEs) Per Infusion
timeFrame: Up to 49 weeks
Secondary outcomes:
measure: Time to First CIDP Relapse
timeFrame: Up to 49 weeks
measure: Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score
timeFrame: Baseline and up to 49 weeks
measure: Change From Baseline in Medical Research Council (MRC) Score
timeFrame: Baseline and up to 49 weeks
measure: Change From Baseline in Rasch-built Overall Disability Scale (R-ODS)
timeFrame: Baseline and up to 49 weeks
measure: Change From Baseline in Mean Grip Strength
timeFrame: Baseline and up to 49 weeks
measure: Percentage of Subjects With Adverse Events (AEs)
timeFrame: Up to 49 weeks
measure: Number of AEs by Severity Per Infusion
timeFrame: Up to 49 weeks
measure: Percentage of Subjects With AEs by Severity
timeFrame: Up to 49 weeks
measure: Number of Causally Related AEs Per Infusion
timeFrame: Up to 49 weeks
measure: Percentage of Subjects With Causally Related AEs
timeFrame: Up to 49 weeks
measure: Number of Serious AEs Per Infusion
timeFrame: Up to 49 weeks
measure: Percentage of Subjects With Serious AEs
timeFrame: Up to 49 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site Reference 8400181
state: Alabama
city: Los Angeles
country: United States
facility: Site Reference 8400167
state: California
city: Kansas City
country: United States
facility: Site Reference 8400166
state: Kansas
city: New York
country: United States
facility: Site Reference 8400169
state: New York
city: Charlotte
country: United States
facility: Site Reference 8400182
state: North Carolina
city: Woolloongabba
country: Australia
facility: Site Reference 0360017
state: Queensland
city: Fitzroy
country: Australia
facility: Site Reference 0360011
state: Victoria
city: Toronto
country: Canada
facility: Site Reference 1240009
state: Ontario
city: Greenfield Park
country: Canada
facility: Site Reference 1240007
state: Quebec
city: Hradec Kralove
country: Czechia
facility: Site Reference 2030009
city: Hradec Kralove
country: Czechia
facility: Site Reference 2030002
city: Nice Cedex 1
country: France
facility: Site Reference 2500022
city: Essen
country: Germany
facility: Site Reference 2760052
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Site Reference 2760069
city: Berlin
country: Germany
facility: Site Reference 2760072
city: Bochum
country: Germany
facility: Site Reference 2760049
city: Essen
country: Germany
facility: Site Reference 2760094
city: Hannover
country: Germany
facility: Site Reference 2760054
city: Leipzig
country: Germany
facility: Site Reference 2760055
city: Potsdam
country: Germany
facility: Site Reference 2760047
city: Wurzburg
country: Germany
facility: Site Reference 2760039
city: Milano
country: Italy
facility: Site Reference 3800031
city: Tokorozawa
country: Japan
facility: Site Reference 3920037
state: Saitama
city: Ube
country: Japan
facility: Site Reference 3920035
state: Yamaguchi
city: Chiba
country: Japan
facility: Site Reference 3920038
city: Kanagawa
country: Japan
facility: Site Reference 3920061
city: Nagoya
country: Japan
facility: Site Reference 3920040
city: Tokyo
country: Japan
facility: Site Reference 3920065
city: Amsterdam
country: Netherlands
facility: Site Reference 5280001
city: Barcelona
country: Spain
facility: Site Reference 7240011
city: Barcelona
country: Spain
facility: Site Reference 7240010
city: London
country: United Kingdom
facility: Site Reference 8260019
city: Salford
country: United Kingdom
facility: Site Reference 8260032
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Prof. Dr. Ivo N. van Schaik
role: PRINCIPAL_INVESTIGATOR
References: