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

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027701
• Other study ID #: IgPro20_3004
• Secondary ID: 2013-004157-24
• Status: Completed
• Phase: Phase 3
• Start date: July 30, 2014
• Est. completion date: July 10, 2017

Study information

• Verified date: September 2018
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 10, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
• Polyneuropathies
• Polyradiculoneuropathy
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Biological:
• IgPro20

Locations

Country	Name	City	State
Australia	Site Reference 0360011	Fitzroy	Victoria
Australia	Site Reference 0360017	Woolloongabba	Queensland
Canada	Site Reference 1240007	Greenfield Park	Quebec
Canada	Site Reference 1240009	Toronto	Ontario
Czechia	Site Reference 2030002	Hradec Kralove
Czechia	Site Reference 2030009	Hradec Kralove
France	Site Reference 2500022	Nice Cedex 1
Germany	Site Reference 2760069	Berlin
Germany	Site Reference 2760072	Berlin
Germany	Site Reference 2760049	Bochum
Germany	Site Reference 2760052	Essen	Nordrhein-Westfalen
Germany	Site Reference 2760094	Essen
Germany	Site Reference 2760054	Hannover
Germany	Site Reference 2760055	Leipzig
Germany	Site Reference 2760047	Potsdam
Germany	Site Reference 2760039	Wurzburg
Italy	Site Reference 3800031	Milano
Japan	Site Reference 3920038	Chiba
Japan	Site Reference 3920061	Kanagawa
Japan	Site Reference 3920040	Nagoya
Japan	Site Reference 3920037	Tokorozawa	Saitama
Japan	Site Reference 3920065	Tokyo
Japan	Site Reference 3920035	Ube	Yamaguchi
Netherlands	Site Reference 5280001	Amsterdam
Spain	Site Reference 7240010	Barcelona
Spain	Site Reference 7240011	Barcelona
United Kingdom	Site Reference 8260019	London
United Kingdom	Site Reference 8260032	Salford
United States	Site Reference 8400181	Birmingham	Alabama
United States	Site Reference 8400182	Charlotte	North Carolina
United States	Site Reference 8400166	Kansas City	Kansas
United States	Site Reference 8400167	Los Angeles	California
United States	Site Reference 8400169	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  France,  Germany,  Italy,  Japan,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events (AEs) Per Infusion		Up to 49 weeks
Secondary	Time to First CIDP Relapse	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).	Up to 49 weeks
Secondary	Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score	The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 ("No upper limb problems") to 5 ("Inability to use either arm for any purposeful movement"), and scores for leg disability range from 0 ("Walking not affected") to 5 ("Restricted to wheelchair, unable to stand and walk a few steps with help"). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the "adjusted" INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.	Baseline and up to 49 weeks
Secondary	Change From Baseline in Medical Research Council (MRC) Score	An adapted version of the MRC sum score as published by Kleyweg and the RMC trial group was used. With the MRC sum score, the following 8 bilateral muscle pairs were assessed, and individual muscle scores as well as the sum score documented: Shoulder abduction; Elbow flexion; Wrist extension; Index finger abduction; Hip flexion; Knee extension; Foot dorsiflexion; Great toe dorsiflexion. The MRC sum score ranges from 0 (paralysis) to 80 (normal strength) points.	Baseline and up to 49 weeks
Secondary	Change From Baseline in Rasch-built Overall Disability Scale (R-ODS)	The R-ODS is a recently published outcome measure that captures activity and social participation in subjects with Guillain-Barré Syndrome, CIDP, and monoclonal gammopathy of uncertain significance. The 24-item questionnaire covers a wide range of tasks of daily life that are each to be rated as "impossible to perform", "able to perform with difficulty", or "easy to perform" (scale of 0 - 2 points respectively). Items are sorted in order of increasing difficulty to perform, based on data from subjects with peripheral neuropathies (chronic inflammatory demyelinating polyneuropathy, Guillain-Barré Syndrome, or monoclonal gammopathy of uncertain significance) and subjects recruited at the university outpatient clinics of Rotterdam and Maastricht.	Baseline and up to 49 weeks
Secondary	Change From Baseline in Mean Grip Strength	The hand-held Vigorimeter from Martin (Tuttlingen, Germany) is a device that measures the strength of small muscles in the hand, ie, grip strength. The subject squeezes a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure is recorded via a rubber tube on a nanometer and expressed in kilopascal (kPa). At each assessment, the subject squeezes 3 times with each hand.	Baseline and up to 49 weeks
Secondary	Percentage of Subjects With Adverse Events (AEs)		Up to 49 weeks
Secondary	Number of AEs by Severity Per Infusion		Up to 49 weeks
Secondary	Percentage of Subjects With AEs by Severity		Up to 49 weeks
Secondary	Number of Causally Related AEs Per Infusion		Up to 49 weeks
Secondary	Percentage of Subjects With Causally Related AEs		Up to 49 weeks
Secondary	Number of Serious AEs Per Infusion		Up to 49 weeks
Secondary	Percentage of Subjects With Serious AEs		Up to 49 weeks