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

NCT02027701 | Completed Phase 3 Results DMC

• 2 other identifiers: IgPro20_30042013-004157-24
• Study Type: interventional
• Target: 82
• Locations: 11 countries
• Sites: 33

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 If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.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

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events (AEs) Per Infusion

  Up to 49 weeks

Secondary Outcomes (12)

• Time to First CIDP Relapse

  Up to 49 weeks

• Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score

  Baseline and up to 49 weeks

• Change From Baseline in Medical Research Council (MRC) Score

  Baseline and up to 49 weeks

• Change From Baseline in Rasch-built Overall Disability Scale (R-ODS)

  Baseline and up to 49 weeks

• Change From Baseline in Mean Grip Strength

  Baseline and up to 49 weeks

Study Arms (1)

IgPro20

EXPERIMENTAL

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

Interventions

IgPro20 BIOLOGICAL

IgPro20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (33)

Site Reference 8400181

Birmingham, Alabama, 35294-0017, United States

Location

Site Reference 8400167

Los Angeles, California, 90033, United States

Location

Site Reference 8400166

Kansas City, Kansas, 66160, United States

Location

Site Reference 8400169

New York, New York, 10021, United States

Location

Site Reference 8400182

Charlotte, North Carolina, 28210, United States

Location

Site Reference 0360017

Woolloongabba, Queensland, 4102, Australia

Location

Site Reference 0360011

Fitzroy, Victoria, 3065, Australia

Location

Site Reference 1240009

Toronto, Ontario, M5G 2C4, Canada

Location

Site Reference 1240007

Greenfield Park, Quebec, J4V2J2, Canada

Location

Site Reference 2030009

Hradec Králové, 50003, Czechia

Location

Site Reference 2030002

Hradec Králové, 50005, Czechia

Location

Site Reference 2500022

Nice, 06002, France

Location

Site Reference 2760052

Essen, North Rhine-Westphalia, 45117, Germany

Location

Site Reference 2760069

Berlin, 10117, Germany

Location

Site Reference 2760072

Berlin, 12200, Germany

Location

Site Reference 2760049

Bochum, 44791, Germany

Location

Site Reference 2760094

Essen, 45147, Germany

Location

Site Reference 2760054

Hanover, 30625, Germany

Location

Site Reference 2760055

Leipzig, DE04103, Germany

Location

Site Reference 2760047

Potsdam, 14471, Germany

Location

Site Reference 2760039

Würzburg, 97080, Germany

Location

Site Reference 3800031

Milan, 20133, Italy

Location

Site Reference 3920037

Tokorozawa, Saitama, 359-8513, Japan

Location

Site Reference 3920035

Ube, Yamaguchi, 755-8505, Japan

Location

Site Reference 3920038

Chiba, 260-8677, Japan

Location

Site Reference 3920061

Kanagawa, 228-8555, Japan

Location

Site Reference 3920040

Nagoya, 466-8560, Japan

Location

Site Reference 3920065

Tokyo, 113-8431, Japan

Location

Site Reference 5280001

Amsterdam, 1105, Netherlands

Location

Site Reference 7240011

Barcelona, 08035, Spain

Location

Site Reference 7240010

Barcelona, 08907, Spain

Location

Site Reference 8260019

London, WC1N 3BG, United Kingdom

Location

Site Reference 8260032

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Hizentra

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: CSL Behring

clinicaltrials@cslbehring.com

Use email contact

Study Officials

• Prof. Dr. Ivo N. van Schaik

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 6, 2014
• Study Start: July 30, 2014
• Primary Completion: July 10, 2017
• Study Completion: July 10, 2017
• Last Updated: October 2, 2018
• Results First Posted: October 2, 2018

Record last verified: 2018-09

Locations

CA (2); JP (6); IT (1); ES (2); DE (9); GB (2); AU (2); FR (1); CZ (2); US (5); NL (1)