Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Inflammatory Demyelinating Polyneuropathy, Polyradiculoneuropathy

In brief

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 who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by 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.

Key facts

Study ID

NCT01545076

Run by

CSL Behring

People needed

208

Starts

2012-03-01

Expected to finish

2016-09-01

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.
• 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.

You may not qualify if…

• 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

Where it is running

• Site reference 8400173 — Phoenix, Arizona, United States
• Site reference 8400172 — Phoenix, Arizona, United States
• Site reference 8400167 — Los Angeles, California, United States
• Site reference 8400077 — Centennial, Colorado, United States
• Site Reference 8400352 — Washington D.C., District of Columbia, United States
• Site reference 8400214 — Miami, Florida, United States
• Site reference 8400162 — Chicago, Illinois, United States
• Site Reference 8400247 — Chicago, Illinois, United States
• Site Reference 8400215 — Indianapolis, Indiana, United States
• Site reference 8400166 — Kansas City, Kansas, United States
• Site Reference 8400347 — New Brunswick, New Jersey, United States
• Site reference 8400169 — New York, New York, United States
• Site reference 8400179 — New York, New York, United States
• Site reference 8400182 — Charlotte, North Carolina, United States
• Site Reference 8400346 — Durham, North Carolina, United States
• Site reference 8400178 — Columbus, Ohio, United States
• Site reference 8400217 — Oklahoma City, Oklahoma, United States
• Site Reference 8400177 — Nashville, Tennessee, United States
• Site reference 8400164 — Houston, Texas, United States
• Site Reference 8400268 — Charlottesville, Virginia, United States
• Site Reference 8400340 — Seattle, Washington, United States
• Site Reference 0360017 — Herston, Queensland, Australia
• Site reference 0360011 — Fitzroy, Victoria, Australia
• Site reference 0360008 — Southport, Australia
• Site reference 8400181 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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