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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Site reference 0360008, Southport, Australia; Recruiting
Site reference 0360016, Sydney, Australia; Withdrawn
Site reference 0400009, Innsbruck, Austria; Withdrawn
Site reference 0400010, Senftenberg, Austria; Withdrawn
Site reference 0560003, Leuven, Belgium; Recruiting
Site reference 1240008, Calgary, Canada; Withdrawn
Site reference 1240006, Edmonton, Canada; Recruiting
Site reference 1240010, Montreal, Canada; Withdrawn
Site reference 1240007, Quebec, Canada; Recruiting
Site reference 1240009, Toronto, Canada; Recruiting
Site reference 2030002, Hradec Kralove, Czech Republic; Recruiting
Site reference 2030009, Hradec Kralove, Czech Republic; Recruiting
Site reference 2030003, Prague, Czech Republic; Recruiting
Site reference 2460002, Helsinki, Finland; Recruiting
Site reference 2460004, Tampere, Finland; Withdrawn
Site reference 2500024, Clermont-Ferrand, France; Recruiting
Site reference 2500013, Marseille, France; Recruiting
Site reference 2500021, Nancy, France; Withdrawn
Site reference 2500022, Nice, France; Recruiting
Site reference 2500023, Paris, France; Withdrawn
Site reference 2500019, Pessac, France; Recruiting
Site reference 2760048, Berlin, Germany; Recruiting
Site reference 2760069, Berlin, Germany; Recruiting
Site reference 2760072, Berlin, Germany; Recruiting
Site reference 2760049, Bochum, Germany; Recruiting
Site reference 2760075, Duesseldorf, Germany; Recruiting
Site reference 2760052, Essen, Germany; Recruiting
Site Reference 2760094, Essen 45122, Germany; Recruiting
Site reference 2760036, Goettingen, Germany; Recruiting
Site reference 2760053, Goettingen, Germany; Recruiting
Site reference 2760054, Hannover, Germany; Recruiting
Site Reference 2760113, Ibbenbueren 49477, Germany; Recruiting
Use Central Contact
Site reference 2760080, Koeln, Germany; Recruiting
Site reference 2760055, Leipzig, Germany; Recruiting
Site reference 2760073, Marburg, Germany; Withdrawn
Site reference 2760057, Muenster, Germany; Withdrawn
Site reference 2760047, Potsdam, Germany; Recruiting
Site reference 2760039, Wuerzburg, Germany; Recruiting
Site reference 3760005, Haifa, Israel; Recruiting
Site reference 3760006, Kfar Saba, Israel; Withdrawn
Site reference 3760002, Tel Aviv, Israel; Recruiting
Site reference 3800026, Chieti, Italy; Recruiting
Site reference 3800027, Firenze, Italy; Recruiting
Site reference 3800028, Genova, Italy; Recruiting
Site reference 3800029, La Spezia, Italy; Withdrawn
Site reference 3800031, Milano, Italy; Recruiting
Site reference 3800032, Milano, Italy; Withdrawn
Site reference 3800041, Monza, Italy; Withdrawn
Site reference 3800034, Novara, Italy; Withdrawn
Site reference 3800035, Roma, Italy; Recruiting
Site reference 3800036, Roma, Italy; Recruiting
Site reference 3800030, Rozzano (Milano), Italy; Recruiting
Site reference 3800037, Torino, Italy; Recruiting
Site Reference 3920040, Aomori 030-8553, Japan; Recruiting
Site Reference 3920042, Aomori 030-8553, Japan; Recruiting
Site reference 3920038, Chiba, Japan; Recruiting
Site reference 3920061, Kanagawa, Japan; Recruiting
Site reference 3920045, Matsumoto, Japan; Recruiting
Site reference 3920058, Osaka, Japan; Recruiting
Site reference 3920037, Saitama, Japan; Recruiting
Site reference 3920034, Tokushima, Japan; Recruiting
Site reference 3920032, Tokyo, Japan; Recruiting
Site Reference 3920062, Tokyo 187-8551, Japan; Recruiting
Site Reference 3920065, Tokyo 113-8431, Japan; Recruiting
Site reference 3920035, Yamaguchi, Japan; Recruiting
Site reference 5280001, Amsterdam, Netherlands; Recruiting
Site reference 5280005, Maastricht, Netherlands; Recruiting
Site reference 5280004, Utrecht, Netherlands; Recruiting
Site reference 7240010, Barcelona, Spain; Recruiting
Site reference 7240011, Barcelona, Spain; Recruiting
Site reference 7240013, Madrid, Spain; Recruiting
Site reference 7240014, Madrid, Spain; Recruiting
Site reference 7240016, Sevilla, Spain; Recruiting
Site reference 7240017, Valencia, Spain; Withdrawn
Site reference 8260019, London, United Kingdom; Recruiting
Site Reference 8260032, Manchester M6 8HD, United Kingdom; Recruiting
Site reference 8400181, Birmingham, Alabama 35233, United States; Recruiting
Site reference 8400172, Phoenix, Arizona 85018, United States; Recruiting
Site reference 8400173, Phoenix, Arizona 85013, United States; Recruiting
Site reference 8400167, Los Angeles, California 90033, United States; Recruiting
Site reference 8400170, Orange, California 92868, United States; Withdrawn
Site reference 8400077, Centennial, Colorado 80112, United States; Recruiting
Site Reference 8400352, Washington, District of Columbia 20037, United States; Recruiting
Use Central Contact
Site reference 8400165, Jacksonville, Florida 32209, United States; Withdrawn
Site reference 8400214, Miami, Florida 33136, United States; Recruiting
Site reference 8400162, Chicago, Illinois 60611, United States; Recruiting
Site Reference 8400215, Indianapolis, Indiana 46202, United States; Recruiting
Site reference 8400166, Kansas City, Kansas 66160, United States; Recruiting
Site Reference 8400347, New Brunswick, New Jersey 08901, United States; Recruiting
Use Central Contact
Site reference 8400169, New York, New York 10021, United States; Recruiting
Site reference 8400179, New York, New York 10021, United States; Recruiting
Site reference 8400207, New York, New York 10032, United States; Withdrawn
Site reference 8400182, Charlotte, North Carolina 28204, United States; Recruiting
Site reference 8400178, Columbus, Ohio 43210, United States; Recruiting
Site reference 8400217, Oklahoma, Oklahoma 73104, United States; Recruiting
Site Reference 0360017, Herston, Queensland 4029, Australia; Recruiting
Site reference 8400164, Houston, Texas 77030, United States; Recruiting
Site reference 0360011, Fitzroy, Victoria, Australia; Recruiting