A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Start Date
5/6/2025
Completion Date
6/25/2028
Summary
The main aim of this study is to evaluate the pharmacokinetic (PK) comparability between TAK-881 and HYQVIA subcutaneous (SC) administration for maintenance therapy of CIDP. The participants who are already receiving intravenous immunoglobulin G (IGIV), conventional subcutaneous intravenous immunoglobulin G (cIGSC), or HYQVIA will be treated with the same dose equivalent as their prior IG treatment with HYQVIA for 20 weeks followed by TAK-881 for 24 weeks. Participants will need to visit the clinic every 3 or 4 weeks until they enter the extension phase. In the extension phase, home infusions are allowed, and visits will occur between every 12 weeks and 24 weeks.
Detailed Description
The study includes a screening phase, a ramp-up phase (if needed), a HYQVIA treatment phase, a TAK-881 treatment phase, and an extension phase. Participants who have been receiving cIGSC or IGIV prior to the study will enter a HYQVIA ramp-up phase, starting 1 to 2 weeks after their last pre-study cIGSC or IGIV dose. Participants already on HYQVIA at the time of screening will proceed directly to the treatment phase. After the TAK-881 dosing phase, participants will move on to the TAK-881 extension phase, with the preference for subsequent infusions in the extension phase to be administered by the participant or caregiver at home.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
TAK-881
HYQVIA
SC Investigational Needle Sets
Conditions
Locations
HonorHealth Neurology
Scottsdale, Arizona 85251
United States
Stanford Neuroscience Health Center
Palo Alto, California 94304
United States
Yale University School of Medicine
New Haven, Connecticut 06510
United States
Neurology Associates
Maitland, Florida 32751
United States
Knight Neurology
Rockledge, Florida 32955
United States
The Washington University
St Louis, Missouri 63130
United States
NYU Langone Health
New York, New York 10016
United States
University of North Carolina (UNC)
Chapel Hill, North Carolina 27599
United States
Duke University Hospital
Durham, North Carolina 27710
United States
Raleigh Neurology Associates
Raleigh, North Carolina 27607
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic - Marquam Hill
Portland, Oregon 97239
United States
Neurology Rare Disease Center
Denton, Texas 76208
United States
The University of Vermont Medical Center
Burlington, Vermont 05401
United States
BCN Research, LLC
Greenfield, Wisconsin 53228
United States
INECO
Rosario, Santa Fe Province 2000
Argentina
Instituto Argentino de Investigacion Neurologica (IADIN)
Buenos Aires, C1015ABR
Argentina
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Czechia
Copenhagen University Hospital
Copenhagen, Capital Region 2100d
Denmark
Aarhus Universitetshospital
Aarhus, Central Jutland 8200
Denmark
Universitätsklinikum Mannheim GmbH
Mannheim, Baden-Wurttemberg 68167
Germany
University of Ulm
Ulm, Baden-Wurttemberg 89081
Germany
Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg
Marburg, Hesse 35043
Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony 30625
Germany
Charite - Universitatsmedizin Berlin
Berlin, 12203
Germany
Attikon University General Hospital
Athens, Attica 12462
Greece
University General Hospital of Patras
Patras, Peloponnese 26504
Greece
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan, Lombardy 20132
Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Milano, Lombardia 20089
Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, Torino, Piemonte 10043
Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, 25123
Italy
Ospedale San Martino
Genova, 16132
Italy
Az Ospedaliera Universitaria Policlinico G Martino
Messina, 98125
Italy
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, 27100
Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, 00133
Italy
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital
Nagoya, Aichi-ken 455-8530
Japan
Kumamoto University Hospital
Kumamoto, Kumamoto 860-8556
Japan
Tohoku Medical and Pharmaceutical University Hospital
Sendai, Miyagi 981-8558
Japan
Nara Medical University Hospital
Kashihara, Nara 634-8522
Japan
Higashimatsuyama Municipal Hospital
Higashi-Matsuyama, Saitama 355-0005
Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga 520-2192
Japan
Tokushima University Hospital
Tokushima, Tokuchima 770-8503
Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo 113-8431
Japan
Oddzial Kliniczny Neurologii
Krakow, Lesser Poland Voivodeship 30-688
Poland
Clinirem Sp zo.o.
Lublin, Lublin Voivodeship 20-064
Poland
Warszawski Uniwersytet Medyczny
Warsaw, Masovian Voivodeship 02-097
Poland
Copernicus Podmiot Leczniczy
Gdansk, Pomeranian Voivodeship 80-462
Poland
Hospital de La Santa Creu I San Pau
Barcelona, 08041
Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götaland County 41345
Sweden