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A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Sponsor: Takeda
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.
Official title: A Phase 3, Single-Arm, Multiple-Dose, Pharmacokinetic Comparability Trial Between TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
59
Start Date
2025-05-06
Completion Date
2028-06-25
Last Updated
2026-01-20
Healthy Volunteers
No
Interventions
TAK-881
Participants will receive SC infusion of TAK-881.
HYQVIA
Participants will receive SC infusion of HYQVIA.
SC Investigational Needle Sets
The single-use only SC needle set will be used to administer TAK-881/HYQVIA to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion.
Locations (52)
HonorHealth Neurology
Scottsdale, Arizona, United States
Stanford Neuroscience Health Center
Palo Alto, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Neurology Associates
Maitland, Florida, United States
Knight Neurology
Rockledge, Florida, United States
The Washington University
St Louis, Missouri, United States
NYU Langone Health
New York, New York, United States
University of North Carolina (UNC)
Chapel Hill, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic - Marquam Hill
Portland, Oregon, United States
Neurology Rare Disease Center
Denton, Texas, United States
The University of Vermont Medical Center
Burlington, Vermont, United States
BCN Research, LLC
Greenfield, Wisconsin, United States
INECO
Rosario, Santa Fe Province, Argentina
Instituto Argentino de Investigacion Neurologica (IADIN)
Buenos Aires, Argentina
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Copenhagen University Hospital
Copenhagen, Capital Region, Denmark
Aarhus Universitetshospital
Aarhus, Central Jutland, Denmark
Universitätsklinikum Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany
University of Ulm
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg
Marburg, Hesse, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Charite - Universitatsmedizin Berlin
Berlin, Germany
Attikon University General Hospital
Athens, Attica, Greece
University General Hospital of Patras
Patras, Peloponnese, Greece
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan, Lombardy, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Milano, Lombardia, Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, Torino, Piemonte, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, Italy
Ospedale San Martino
Genova, Italy
Az Ospedaliera Universitaria Policlinico G Martino
Messina, Italy
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Italy
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital
Nagoya, Aichi-ken, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Tohoku Medical and Pharmaceutical University Hospital
Sendai, Miyagi, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Higashimatsuyama Municipal Hospital
Higashi-Matsuyama, Saitama, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan
Tokushima University Hospital
Tokushima, Tokuchima, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Oddzial Kliniczny Neurologii
Krakow, Lesser Poland Voivodeship, Poland
Clinirem Sp zo.o.
Lublin, Lublin Voivodeship, Poland
Warszawski Uniwersytet Medyczny
Warsaw, Masovian Voivodeship, Poland
Copernicus Podmiot Leczniczy
Gdansk, Pomeranian Voivodeship, Poland
Hospital de La Santa Creu I San Pau
Barcelona, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götaland County, Sweden