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RECRUITING
NCT06747351
PHASE3

A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Sponsor: Takeda

View on ClinicalTrials.gov

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

BIOLOGICAL

TAK-881

Participants will receive SC infusion of TAK-881.

BIOLOGICAL

HYQVIA

Participants will receive SC infusion of HYQVIA.

DEVICE

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