A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Baseline-Uncorrected Area Under the Curve During the Dosing Interval at Steady-State (AUC0-tau;ss) Based on Total Immunoglobulin G (IgG) Levels — 3-Week dosing: Day 1 (pre- and post-infusion), 24, 72, 120 hours and 7, 14, 17, 21 days (post-infusion); 4-Week dosing: Day 1 (pre- and post-infusion), 24, 72, 120 hours and 7, 14, 21, 28 days (post-infusion) of last infusion
Trial sites (52)
| Facility | City | Region | Status |
|---|---|---|---|
| HonorHealth Neurology | Scottsdale | Arizona | Recruiting |
| Stanford Neuroscience Health Center | Palo Alto | California | Not Yet Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | Not Yet Recruiting |
| Neurology Associates | Maitland | Florida | Recruiting |
| Knight Neurology | Rockledge | Florida | Recruiting |
| The Washington University | St Louis | Missouri | Not Yet Recruiting |
| NYU Langone Health | New York | New York | Recruiting |
| University of North Carolina (UNC) | Chapel Hill | North Carolina | Recruiting |
| Duke University Hospital | Durham | North Carolina | Recruiting |
| Raleigh Neurology Associates | Raleigh | North Carolina | Recruiting |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Not Yet Recruiting |
| Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic - Marquam Hill | Portland | Oregon | Not Yet Recruiting |
| Neurology Rare Disease Center | Denton | Texas | Recruiting |
| The University of Vermont Medical Center | Burlington | Vermont | Not Yet Recruiting |
| BCN Research, LLC | Greenfield | Wisconsin | Recruiting |
| INECO | Rosario | Santa Fe Province | Not Yet Recruiting |
| Instituto Argentino de Investigacion Neurologica (IADIN) | Buenos Aires | Argentina | Not Yet Recruiting |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | Czechia | Not Yet Recruiting |
| Copenhagen University Hospital | Copenhagen | Capital Region | Not Yet Recruiting |
| Aarhus Universitetshospital | Aarhus | Central Jutland | Recruiting |
| Universitätsklinikum Mannheim GmbH | Mannheim | Baden-Wurttemberg | Not Yet Recruiting |
| University of Ulm | Ulm | Baden-Wurttemberg | Not Yet Recruiting |
| Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg | Marburg | Hesse | Not Yet Recruiting |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | Not Yet Recruiting |
| Charite - Universitatsmedizin Berlin | Berlin | Germany | Not Yet Recruiting |
| Attikon University General Hospital | Athens | Attica | Not Yet Recruiting |
| University General Hospital of Patras | Patras | Peloponnese | Not Yet Recruiting |
| Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele | Milan | Lombardy | Not Yet Recruiting |
| IRCCS Istituto Clinico Humanitas | Rozzano | Milano, Lombardia | Not Yet Recruiting |
| Azienda Ospedaliero - Universitaria San Luigi Gonzaga | Orbassano | Torino, Piemonte | Not Yet Recruiting |
| ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia | Brescia | Italy | Not Yet Recruiting |
| Ospedale San Martino | Genova | Italy | Not Yet Recruiting |
| Az Ospedaliera Universitaria Policlinico G Martino | Messina | Italy | Not Yet Recruiting |
| Fondazione Istituto Neurologico Casimiro Mondino | Pavia | Italy | Not Yet Recruiting |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | Not Yet Recruiting |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Rome | Italy | Not Yet Recruiting |
| Japan Organization of Occupational Health and Safety Chubu Rosai Hospital | Nagoya | Aichi-ken | Not Yet Recruiting |
| Kumamoto University Hospital | Kumamoto | Kumamoto | Recruiting |
| Tohoku Medical and Pharmaceutical University Hospital | Sendai | Miyagi | Not Yet Recruiting |
+ 12 more sites — see the full list on the official registry below.
More Takeda trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06747351 on ClinicalTrials.gov ↗ ← All trials in Spain