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A Phase 3, Single-Arm, Multiple-Dose, Pharmacokinetic Comparability Trial Between TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
May 6, 2025
Primary Completion Date
June 25, 2028
Completion Date
June 25, 2028
Last Updated
January 20, 2026
59
ESTIMATED participants
TAK-881
BIOLOGICAL
HYQVIA
BIOLOGICAL
SC Investigational Needle Sets
DEVICE
Lead Sponsor
Takeda
Collaborators
NCT06538064
NCT03861481
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03864185