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NCT06747351 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
A Phase 3 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), sponsored by Takeda.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 59
- Enrollment target
- 20
- Study locations
NCT06747351: Recruiting Phase 3 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), sponsored by Takeda.
NCT06747351 is a Phase 3 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) that is actively recruiting participants, run by Takeda. The registered enrollment target is 59 participants, above the 33-participant average among 3 other Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) trials with a reported enrollment target (79% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06747351, a Phase 3 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 59 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- BIOLOGICAL TAK-881
- BIOLOGICAL HYQVIA
- DEVICE SC Investigational Needle Sets
Study Locations (20)
North Carolina
- University of North Carolina (UNC) - Chapel Hill
- Duke University Hospital - Durham
- Raleigh Neurology Associates - Raleigh
- Atrium Health Wake Forest Baptist - Winston-Salem
Florida
- Neurology Associates - Maitland
- Knight Neurology - Rockledge
Other
- Instituto Argentino de Investigacion Neurologica (IADIN) - Buenos Aires
- Fakultni nemocnice Hradec Kralove - Hradec Králové
Arizona
- HonorHealth Neurology - Scottsdale
California
- Stanford Neuroscience Health Center - Palo Alto
Connecticut
- Yale University School of Medicine - New Haven
Missouri
- The Washington University - St Louis
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2025-05-06 |
| Est. Completion | 2028-06-25 |
| Phase | Phase 3 |
What NCT06747351 shows while recruiting
NCT06747351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, above the 33-participant average among 3 other Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) trials with a reported enrollment target (79% higher).
The record links to 1 condition, with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) appearing as the primary indexed condition, and to 3 interventions - of which TAK-881 is the first listed.
NCT06747351 names 20 study sites across 15 states, led by North Carolina, Florida, Other.
Frequently Asked Questions
What is clinical trial NCT06747351 about?
NCT06747351 is a clinical study titled "A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)". 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 immunog...
What is the current status of trial NCT06747351?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 59 participants. The study started on 2025-05-06. Estimated completion is 2028-06-25.
What conditions does trial NCT06747351 study?
This clinical trial studies the following conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP).
What interventions are being tested in trial NCT06747351?
The interventions under investigation include: TAK-881 (BIOLOGICAL), HYQVIA (BIOLOGICAL), SC Investigational Needle Sets (DEVICE).
Who is sponsoring clinical trial NCT06747351?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06747351 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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