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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517450-95-00
Acronym
TAK-881-3003
Enrollment
46
Registered
2025-06-02
Start date
2025-06-23
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Brief summary

01. Baseline-uncorrected area under the curve during the dosing interval at steady-state (AUC0-τ,ss) based on total IgG levels.

Interventions

DRUGHyQvia 100 mg/mL solution for infusion for subcutaneous use
DRUGTAK-881

Sponsors

Takeda Development Center Americas Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
01. Baseline-uncorrected area under the curve during the dosing interval at steady-state (AUC0-τ,ss) based on total IgG levels.—

Countries

Czechia, Denmark, Germany, Greece, Italy, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026