drugset / Trial / NCT05755035
A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases
RandomizedCrossoverOpen-labelTreatment
Summary
The main aim of this study is to evaluate the PK, safety, tolerability and immunogenicity of subcutaneous (SC) administration of TAK-881 in adult and pediatric participants with PIDD and compare them to HYQVIA in participants 16 years old and older. The participants will be treated with TAK-881/HYQVIA or HYQVIA/TAK-881 with the same dose and dosing interval of immunoglobulin for up to 51 weeks (for participants greater than or equal to \[\>=\]16 years) and only with TAK-881 for up to 27 weeks (for participants aged 2 to less than \[\<\]16 years) as they were treated with another immunoglobulin before enrollment. Participants will need to visit the clinic every 3 or 4 weeks during the duration of the study.
Timeline
- Start
- 2023-10-24
- Primary completion
- 2026-01-20
- Completion
- 2026-01-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HYQVIA | Protein / enzyme biologic | — | Subcutaneous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | — | Subcutaneous |