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NCT05755035 · ClinicalTrials.gov registry record · Phase 2
A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases
A Phase 2 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT05755035 is a Phase 2 study that has completed, run by Takeda. The registered enrollment target is 65 participants.
The verdict
NCT05755035, a Phase 2 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL TAK-881
- BIOLOGICAL HYQVIA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2023-10-24 |
| Est. Completion | 2026-01-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05755035
The ClinicalTrials.gov registry entry for NCT05755035 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TAK-881 is the first listed.
NCT05755035 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05755035 about?
NCT05755035 is a clinical study titled "A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases". 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/HYQ...
What is the current status of trial NCT05755035?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2023-10-24. Estimated completion is 2026-01-20.
What interventions are being tested in trial NCT05755035?
The interventions under investigation include: TAK-881 (BIOLOGICAL), HYQVIA (BIOLOGICAL).
Who is sponsoring clinical trial NCT05755035?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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