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A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases
NCT06076642 · View on ClinicalTrials.gov ↗
Study Summary
The main aim of this study is to learn if TAK-881 is safe and well tolerated during long-term use in adults and children with PIDD who are eligible and completed study TAK-881-3001 (NCT05755035). The participants will receive the first dose of TAK-881 immunoglobulin (IgG) infusion at the same dosage as the last dose administered in study TAK-881-3001 (NCT05755035). After the first TAK-881 infusion in study TAK-881-3002, the dosing interval (can be adjusted by participant/caregiver) and/or the dose of TAK-881 can be adjusted by the study doctor to every 2, 3 or 4 weeks at scheduled site visits. Participants will visit the clinic every 12 weeks until the End of Study (EOS) visit.
Conditions Studied
Interventions
- BIOLOGICAL TAK-881
- DEVICE SC Investigational Needle Sets
Study Locations (5)
Georgia
- Central Georgia Infectious Disease Consultants — Macon
Illinois
- Sneeze, Wheeze, & Itch Associates, LLC — Normal
New York
- Montefiore Medical Center — The Bronx
North Carolina
- Duke Asthma, Allergy and Airway Center — Durham
Texas
- Allergy Partners of North Texas — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2024-11-04 |
| Est. Completion | 2029-01-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06076642
The ClinicalTrials.gov registry entry for NCT06076642 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Primary Immunodeficiency Diseases (PID) appearing as the primary indexed condition, and to 2 interventions — of which TAK-881 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06076642 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Georgia, Illinois, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06076642 about?
NCT06076642 is a clinical study titled "A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases". The main aim of this study is to learn if TAK-881 is safe and well tolerated during long-term use in adults and children with PIDD who are eligible and completed study TAK-881-3001 (NCT05755035). The participants will receive the first dose of TAK-881 immunoglobulin (IgG) infusion at the same dosag...
What is the current status of trial NCT06076642?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 39 participants. The study started on 2024-11-04. Estimated completion is 2029-01-15.
What conditions does trial NCT06076642 study?
This clinical trial studies the following conditions: Primary Immunodeficiency Diseases (PID). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06076642?
The interventions under investigation include: TAK-881 (BIOLOGICAL), SC Investigational Needle Sets (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06076642?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06076642 being conducted?
This trial has 5 study locations across Georgia, Illinois, New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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