A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases
Condition(s) studied
Investigational drug(s) / intervention(s)
TAK-881: Participants will receive SC infusion of TAK-881.
Koru 24 G HIgH Flo Subcutaneous Safety Needle Set (investigational in the US): The single-use only SC needle set will be used to administer TAK-881 to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion.
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.
Eligibility
Primary outcome measure(s)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — Up to Week 121
- Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TAK-881-related TEAEs — Up to Week 121
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California, Irvine Medical Sciences I | Irvine | California | |
| Allergy & Asthma Clinical Research | Walnut Creek | California | |
| National Jewish Medical And Research Center | Denver | Colorado | |
| University of South Florida | St. Petersburg | Florida | |
| Central Georgia Infectious Disease Consultants | Macon | Georgia | |
| Rush University Medical Center-Allergy/ Immunology Center | Chicago | Illinois | |
| Sneeze, Wheeze, & Itch Associates, LLC | Normal | Illinois | |
| Louisiana State University Health Science Center | New Orleans | Louisiana | |
| North Shore-Long Island Jewish Health Systems | Great Neck | New York | |
| Montefiore Medical Center | The Bronx | New York | |
| Duke Asthma, Allergy and Airway Center | Durham | North Carolina | |
| Allergy, Asthma and Immunology Center | Tulsa | Oklahoma | |
| Allergy Partners of North Texas | Dallas | Texas | |
| University Hospital Brno | Brno | Czechia | |
| Fakultni nemocnice Motol a Homolka Ustav imunologie | Prague | Czechia | |
| Aarhus Universitetshospital | Aarhus | Denmark | |
| General Hospital of Thessaloniki | Thessaloniki | Greece | |
| Uniwersyteckie Centrum Kliniczne (UCK) | Gdansk | Poland | |
| Osrodek Pediatryczny im. DR J. Korczaka, Wojewodzkie | Lodz | Poland | |
| Wojskowy Instytut Medyczny Panstwowy Instytut | Warsaw | Poland | |
| Instytut Pomnik - Centrum Zdrowia Dziecka | Warsaw | Poland | |
| NUDCH (National Institute of Childrens Diseases) | Bratislava | Slovakia | |
| OKIA s.r.o | Košice | Slovakia | |
| Klinika Deti a Dorastu - Odborne Ambulancie UNM a JLF UK | Martin | Slovakia | |
| Hospital Sant Joan de Deu Barcelona | Barcelona | Spain |
More Takeda trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06076642 on ClinicalTrials.gov ↗ ← All trials in Spain