Ireland
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Active, not recruiting Phase 3

A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases

NCT06076642 · tracked via the Priya Life Science Spain tracker
Sponsor
Phase
Phase 3
Started
2024-11-04
Last updated
2026-04-08

Condition(s) studied

Primary Immunodeficiency Diseases (PID)

Investigational drug(s) / intervention(s)

TAK-881 →Koru 24 G HIgH Flo Subcutaneous Safety Needle Set (investigational in the US)

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

Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria Participants who meet ALL of the following criteria are eligible for this study: * Participant must have completed Study TAK-881-3001 (NCT05755035). * Participant or, in the case of minors, legally designated representative(s) is/are willing and able to comply with the requirements of the protocol. * Participant or, in the case of minors, legally designated representative(s) has/have provided informed consent/assent (if applicable), including providing consent for use of the investigational medical device (in US sites only), prior to the initiation of any study procedures. Exclusion Criteria * Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in this long-term follow-up study. * New medical condition that developed during participation in Study TAK-881-3001 (NCT05755035), that, in the judgment of the investigator, could increase risk to the participant or interfere with the evaluation of TAK-881 and/or conduct of the study. * Participant was enrolled in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to screening (with the exception of Study TAK-881-3001 \[NCT05755035\]). * Participant is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study. * Participant is a family member or employee of the investigator or the investigator's site staff. * Participants with potential to become pregnant who meet any one of the following criteria:- 1. Participant has a positive pregnancy test. 2. Participant does not agree to employ a highly effective form of contraception for the duration of the study. * If participant is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during the study.

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)

FacilityCityRegionStatus
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
Official registry record

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