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

Running, not enrolling · Phase 3

Conditions studied: Primary Immunodeficiency Diseases (PID)

In brief

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.

Key facts

Study ID

NCT06076642

Run by

Takeda

People needed

53

Starts

2024-11-04

Expected to finish

2028-05-16

Last updated by the study team

2026-04-08

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:-
• Participant has a positive pregnancy test.
• 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.

Where it is running

• University of California, Irvine Medical Sciences I — Irvine, California, United States
• Allergy & Asthma Clinical Research — Walnut Creek, California, United States
• National Jewish Medical And Research Center — Denver, Colorado, United States
• University of South Florida — St. Petersburg, Florida, United States
• Central Georgia Infectious Disease Consultants — Macon, Georgia, United States
• Rush University Medical Center-Allergy/ Immunology Center — Chicago, Illinois, United States
• Sneeze, Wheeze, & Itch Associates, LLC — Normal, Illinois, United States
• Louisiana State University Health Science Center — New Orleans, Louisiana, United States
• North Shore-Long Island Jewish Health Systems — Great Neck, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke Asthma, Allergy and Airway Center — Durham, North Carolina, United States
• Allergy, Asthma and Immunology Center — Tulsa, Oklahoma, United States
• Allergy Partners of North Texas — Dallas, Texas, United States
• 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

Full record on ClinicalTrials.gov

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