Long-term Safety and Tolerability of TAK-881 in Subjects With Primary Immunodeficiency Diseases (PIDD)

TAK-881-3002

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 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.

2024-12-06

2027-05-07

2027-05-07

Not yet recruiting

Early phase I

39

Inclusion Criteria Participants who meet ALL of the following criteria are eligible for this study: * Participant must have completed Study TAK-881-3001 (NCT05755035). * If female of childbearing potential, the participant presents with a negative pregnancy test at screening and agrees to employ an acceptable form of contraception for the duration of the study. * Participant/legally authorized representative is willing and able to comply with the requirements of the protocol. * Participant/Participant's legally authorized representative has provided informed consent/assent, if applicable, (that is, in writing, documented via a signed and dated informed consent form (ICF) and/or eConsent, if available), and any required privacy authorization 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 has participated 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. * If female, Participant is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during the study.

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2023-10-11