RecruitingPhase 3NCT06076642

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

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

Sponsor

Takeda

Enrollment

39 participants

Start Date

Nov 4, 2024

Study Type

INTERVENTIONAL

Conditions

Primary Immunodeficiency Diseases (PID)

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

Min Age: 2 Years

Inclusion Criteria4

Participants who meet ALL of the following criteria are eligible for this study:
Participant must have completed Study TAK-881-3001 (NCT05755035).
Participant/Participant's parent(s)/legal guardian(s) is/are willing and able to comply with the requirements of the protocol.
Participant/Participant's parent(s)/legal guardian(s) has/have provided informed consent/assent (if applicable), including providing consent for use of the investigational medical device, prior to the initiation of any study procedures.

Exclusion Criteria9

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.
Women of childbearing potential 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 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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Interventions

BIOLOGICALTAK-881

Participants will receive SC infusion of TAK-881.

DEVICESC Investigational Needle Sets

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.