Status:
RECRUITING
A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases
Lead Sponsor:
Takeda
Collaborating Sponsors:
Takeda Development Center Americas, Inc.
Baxalta Innovations GmbH, now part of Takeda
Conditions:
Primary Immunodeficiency Diseases (PID)
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief 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...
Detailed Description
The study consists of two Epochs: Epoch 1 and Epoch 2. In Epoch 1 eligible participants will have the opportunity to receive TAK-881 for a minimum of 6 months. After 6 months in study TAK-881-3002, th...
Eligibility Criteria
Inclusion
- 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/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 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.
- 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.
Exclusion
Key Trial Info
Start Date :
November 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2029
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06076642
Start Date
November 4 2024
End Date
January 15 2029
Last Update
May 8 2025
Active Locations (5)
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1
Central Georgia Infectious Disease Consultants
Macon, Georgia, United States, 31201
2
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, United States, 61761
3
Montefiore Medical Center
The Bronx, New York, United States, 10461
4
Duke Asthma, Allergy and Airway Center
Durham, North Carolina, United States, 27705