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)
2 other identifiers
interventional
53
7 countries
25
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2024
Typical duration for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2023
CompletedFirst Posted
Study publicly available on registry
October 11, 2023
CompletedStudy Start
First participant enrolled
November 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 16, 2028
April 8, 2026
April 1, 2026
3.5 years
October 4, 2023
April 2, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (28)
Annualized Rate of all Infections
Up to Week 121
Annualized Rate of Acute Serious Bacterial Infections (ASBIs)
Up to Week 121
Annualized Rate of Episodes of Fever
Up to Week 121
Time to First ASBI
Up to Week 121
Duration of Infections
Up to Week 121
- +23 more secondary outcomes
Study Arms (1)
TAK-881
EXPERIMENTALEpoch 1: Participants who completed study TAK-881-3001 (NCT05755035) and met eligibility criteria will receive TAK-881 using Koru 24 G HlgH Flo subcutaneous (SC) safety needle set (investigational in the US) at the same dose and same treatment interval as at the last infusion in TAK-881-3001 (NCT05755035) at Week 1 and at Weeks 13 and Week 25 of study TAK-881-3002. Epoch 2: Participants with anti-rHuPH20 antibody titer \>=1:160 at any time point during Study TAK-881-3001 (NCT05755035) and/or Study TAK-881-3002 Epoch 1, will continue receiving TAK-881 every 12 weeks for up to Week 121. After the first TAK-881 infusion in study TAK-881-3002, the interval and/or the dose may be adjusted only at scheduled site visits at the investigator's discretion.
Interventions
Participants will receive SC infusion of TAK-881.
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baxalta Innovations GmbH, now part of Takedacollaborator
- Takedalead
- Takeda Development Center Americas, Inc.collaborator
Study Sites (25)
University of California, Irvine Medical Sciences I
Irvine, California, 92697, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, 94598, United States
National Jewish Medical And Research Center
Denver, Colorado, 80206-2761, United States
University of South Florida
St. Petersburg, Florida, 33701, United States
Central Georgia Infectious Disease Consultants
Macon, Georgia, 31201, United States
Rush University Medical Center-Allergy/ Immunology Center
Chicago, Illinois, 60612-3852, United States
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, 61761, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70118, United States
North Shore-Long Island Jewish Health Systems
Great Neck, New York, 11021, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Duke Asthma, Allergy and Airway Center
Durham, North Carolina, 27705, United States
Allergy, Asthma and Immunology Center
Tulsa, Oklahoma, 74136, United States
Allergy Partners of North Texas
Dallas, Texas, 75230, United States
University Hospital Brno
Brno, 62500, Czechia
Fakultni nemocnice Motol a Homolka Ustav imunologie
Prague, 150 06, Czechia
Aarhus Universitetshospital
Aarhus, 8200, Denmark
General Hospital of Thessaloniki
Thessaloniki, 56429, Greece
Uniwersyteckie Centrum Kliniczne (UCK)
Gdansk, 80-952, Poland
Osrodek Pediatryczny im. DR J. Korczaka, Wojewodzkie
Lodz, 90329, Poland
Wojskowy Instytut Medyczny Panstwowy Instytut
Warsaw, 04-141, Poland
Instytut Pomnik - Centrum Zdrowia Dziecka
Warsaw, 04-730, Poland
NUDCH (National Institute of Childrens Diseases)
Bratislava, 833 40, Slovakia
OKIA s.r.o
Košice, 040 01, Slovakia
Klinika Deti a Dorastu - Odborne Ambulancie UNM a JLF UK
Martin, 036 01, Slovakia
Hospital Sant Joan de Deu Barcelona
Barcelona, 08950, Spain
Related Links
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 4, 2023
First Posted
October 11, 2023
Study Start
November 4, 2024
Primary Completion (Estimated)
May 16, 2028
Study Completion (Estimated)
May 16, 2028
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.