A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases
NCT ID: NCT06076642
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
39 participants
INTERVENTIONAL
2024-11-04
2029-01-15
Brief Summary
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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.
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Detailed Description
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* Epoch 1: Participants with an anti-rHuPH20 antibody titer less than \[\<\] 1:160 will complete the EOS visit on the day of the first non-investigational product (IP) infusion following Study Visit Week 25.
* Epoch 2: Participants with an anti-rHuPH20 antibody titer greater than or equal to \[\>=\] 1:160 at any time point during Study TAK-881-3001 (NCT05755035) and/or study TAK-881-3002 (Epoch 1), will continue with an additional two years of TAK-881 treatment and undergo safety follow-up and will complete the EOS visit on the day of the first non-IP infusion following study Visit Week 121.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TAK-881
Epoch 1: Participants who completed study TAK-881-3001 (NCT05755035) and met eligibility criteria will receive TAK-881 subcutaneous (SC) infusion using investigational needle sets 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.
TAK-881
Participants will receive SC infusion of TAK-881.
SC 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.
Interventions
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TAK-881
Participants will receive SC infusion of TAK-881.
SC 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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:-
1. Participant has a positive pregnancy test.
2. 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.
2 Years
ALL
No
Sponsors
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Takeda Development Center Americas, Inc.
INDUSTRY
Baxalta Innovations GmbH, now part of Takeda
UNKNOWN
Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Central Georgia Infectious Disease Consultants
Macon, Georgia, United States
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke Asthma, Allergy and Airway Center
Durham, North Carolina, United States
Allergy Partners of North Texas
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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2023-505946-24-00
Identifier Type: CTIS
Identifier Source: secondary_id
TAK-881-3002
Identifier Type: -
Identifier Source: org_study_id
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