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.
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, the results of the anti-rHuPH20 binding antibody assay from either study TAK-881-3001 (NCT05755035) or study TAK-881-3002 (Epoch 1) will be used to determine the next steps in the study: * 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
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.
Central Georgia Infectious Disease Consultants
Macon, Georgia, United States
RECRUITINGSneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, United States
RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
RECRUITINGDuke Asthma, Allergy and Airway Center
Durham, North Carolina, United States
RECRUITINGAllergy Partners of North Texas
Dallas, Texas, United States
RECRUITINGNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 121
Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TAK-881-related TEAEs
Time frame: Up to Week 121
Annualized Rate of all Infections
Time frame: Up to Week 121
Annualized Rate of Acute Serious Bacterial Infections (ASBIs)
Time frame: Up to Week 121
Annualized Rate of Episodes of Fever
Time frame: Up to Week 121
Time to First ASBI
Time frame: Up to Week 121
Duration of Infections
Time frame: Up to Week 121
Number of Participants With Positive Binding Antibodies and Neutralizing Antibodies to rHuPH20
Time frame: Up to Week 121
Trough Level of Total IgG
Time frame: Up to Week 121
Doses of TAK-881
Time frame: Up to Week 121
Treatment Interval of TAK-881
Time frame: Up to Week 121
Number of Infusions Per Month With Investigational Medical Device Using TAK-881
Time frame: Up to Week 121
Number of Infusions Sites (Needle Sticks) per Month With Investigational Medical Device Using TAK-881
Time frame: Up to Week 121
Number of Infusions Sites (Needle Sticks) per infusion With Investigational Medical Device Using TAK-881
Time frame: Up to Week 121
Duration of Infusions (minutes) With Investigational Medical Device Using TAK-881
Time frame: Up to Week 121
Monthly Infusion Time (minutes/month) With Investigational Medical Device Using TAK-881
Time frame: Up to Week 121
Maximum Tolerated Infusion Rate per Site (milliliter/hour/site) With Investigational Medical Device Using TAK-881
Time frame: Up to Week 121
Infusion Volume per Site (milliliter/site) With Investigational Medical Device Using TAK-881
Time frame: Up to Week 121
Number of Participants who have Infusions of TAK-881 at Physical Location
Physical location includes site/infusion center or home.
Time frame: Up to Week 121
Number of Participants, Caregiver, or Healthcare Professional (HCP) who have Administration of TAK-881
Time frame: Up to Week 121
Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores in Participants Aged >=16 Years
TSQM-9 is a 9-item, validated, self-administered instrument to assess participants satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The item scores of each of the 3 domains are summed and transformed to create a total score of 0 (extremely dissatisfied) to 100 (extremely satisfied). Higher score indicates greater satisfaction in that domain.
Time frame: From Week 13 up to Week 121
Health-Related Quality of Life (HRQoL): EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Score in Participants Aged >=12 Years
The EQ-5D-5L is a validated, self-administered assessment of overall health designed by the EuroQol Group. The instrument consists of two components: the EQ-5D descriptive system and the standard vertical EQ visual analogue scale (EQ-VAS). The descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has five response categories: no problems, slight problems, some or moderate problems, severe problems, or extreme problems. Participants will be asked to describe their health state that day by choosing one of 5 responses that reflect the levels of severity for each of the 5 dimensions. The EQ-VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health. Higher score indicates best health status.
Time frame: From Baseline up to Week 121
Treatment Preference Measured by a Disease-specific Questionnaire for Participants and the Investigational Medical Device Using TAK-881 in Participants Aged >=12 Years
The disease-specific treatment preference questionnaire is a self-administered, non-validated scale to assess participant preference for various attributes of IgG therapy and accompanying devices, such as ease of use of administration of TAK-881 complexity of administration, and convenience. The questionnaire consists of two components. The first component asks participants to indicate the extent to which they like or dislike aspects of TAK-881, including treatment frequency, time, ease, convenience, and complexity. Each item has five response categories: like very much, like, no preference, dislike, and dislike very much. The second component is a single question asking whether they would choose to continue receiving treatment after the trial ends.
Time frame: At Weeks 25 and 73
Number of Days not Able to go to School, Work, Daycare, or to Perform Normal Daily Activities Due to Infections and/or their Treatment or Other Illnesses
Time frame: Up to Week 121
Number of Days on Antibiotics
Time frame: Up to Week 121
Number of Hospitalizations With Indications (Infection or other Illnesses)
Time frame: Up to Week 121
Number of Days of Hospitalization
Time frame: Up to Week 121
Number of Acute Physician Visits Due to Infection or Other Illnesses
Time frame: Up to Week 121
Infusion Preparation Time For TAK-881 by HCP
Time frame: Up to Week 121
Infusion Preparation Time For TAK-881 by Participants/Caregiver
Time frame: Up to Week 121
Number of Participants With Adverse Events (AEs) Related to the Investigational Medical Device
Time frame: Up to Week 121
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