Primary immunodeficiency disease (or PIDD) is a group of conditions in which the immune system does not work properly. Some people with PIDD do not make enough antibodies. Antibodies are proteins that help to either protect the body from infections or fight infections. The main type of antibodies that helps protect the body from infection is IgG. People who do not make enough IgG often need medical treatment that gives the body those antibodies. This treatment is called IgG replacement therapy. It can be given through a vein (intravenous or IV) or under the skin (subcutaneous SC). TAK-664 is approved worldwide for SC IG replacement therapy. The study wants to learn more about TAK-664 given to people with PIDD who have not yet been treated with IG (called 'treatment-naïve'). The main aim of the study is to check if giving TAK-664 daily for 5 days, and then once more 3 days later (Day 8), can raise IgG to the target level and keep IgG there. Another aim of the study is to learn if TAK-664 given once a week can keep the IgG at the target levels during the study. The study also wants to find out how much the IgG levels raise and learn how many infections occur and how they are treated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Participants will receive TAK-664 infusion.
Percentage of Participants who Achieve a Total Serum IgG Trough Level of >=500 mg/dL
Serum trough levels of total IgG will be determined by using validated assay methods.
Time frame: At Day 15
Percentage of Participants who Achieve a Total Serum IgG Trough level of >=500 mg/dL on Day 8
Serum trough levels of total IgG will be determined by using validated assay methods.
Time frame: At Day 8
Percentage of Participants who Achieve a Total Serum IgG Trough level of >=500 mg/dL at Weeks 4, 6, and 9
Serum trough levels of total IgG will be determined by using validated assay methods.
Time frame: At Weeks 4, 6, and 9
Percentage of Participants who Achieve a Total Serum IgG Trough Level of >=700 mg/dL
Serum trough levels of total IgG will be determined by using validated assay methods.
Time frame: At Weeks 6, and 9
Change in Total Serum IgG Trough Level of >=100 mg/dL From Baseline to Days 8 and 15
Serum trough levels of total IgG will be determined by using validated assay methods.
Time frame: Baseline up to Days 8 and 15
Annualized Rate of All Infections
The annual rate of infections will be calculated as the mean number of infections per participant per year.
Time frame: From first dose of study drug up to end of trial (EOT) (up to 10 weeks)
Annualized Rate of Acute Serious Bacterial Infections (ASBIs)
The ASBI rate will be calculated as the mean number of acute serious bacterial infections per participant per year.
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
Duration of Infections
The duration of an infection will be calculated as the number of days between the AE start date and the AE end date. Infections will be extracted from adverse events (AE) reporting.
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
Annualized Rate of Days on Oral or Parenteral Antibiotics for Prophylaxis or Treatment of Infections
Annualized rate of days on oral or parenteral antibiotics will be calculated as the total number of days participants received oral or parenteral antibiotics for prophylaxis or treatment of infections divided by the total participant-years of follow-up.
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
Number of Hospitalizations Due to Infections
Number of hospitalizations due to infections will be standardized to per year.
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
Total Number of Days of Hospital Stay Due to Infections
Total number of days of hospital stay due to infections will be standardized to per year.
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to TAK-664
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. TEAEs are defined as AEs that started at or after the initiation of the first administration of TAK-664. Serious TEAEs are the AEs that result in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in-patient hospitalization; congenital anomaly/birth defect or are otherwise considered medically important. Any TEAE that is recorded by the investigator as related to TAK-664 is considered as TEAE related to TAK-664.
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
Number of Participants With TEAEs Temporally Associated With TAK-664
Temporally associated TEAEs are defined as TEAEs which begin during or within 72 hours of the completion of TAK-664 infusion.
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
Number of Infusions of TAK-664 Without Infusion Rate Reduction, Interruption, or Infusion Withdrawals due to TAK-664-related TEAEs
Number of infusions of TAK-664 without infusion rate reduction, interruption, or infusion withdrawals due to TAK-664-related TEAEs will be reported.
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
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