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IGSC 20% infusion · 1 trial · 1 indication
TEAEs were defined as adverse events (AEs) with onset after date-time of first dose of study drug (intravenous immunoglobulin \[IGIV\] or IGSC), or medical conditions present prior to the start of study drug (IGIV or IGSC) but increased in severity or relationship after date-time of first dose of study drug (IGIV or IGSC). A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.
TEAEs were defined as adverse events (AEs) with onset after date-time of first dose of study drug (intravenous immunoglobulin \[IGIV\] or IGSC), or medical conditions present prior to the start of study drug (IGIV or IGSC) but increased in severity or relationship after date-time of first dose of study drug (IGIV or IGSC). Any TEAE that was recorded by the investigator as "probably related" or "possibly related" to study drug was considered as study drug related AE, and any AE recorded as "unlikely related" or "not related" was considered as unrelated AE.
A severe TEAE was an AE that caused considerable interference with the participant's usual activities. Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infusion site". Systemic TEAEs were defined as AEs that were not included in the Medical Dictionary for Regulatory Activities (MedDRA) Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site" or "infusion site".
Infusion associated TEAEs were defined as any TEAE that began during study drug infusion or within 72 hours of completion of study drug infusion. TEAEs leading to premature discontinuation from study and infusion-associated TEAEs were reported.
| Arm | Type | Description |
|---|---|---|
| IGSC, 20% | EXPERIMENTAL | Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of Immune globulin subcutaneous (IGSC) infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available. |
| Name | Type | Description |
|---|---|---|
| IGSC 20% infusion | BIOLOGICAL | IGSC 20% infusion, |
Inclusion Criteria: 1. Participant has completed or is about to complete Takeda Clinical Study TAK-664-3001. A participant is considered to have completed Study TAK-664-3001 successfully if they fulfill the following criterion: Completed Epoch 2, in which IGSC, 20% is administered weekly (compl...
IGSC 20% infusion is used for Primary Immunodeficiency Disease. It is an investigational therapy being developed by Takeda Pharmaceutical Company Limited for this condition. The drug is currently in Phase 3 clinical development, meaning it is still being studied and has not yet been approved for use.
IGSC 20% infusion is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug for the treatment of Primary Immunodeficiency Disease. As of the latest data, the drug is in Phase 3 development.
IGSC 20% infusion is in Phase 3 clinical development. It is being studied for Primary Immunodeficiency Disease. The drug is investigational and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed as part of its development program.
IGSC 20% infusion has one completed Phase 3 clinical trial, identified as NCT04842643. This trial, titled 'An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease,' enrolled 12 participants in Japan. The study was uncontrolled and included patients aged 2 years and older.
Yes, IGSC 20% infusion is also known as TAK-664. The clinical trial NCT04842643, which studies the drug for Primary Immunodeficiency Disease, refers to it as TAK-664. This alternative name is used in the trial title and related documentation.