Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Alpha1-Proteinase Inhibitor, A1PI
GLASSIA · 1 trial · 1 indication
An Adverse Events (AEs) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. Any AE that occurs on or after the first dose of IP infusion will be considered a TEAE. A TEAE that is considered potentially related to the presence of protein aggregates (particle load) in the GLASSIA solution is defined as any embolic or thrombotic event. Number of participants with TEAEs potentially related to the presence of protein aggregates (particle load) in the GLASSIA solution were reported.
An Treatment-emergent AR and suspected AR was any TEAE which met any of the following criteria: a; A TEAE that began during infusion or within 24 hours (or 1 day where time of onset is not available) following the end of IP infusion, or b; A TEAE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or c; A TEAE for which causality assessment was missing or indeterminate. Number of participants with both treatment-emergent ARs plus suspected ARs were collectively reported.
An Treatment-emergent AR and suspected AR was any TEAE which met any of the following criteria: a; A TEAE that began during infusion or within 72 hours (or 3 days where time of onset is not available) following the end of IP infusion, or b; A TEAE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or c; A TEAE for which causality assessment was missing or indeterminate. Number of participants with both treatment-emergent ARs plus suspected ARs were collectively reported.
An AE was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. Infusions may be interrupted or discontinued in an individual participant in the event of intolerable moderate to severe infusion-related AEs and/or at the discretion of the investigator. Number of infusions that are discontinued, slowed, or interrupted due to TEAEs were reported.
Development of Binding/Neutralizing Anti-A1PI Antibodies=Negative or missing at Baseline and confirmed positive at any post-infusion time point. Participants that had a positive result at Baseline and missing at all post-infusion time points were included as "No Development". Neutralizing anti-A1PI antibodies were only assessed in case of positive binding anti-A1PI antibodies. Anti-A1PI antibodies was detected using validated binding and neutralizing anti-A1PI antibody assays at a qualified immunoassay laboratory. Number of participants who developed binding and/or neutralizing anti-A1PI antibodies were reported.
Change from baseline in antigenic A1PI levels in ELF up to Week 14 was reported. Bronchoalveolar Lavage (BAL) procedures were performed at baseline and on-treatment BAL visit during GLASSIA augmentation therapy. Data for this outcome measure was analyzed and planned to be reported based on overall arm (Arms/Groups were combined as pre-specified in the study protocol).
Change from baseline in functional A1PI (also known as Anti-Neutrophil Elastase Capacity \[ANEC\]) levels in ELF up to Week 14 was reported. BAL procedures were performed at baseline and on-treatment BAL visit during GLASSIA augmentation therapy. Data for this outcome measure was analyzed and planned to be reported based on overall arm (Arms/Groups were combined as pre-specified in the study protocol).
| Arm | Type | Description |
|---|---|---|
| Cohort I: GLASSIA (High-end) | EXPERIMENTAL | Participants will receive weekly IV infusions of GLASSIA (lot with particle loads representing the high end within) at 60 milligrams per kilogram (mg/kg) BW active A1PI protein administered at a rate of 0.2 milliliters per kilogram of body weight per minute (ml/kg/min) for 25 weeks (25 planned infusions) via an IV administration. |
| Cohort II: GLASSIA (Low-end) | EXPERIMENTAL | Participants will receive weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein administered at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions) via an IV administration. |
| Name | Type | Description |
|---|---|---|
| GLASSIA | BIOLOGICAL | Participants will receive weekly IV infusions of GLASSIA at 60 mg/kg BW active A1PI protein administered at a rate of 0.2 mL/kg/min for 25 weeks (25 planned infusions) via an IV administration. |
Inclusion Criteria: 1. Male or female participants meeting the following age criteria: 1. For participants who will undergo bronchoscopy/ bronchoalveolar lavage (BAL) procedures: 18 to 75 years of age at the time of screening. 2. For participants who will be waived from undergoing bronchosco...
GLASSIA is used for alpha1-antitrypsin deficiency, a rare inherited condition. It is developed by Takeda Pharmaceutical Company Limited under the ticker TAK. The clinical program for GLASSIA in this indication has reached Phase 3, and the completed study enrolled adults aged 18 years and older in the United States and Canada.
GLASSIA is made by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the developer of record for the GLASSIA program in alpha1-antitrypsin deficiency, and the company sponsored the Phase 3 study conducted in the United States and Canada.
GLASSIA is in Phase 3 development for alpha1-antitrypsin deficiency. One Phase 3 trial has been completed, and no active trials are currently listed for the program. The completed study was randomized, double blind, and controlled, and it enrolled 34 participants.
GLASSIA has been studied in the Phase 3 trial NCT02525861, titled the GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study. That trial is completed, enrolled 34 participants, and was conducted in the United States and Canada in adults aged 18 years and older with alpha1-antitrypsin deficiency.
GLASSIA is an investigational therapy in Phase 3 development for alpha1-antitrypsin deficiency, and the program's single Phase 3 trial has been completed. The completed study, NCT02525861, was randomized, double blind, and controlled, with 34 participants enrolled across the United States and Canada.