Alpha-1 Antitrypsin Deficiency (AATD) Emphysema
Conditions
Brief summary
Incidences of all treatment-emergent adverse events (TEAEs), TEAEs ≥Grade 3, serious adverse events (SAEs), TEAEs requiring withdrawal from investigational product (IP) treatment leading to discontinuation from SAR447537, and adverse events of special interest (AESIs) (including infusion-related reactions) leading to discontinuation from and adverse events of special interest (AESIs) (including infusion-related reactions).
Detailed description
Annual rate of change in lung density assessed by serial quantitative CT (15th percentile point [PD15]) at total lung capacity (TLC), centrally read, from Baseline to End of Treatment (EoT)., Serum PK profile of SAR447537 and fAAT., Population PK modeling to assess impact of physiologically relevant participant characteristics (eg, covariates including, but not limited to, age, sex, body size, ethnicity) and disease on PK of SAR447537 through Population PK modeling., Incidence of anti-drug antibodies (ADAs) against SAR447537 as well as neutralizing anti-drug antibodies (NAbs) against SAR447537.
Interventions
Sponsors
Sanofi AATD Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidences of all treatment-emergent adverse events (TEAEs), TEAEs ≥Grade 3, serious adverse events (SAEs), TEAEs requiring withdrawal from investigational product (IP) treatment leading to discontinuation from SAR447537, and adverse events of special interest (AESIs) (including infusion-related reactions) leading to discontinuation from and adverse events of special interest (AESIs) (including infusion-related reactions). | — |
Secondary
| Measure | Time frame |
|---|---|
| Annual rate of change in lung density assessed by serial quantitative CT (15th percentile point [PD15]) at total lung capacity (TLC), centrally read, from Baseline to End of Treatment (EoT)., Serum PK profile of SAR447537 and fAAT., Population PK modeling to assess impact of physiologically relevant participant characteristics (eg, covariates including, but not limited to, age, sex, body size, ethnicity) and disease on PK of SAR447537 through Population PK modeling., Incidence of anti-drug antibodies (ADAs) against SAR447537 as well as neutralizing anti-drug antibodies (NAbs) against SAR447537. | — |
Countries
Denmark, Ireland, Poland, Spain, Sweden
Outcome results
None listed