Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05897424 | Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema | PHASE2 | ACTIVE NOT_RECRUITING | 185 | — | — | Jun 20, 2024 | Sep 30, 2028 | Apr 13, 2026 | 40 | United States, Australia +7 |
| NCT05856331 | Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema | PHASE2 | COMPLETED | 99 | — | — | Oct 12, 2023 | Aug 6, 2025 | Aug 11, 2025 | 65 | United States, Australia +6 |
Incidence of all treatment emergent adverse events (TEAEs), TEAEs ≥ Grade 3, serious adverse events (SAEs), TEAEs leading to discontinuation from SAR447537, and adverse events of special interest (AESIs) (including infusion-related reactions).
To assess the mean change in average fAAT concentration as measured by anti-neutrophil elastase capacity \[ANEC\] from baseline to average serum trough fAAT concentration at steady-state (Ctrough,ss) in participants treated with SAR447537 compared to A1PI
| Arm | Type | Description |
|---|---|---|
| SAR447537 (INBRX-101) | EXPERIMENTAL | A1PI, Recombinant, Bivalent Fc Fusion Protein, in a solution for intravenous injection |
| SAR447537 (INBRX-101) Q3W | EXPERIMENTAL | IV every 3-weeks (Q3W) and placebo (normal saline) |
| SAR447537 (INBRX-101) Q4W | EXPERIMENTAL | IV every 4-weeks (Q4W) and placebo (normal saline) |
| Zemaira (A1PI) | ACTIVE_COMPARATOR | 60 mg/kg IV once weekly (QW) and placebo (normal saline) |
| Name | Type | Description |
|---|---|---|
| SAR447537 | DRUG | A1PI, Recombinant, Bivalent Fc Fusion Protein |
| Zemaira | DRUG | Alpha1-Proteinase Inhibitor (Human) |
Inclusion Criteria: 1. Males or females 18-80 years of age, inclusive, at the time of screening 2. Diagnosis of AATD 3. Evidence of emphysema secondary to AATD 4. FEV1 of ≥ 30% predicted at screening and post-bronchodilator FEV1/FVC\<0.7 5. Current non-smoking status Exclusion Criteria: For newly...