Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Sanofi
- Study ID
- NCT05856331
- Phase
- PHASE2
- Status
- Completed
Conditions
- Alpha 1-Antitrypsin Deficiency
- Emphysema
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- SAR447537 — DRUGA1PI, Recombinant, Bivalent Fc Fusion Protein
- Zemaira — DRUGAlpha1-Proteinase Inhibitor (Human)
Study Details
Phase 2 study to compare SAR447537 (INBRX-101) to plasma derived A1PI therapy in adults with AATD emphysema
Key Dates
- First listed
- May 12, 2023
- Start date
- Oct 12, 2023
- Status verified
- Aug 2025
- Primary completion
- Aug 6, 2025
- Completion
- Aug 6, 2025
Study Design
- Enrollment
- 99 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SAR447537 (INBRX-101) Q3WIV every 3-weeks (Q3W) and placebo (normal saline)
- Experimental: SAR447537 (INBRX-101) Q4WIV every 4-weeks (Q4W) and placebo (normal saline)
- Active Comparator: Zemaira (A1PI)60 mg/kg IV once weekly (QW) and placebo (normal saline)
Primary Outcome Measure
Serum functional AAT (fAAT) levels at steady-state [ Time Frame: 32 Weeks ]
Locations (39)
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