NCT05897424

Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema

A Phase 2, Single Arm, Open Label Extension Study, Evaluating the Long-Term Safety and Clinical Efficacy of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 185 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD emphysema

Detailed description

This is a Phase 2, Single Arm, Open Label Extension Study, Evaluating the Long-Term Safety and Clinical Efficacy of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema.

Conditions

• Alpha 1-Antitrypsin Deficiency
• Emphysema

Interventions

Type	Name	Description
DRUG	SAR447537	A1PI, Recombinant, Bivalent Fc Fusion Protein

Timeline

• Start date: 2024-06-20
• Primary completion: 2028-06-30
• Completion: 2028-09-30
• First posted: 2023-06-09
• Last updated: 2026-04-13

Locations

40 sites across 9 countries: United States, Australia, Denmark, Ireland, New Zealand, Poland, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study