NCT05856331

Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema

Phase 2, Double-Blind, Randomized, Active-Control, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of SAR447537 (INBRX-101) Compared to Plasma-Derived Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Phase 2 study to compare SAR447537 (INBRX-101) to plasma derived A1PI therapy in adults with AATD emphysema

Detailed description

This is a Phase 2, Double-Blind, Randomized, Active-Control, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of SAR447537 (INBRX-101) Compared to Plasma-Derived Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy 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
DRUG	Zemaira	Alpha1-Proteinase Inhibitor (Human)

Timeline

• Start date: 2023-10-12
• Primary completion: 2025-08-06
• Completion: 2025-08-06
• First posted: 2023-05-12
• Last updated: 2025-08-11

Locations

65 sites across 8 countries: United States, Australia, Denmark, New Zealand, Poland, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study