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

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.

Inclusion criteria

• Males or females 18-80 years of age, inclusive, at the time of screening
• Diagnosis of AATD
• Evidence of emphysema secondary to AATD
• FEV1 of ≥ 30% and ≤ 80% predicted at screening
• Current non-smoking status.

Exclusion criteria

• Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug
• Known or suspected allergy to components of SAR447537 (INBRX-101), A1PI or human IgG
• Known selective or severe Immunoglobulin A (IgA) deficiency
• Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
• Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days
• On waiting list for lung or liver transplant
• Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening
• Evidence of decompensated cirrhosis
• Active cancers or has a history of malignancy within 5 years prior to screening
• History of unstable cor pulmonale
• Clinically significant congestive heart failure