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

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.

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% predicted at screening and post-bronchodilator FEV1/FVC<0.7
• Current non-smoking status

Exclusion criteria

For newly identified participants

• Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug
• Known or suspected allergy to components of SAR447537, A1PI or human IgG
• Uncontrolled diabetes mellitus despite adequate antidiabetic pharmacologic treatment with a screening HbA1c value ≥9%
• 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

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.