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

Launched by SANOFI · May 31, 2023

Keywords

ClinConnect Summary

This clinical trial, called the Open Label Extension Study of INBRX-101, is looking at a new treatment for adults with Alpha 1-Antitrypsin Deficiency (AATD) emphysema, a lung condition that makes it hard to breathe. The study is currently recruiting participants who are between 18 and 80 years old and have been diagnosed with AATD and have evidence of emphysema due to this condition. To be eligible, participants must not be smokers and have certain lung function measurements that meet the study requirements.

If you choose to participate, you will receive the study medication, INBRX-101, and you'll be monitored throughout the trial to see how well it works for you. It’s important to note that there are some restrictions for joining, such as not having certain other health conditions or recent treatments that could interfere with the study. This trial aims to gather more information about the safety and effectiveness of INBRX-101 in managing the symptoms of AATD emphysema, which could potentially help improve the quality of life for people living with this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females 18-80 years of age, inclusive, at the time of screening
• • 2. Diagnosis of AATD
• • 3. Evidence of emphysema secondary to AATD
• • 4. FEV1 of ≥ 30% predicted at screening and post-bronchodilator FEV1/FVC\<0.7
• • 5. Current non-smoking status
• Exclusion Criteria:
• • 1. Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug
• • 2. Known or suspected allergy to components of SAR447537, A1PI or human IgG
• • 3. Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
• • 4. Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days
• • 5. On waiting list for lung or liver transplant
• • 6. Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening
• • 7. Evidence of decompensated cirrhosis
• • 8. Active cancers or has a history of malignancy within 5 years prior to screening
• • 9. History of unstable cor pulmonale
• • 10. Clinically significant congestive heart failure
• • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.