Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema
Study of Investigational Medication in Adults with Alpha-1 Antitrypsin Deficiency
Study Overview
Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD emphysema
Study Details
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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Alpha 1-Antitrypsin Deficiency, Emphysema
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Age: 18 years - 80 years
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Gender: All
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.
The purpose of this study is to investigate Alpha-1 Antitrypsin Deficiency emphysema. This study investigates the long-term effects of an investigational medication on this condition.
The study evaluates the safety and clinical effects of the investigational medication over an extended period. It focuses on understanding how the medication works in people with Alpha-1 Antitrypsin Deficiency emphysema.
- Who can participate: Adults aged 18 to 80 with Alpha-1 Antitrypsin Deficiency can participate. Participants must have specific lung function criteria and be non-smokers.
- Study details: Participants will take the investigational medication to see how it affects their condition. A placebo is not used in this study.
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