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

Open Label Extension Study on Investigational Medication for Adults with AATD Emphysema

Recruiting
18 years - 80 years
All
Phase 2
130 participants needed
1 Location

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
  • Age: 18 years - 80 years
  • Gender: All

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.

Updated on 28 Mar 2025. Study ID: NCT05897424

This study investigates the long-term safety and effects of an investigational medication in adults with Alpha-1 Antitrypsin Deficiency (AATD) emphysema. AATD is a genetic condition that can lead to lung diseases like emphysema. Emphysema is a lung condition that causes shortness of breath due to damaged air sacs in the lungs.

Participants in this study will receive the investigational medication and be monitored for safety and effectiveness. The study involves regular health assessments and tests to evaluate lung function and overall health.

  • Who can participate: Adults aged 18 to 80 with a diagnosis of AATD and evidence of emphysema can participate. They must have a specific lung function test result and be non-smokers. Certain medical conditions and recent treatments may disqualify potential participants.
  • Study details: This is an open label study where participants will receive an investigational medication to assess its safety and effectiveness in treating AATD emphysema. They will undergo regular health checks and tests to monitor their condition.

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