Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency 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 22 May 2025. Study ID: NCT05897424

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