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

Study on Long-Term Effects of Investigational Medication in Adults with Alpha-1 Antitrypsin Deficiency (AATD) Emphysema

Recruiting
18 years - 80 years
All
Phase 2
185 participants needed
2 Locations

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:

For newly identified participants

  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. Uncontrolled diabetes mellitus despite adequate antidiabetic pharmacologic treatment with a screening HbA1c value ≥9%
  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

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

This study investigates the long-term effects of an investigational medication in adults with Alpha-1 Antitrypsin Deficiency (AATD) emphysema. The purpose of this study is to understand how the investigational medication affects individuals with this condition over an extended period.

Participants in this study will receive the investigational medication and will be monitored for safety and clinical efficacy. The study will not involve any placebo group, as all participants will be receiving the investigational treatment. Participants will undergo regular health assessments to track their progress and any changes in their condition.

  • Who can participate: Adults aged 18 to 80 years with a diagnosis of Alpha-1 Antitrypsin Deficiency and evidence of emphysema can participate. They must have a specific lung function measurement and be non-smokers. Key exclusions include recent use of certain therapies, uncontrolled diabetes, and active cancers.
  • Study details: Participants will receive the investigational medication and attend regular health assessments. There is no placebo group, meaning all participants will be treated with the investigational medication.
Updated on 31 Oct 2025. Study ID: NCT05897424

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