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Long-term evaluation of SAR447537 in adults with Alpha-1 Antitrypsin Deficiency Emphysema

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

Phase 2 Interventional Sanofi · NCT05897424

This study is testing a new treatment called SAR447537 to see if it can improve lung function and overall health in adults with Alpha-1 Antitrypsin Deficiency emphysema.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment130 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorSanofi Industry-sponsored
Locations41 sites (Birmingham, Alabama and 40 other locations)
Trial IDNCT05897424 on ClinicalTrials.gov

What this trial studies

This Phase 2, single-arm, open-label extension study aims to assess the long-term safety and clinical efficacy of SAR447537 (INBRX-101) in adults diagnosed with Alpha-1 Antitrypsin Deficiency (AATD) emphysema. Participants will be monitored for their response to the treatment over an extended period, focusing on improvements in lung function and overall health. The study includes adults aged 18 to 80 who meet specific criteria related to their AATD diagnosis and emphysema severity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with a confirmed diagnosis of AATD and evidence of emphysema.

Not a fit: Patients currently receiving A1PI augmentation therapy or those with certain comorbidities, such as uncontrolled diabetes or active cancers, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients suffering from AATD emphysema.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in treating conditions related to AATD.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alpha 1-Antitrypsin DeficiencyEmphysemaAATDINBRX-101AATSAR447537
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.