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

NCT05897424

Active Not RecruitingPhase 2

Sponsor: Sanofi

Conditions: Alpha 1-Antitrypsin Deficiency, Emphysema

Interventions: SAR447537

Countries: United States, Australia, Denmark, Ireland, New Zealand, Poland, Spain, Sweden

Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD emphysema

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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:

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.
Locations (40)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • Los Angeles, California, United States
  • Sacramento, California, United States
  • Denver, Colorado, United States
  • Danbury, Connecticut, United States
  • Gainesville, Florida, United States
  • Indianapolis, Indiana, United States
  • Boston, Massachusetts, United States
  • Minneapolis, Minnesota, United States
  • Hannibal, Missouri, United States
  • New York, New York, United States
  • Portland, Oregon, United States
  • Hershey, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Spartanburg, South Carolina, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Chermside, Queensland, Australia
  • South Brisbane, Queensland, Australia
  • North Adelaide, South Australia, Australia
  • Box Hill, Victoria, Australia
  • Fitzroy, Victoria, Australia
  • Frankston, Victoria, Australia
  • Hellerup, Denmark
  • Vejle, Denmark
  • Dublin, Dublin, Ireland
  • Auckland, New Zealand
  • Wellington, New Zealand
  • Warsaw, Masovian Voivodeship, Poland
  • + 10 more on CT.gov