Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
Completed · Phase 2
Conditions studied: Alpha 1-Antitrypsin Deficiency, Emphysema
In brief
Phase 2 study to compare SAR447537 (INBRX-101) to plasma derived A1PI therapy in adults with AATD emphysema
Key facts
- Study ID
- NCT05856331
- Run by
- Sanofi
- People needed
- 99
- Starts
- 2023-10-12
- Expected to finish
- 2025-08-06
- Last updated by the study team
- 2025-08-11
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males or females 18-80 years of age, inclusive, at the time of screening
- Diagnosis of AATD
- Evidence of emphysema secondary to AATD
- FEV1 of ≥ 30% and ≤ 80% predicted at screening
- Current non-smoking status.
You may not qualify if…
- Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug
- Known or suspected allergy to components of SAR447537 (INBRX-101), A1PI or human IgG
- Known selective or severe Immunoglobulin A (IgA) deficiency
- Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
- Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days
- On waiting list for lung or liver transplant
- Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening
- Evidence of decompensated cirrhosis
- Active cancers or has a history of malignancy within 5 years prior to screening
- History of unstable cor pulmonale
- Clinically significant congestive heart failure
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- St Joseph's Hospital and Medical Center- Site Number : 126 — Phoenix, Arizona, United States
- St Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
- David Geffen School of Medicine- Site Number : 124 — Los Angeles, California, United States
- David Geffen School of Medicine — Los Angeles, California, United States
- UC Davis Comprehensive Cancer Center- Site Number : 110 — Sacramento, California, United States
- UC Davis Medical Center — Sacramento, California, United States
- National Jewish Medical and Research Center- Site Number : 123 — Denver, Colorado, United States
- National Jewish Medical and Research Center — Denver, Colorado, United States
- Western Connecticut Medical Group — Danbury, Connecticut, United States
- University of Florida College of Medicine- Site Number : 101 — Gainesville, Florida, United States
- University of Florida — Gainesville, Florida, United States
- Bruce W. Carter Miami VA Medical Center - NAVREF - PPDS- Site Number : 114 — Miami, Florida, United States
- University of Miami — Miami, Florida, United States
- Pulmonary and Sleep of Tampa Bay- Site Number : 115 — Tampa, Florida, United States
- Pulmonary and Sleep of Tampa Bay — Tampa, Florida, United States
- Loyola University Medical Center- Site Number : 112 — Maywood, Illinois, United States
- Loyola University Medical Center — Maywood, Illinois, United States
- Indiana University — Indianapolis, Indiana, United States
- M Health Fairview Clinics and Surgery Center - Minneapolis- Site Number : 125 — Minneapolis, Minnesota, United States
- M Health Fairview Clinics and Surgery Center - Minneapolis — Minneapolis, Minnesota, United States
- Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 111 — Hannibal, Missouri, United States
- Hannibal Clinic — Hannibal, Missouri, United States
- Columbia University Irving Medical Center- Site Number : 104 — New York, New York, United States
- University of Alabama at Birmingham- Site Number : 105 — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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