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Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema

NCT05856331

CompletedPhase 2

Sponsor: Sanofi

Conditions: Alpha 1-Antitrypsin Deficiency, Emphysema

Interventions: SAR447537, Zemaira

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

Phase 2 study to compare SAR447537 (INBRX-101) to plasma derived A1PI therapy 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% and ≤ 80% predicted at screening
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 (INBRX-101), A1PI or human IgG
3. Known selective or severe Immunoglobulin A (IgA) deficiency
4. Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
5. Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days
6. On waiting list for lung or liver transplant
7. Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening
8. Evidence of decompensated cirrhosis
9. Active cancers or has a history of malignancy within 5 years prior to screening
10. History of unstable cor pulmonale
11. Clinically significant congestive heart failure

Locations (65)

Birmingham, Alabama, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Sacramento, California, United States
Denver, Colorado, United States
Denver, Colorado, United States
Danbury, Connecticut, United States
Gainesville, Florida, United States
Gainesville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Maywood, Illinois, United States
Maywood, Illinois, United States
Indianapolis, Indiana, United States
Minneapolis, Minnesota, United States
Minneapolis, Minnesota, United States
Hannibal, Missouri, United States
Hannibal, Missouri, United States
New York, New York, United States
Portland, Oregon, United States
Portland, Oregon, United States
DuBois, Pennsylvania, United States
DuBois, Pennsylvania, United States
Hershey, Pennsylvania, United States
+ 35 more on CT.gov