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

Running, not enrolling · Phase 2

Conditions studied: Alpha 1-Antitrypsin Deficiency, Emphysema

In brief

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

Key facts

Study ID

NCT05897424

Run by

Sanofi

People needed

185

Starts

2024-06-20

Expected to finish

2028-09-30

Last updated by the study team

2026-04-13

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% predicted at screening and post-bronchodilator FEV1/FVC<0.7
• Current non-smoking status

You may not qualify if…

• For newly identified participants
• Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug
• Known or suspected allergy to components of SAR447537, A1PI or human IgG
• Uncontrolled diabetes mellitus despite adequate antidiabetic pharmacologic treatment with a screening HbA1c value ≥9%
• 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
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• UAB Lung Health Center- Site Number : 105 — Birmingham, Alabama, United States
• St Joseph's Hospital and Medical Center- Site Number : 126 — Phoenix, Arizona, United States
• David Geffen School of Medicine at UCLA- Site Number : 124 — Los Angeles, California, United States
• University of California Davis Medical Center- Site Number : 110 — Sacramento, California, United States
• National Jewish Medical and Research Center- Site Number : 123 — Denver, Colorado, United States
• Nuvance Health Medical Practices, Pulmonary & Sleep Specialists- Site Number : 119 — Danbury, Connecticut, United States
• University of Florida - Gainesville - 1600 SW Archer Rd- Site Number : 101 — Gainesville, Florida, United States
• Indiana University- Site Number : 127 — Indianapolis, Indiana, United States
• Brigham and Women's Hospital -75 Francis Street- Site Number : 131 — Boston, Massachusetts, United States
• University of Minnesota-420 Delaware Str SE- Site Number : 125 — Minneapolis, Minnesota, United States
• Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 111 — Hannibal, Missouri, United States
• Columbia University Irving Medical Center- Site Number : 104 — New York, New York, United States
• Oregon Health and Science University- Site Number : 117 — Portland, Oregon, United States
• Penn State Health Milton S. Hershey Medical Center- Site Number : 122 — Hershey, Pennsylvania, United States
• Temple University Hospital - 3401 N Broad St- Site Number : 130 — Philadelphia, Pennsylvania, United States
• Velocity Clinical Research - Spartanburg - PPDS- Site Number : 120 — Spartanburg, South Carolina, United States
• Houston Methodist Hospital- Site Number : 113 — Houston, Texas, United States
• University of Utah Health Care- Site Number : 106 — Salt Lake City, Utah, United States
• Investigational Site Number : 202 — Chermside, Queensland, Australia
• Investigational Site Number : 204 — South Brisbane, Queensland, Australia
• Investigational Site Number : 201 — North Adelaide, South Australia, Australia
• Investigational Site Number : 207 — Box Hill, Victoria, Australia
• Investigational Site Number : 203 — Fitzroy, Victoria, Australia
• Investigational Site Number : 205 — Frankston, Victoria, Australia
• Investigational Site Number : 701 — Hellerup, Denmark

Full record on ClinicalTrials.gov

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