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RECRUITING
NCT05897424
PHASE2

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

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

185

Start Date

2024-06-20

Completion Date

2028-09-30

Last Updated

2025-10-24

Healthy Volunteers

No

Interventions

DRUG

SAR447537

A1PI, Recombinant, Bivalent Fc Fusion Protein

Locations (40)

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

Investigational Site Number : 702

Vejle, Denmark

Investigational Site Number : 501

Dublin, Dublin, Ireland

Investigational Site Number : 403

Auckland, New Zealand

Investigational Site Number : 404

Wellington, New Zealand

Investigational Site Number : 801

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number : 802

Krakow, Poland

Investigational Site Number : 901

Santander, Cantabria, Spain

Investigational Site Number : 902

Madrid, Spain

Investigational Site Number : 903

Santiago de Compostela, Spain

Investigational Site Number : 601

Gothenburg, Sweden

Investigational Site Number : 308

Dundee, Angus, United Kingdom

Investigational Site Number : 306

Wythenshawe, Cheshire, United Kingdom

Investigational Site Number : 307

Exeter, Devon, United Kingdom

Investigational Site Number : 304

Southampton, Hampshire, United Kingdom

Investigational Site Number : 309

Coventry, United Kingdom