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
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD emphysema
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
UAB Lung Health Center- Site Number : 105
ACTIVE_NOT_RECRUITING
Birmingham
Arizona
St Joseph's Hospital and Medical Center- Site Number : 126
ACTIVE_NOT_RECRUITING
Phoenix
California
David Geffen School of Medicine at UCLA- Site Number : 124
RECRUITING
Los Angeles
University of California Davis Medical Center- Site Number : 110
ACTIVE_NOT_RECRUITING
Sacramento
Colorado
National Jewish Medical and Research Center- Site Number : 123
ACTIVE_NOT_RECRUITING
Denver
Connecticut
Nuvance Health Medical Practices, Pulmonary & Sleep Specialists- Site Number : 119
ACTIVE_NOT_RECRUITING
Danbury
Florida
University of Florida - Gainesville - 1600 SW Archer Rd- Site Number : 101
ACTIVE_NOT_RECRUITING
Gainesville
Indiana
Indiana University- Site Number : 127
ACTIVE_NOT_RECRUITING
Indianapolis
Massachusetts
Brigham and Women's Hospital -75 Francis Street- Site Number : 131
ACTIVE_NOT_RECRUITING
Boston
Minnesota
University of Minnesota-420 Delaware Str SE- Site Number : 125
ACTIVE_NOT_RECRUITING
Minneapolis
Missouri
Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 111
ACTIVE_NOT_RECRUITING
Hannibal
New York
Columbia University Irving Medical Center- Site Number : 104
ACTIVE_NOT_RECRUITING
New York
Oregon
Oregon Health and Science University- Site Number : 117
ACTIVE_NOT_RECRUITING
Portland
Pennsylvania
Penn State Health Milton S. Hershey Medical Center- Site Number : 122
ACTIVE_NOT_RECRUITING
Hershey
Temple University Hospital - 3401 N Broad St- Site Number : 130
ACTIVE_NOT_RECRUITING
Philadelphia
South Carolina
Velocity Clinical Research - Spartanburg - PPDS- Site Number : 120
ACTIVE_NOT_RECRUITING
Spartanburg
Texas
Houston Methodist Hospital- Site Number : 113
RECRUITING
Houston
Utah
University of Utah Health Care- Site Number : 106
ACTIVE_NOT_RECRUITING
Salt Lake City
Other Locations
Australia
Investigational Site Number : 207
ACTIVE_NOT_RECRUITING
Box Hill
Investigational Site Number : 202
ACTIVE_NOT_RECRUITING
Chermside
Investigational Site Number : 203
ACTIVE_NOT_RECRUITING
Fitzroy
Investigational Site Number : 205
ACTIVE_NOT_RECRUITING
Frankston
Investigational Site Number : 201
ACTIVE_NOT_RECRUITING
North Adelaide
Investigational Site Number : 204
ACTIVE_NOT_RECRUITING
South Brisbane
Denmark
Investigational Site Number : 701
ACTIVE_NOT_RECRUITING
Hellerup
Investigational Site Number : 702
ACTIVE_NOT_RECRUITING
Vejle
Ireland
Investigational Site Number : 501
ACTIVE_NOT_RECRUITING
Dublin
New Zealand
Investigational Site Number : 403
ACTIVE_NOT_RECRUITING
Auckland
Investigational Site Number : 404
ACTIVE_NOT_RECRUITING
Wellington
Poland
Investigational Site Number : 802
ACTIVE_NOT_RECRUITING
Krakow
Investigational Site Number : 801
ACTIVE_NOT_RECRUITING
Warsaw
Spain
Investigational Site Number : 902
ACTIVE_NOT_RECRUITING
Madrid
Investigational Site Number : 901
ACTIVE_NOT_RECRUITING
Santander
Investigational Site Number : 903
ACTIVE_NOT_RECRUITING
Santiago De Compostela
Sweden
Investigational Site Number : 601
ACTIVE_NOT_RECRUITING
Gothenburg
United Kingdom
Investigational Site Number : 309
ACTIVE_NOT_RECRUITING
Coventry
Investigational Site Number : 308
ACTIVE_NOT_RECRUITING
Dundee
Investigational Site Number : 307
ACTIVE_NOT_RECRUITING
Exeter
Investigational Site Number : 304
ACTIVE_NOT_RECRUITING
Southampton
Investigational Site Number : 306
ACTIVE_NOT_RECRUITING
Wythenshawe
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-06-20
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 185
Treatments
Experimental: SAR447537 (INBRX-101)
A1PI, Recombinant, Bivalent Fc Fusion Protein, in a solution for intravenous injection
Related Therapeutic Areas
Sponsors
Leads: Sanofi