Phase
Condition
Emphysema
Treatment
SAR447537
INBRX-101
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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
Exclusion
Exclusion Criteria:
Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of studydrug
Known or suspected allergy to components of SAR447537, A1PI or human IgG
Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapieswithin 30 days
On waiting list for lung or liver transplant
Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to orduring 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
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study Design
Study Description
Connect with a study center
Investigational Site Number : 202
Brisbane, Queensland 4032
AustraliaActive - Recruiting
Lung Research Qld
Chermside, Queensland 4032
AustraliaSite Not Available
Investigational Site Number : 204
South Brisbane, Queensland 4101
AustraliaActive - Recruiting
Investigational Site Number : 201
Adelaide, South Australia 5000
AustraliaActive - Recruiting
Investigational Site Number : 205
Frankston, Victoria 3199
AustraliaActive - Recruiting
Investigational Site Number : 203
Melbourne, Victoria 3065
AustraliaActive - Recruiting
Investigational Site Number : 207
Melbourne, Victoria 3128
AustraliaActive - Recruiting
Investigational Site Number : 701
Hellerup, 2900
DenmarkActive - Recruiting
Investigational Site Number : 702
Vejle, 7100
DenmarkActive - Recruiting
Investigational Site Number : 501
Dublin 9, Dublin D09 XR63
IrelandActive - Recruiting
Investigational Site Number : 403
Auckland, 1051
New ZealandActive - Recruiting
Investigational Site Number : 404
Wellington, 6021
New ZealandActive - Recruiting
Investigational Site Number : 802
Krakow, Malopolskie 31-501
PolandActive - Recruiting
Investigational Site Number : 903
Santiago de Compostela, A Coruña [La Coruña] 15706
SpainActive - Recruiting
Investigational Site Number : 901
Santander, Cantabria 39008
SpainActive - Recruiting
Investigational Site Number : 902
Madrid, 28040
SpainActive - Recruiting
Investigational Site Number : 601
Gothenburg, 413 45
SwedenActive - Recruiting
Investigational Site Number : 308
Dundee, Angus DD1 9SY
United KingdomActive - Recruiting
Investigational Site Number : 307
Exeter, Devon EX2 5DW
United KingdomActive - Recruiting
Investigational Site Number : 304
Southampton, Hampshire SO16 6YD
United KingdomActive - Recruiting
Investigational Site Number : 309
Coventry, CV2 2DX
United KingdomActive - Recruiting
Investigational Site Number: 306
Manchester, M23 9QZ
United KingdomActive - Recruiting
Investigational Site Number : 306
Wythenshawe, M23 9QZ
United KingdomActive - Recruiting
University of Alabama at Birmingham- Site Number : 105
Birmingham, Alabama 35233
United StatesActive - Recruiting
St. Joseph's Hospital and Medical Center- Site Number : 126
Phoenix, Arizona 85013
United StatesActive - Recruiting
David Geffen School of Medicine at UCLA- Site Number : 124
Los Angeles, California 90095-3075
United StatesActive - Recruiting
University of California Davis Medical Center
Sacramento, California 95817-2201
United StatesActive - Recruiting
National Jewish Health Medical Center- Site Number : 123
Denver, Colorado 80206
United StatesActive - Recruiting
Nuvance Health Medical Practices, Pulmonary & Sleep Specialists- Site Number : 119
Danbury, Connecticut 06810-5038
United StatesActive - Recruiting
Meris Clinical Research-310 Oakfield Dr- Site Number : 115
Brandon, Florida 33511-5706
United StatesActive - Recruiting
University of Florida - Gainesville - 1600 SW Archer Rd- Site Number : 101
Gainesville, Florida 32610-3003
United StatesActive - Recruiting
Indiana University Health University Hospital- Site Number : 127
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Brigham and Women's Hospital -75 Francis Street- Site Number : 131
Boston, Massachusetts 02115-6105
United StatesActive - Recruiting
University of Minnesota-420 Delaware Str SE- Site Number : 125
Minneapolis, Minnesota 55455-0341
United StatesActive - Recruiting
Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 111
Hannibal, Missouri 63401-6890
United StatesActive - Recruiting
Columbia University Irving Medical Center- Site Number : 104
New York, New York 10032-3729
United StatesActive - Recruiting
Oregon Health and Science University- Site Number : 117
Portland, Oregon 97239
United StatesActive - Recruiting
Penn State Health Milton S. Hershey Medical Center- Site Number : 122
Hershey, Pennsylvania 17033-2360
United StatesActive - Recruiting
Temple University Hospital - 3401 N Broad St- Site Number : 130
Philadelphia, Pennsylvania 19140-5103
United StatesActive - Recruiting
Velocity Clinical Research - Spartanburg - PPDS- Site Number : 120
Spartanburg, South Carolina 29303-4225
United StatesActive - Recruiting
Houston Methodist Hospital- Site Number : 113
Houston, Texas 77030
United StatesActive - Recruiting
University of Utah Health Care- Site Number : 106
Salt Lake City, Utah 84132-0001
United StatesActive - Recruiting
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