Phase
Condition
Emphysema
Treatment
INBRX-101
SAR447537
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:
For newly identified participants
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
Uncontrolled diabetes mellitus despite adequate antidiabetic pharmacologic treatmentwith a screening HbA1c value ≥9%
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
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
AustraliaSite Not Available
Lung Research Qld
Chermside, Queensland 4032
AustraliaSite Not Available
Investigational Site Number : 204
South Brisbane, Queensland 4101
AustraliaSite Not Available
Investigational Site Number : 202
Chermside 6943582, Queensland 2152274 4032
AustraliaSite Not Available
Investigational Site Number : 204
South Brisbane 2207259, Queensland 2152274 4101
AustraliaSite Not Available
Investigational Site Number : 201
Adelaide, South Australia 5000
AustraliaSite Not Available
Investigational Site Number : 201
North Adelaide 8469169, South Australia 2061327 5000
AustraliaSite Not Available
Investigational Site Number : 205
Frankston, Victoria 3199
AustraliaSite Not Available
Investigational Site Number : 203
Melbourne, Victoria 3065
AustraliaSite Not Available
Investigational Site Number : 207
Melbourne, Victoria 3128
AustraliaActive - Recruiting
Investigational Site Number : 207
Box Hill 2174360, Victoria 2145234 3128
AustraliaSite Not Available
Investigational Site Number : 203
Fitzroy 2166584, Victoria 2145234 3065
AustraliaSite Not Available
Investigational Site Number : 205
Frankston 2166144, Victoria 2145234 3199
AustraliaSite Not Available
Investigational Site Number : 701
Hellerup, 2900
DenmarkSite Not Available
Investigational Site Number : 701
Hellerup 2620516, 2900
DenmarkSite Not Available
Investigational Site Number : 702
Vejle, 7100
DenmarkSite Not Available
Investigational Site Number : 702
Vejle 2610613, 7100
DenmarkSite Not Available
Investigational Site Number : 501
Dublin 2964574, Dublin D09 XR63
IrelandSite Not Available
Investigational Site Number : 501
Dublin 9, Dublin D09 XR63
IrelandSite Not Available
Investigational Site Number : 403
Auckland, 1051
New ZealandSite Not Available
Investigational Site Number : 403
Auckland 2193733, 1051
New ZealandSite Not Available
Investigational Site Number : 404
Wellington, 6021
New ZealandSite Not Available
Investigational Site Number : 404
Wellington 2179537, 6021
New ZealandSite Not Available
Investigational Site Number : 802
Krakow, Malopolskie 31-501
PolandSite Not Available
Investigational Site Number : 801
Warsaw 756135, Masovian Voivodeship 858787 01-138
PolandSite Not Available
Investigational Site Number : 801
Warszawa, Mazowieckie 01-138
PolandSite Not Available
Investigational Site Number : 802
Krakow 3094802, 30-688
PolandSite Not Available
Investigational Site Number : 903
Santiago de Compostela, A Coruña [La Coruña] 15706
SpainSite Not Available
Investigational Site Number : 901
Santander, Cantabria 39008
SpainSite Not Available
Investigational Site Number : 901
Santander 3109718, Cantabria 3336898 39008
SpainSite Not Available
Investigational Site Number : 902
Madrid, 28040
SpainSite Not Available
Investigational Site Number : 902
Madrid 3117735, 28040
SpainSite Not Available
Investigational Site Number : 903
Santiago de Compostela 3109642, 15706
SpainSite Not Available
Investigational Site Number : 601
Gothenburg, 413 45
SwedenSite Not Available
Investigational Site Number : 601
Gothenburg 2711537, 413 46
SwedenSite Not Available
Investigational Site Number : 308
Dundee, Angus DD1 9SY
United KingdomSite Not Available
Investigational Site Number : 308
Dundee 2650752, Angus DD1 9SY
United KingdomSite Not Available
Investigational Site Number : 306
Wythenshawe, Cheshire M23 9QZ
United KingdomSite Not Available
Investigational Site Number : 306
Wythenshawe 2633432, Cheshire M23 9QZ
United KingdomSite Not Available
Investigational Site Number : 307
Exeter, Devon EX2 5DW
United KingdomSite Not Available
Investigational Site Number : 307
Exeter 2649808, Devon EX2 5DW
United KingdomSite Not Available
Investigational Site Number : 304
Southampton, Hampshire SO16 6YD
United KingdomSite Not Available
Investigational Site Number : 304
Southampton 2637487, Hampshire SO16 6YD
United KingdomSite Not Available
Investigational Site Number : 302
Birmingham, Warwickshire B15 2WB
United KingdomSite Not Available
Investigational Site Number : 309
Coventry, CV2 2DX
United KingdomSite Not Available
Investigational Site Number : 309
Coventry 2652221, CV2 2DX
United KingdomSite Not Available
Investigational Site Number: 306
Manchester, M23 9QZ
United KingdomSite Not Available
University of Alabama at Birmingham- Site Number : 105
Birmingham, Alabama 35233
United StatesActive - Recruiting
UAB Lung Health Center- Site Number : 105
Birmingham 4049979, Alabama 4829764 35205-2610
United StatesSite Not Available
St. Joseph's Hospital and Medical Center- Site Number : 126
Phoenix, Arizona 85013
United StatesSite Not Available
St Joseph's Hospital and Medical Center- Site Number : 126
Phoenix 5308655, Arizona 5551752 85013-4220
United StatesSite Not Available
David Geffen School of Medicine at UCLA- Site Number : 124
Los Angeles, California 90095-3075
United StatesSite Not Available
University of California Davis Health- Site Number : 110
Sacramento, California 95817
United StatesSite Not Available
University of California Davis Medical Center
Sacramento, California 95817-2201
United StatesActive - Recruiting
David Geffen School of Medicine at UCLA- Site Number : 124
Los Angeles 5368361, California 5332921 90095-3075
United StatesActive - Recruiting
University of California Davis Medical Center- Site Number : 110
Sacramento 5389489, California 5332921 95817-2201
United StatesSite Not Available
National Jewish Health Medical Center- Site Number : 123
Denver, Colorado 80206
United StatesSite Not Available
National Jewish Medical and Research Center- Site Number : 123
Denver 5419384, Colorado 5417618 80206-2761
United StatesSite Not Available
Nuvance Health Medical Practices, Pulmonary & Sleep Specialists- Site Number : 119
Danbury, Connecticut 06810-5038
United StatesSite Not Available
Nuvance Health Medical Practices, Pulmonary & Sleep Specialists- Site Number : 119
Danbury 4832353, Connecticut 4831725 06810-5038
United StatesSite Not Available
Meris Clinical Research-310 Oakfield Dr- Site Number : 115
Brandon, Florida 33511-5706
United StatesSite Not Available
University of Florida - Gainesville - 1600 SW Archer Rd- Site Number : 101
Gainesville, Florida 32610-3003
United StatesSite Not Available
University of Florida - Gainesville - 1600 SW Archer Rd- Site Number : 101
Gainesville 4156404, Florida 4155751 32610-3003
United StatesSite Not Available
Indiana University Health University Hospital- Site Number : 127
Indianapolis, Indiana 46202
United StatesSite Not Available
Indiana University- Site Number : 127
Indianapolis 4259418, Indiana 4921868 46202-5128
United StatesSite Not Available
Brigham and Women's Hospital -75 Francis Street- Site Number : 131
Boston, Massachusetts 02115-6105
United StatesSite Not Available
Brigham and Women's Hospital -75 Francis Street- Site Number : 131
Boston 4930956, Massachusetts 6254926 02115-6105
United StatesSite Not Available
University of Minnesota-420 Delaware Str SE- Site Number : 125
Minneapolis, Minnesota 55455-0341
United StatesSite Not Available
University of Minnesota-420 Delaware Str SE- Site Number : 125
Minneapolis 5037649, Minnesota 5037779 55455-0341
United StatesSite Not Available
Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 111
Hannibal, Missouri 63401-6890
United StatesSite Not Available
Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 111
Hannibal 4389418, Missouri 4398678 63401-6890
United StatesSite Not Available
Columbia University Irving Medical Center- Site Number : 104
New York, New York 10032-3729
United StatesSite Not Available
Columbia University Irving Medical Center- Site Number : 104
New York 5128581, New York 5128638 10032-3729
United StatesSite Not Available
Oregon Health and Science University- Site Number : 117
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health and Science University- Site Number : 117
Portland 5746545, Oregon 5744337 97239-3011
United StatesSite Not Available
Penn State Health Milton S. Hershey Medical Center- Site Number : 122
Hershey, Pennsylvania 17033-2360
United StatesSite Not Available
Temple University Hospital - 3401 N Broad St- Site Number : 130
Philadelphia, Pennsylvania 19140-5103
United StatesSite Not Available
Penn State Health Milton S. Hershey Medical Center- Site Number : 122
Hershey 5193342, Pennsylvania 6254927 17033-2360
United StatesSite Not Available
Temple University Hospital - 3401 N Broad St- Site Number : 130
Philadelphia 4560349, Pennsylvania 6254927 19140-5103
United StatesSite Not Available
Velocity Clinical Research - Spartanburg - PPDS- Site Number : 120
Spartanburg, South Carolina 29303-4225
United StatesSite Not Available
Velocity Clinical Research - Spartanburg - PPDS- Site Number : 120
Spartanburg 4597200, South Carolina 4597040 29303-4225
United StatesSite Not Available
Houston Methodist Hospital- Site Number : 113
Houston, Texas 77030
United StatesActive - Recruiting
Houston Methodist West Hospital- Site Number : 113
Houston, Texas 77094
United StatesSite Not Available
Houston Methodist Hospital- Site Number : 113
Houston 4699066, Texas 4736286 77030-2703
United StatesActive - Recruiting
University of Utah Health Care- Site Number : 106
Salt Lake City, Utah 84132-0001
United StatesSite Not Available
University of Utah Health Care- Site Number : 106
Salt Lake City 5780993, Utah 5549030 84132-0001
United StatesSite Not Available

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