Phase
Condition
Bronchiectasis
Treatment
Placebo
Itepekimab (SAR440340)
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be 18 to 85 years of age inclusive.
Clinical history consistent with NCFB (cough, chronic sputum production and/orrecurrent respiratory infections).
Participants with a FEV1 % predicted ≥30%.
Participants with at least 2 moderate or 1 severe Pulmonary exacerbations (PEs) inthe past 12 months.
Exclusion
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Have bronchiectasis due to CF, hypogammaglobulinemia, common variableimmunodeficiency, known active nontuberculous mycobacteria (NTM) lung infection, orpulmonary fibrosis.
Known or suspected immunodeficiency disorder.
Pulmonary exacerbation which has not resolved clinically during screening period.
Have significant haemoptysis.
Have any clinically significant abnormal laboratory values at Screening or diseasesor disorders.
History of lung transplantation.
History of malignancy within 5 years before Screening, or during the screeningperiod
Currently being treated with antimicrobial therapy for tuberculosis (TB).
Currently on active treatment for allergic bronchopulmonary aspergillosis (ABPA).
Participants with active autoimmune disease or participants using immunosuppressivetherapy for autoimmune disease
Known allergy to itepekimab or to excipients
Live-attenuated vaccine(s) within 4 weeks prior to Screening or plans to receivesuch vaccines during the study
Unstable ischemic heart disease
Cardiomyopathy or other relevant cardiovascular disorder
Clinically significant new abnormal electrocardiogram (ECG) within 6 months priorto, or at Screening
History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serologyat Screening.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Design
Connect with a study center
Investigational Site Number : 0320004
Caba, Buenos Aires 1427
ArgentinaSite Not Available
Investigational Site Number : 0320002
La Plata, Buenos Aires 1900
ArgentinaActive - Recruiting
Investigational Site Number : 0320001
Buenos Aires, 1414
ArgentinaActive - Recruiting
Investigational Site Number : 0320003
Buenos Aires, 1121
ArgentinaActive - Recruiting
Investigational Site Number : 0320004
Buenos Aires, 1430
ArgentinaActive - Recruiting
Investigational Site Number : 0320008
Buenos Aires, 1280
ArgentinaActive - Recruiting
Investigational Site Number : 0320001
Ciudad Autonoma Buenos Aires, C1414AIF
ArgentinaSite Not Available
Investigational Site Number : 0320007
Córdoba, 5003
ArgentinaActive - Recruiting
Investigational Site Number : 0320006
Mendoza, 5500
ArgentinaActive - Recruiting
Investigational Site Number : 0320005
San Miguel de Tucuman, T4000IAI
ArgentinaSite Not Available
Investigational Site Number : 0320005
San Miguel de Tucumán, 4000
ArgentinaActive - Recruiting
OC ONCOCLINICAS UMC- Site Number : 0760007
Uberlandia, Minas Gerais 38411-186
BrazilActive - Recruiting
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
Porto Alegre, Rio Grande Do Sul 90610-000
BrazilSite Not Available
Irmandade da Santa Casa de Misericordia de Porto Alegre- Site Number : 0760005
Porto Alegre, Rio Grande Do Sul 90020-090
BrazilActive - Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
Porto Alegre, Rio Grande Do Sul 90020-090
BrazilActive - Recruiting
WM Clinica Pneumologica- Site Number : 0760004
Porto Alegre, Rio Grande Do Sul 91010-004
BrazilSite Not Available
InCor - Instituto do Coraçao do Hospital das Clinicas da FMUSP Site Number : 0760002
Sao Paulo, São Paulo 05403-900
BrazilSite Not Available
Incor - Instituto do Coracao- Site Number : 0760002
São Paulo, 05403-900
BrazilSite Not Available
Investigational Site Number : 1240003
Guelph, Ontario N1H 6J2
CanadaSite Not Available
Investigational Site Number : 1240005
Sherbrooke, Quebec J1H 5N4
CanadaSite Not Available
Investigational Site Number : 1240001
Trois-Rivieres, Quebec G8T 7A1
CanadaSite Not Available
Investigational Site Number : 1240001
Trois-rivières, Quebec G8T 7A1
CanadaSite Not Available
Investigational Site Number : 1520001
Talca, Maule 3465584
ChileSite Not Available
Investigational Site Number : 1520002
Santiago, Reg Metropolitana De Santiago 7500692
ChileSite Not Available
Investigational Site Number : 1520003
Santiago, Reg Metropolitana De Santiago 7500587
ChileSite Not Available
Investigational Site Number : 1520004
Quillota, Valparaíso 2260877
ChileSite Not Available
Investigational Site Number : 1560005
Beijing, 100020
ChinaCompleted
Investigational Site Number : 1560008
Changchun, 130021
ChinaSite Not Available
Investigational Site Number : 1560004
Chengdu, 610041
ChinaSite Not Available
Investigational Site Number : 1560001
Guangzhou, 510120
ChinaSite Not Available
Investigational Site Number : 1560002
Shanghai, 200433
ChinaActive - Recruiting
Investigational Site Number : 1560006
Shanghai, 200025
ChinaActive - Recruiting
Investigational Site Number : 1560007
Shenyang, 110004
ChinaSite Not Available
Investigational Site Number : 1560003
Xuzhou, 221006
ChinaSite Not Available
Investigational Site Number : 2030006
Cesky Krumlov, 381 01
CzechiaSite Not Available
Investigational Site Number : 2030002
Jindrichuv Hradec III, 37701
CzechiaSite Not Available
Investigational Site Number : 2030002
Jindřichův Hradec, 377 01
CzechiaActive - Recruiting
Investigational Site Number : 2030004
Kralupy Nad Vltavou, 278 01
CzechiaActive - Recruiting
Investigational Site Number : 2030003
Pilsen, 305 99
CzechiaActive - Recruiting
Investigational Site Number : 2030005
Prague, 190 00
CzechiaActive - Recruiting
Investigational Site Number : 2030005
Praha 9, 190 00
CzechiaSite Not Available
Investigational Site Number : 2030006
Český Krumlov, 381 01
CzechiaActive - Recruiting
Investigational Site Number : 2080002
Aalborg, 9000
DenmarkSite Not Available
Investigational Site Number : 2080005
Aarhus, 8200
DenmarkSite Not Available
Investigational Site Number : 2080005
Aarhus N, 8200
DenmarkSite Not Available
Investigational Site Number : 2080004
Odense, 5000
DenmarkSite Not Available
Investigational Site Number : 2080004
Odense C, 5000
DenmarkSite Not Available
Investigational Site Number : 2080001
Vejle, 7100
DenmarkSite Not Available
Investigational Site Number : 2500005
Brest, 29200
FranceActive - Recruiting
Investigational Site Number : 2500005
Brest cedex 2, 29609
FranceSite Not Available
Investigational Site Number : 2500001
Lyon, 69004
FranceActive - Recruiting
Investigational Site Number : 2500002
Montpellier, 34090
FranceActive - Recruiting
Investigational Site Number : 2500004
Nice, 06001
FranceActive - Recruiting
Investigational Site Number : 2500003
Paris, 75679
FranceActive - Recruiting
Investigational Site Number : 2500007
Pontoise, 95300
FranceActive - Recruiting
Investigational Site Number : 2500006
Saint-herblain, 44800
FranceActive - Recruiting
Investigational Site Number : 2760001
Ahrensburg, 22926
GermanyActive - Recruiting
Investigational Site Number : 2760005
Bendorf, 56170
GermanyActive - Recruiting
Investigational Site Number : 2760010
Berlin, 12159
GermanyActive - Recruiting
Investigational Site Number : 2760009
Cottbus, 03050
GermanyActive - Recruiting
Investigational Site Number : 2760007
Essen, 45239
GermanyActive - Recruiting
Investigational Site Number : 2760003
Frankfurt, 60596
GermanyActive - Recruiting
Investigational Site Number : 2760003
Frankfurt am Main, 60596
GermanySite Not Available
Investigational Site Number : 2760001
GROßHANSDORF, 22927
GermanySite Not Available
Investigational Site Number : 2760004
Lübeck, 23552
GermanyActive - Recruiting
Investigational Site Number : 2760002
Mainz, 55128
GermanyActive - Recruiting
Investigational Site Number : 2760011
Meunchen, 80336
GermanySite Not Available
Investigational Site Number : 2760011
Munich, 80337
GermanyActive - Recruiting
Investigational Site Number : 3000002
Athens, 115 27
GreeceActive - Recruiting
Investigational Site Number : 3000001
Ioannina, 455 00
GreeceSite Not Available
Investigational Site Number : 3000003
Thessaloniki, 570 10
GreeceSite Not Available
Investigational Site Number : 3760008
Ashkelon, 7830604
IsraelSite Not Available
Investigational Site Number : 3760006
Haifa, 3436212
IsraelSite Not Available
Investigational Site Number : 3760001
Jerusalem, 9112001
IsraelSite Not Available
Investigational Site Number : 3760003
Jerusalem, 9103102
IsraelSite Not Available
Investigational Site Number : 3760002
Petah Tikva, 4941492
IsraelSite Not Available
Investigational Site Number : 3760002
Petah-Tikva, 49100
IsraelSite Not Available
Investigational Site Number : 3760009
Ramat Gan, 5262100
IsraelSite Not Available
Investigational Site Number : 3760004
Rehovot, 7610001
IsraelSite Not Available
Investigational Site Number : 3760007
Tel Aviv, 6423906
IsraelSite Not Available
Investigational Site Number : 3760010
Tel Aviv, 6789140
IsraelSite Not Available
Investigational Site Number : 3760010
Tel-Aviv,
IsraelSite Not Available
Investigational Site Number : 3800001
Milan, Lombardia 20122
ItalyActive - Recruiting
Investigational Site Number : 3800001
Milano, Lombardia 20122
ItalySite Not Available
Investigational Site Number : 3800002
Rozzano, Milano 20089
ItalyActive - Recruiting
Investigational Site Number : 3800004
Palermo, 90127
ItalyActive - Recruiting
Investigational Site Number : 3800003
Pavia, 27100
ItalyActive - Recruiting
Investigational Site Number : 3800006
Reggio Emilia, 42123
ItalyActive - Recruiting
Investigational Site Number : 3920002
Kamogawa, Chiba 296-0041
JapanSite Not Available
Investigational Site Number : 3920002
Kamogawa-shi, Chiba 296-0041
JapanSite Not Available
Investigational Site Number : 3920004
Himeji, Hyogo 670-0849
JapanSite Not Available
Investigational Site Number : 3920004
Himeji-shi, Hyogo 670-0849
JapanSite Not Available
Investigational Site Number : 3920005
Kiyose, Tokyo 204-8522
JapanSite Not Available
Investigational Site Number : 3920005
Kiyose-City, Tokyo 204-8522
JapanSite Not Available
Investigational Site Number : 3920001
Shinagawa-ku, Tokyo 140-8522
JapanSite Not Available
Investigational Site Number : 3920003
Shinjuku-ku, Tokyo 162-8655
JapanSite Not Available
Investigational Site Number : 3920001
Tokyo, 140-8522
JapanSite Not Available
Investigational Site Number : 3920003
Tokyo, 162-8655
JapanSite Not Available
Investigational Site Number : 5280002
Alkmaar, 1815 JD
NetherlandsSite Not Available
Investigational Site Number : 5280005
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Investigational Site Number : 5280004
Breda, 4818 CK
NetherlandsSite Not Available
Investigational Site Number : 5280003
Den Haag, 2545 AA
NetherlandsSite Not Available
Investigational Site Number : 5280001
Rotterdam, 3015 CE
NetherlandsSite Not Available
Investigational Site Number : 5280003
The Hague, 2545 CH
NetherlandsSite Not Available
Investigational Site Number : 6160005
Lodz, Lódzkie 90-153
PolandActive - Recruiting
Investigational Site Number : 6160001
Bialystok, Podlaskie 15-044
PolandActive - Recruiting
Investigational Site Number : 6160002
Ostrowiec Swietokrzyski, Swietokrzyskie 27-400
PolandActive - Recruiting
Investigational Site Number : 6160003
Lodz, 90-302
PolandActive - Recruiting
Investigational Site Number : 6160006
Wejherowo, 84-200
PolandActive - Recruiting
Investigational Site Number : 7240003
Barcelona, Barcelona [Barcelona] 08035
SpainSite Not Available
Investigational Site Number : 7240006
Barcelona, Barcelona [Barcelona] 08036
SpainSite Not Available
Investigational Site Number : 7240007
Barcelona, Barcelona [Barcelona] 08017
SpainSite Not Available
Investigational Site Number : 7240001
Hospitalet de Llobregat, Barcelona [Barcelona] 08907
SpainSite Not Available
Investigational Site Number : 7240001
L'hospitalet de Llobregat, Barcelona [Barcelona] 08907
SpainSite Not Available
Investigational Site Number : 7240009
Santander, Cantabria 39008
SpainSite Not Available
Investigational Site Number : 7240011
Girona, Girona [Gerona] 17007
SpainActive - Recruiting
Investigational Site Number : 7240012
Girona, Girona [Gerona] 17005
SpainSite Not Available
Investigational Site Number : 7240002
Madrid, Madrid, Comunidad De 28007
SpainSite Not Available
Investigational Site Number : 7240002
Madrid / Madrid, Madrid, Comunidad De 28007
SpainSite Not Available
Investigational Site Number : 7240010
Valencia, 46026
SpainSite Not Available
Investigational Site Number : 1580005
Kaohsiung, 807
TaiwanSite Not Available
Investigational Site Number : 1580005
Kaohsiung City, 807
TaiwanSite Not Available
Investigational Site Number : 1580002
New Taipei City, 220
TaiwanCompleted
Investigational Site Number : 1580006
Taichung, 404
TaiwanSite Not Available
Investigational Site Number : 1580003
Taipei, 11031
TaiwanSite Not Available
Investigational Site Number : 1580003
Taipei City, 110
TaiwanSite Not Available
Investigational Site Number : 1580004
Taipei City, 100
TaiwanSite Not Available
Investigational Site Number : 7920003
Adana, 01330
TurkeyActive - Recruiting
Investigational Site Number : 7920002
Akdeniz, 33070
TurkeyActive - Recruiting
Investigational Site Number : 7920005
Ankara, 06620
TurkeyActive - Recruiting
Investigational Site Number : 7920001
Istanbul, 34093
TurkeyActive - Recruiting
Investigational Site Number : 7920004
Izmit, 41001
TurkeyActive - Recruiting
Investigational Site Number : 7920004
Kocaeli, 41100
TurkeySite Not Available
Investigational Site Number : 7920002
Mersin, 33070
TurkeySite Not Available
Investigational Site Number : 7920006
Samsun, 55139
TurkeyActive - Recruiting
Investigational Site Number : 8260009
Cambridge, Cambridgeshire CB23 3RE
United KingdomActive - Recruiting
Investigational Site Number : 8260008
Norwich, Norfolk NR4 7UY
United KingdomActive - Recruiting
Investigational Site Number : 8260003
North Shields, North Tyneside NE29 8NH
United KingdomActive - Recruiting
Investigational Site Number : 8260003
Tyne And Wear, North Tyneside NE29 8NH
United KingdomSite Not Available
Investigational Site Number : 8260004
Lancaster, LA1 4RP
United KingdomActive - Recruiting
Investigational Site Number : 8260001
Newcastle Upon Tyne, NE7 7DN
United KingdomActive - Recruiting
Investigational Site Number : 8260005
Reading, RG1 5AN
United KingdomActive - Recruiting
University of Alabama at Birmingham- Site Number : 8400040
Birmingham, Alabama 35233
United StatesActive - Recruiting
Phoenix Medical Group- Site Number : 8400033
Peoria, Arizona 85381
United StatesSite Not Available
Pulmonary Associates - Phoenix - East McDowell Road- Site Number : 8400012
Phoenix, Arizona 85006
United StatesActive - Recruiting
Pulmonary Associates Site Number : 8400012
Phoenix, Arizona 85006
United StatesActive - Recruiting
Southern California Institute For Respiratory Diseases, Inc. Site Number : 8400002
Los Angeles, California 90048
United StatesActive - Recruiting
Southern California Institute for Respiratory Diseases- Site Number : 8400002
Los Angeles, California 90048
United StatesSite Not Available
Institute Healthcare Assessment- Site Number : 8400037
San Diego, California 92120
United StatesActive - Recruiting
Institute of HealthCare Assessment, Inc. Site Number : 8400037
San Diego, California 92120
United StatesActive - Recruiting
Allianz Research Institute Site Number : 8400013
Westminster, California 92683
United StatesActive - Recruiting
Allianz Research Institute- Site Number : 8400013
Westminster, California 92683
United StatesActive - Recruiting
Allianz Research Institute CO Site Number : 8400038
Aurora, Colorado 80014
United StatesActive - Recruiting
Allianz Research Institute CO- Site Number : 8400038
Aurora, Colorado 80014
United StatesActive - Recruiting
University Of Connecticut Health Center Site Number : 8400020
Farmington, Connecticut 06030
United StatesActive - Recruiting
University Of Connecticut Health Center- Site Number : 8400020
Farmington, Connecticut 06030
United StatesActive - Recruiting
University of Connecticut Health Center- Site Number : 8400020
Farmington, Connecticut 06032
United StatesActive - Recruiting
Yale New Haven Hospital- Site Number : 8400065
New Haven, Connecticut 06510
United StatesActive - Recruiting
Advanced Pulmonary Research Institute Site Number : 8400007
Loxahatchee Groves, Florida 33470
United StatesActive - Recruiting
Advanced Pulmonary Research Institute- Site Number : 8400007
Loxahatchee Groves, Florida 33470
United StatesActive - Recruiting
Clever Medical Research, LLC Site Number : 8400001
Miami, Florida 33126
United StatesActive - Recruiting
Clever Medical Research, LLC- Site Number : 8400001
Miami, Florida 33126
United StatesActive - Recruiting
Clever Medical Research- Site Number : 8400001
Miami, Florida 33126
United StatesActive - Recruiting
High Quality Research Site Number : 8400047
Miami, Florida 33184
United StatesActive - Recruiting
High Quality Research- Site Number : 8400047
Miami, Florida 33184
United StatesActive - Recruiting
My Community Research Center Site Number : 8400023
Miami, Florida 33155
United StatesActive - Recruiting
My Community Research Center- Site Number : 8400023
Miami, Florida 33155
United StatesActive - Recruiting
Destiny Research Center- Site Number : 8400049
Palmetto Bay, Florida 33157
United StatesActive - Recruiting
Avanza Medical Research Center Site Number : 8400018
Pensacola, Florida 32503
United StatesActive - Recruiting
Avanza Medical Research Center- Site Number : 8400018
Pensacola, Florida 32503
United StatesActive - Recruiting
Broward Pulmonary and Sleep Specialists Site Number : 8400010
Plantation, Florida 33324
United StatesActive - Recruiting
Broward Pulmonary and Sleep Specialists- Site Number : 8400010
Plantation, Florida 33324
United StatesActive - Recruiting
Private Practice - Dr. Frank Hull - Plantation- Site Number : 8400010
Plantation, Florida 33324
United StatesActive - Recruiting
Northwestern Memorial Hospital- Site Number : 8400043
Chicago, Illinois 60611
United StatesActive - Recruiting
University of Kansas Medical Center- Site Number : 8400045
Kansas City, Kansas 66160
United StatesActive - Recruiting
University of Michigan Health System - Ann Arbor- Site Number : 8400055
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Pulmonary and Medicine Associates- Site Number : 8400057
Warren, Michigan 48088
United StatesActive - Recruiting
Washington University- Site Number : 8400046
Saint Louis, Missouri 63110
United StatesActive - Recruiting
NYU Langone Medical Center- Site Number : 8400032
New York, New York 10016
United StatesActive - Recruiting
New York University Site Number : 8400032
New York, New York 10017
United StatesActive - Recruiting
New York University- Site Number : 8400032
New York, New York 10017
United StatesActive - Recruiting
American Health Research - Charlotte- Site Number : 8400017
Charlotte, North Carolina 28277
United StatesActive - Recruiting
American Health Research Site Number : 8400017
Charlotte, North Carolina 28277
United StatesActive - Recruiting
Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400009
Huntersville, North Carolina 28078
United StatesActive - Recruiting
Advanced Respiratory and Sleep Medicine Site Number : 8400009
Huntersville, North Carolina 28078
United StatesActive - Recruiting
Southeastern Research Center Site Number : 8400008
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
Southeastern Research Center- Site Number : 8400008
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
Clinical Research Associates of Central PA - Dubois- Site Number : 8400005
DuBois, Pennsylvania 15801
United StatesActive - Recruiting
Clinical Research of Central PA Site Number : 8400005
DuBois, Pennsylvania 15801
United StatesActive - Recruiting
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400039
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Temple University Hospital Site Number : 8400015
Philadelphia, Pennsylvania 19140-5103
United StatesActive - Recruiting
Temple University Hospital- Site Number : 8400015
Philadelphia, Pennsylvania 19140
United StatesActive - Recruiting
Medical University Of South Carolina- Site Number : 8400027
Charleston, South Carolina 29425
United StatesActive - Recruiting
Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8400027
Charleston, South Carolina 29425
United StatesActive - Recruiting
Metroplex Pulmonary and Sleep Center Site Number : 8400014
McKinney, Texas 75069
United StatesActive - Recruiting
Metroplex Pulmonary and Sleep Center- Site Number : 8400014
McKinney, Texas 75069
United StatesActive - Recruiting
Clincove: Plano Primary Care Clinic Site Number : 8400019
Plano, Texas 75024
United StatesActive - Recruiting
Clincove: Plano Primary Care Clinic- Site Number : 8400019
Plano, Texas 75024
United StatesActive - Recruiting
Plano Primary Care Clinic- Site Number : 8400019
Plano, Texas 75024
United StatesActive - Recruiting
Pioneer Research Solutions, Inc. Site Number : 8400048
Sugar Land, Texas 77479
United StatesActive - Recruiting
Pioneer Research Solutions, Inc.- Site Number : 8400048
Sugar Land, Texas 77479
United StatesActive - Recruiting
The University of Texas Health Center at Tyler- Site Number : 8400053
Tyler, Texas 75708
United StatesActive - Recruiting
The University of Texas Health Science Center at Tyler- Site Number : 8400053
Tyler, Texas 75708
United StatesActive - Recruiting
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