Phase
Condition
Asthma
Treatment
Amlitelimab
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants with moderate-to-severe asthma who completed the treatment period ofthe parent study per protocol
Participants on background dose with medium-to-high doses of ICS therapy (≥500 µg offluticasone propionate daily or comparable ICS dosage up to a maximum of 2000 µg/dayof fluticasone propionate or clinically comparable) in combination with a second orthird controller (eg, LABA, LTRA, LAMA, methylxanthines), with or without OCS (up toa maximum of 15 mg prednisone or equivalent daily or 30 mg every other day) asmaintained during the parent study in which they participated Note for Japan:participants must be on ≥400 μg of fluticasone propionate daily or equivalent.
Contraception for male and female participants;
For female participants:
incapable of becoming pregnant
not pregnant or breast feeding
not to donate or cryopreserve eggs for female participants For male participants
No sperm donation or cryopreserving sperms
Exclusion
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Chronic lung disease other than asthma
Participants who developed a new medical condition or a change in status of anestablished medical condition or require a new treatment or medication prior toenrollment, which (per Investigator's medical judgment) would adversely affect theparticipation in this study or would require permanent IMP discontinuation
Current smoker or active vaping of any products and/or marijuana smoking
Prescription drug or substance abuse, including alcohol, considered significant bythe Investigator
Any new development with the participant's disease or condition or any significantlaboratory test abnormality during the parent study that, in the opinion of theInvestigator, may present an unreasonable risk for the participant
Sensitivity to any of the study interventions, or components thereof, or drug orother allergy that, in the opinion of the Investigator, contraindicatesparticipation in the study
Individuals accommodated in an institution because of regulatory or legal order;prisoners or participants who are legally institutionalized
Participant not suitable for participation, whatever the reason, as judged by theInvestigator, including medical or clinical conditions, or participants potentiallyat risk of noncompliance to study procedures
Participants are employees of the investigative site or other individuals directlyinvolved in the conduct of the study, or immediate family members of suchindividuals
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Study Design
Study Description
Connect with a study center
Investigational Site Number : 0320001
Caba, Buenos Aires C1425BEN
ArgentinaSite Not Available
Investigational Site Number : 0320002
Caba, Buenos Aires C1425FVH
ArgentinaActive - Recruiting
Investigational Site Number : 0320008
La Plata, Buenos Aires 1900
ArgentinaSite Not Available
Investigational Site Number : 0320002
CABA, Buenos Aires 3435907 C1425FVH
ArgentinaSite Not Available
Investigational Site Number : 0320008
La Plata 3432043, Buenos Aires 3435907 B1900BNN
ArgentinaSite Not Available
Investigational Site Number : 0320009
Buenos Aires 3435910, Buenos Aires F.D. 3433955 1060
ArgentinaSite Not Available
Investigational Site Number : 0320005
Rosario, Santa Fe Province 2000
ArgentinaSite Not Available
Investigational Site Number : 0320006
Rosario, Santa Fe Province 2000
ArgentinaSite Not Available
Investigational Site Number : 0320007
Rosario, Santa Fe Province 2000
ArgentinaSite Not Available
Investigational Site Number : 0320005
Rosario 3838583, Santa Fe Province 3836276 S2000JKR
ArgentinaSite Not Available
Investigational Site Number : 0320006
Rosario 3838583, Santa Fe Province 3836276 2000
ArgentinaSite Not Available
Investigational Site Number : 0320007
Rosario 3838583, Santa Fe Province 3836276 S2000DEJ
ArgentinaSite Not Available
Investigational Site Number : 0320001
Buenos Aires, 1425
ArgentinaSite Not Available
Investigational Site Number : 0320002
Buenos Aires, 1425
ArgentinaSite Not Available
Investigational Site Number : 0320003
Buenos Aires, 1414
ArgentinaSite Not Available
Investigational Site Number : 0320004
Buenos Aires, 1121
ArgentinaSite Not Available
Investigational Site Number : 0320009
Buenos Aires, 1650
ArgentinaSite Not Available
Investigational Site Number : 0320004
Ciudad Autonoma Bs As, C1121ABE
ArgentinaSite Not Available
Investigational Site Number : 0320001
Ciudad Autonoma Buenos Aires, C1425BEN
ArgentinaSite Not Available
Investigational Site Number : 0320003
Ciudad Autonoma Buenos Aires, C1414AIF
ArgentinaSite Not Available
Proar Site Number : 0760004
Salvador, Bahia 40060-330
BrazilActive - Recruiting
Proar- Site Number : 0760004
Salvador, Bahia 40060-330
BrazilActive - Recruiting
CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760002
Vitoria, Espírito Santo 29055 450
BrazilActive - Recruiting
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760002
Vitoria, Espírito Santo 29055-450
BrazilSite Not Available
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760002
Vitória, Espírito Santo 29055-450
BrazilSite Not Available
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760002
Vitória 3444924, Espírito Santo 3463930 29055-450
BrazilSite Not Available
Associacao Proar- Site Number : 0760004
Salvador, Estado de Bahia 40060-330
BrazilSite Not Available
Proar- Site Number : 0760004
Salvador 3450554, Estado de Bahia 3471168 40060-330
BrazilSite Not Available
Hospital São Vicente de Paulo - Passo Fundo- Site Number : 0760001
Passo Fundo, Rio Grande Do Sul 99010-080
BrazilSite Not Available
Instituto Mederi de Pesquisa e Saude Site Number : 0760001
Passo Fundo, Rio Grande Do Sul 99010-120
BrazilActive - Recruiting
Hospital Sao Lucas da PUCRS Site Number : 0760006
Porto Alegre, Rio Grande Do Sul 90610-000
BrazilActive - Recruiting
Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760007
Porto Alegre, Rio Grande Do Sul 90020-090
BrazilActive - Recruiting
Irmandade da Santa Casa de Misericordia de Porto Alegre- Site Number : 0760007
Porto Alegre, Rio Grande Do Sul 90020-090
BrazilSite Not Available
Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001
Passo Fundo, Rio Grande do Sul 99010-170
BrazilSite Not Available
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006
Porto Alegre, Rio Grande do Sul 90610-000
BrazilSite Not Available
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760007
Porto Alegre, Rio Grande do Sul 90020-090
BrazilSite Not Available
Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001
Passo Fundo 3454857, Rio Grande do Sul 3451133 99010-170
BrazilSite Not Available
Hospital Sao Lucas da PUCRS- Site Number : 0760006
Porto Alegre 3452925, Rio Grande do Sul 3451133 90610-000
BrazilSite Not Available
Irmandade da Santa Casa de Misericordia de Porto Alegre- Site Number : 0760007
Porto Alegre 3452925, Rio Grande do Sul 3451133 90020-090
BrazilSite Not Available
Hospital das Clinicas de Sao Paulo Site Number : 0760008
Sao Paulo, São Paulo 05403-000
BrazilSite Not Available
Clinica de Alergia Martti Antila- Site Number : 0760003
Sorocaba, São Paulo 18040-425
BrazilSite Not Available
Hospital das Clinicas de Sao Paulo- Site Number : 0760008
São Paulo 3448439, São Paulo 3448433 05403-000
BrazilSite Not Available
Clínica de Alergia Martti Antila Site Number : 0760003
Sorocaba, 18040-425
BrazilActive - Recruiting
Clínica de Alergia Martti Antila- Site Number : 0760003
Sorocaba 3447399, 18040-425
BrazilSite Not Available
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008
São Paulo, 05403-000
BrazilSite Not Available
Investigational Site Number : 1240008
Ottawa, Ontario K1G 6C6
CanadaSite Not Available
Investigational Site Number : 1240008
Ottawa 6094817, Ontario 6093943 K1G 6C6
CanadaSite Not Available
Investigational Site Number : 1240007
Trois-Rivieres, Quebec G8T 7A1
CanadaSite Not Available
Investigational Site Number : 1240007
Trois-Rivières, Quebec G8T 7A1
CanadaSite Not Available
Investigational Site Number : 1240007
Trois-Rivières 6169141, Quebec 6115047 G8T 7A1
CanadaSite Not Available
Investigational Site Number : 1520006
Talca, Maule Region 3465584
ChileSite Not Available
Investigational Site Number : 1520006
Talca 3870294, Maule Region 3880306 3465584
ChileSite Not Available
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago 7500692
ChileSite Not Available
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago 7750495
ChileSite Not Available
Investigational Site Number : 1520008
Santiago, Reg Metropolitana de Santiago 8380465
ChileSite Not Available
Investigational Site Number : 1520001
Santiago 3871336, Reg Metropolitana de Santiago 7500692
ChileSite Not Available
Investigational Site Number : 1520003
Santiago 3871336, Reg Metropolitana de Santiago 7750495
ChileSite Not Available
Investigational Site Number : 1520008
Santiago 3871336, Reg Metropolitana de Santiago 8380465
ChileSite Not Available
Investigational Site Number : 1520005
Quillota 3874119, Región de Valparaíso 3868621 2260877
ChileSite Not Available
Investigational Site Number : 1520005
Quillota, Valparaiso 2260877
ChileSite Not Available
Investigational Site Number : 3480009
Edelény, 3780
HungarySite Not Available
Investigational Site Number : 3480009
Edelény 721246, 3780
HungarySite Not Available
Investigational Site Number : 3480011
Gã¶dã¶llã¶, 2100
HungarySite Not Available
Investigational Site Number : 3480011
Gödöllö, 2100
HungarySite Not Available
Investigational Site Number : 3480011
Gödöllő, 2100
HungarySite Not Available
Investigational Site Number : 3480006
Puspokladany, 4150
HungarySite Not Available
Investigational Site Number : 3480006
Püspökladány, 4150
HungarySite Not Available
Investigational Site Number : 3480006
Püspökladány 716301, 4150
HungarySite Not Available
Investigational Site Number : 3480012
Szazhalombatta, 2440
HungarySite Not Available
Investigational Site Number : 3480012
Százhalombatta, 2440
HungarySite Not Available
Investigational Site Number : 3480012
Százhalombatta 3044821, 2440
HungarySite Not Available
Investigational Site Number : 3800004
Naples, Napoli 80131
ItalySite Not Available
Investigational Site Number : 3800003
Rome, Roma 00168
ItalySite Not Available
Investigational Site Number : 3800003
Rome 3169070, Roma 00168
ItalySite Not Available
Investigational Site Number : 3800004
Naples 3172394, 80131
ItalySite Not Available
Investigational Site Number : 3800004
Napoli, 80131
ItalySite Not Available
Investigational Site Number : 3800003
Roma, 00168
ItalySite Not Available
Investigational Site Number : 3800001
Verona, 37134
ItalySite Not Available
Investigational Site Number : 3800001
Verona 3164527, 37134
ItalySite Not Available
Investigational Site Number : 3920010
Sakai, Osaka 591-8555
JapanSite Not Available
Investigational Site Number : 3920010
Sakai-shi, Osaka 591-8555
JapanSite Not Available
Investigational Site Number : 3920010
Sakai 1853195, Osaka 1853904 591-8555
JapanSite Not Available
Investigational Site Number : 3920004
Chuo, Tokyo 104-0031
JapanSite Not Available
Investigational Site Number : 3920004
Chūō, Tokyo 104-0031
JapanSite Not Available
Investigational Site Number : 3920004
Chuo-ku, Tokyo 1850144 104-0031
JapanSite Not Available
Investigational Site Number : 3920005
Chuo-ku, Tokyo 1850144 103-0027
JapanSite Not Available
Investigational Site Number : 3920001
Shinagawa-ku, Tokyo 1850144 140-8522
JapanSite Not Available
Investigational Site Number : 3920019
Hiroshima, 732-0052
JapanSite Not Available
Investigational Site Number : 3920019
Hiroshima 1862415, 732-0052
JapanSite Not Available
Investigational Site Number : 3920019
Hiroshima-shi, 730-0013
JapanSite Not Available
Investigational Site Number : 3920001
Tokyo, 140-8522
JapanSite Not Available
Investigational Site Number : 3920005
Tokyo, 103-0027
JapanSite Not Available
Investigational Site Number : 4100004
Daegu, Daegu-gwangyeoksi 42415
Korea, Republic ofSite Not Available
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi 03722
Korea, Republic ofSite Not Available
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi 05505
Korea, Republic ofSite Not Available
Investigational Site Number : 4100005
Seoul, Seoul-teukbyeolsi 05030
Korea, Republic ofSite Not Available
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi 06591
Korea, Republic ofSite Not Available
Investigational Site Number : 4840001
Guadalajara, Jalisco 44100
MexicoSite Not Available
Investigational Site Number : 4840005
Guadalajara, Jalisco 44670
MexicoSite Not Available
Investigational Site Number : 4840001
Guadalajara 4005539, Jalisco 4004156 44100
MexicoSite Not Available
Investigational Site Number : 4840005
Guadalajara 4005539, Jalisco 4004156 44670
MexicoSite Not Available
Investigational Site Number : 4840008
Mérida, Yucatán 97070
MexicoSite Not Available
Investigational Site Number : 4840002
Chihuahua, 31000
MexicoSite Not Available
Investigational Site Number : 4840002
Chihuahua City, 31000
MexicoSite Not Available
Investigational Site Number : 4840002
Chihuahua City 4014338, 31000
MexicoSite Not Available
Investigational Site Number : 4840008
Mérida 3523349, 97070
MexicoSite Not Available
Investigational Site Number : 4840008
Yucatan, 97070
MexicoSite Not Available
Investigational Site Number : 6160001
Poznan, Greater Poland Voivodeship 60-693
PolandSite Not Available
Investigational Site Number : 6160001
Poznan 3088171, Greater Poland Voivodeship 3337498 60-693
PolandSite Not Available
Investigational Site Number : 6160006
Krakow, Lesser Poland Voivodeship 31-209
PolandSite Not Available
Investigational Site Number : 6160007
Tarnów, Lesser Poland Voivodeship 33-100
PolandSite Not Available
Investigational Site Number : 6160006
Krakow 3094802, Lesser Poland Voivodeship 858786 31-559
PolandSite Not Available
Investigational Site Number : 6160004
Bialystok, Podlaskie Voivodeship 15-044
PolandSite Not Available
Investigational Site Number : 6160004
Bialystok 776069, Podlaskie Voivodeship 858789 15-044
PolandSite Not Available
Investigational Site Number : 6160002
Gdansk, Pomeranian Voivodeship 80-405
PolandSite Not Available
Investigational Site Number : 6160003
Elblag, 82-300
PolandSite Not Available
Investigational Site Number : 6160003
Elblag 3099759, 82-300
PolandSite Not Available
Investigational Site Number : 6160002
Gdansk 3099434, 80-405
PolandSite Not Available
Investigational Site Number : 6160007
Tarnow, 33-100
PolandSite Not Available
Investigational Site Number : 6160007
Tarnów 757026, 33-100
PolandSite Not Available
Investigational Site Number : 7100007
Benoni, 1500
South AfricaSite Not Available
Investigational Site Number : 7100007
Benoni 1020098, 1501
South AfricaSite Not Available
Investigational Site Number : 7100001
Cape Town, 7700
South AfricaSite Not Available
Investigational Site Number : 7100002
Cape Town, 7530
South AfricaSite Not Available
Investigational Site Number : 7100001
Cape Town 3369157, 7937
South AfricaSite Not Available
Investigational Site Number : 7100002
Cape Town 3369157, 7530
South AfricaSite Not Available
Investigational Site Number : 7100007
Johannesburg, 1500
South AfricaSite Not Available
Investigational Site Number : 7100004
Middelburg, 1055
South AfricaSite Not Available
Investigational Site Number : 7100004
Middelburg 976361, 1055
South AfricaSite Not Available
Investigational Site Number : 4100004
Daegu 1835329, Daegu 1835327 42415
South KoreaSite Not Available
Investigational Site Number : 4100004
Daegu, Gyeongsangbuk-do 42415
South KoreaSite Not Available
Investigational Site Number : 4100006
Moncton, Seoul-teukbyeolsi E1C 6Z8
South KoreaSite Not Available
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi 03722
South KoreaSite Not Available
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi 05505
South KoreaSite Not Available
Investigational Site Number : 4100005
Seoul, Seoul-teukbyeolsi 05030
South KoreaSite Not Available
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi 06591
South KoreaSite Not Available
Investigational Site Number : 4100001
Seoul 1835848, Seoul-teukbyeolsi 03722
South KoreaSite Not Available
Investigational Site Number : 4100002
Seoul 1835848, Seoul-teukbyeolsi 138-878
South KoreaSite Not Available
Investigational Site Number : 4100005
Seoul 1835848, Seoul-teukbyeolsi 05030
South KoreaSite Not Available
Investigational Site Number : 7920002
Akdeniz, 33070
TurkeySite Not Available
Investigational Site Number : 7920001
Istanbul, 34098
TurkeySite Not Available
Investigational Site Number : 7920003
Izmir, 35100
TurkeySite Not Available
Investigational Site Number : 7920005
Izmit, 41001
TurkeySite Not Available
Investigational Site Number : 7920008
Kayseri, 38039
TurkeySite Not Available
Investigational Site Number : 7920005
Kocaeli, 41100
TurkeySite Not Available
Investigational Site Number : 7920002
Mersin, 33070
TurkeySite Not Available
Investigational Site Number : 7920001
Istanbul, 34098
Turkey (Türkiye)Site Not Available
Investigational Site Number : 7920001
Istanbul 745044, 34098
Turkey (Türkiye)Site Not Available
Investigational Site Number : 7920003
Izmir, 35100
Turkey (Türkiye)Site Not Available
Investigational Site Number : 7920003
Izmir 311046, 35100
Turkey (Türkiye)Site Not Available
Investigational Site Number : 7920008
Kayseri, 38039
Turkey (Türkiye)Site Not Available
Investigational Site Number : 7920008
Kayseri 308464, 38039
Turkey (Türkiye)Site Not Available
Investigational Site Number : 7920005
Kocaeli 306970, 41100
Turkey (Türkiye)Site Not Available
Investigational Site Number : 7920002
Mersin, 33070
Turkey (Türkiye)Site Not Available
Investigational Site Number : 7920002
Mersin 304531, 33070
Turkey (Türkiye)Site Not Available
Investigational Site Number : 7920005
İzmit, 41001
Turkey (Türkiye)Site Not Available
Investigational Site Number : 8260001
Bradford, BD9 6RJ
United KingdomSite Not Available
Investigational Site Number : 8260001
Bradford 2654993, BD9 6RJ
United KingdomSite Not Available
Bensch Clinical Research LLC Site Number : 8400004
Stockton, California 95207
United StatesActive - Recruiting
Bensch Research Associates- Site Number : 8400004
Stockton, California 95207
United StatesSite Not Available
Allianz Research Institute Site Number : 8400023
Westminster, California 92683
United StatesSite Not Available
Bensch Clinical Research LLC- Site Number : 8400004
Stockton 5399020, California 5332921 95207
United StatesSite Not Available
Helix Biomedics, LLC Site Number : 8400029
Boynton Beach, Florida 33435
United StatesActive - Recruiting
Helix Biomedics- Site Number : 8400029
Boynton Beach, Florida 33435
United StatesSite Not Available
Savin Medical Group - Miami- Site Number : 8400015
Miami, Florida 33126
United StatesSite Not Available
Savin Medical Group, LLC Site Number : 8400015
Miami, Florida 33126
United StatesActive - Recruiting
Savin Medical Group, LLC- Site Number : 8400015
Miami, Florida 33126
United StatesActive - Recruiting
Savin Medical Group - Miami Lakes- Site Number : 8400015
Miami Lakes, Florida 33014
United StatesSite Not Available
Pines Care Research Center LLC Site Number : 8400028
Pembroke Pines, Florida 33023
United StatesActive - Recruiting
Pines Care Research Center- Site Number : 8400028
Pembroke Pines, Florida 33025
United StatesSite Not Available
Helix Biomedics, LLC - Site Number : 8400029
Boynton Beach 4148677, Florida 4155751 33435
United StatesSite Not Available
Savin Medical Group - Miami- Site Number : 8400015
Miami 4164138, Florida 4155751 33126
United StatesSite Not Available
Pines Care Research Center LLC- Site Number : 8400028
Pembroke Pines 4168139, Florida 4155751 33025
United StatesSite Not Available
Treasure Valley Medical Research Site Number : 8400031
Boise, Idaho 83706
United StatesActive - Recruiting
Treasure Valley Medical Research- Site Number : 8400031
Boise, Idaho 83706
United StatesSite Not Available
Treasure Valley Medical Research- Site Number : 8400031
Boise 5586437, Idaho 5596512 83706
United StatesSite Not Available
Johns Hopkins Bayview Medical Center- Site Number : 8400012
Baltimore, Maryland 21224
United StatesSite Not Available
Johns Hopkins University School of Medicine- Site Number : 8400012
Baltimore 4347778, Maryland 4361885 21224
United StatesSite Not Available
OK Clinical Research, LLC Site Number : 8400001
Edmond, Oklahoma 73034
United StatesActive - Recruiting
OK Clinical Research- Site Number : 8400001
Edmond, Oklahoma 73034
United StatesSite Not Available
Site number 8400001
Edmond, Oklahoma 73034-3257
United StatesActive - Recruiting
OK Clinical Research, LLC- Site Number : 8400001
Edmond 4535740, Oklahoma 4544379 73034
United StatesSite Not Available
South Texas Medical Research Institute - TTS Research- Site Number : 8400011
Boerne, Texas 78006
United StatesSite Not Available
TTS Research Site Number : 8400011
Boerne, Texas 78006
United StatesActive - Recruiting
TTS Research- Site Number : 8400011
Boerne 4675373, Texas 4736286 78006
United StatesSite Not Available

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