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 : 0320009
Buenos Aires, Ciudad De Buenos Aires 1650
ArgentinaSite Not Available
Investigational Site Number : 0320005
Rosario, Santa Fe 2000
ArgentinaSite Not Available
Investigational Site Number : 0320006
Rosario, Santa Fe 2000
ArgentinaSite Not Available
Investigational Site Number : 0320007
Rosario, Santa Fe 2000
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 : 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
ArgentinaActive - Recruiting
Associacao Proar- Site Number : 0760004
Salvador, Bahia 40060-330
BrazilSite 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
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
Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001
Passo Fundo, Rio Grande Do Sul 99010-170
BrazilSite Not Available
Hospital Sao Lucas da PUCRS Site Number : 0760006
Porto Alegre, Rio Grande Do Sul 90610-000
BrazilActive - Recruiting
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 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
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760007
Porto Alegre, Rio Grande Do Sul 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, 18040-425
BrazilSite Not Available
Clínica de Alergia Martti Antila Site Number : 0760003
Sorocaba, 18040-425
BrazilActive - Recruiting
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 : 1240007
Trois-Rivieres, Quebec G8T 7A1
CanadaSite Not Available
Investigational Site Number : 1240007
Trois-rivières, Quebec G8T 7A1
CanadaSite Not Available
Investigational Site Number : 1520006
Talca, Maule 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 : 1520005
Quillota, Valparaíso 2260877
ChileSite Not Available
Investigational Site Number : 3480009
Edelény, 3780
HungaryActive - Recruiting
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
HungaryActive - Recruiting
Investigational Site Number : 3480006
Puspokladany, 4150
HungarySite Not Available
Investigational Site Number : 3480006
Püspökladány, 4150
HungaryActive - Recruiting
Investigational Site Number : 3480012
Szazhalombatta, 2440
HungarySite Not Available
Investigational Site Number : 3480012
Százhalombatta, 2440
HungarySite Not Available
Investigational Site Number : 3800003
Rome, Roma 00168
ItalySite Not Available
Investigational Site Number : 3800004
Naples, 80131
ItalyActive - Recruiting
Investigational Site Number : 3800004
Napoli, 80131
ItalySite Not Available
Investigational Site Number : 3800003
Roma, 00168
ItalyActive - Recruiting
Investigational Site Number : 3800001
Verona, 37134
ItalyActive - Recruiting
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 : 3920004
Chuo, Tokyo 104-0031
JapanSite Not Available
Investigational Site Number : 3920004
Chuo-ku, Tokyo 104-0031
JapanActive - Recruiting
Investigational Site Number : 3920005
Chuo-ku, Tokyo 103-0027
JapanSite Not Available
Investigational Site Number : 3920019
Hiroshima, 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 : 4840002
Chihuahua, 31000
MexicoSite Not Available
Investigational Site Number : 4840008
Mérida, 97070
MexicoSite Not Available
Investigational Site Number : 4840008
Yucatan, 97070
MexicoSite Not Available
Investigational Site Number : 6160006
Krakow, Malopolskie 31-209
PolandActive - Recruiting
Investigational Site Number : 6160004
Bialystok, Podlaskie 15-044
PolandActive - Recruiting
Investigational Site Number : 6160001
Poznan, Wielkopolskie 60-693
PolandActive - Recruiting
Investigational Site Number : 6160003
Elblag, 82-300
PolandActive - Recruiting
Investigational Site Number : 6160002
Gdansk, 80-405
PolandSite Not Available
Investigational Site Number : 6160007
Tarnow, 33-100
PolandActive - Recruiting
Investigational Site Number : 7100007
Benoni, 1500
South AfricaActive - Recruiting
Investigational Site Number : 7100001
Cape Town, 7700
South AfricaActive - Recruiting
Investigational Site Number : 7100002
Cape Town, 7530
South AfricaActive - Recruiting
Investigational Site Number : 7100007
Johannesburg, 1500
South AfricaSite Not Available
Investigational Site Number : 7100004
Middelburg, 1055
South AfricaActive - Recruiting
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 : 8260001
Bradford, 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
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
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 33024
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
Johns Hopkins Bayview Medical Center- Site Number : 8400012
Baltimore, Maryland 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
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
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