Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma
NCT ID: NCT06102005
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
685 participants
INTERVENTIONAL
2023-10-16
2026-03-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lunsekimig Dose1 interval 1
Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 1
Lunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Lunsekimig Dose 1 interval 2
Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 2
Lunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Lunsekimig Dose 2 interval 1
Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 1
Lunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Lunsekimig Dose 2 interval 2
Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 2
Lunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Placebo
Participants will receive placebo (subcutaneous injection) according to established dosing intervals corresponding to Dose 1 and Dose 2
Placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Interventions
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Lunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Eligibility Criteria
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Inclusion Criteria
* Participants with existing treatment with moderate-to-high doses of ICS therapy for in combination with at least 1 but no more than 2 additional controller medications at least 3 months with a stable dose ≥1 month prior to Visit 1
* At least 1 asthma exacerbation in the past year, with at least one exacerbation occurring while on treatment with moderate to high doses of ICS therapy
* ACQ-5 score more than 1.5 at Screening (Visit 1)
Exclusion Criteria
* Current smoker or former smoker with cessation within 6 months of Screening or history of \>10 pack-years. Active vaping of any products and/or marijuana smoking within 6 months of Screening.
* Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening
* Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening
* For participants on chronic OCS use for the maintenance treatment of asthma: history of a serious infection requiring hospitalization within the past 12 months prior to Randomization (Visit 2).
* Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening
* Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease
* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
18 Years
80 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinial Science & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Allergy, Asthma & Immunology Associates- Site Number : 8400009
Scottsdale, Arizona, United States
Yuma Pulmonary & Sleep Research, LLC- Site Number : 8400072
Yuma, Arizona, United States
Antelope Valley Clinical Trials- Site Number : 8400020
Lancaster, California, United States
Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400032
Northridge, California, United States
Optimus Medical- Site Number : 8400046
San Francisco, California, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center- Site Number : 8400038
San Jose, California, United States
Clinical Trials Management Services - Thousand Oaks- Site Number : 8400053
Thousand Oaks, California, United States
Allianz Research Institute CO- Site Number : 8400026
Aurora, Colorado, United States
Velocity Clinical Research - Denver- Site Number : 8400027
Englewood, Colorado, United States
Western States Clinical Research- Site Number : 8400014
Wheat Ridge, Colorado, United States
Beautiful Minds Clinical Research Center- Site Number : 8400049
Cutler Bay, Florida, United States
Qway Research - Hialeah- Site Number : 8400015
Hialeah, Florida, United States
Clintex Research Group - Miami - Coral Way- Site Number : 8400048
Miami, Florida, United States
High Quality Research- Site Number : 8400039
Miami, Florida, United States
Innovations Biotech- Site Number : 8400040
Miami, Florida, United States
New Access Medical Center- Site Number : 8400043
Miami, Florida, United States
Deluxe Health Center- Site Number : 8400045
Miami Lakes, Florida, United States
Advanced Research Institute - New Port Richey- Site Number : 8400044
New Port Richey, Florida, United States
Pines Care Research Center- Site Number : 8400057
Pembroke Pines, Florida, United States
Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019
Sarasota, Florida, United States
Appalachian Clinical Research- Site Number : 8400050
Calhoun, Georgia, United States
PMG Research of Christie Clinic- Site Number : 8400066
Champaign, Illinois, United States
Velocity Clinical Research Lafayette Site Number : 8400060
Lafayette, Louisiana, United States
Javara - Privia Medical Group - Annapolis- Site Number : 8400033
Annapolis, Maryland, United States
Brigham & Women's Hospital- Site Number : 8400034
Boston, Massachusetts, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400004
Ann Arbor, Michigan, United States
Javara - Mankato Clinic- Site Number : 8400051
Mankato, Minnesota, United States
Midwest Clinical Research Center - St. Louis- Site Number : 8400006
St Louis, Missouri, United States
Circuit Clinical - Middletown Medical - 111 Maltese Drive- Site Number : 8400065
Middletown, New York, United States
Icahn School of Medicine at Mount Sinai- Site Number : 8400058
New York, New York, United States
Carolina Clinical Research - Charlotte- Site Number : 8400071
Charlotte, North Carolina, United States
Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029
Charlotte, North Carolina, United States
Clinical Research Of Gastonia- Site Number : 8400013
Gastonia, North Carolina, United States
Bernstein Clinical Research Center- Site Number : 8400016
Cincinnati, Ohio, United States
Asthma & Allergy Center - Toledo- Site Number : 8400017
Toledo, Ohio, United States
OK Clinical Research- Site Number : 8400021
Edmond, Oklahoma, United States
Velocity Clinical Research - Medford- Site Number : 8400059
Medford, Oregon, United States
Clinical Research Associates of Central PA - Dubois- Site Number : 8400069
DuBois, Pennsylvania, United States
Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007
Pittsburgh, Pennsylvania, United States
Circuit Clinical - PMSI Comprehensive Healthcare for Life - Pottstown - Medical Drive- Site Number : 8400064
Pottstown, Pennsylvania, United States
VitaLink Research - Anderson - East Greenville- Site Number : 8400063
Anderson, South Carolina, United States
Velocity Clinical Research - Charleston- Site Number : 8400061
Charleston, South Carolina, United States
Orion Clinical Research- Site Number : 8400001
Austin, Texas, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400010
Boerne, Texas, United States
Baylor University Medical Center- Site Number : 8400002
Dallas, Texas, United States
Western Sky Medical Research- Site Number : 8400023
El Paso, Texas, United States
Metroplex Pulmonary and Sleep Center- Site Number : 8400022
McKinney, Texas, United States
VAST Clinical Research- Site Number : 8400062
Plano, Texas, United States
Investigational Site Number : 0320007
Berazategui, Buenos Aires, Argentina
Investigational Site Number : 0320003
La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320002
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320006
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320005
Buenos Aires, , Argentina
Investigational Site Number : 0320004
Buenos Aires, , Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320009
Mendoza, , Argentina
Investigational Site Number : 0320008
San Miguel de Tucumán, , Argentina
Investigational Site Number : 0320010
Santa Fe, , Argentina
Associacao Proar- Site Number : 0760003
Salvador, Estado de Bahia, Brazil
Universidade Federal de Goias- Site Number : 0760007
Goiânia, Goiás, Brazil
Centro de Estudos em Terapias Inovadoras- Site Number : 0760002
Curitiba, Paraná, Brazil
Inst de Medicina Integral Professor Fernando Figueira- Site Number : 0760009
Recife, Pernambuco, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Dia do Pulmão- Site Number : 0760005
Blumenau, Santa Catarina, Brazil
CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006
Rio de Janeiro, , Brazil
Incor - Instituto do Coracao- Site Number : 0760011
São Paulo, , Brazil
Investigational Site Number : 1240003
Hamilton, Ontario, Canada
Investigational Site Number : 1240005
Stoney Creek, Ontario, Canada
Investigational Site Number : 1240004
Sherbrooke, Quebec, Canada
Investigational Site Number : 1240001
Trois-Rivières, Quebec, Canada
Investigational Site Number : 1520010
Valdivia, Los Ríos Region, Chile
Investigational Site Number : 1520001
Talca, Maule Region, Chile
Investigational Site Number : 1520006
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520009
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520008
Quillota, Región de Valparaíso, Chile
Investigational Site Number : 1520011
Viña del Mar, Región de Valparaíso, Chile
Investigational Site Number : 1560011
Beijing, , China
Investigational Site Number : 1560010
Changchun, , China
Investigational Site Number : 1560017
Changsha, , China
Investigational Site Number : 1560008
Chengdu, , China
Investigational Site Number : 1560001
Guangzhou, , China
Investigational Site Number : 1560009
Guangzhou, , China
Investigational Site Number : 1560006
Hefei, , China
Investigational Site Number : 1560014
Hohhot, , China
Investigational Site Number : 1560018
Mianyang, , China
Investigational Site Number : 1560007
Nanchang, , China
Investigational Site Number : 1560002
Pingxiang, , China
Investigational Site Number : 1560013
Shanghai, , China
Investigational Site Number : 1560015
Shenyang, , China
Investigational Site Number : 1560005
Wenzhou, , China
Investigational Site Number : 1560003
Wuhan, , China
Investigational Site Number : 1560004
Xuzhou, , China
Investigational Site Number : 1560016
Yangzhou, , China
Investigational Site Number : 1560012
Zhanjiang, , China
Investigational Site Number : 3560002
Coimbatore, , India
Investigational Site Number : 3560006
Delhi, , India
Investigational Site Number : 3560009
Hyderabad, , India
Investigational Site Number : 3560008
Kanpur, , India
Investigational Site Number : 3560007
Kozhikode, , India
Investigational Site Number : 3560003
Lucknow, , India
Investigational Site Number : 3560001
Nagpur, , India
Investigational Site Number : 3560004
Pune, , India
Investigational Site Number : 3760006
Ashkelon, , Israel
Investigational Site Number : 3760001
Haifa, , Israel
Investigational Site Number : 3760008
Haifa, , Israel
Investigational Site Number : 3760003
Jerusalem, , Israel
Investigational Site Number : 3760002
Jerusalem, , Israel
Investigational Site Number : 3760010
Petah Tikva, , Israel
Investigational Site Number : 3760009
Ramat Gan, , Israel
Investigational Site Number : 3760004
Rehovot, , Israel
Investigational Site Number : 3760007
Tel Aviv, , Israel
Investigational Site Number : 3920004
Kamogawa, Chiba, Japan
Investigational Site Number : 3920002
Sakaidechō, Kagawa-ken, Japan
Investigational Site Number : 3920010
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920011
Chūō, Tokyo, Japan
Investigational Site Number : 3920005
Ube, Yamaguchi, Japan
Investigational Site Number : 3920008
Fukushima, , Japan
Investigational Site Number : 3920003
Higashiōmi, , Japan
Investigational Site Number : 3920006
Kyoto, , Japan
Investigational Site Number : 3920009
Kyoto, , Japan
Investigational Site Number : 3920012
Miyazaki, , Japan
Investigational Site Number : 4840001
Guadalajara, Jalisco, Mexico
Investigational Site Number : 4840004
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840005
San Juan del Río, Querétaro, Mexico
Investigational Site Number : 4840002
Chihuahua City, , Mexico
Investigational Site Number : 4840003
Durango, , Mexico
Investigational Site Number : 4840007
Mérida, , Mexico
Investigational Site Number : 4840008
Veracruz, , Mexico
Investigational Site Number : 7100004
Benoni, , South Africa
Investigational Site Number : 7100005
Benoni, , South Africa
Investigational Site Number : 7100003
Cape Town, , South Africa
Investigational Site Number : 7100002
Cape Town, , South Africa
Investigational Site Number : 7100001
Durban, , South Africa
Investigational Site Number : 7100006
Lochner ROAD, , South Africa
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100005
Seoul, , South Korea
Investigational Site Number : 7920001
Akdeniz, , Turkey (Türkiye)
Investigational Site Number : 7920006
Bursa, , Turkey (Türkiye)
Investigational Site Number : 7920002
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920003
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920004
Izmir, , Turkey (Türkiye)
Investigational Site Number : 7920005
İzmit, , Turkey (Türkiye)
Investigational Site Number : 7920007
Kayseri, , Turkey (Türkiye)
Investigational Site Number : 8260001
Cambridge, Cambridgeshire, United Kingdom
Investigational Site Number : 8260004
Glasgow, Edinburgh, City of, United Kingdom
Investigational Site Number : 8260005
Chertsey, Surrey, United Kingdom
Investigational Site Number : 8260003
Birmingham, , United Kingdom
Investigational Site Number : 8260008
Bradford, , United Kingdom
Investigational Site Number : 8260009
Bristol, , United Kingdom
Countries
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Other Identifiers
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U1111-1280-5514
Identifier Type: OTHER
Identifier Source: secondary_id
2023-503712-33
Identifier Type: REGISTRY
Identifier Source: secondary_id
DRI16762
Identifier Type: -
Identifier Source: org_study_id
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