Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
NCT ID: NCT06676319
Last Updated: 2026-01-13
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
1147 participants
INTERVENTIONAL
2024-11-07
2027-10-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous (SC) lunsekimig compared with placebo in male and female participants (aged 18 to 80 years, inclusive) with asthma, who are not currently eligible for biologic treatments.
Study details include:
* The study duration will be approximately 64 weeks for participants not transitioning into the LTS study and approximately 60 weeks for participants transitioning into the LTS study.
* The investigational treatment duration will be up to approximately 52 weeks.
* The number of visits will be 18.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma
NCT06102005
Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.
NCT06609239
Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans
NCT00702325
MGR001 / Advair Diskus Local Equivalence Study in Asthma
NCT02245672
Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)
NCT00284856
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lunsekimig
Participants will receive lunsekimig (SC injection) every 4 weeks
Lunsekimig
Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection
Short-Acting Beta Agonists (SABA)
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
Fluticasone/Salmeterol
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation
Budesonide/Formoterol
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
Budesonide/Albuterol
Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation
Placebo
Participants will receive placebo (SC injection) every 4 weeks
Short-Acting Beta Agonists (SABA)
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
Placebo
Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection
Fluticasone/Salmeterol
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation
Budesonide/Formoterol
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
Budesonide/Albuterol
Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lunsekimig
Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection
Short-Acting Beta Agonists (SABA)
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
Placebo
Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection
Fluticasone/Salmeterol
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation
Budesonide/Formoterol
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
Budesonide/Albuterol
Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least 1 asthma exacerbation in the year prior to Screening (Visit 1).
* Pre-BD FEV1 of equal or more than 40% of predicted normal (by Global Lung Function Initiative \[GLI\] standards) at Screening (Visit 1).
Exclusion Criteria
* Other severe lung diseases (eg, chronic obstructive pulmonary disease \[COPD\]. bronchiectasis, idiopathic pulmonary fibrosis, etc) which may impair lung function.
* 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 (Visit 1) (counting from the date of completion of treatment for asthma exacerbation).
* Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening (Visit 1).
* Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
* Evidence of any infection requiring systemic anti-infective treatment within 2 weeks before Screening (Visit 1) or during the screening period. Significant viral infections within 2 weeks before Screening (Visit 1) or during the screening period even if the participant has not received systemic antiviral treatment (eg, influenza receiving only symptomatic treatment).
* 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 TB), or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1).
* 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.
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical study.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Center for Clinical Trials - Saraland- Site Number : 8400096
Saraland, Alabama, United States
Chandler Clinical Research Trials- Site Number : 8400075
Chandler, Arizona, United States
Epic Medical Research - Sun City- Site Number : 8400052
Sun City, Arizona, United States
Tucson Clinical Research Institute- Site Number : 8400085
Tucson, Arizona, United States
Modena Allergy + Asthma- Site Number : 8400021
La Jolla, California, United States
Velocity Clinical Research - San Diego- Site Number : 8400024
La Mesa, California, United States
Ark Clinical Research- Site Number : 8400097
Long Beach, California, United States
Downtown L.A. Research Center- Site Number : 8400080
Los Angeles, California, United States
Carbon Health - North Hollywood - NoHo West- Site Number : 8400061
North Hollywood, California, United States
Carbon Health - San Mateo - Hillsdale Mall- Site Number : 8400062
San Mateo, California, United States
Modena Allergy And Asthma- Site Number : 8400068
Torrance, California, United States
Howard University Hospital- Site Number : 8400107
Washington D.C., District of Columbia, United States
Helix Biomedics- Site Number : 8400005
Boynton Beach, Florida, United States
Beautiful Minds Clinical Research Center- Site Number : 8400019
Cutler Bay, Florida, United States
Alfa Medical Research- Site Number : 8400071
Davie, Florida, United States
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400082
DeBary, Florida, United States
Royal Clinical Trials - Inverness- Site Number : 8400067
Inverness, Florida, United States
Premier Medical Associates- Site Number : 8400077
Lady Lake, Florida, United States
D&H Pompano Research Center- Site Number : 8400072
Margate, Florida, United States
Research Institute of South Florida- Site Number : 8400023
Miami, Florida, United States
Innovations Biotech- Site Number : 8400044
Miami, Florida, United States
Oviedo Medical Research - Site number: 8400091
Oviedo, Florida, United States
Tellabio International Research Services- Site Number : 8400083
Pembroke Pines, Florida, United States
Avanza Medical Research Center- Site Number : 8400056
Pensacola, Florida, United States
Hull and Hull Medical Specialists- Site Number : 8400079
Plantation, Florida, United States
Ilumina Medical Research- Site Number : 8400095
Saint Cloud, Florida, United States
Private Practice - Dr. David Kavtaradze- Site Number : 8400081
Cordele, Georgia, United States
EmVenio Research- Site Number : 8400109
Riverdale, Georgia, United States
Christie Clinic in Champaign on University- Site Number : 8400003
Champaign, Illinois, United States
Velocity Clinical Research - Rockville- Site Number : 8400036
Rockville, Maryland, United States
Javara - Privia Medical Group - Silver Spring Lockwood- Site Number : 8400042
Silver Spring, Maryland, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400014
Ann Arbor, Michigan, United States
Clarkston Medical Group- Site Number : 8400054
Clarkston, Michigan, United States
Javara - Mankato Clinic- Site Number : 8400001
Mankato, Minnesota, United States
Mayo Clinic in Rochester - Minnesota- Site Number : 8400057
Rochester, Minnesota, United States
Hannibal Regional Healthcare System- Site Number : 8400078
Hannibal, Missouri, United States
Pioneer Clinical Research - New York- Site Number : 8400092
New York, New York, United States
Icahn School of Medicine at Mount Sinai - Mount Sinai Health System- Site Number : 8400069
New York, New York, United States
Piedmont Healthcare - Family Medicine- Site Number : 8400064
Statesville, North Carolina, United States
Cleveland Clinic - Cleveland- Site Number : 8400106
Cleveland, Ohio, United States
Asthma & Allergy Center - Toledo- Site Number : 8400020
Toledo, Ohio, United States
OK Clinical Research- Site Number : 8400060
Edmond, Oklahoma, United States
Clinical Research Associates of Central PA- Site Number : 8400013
DuBois, Pennsylvania, United States
ADAC Research- Site Number : 8400070
Greenville, South Carolina, United States
Orion Clinical Research
Austin, Texas, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400015
Boerne, Texas, United States
Epic Medical Research - De Soto- Site Number : 8400051
DeSoto, Texas, United States
Axsendo Clinical Research - Houston- Site Number : 8400065
Houston, Texas, United States
Radiance Clinical Research
Lampasas, Texas, United States
Metroplex Pulmonary and Sleep Center- Site Number : 8400012
McKinney, Texas, United States
STAAMP Research - San Antonio- Site Number : 8400059
San Antonio, Texas, United States
Bandera Family Health Care - San Antonio- Site Number : 8400049
San Antonio, Texas, United States
Javara - San Marcos - Redwood Road- Site Number : 8400040
San Marcos, Texas, United States
Javara - Privia Medical Group North Texas - Stephenville- Site Number : 8400038
Stephenville, Texas, United States
Simcare Medical Research- Site Number : 8400102
Sugar Land, Texas, United States
Children's Wisconsin- Site Number : 8400073
Milwaukee, Wisconsin, United States
Investigational Site Number : 0320007
Berazategui, Buenos Aires, Argentina
Investigational Site Number : 0320011
La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320013
Lobos, Buenos Aires, Argentina
Investigational Site Number : 0320006
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320010
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320016
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320003
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320005
Buenos Aires, , Argentina
Investigational Site Number : 0320012
Buenos Aires, , Argentina
Investigational Site Number : 0320002
Buenos Aires, , Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320004
Buenos Aires, , Argentina
Investigational Site Number : 0320008
Corrientes, , Argentina
Investigational Site Number : 0320014
Mendoza, , Argentina
Investigational Site Number : 0320015
Mendoza, , Argentina
Investigational Site Number : 0320009
Santa Fe, , Argentina
Investigational Site Number : 0560001
Ghent, , Belgium
Investigational Site Number : 0560003
Liège, , Belgium
Investigational Site Number : 0560002
Mechelen, , Belgium
Associacao Proar- Site Number : 0760002
Salvador, Estado de Bahia, Brazil
Universidade Federal de Goias- Site Number : 0760011
Goiânia, Goiás, Brazil
Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760006
Curitiba, Paraná, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, Brazil
WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003
Porto Alegre, Rio Grande do Sul, Brazil
Incor - Instituto do Coracao- Site Number : 0760004
São Paulo, , Brazil
Investigational Site Number : 1240011
Kelowna, British Columbia, Canada
Investigational Site Number : 1240012
North Vancouver, British Columbia, Canada
Investigational Site Number : 1240013
Ajax, Ontario, Canada
Investigational Site Number : 1240003
Guelph, Ontario, Canada
Investigational Site Number : 1240006
Stoney Creek, Ontario, Canada
Investigational Site Number : 1240008
Toronto, Ontario, Canada
Investigational Site Number : 1240014
Montreal, Quebec, Canada
Investigational Site Number : 1240002
Sherbrooke, Quebec, Canada
Investigational Site Number : 1520002
Talca, Maule Region, Chile
Investigational Site Number : 1520009
Lo Barnechea, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520010
Recoleta, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520006
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520005
Quillota, Región de Valparaíso, Chile
Investigational Site Number : 1520004
Viña del Mar, Región de Valparaíso, Chile
Investigational Site Number : 1520007
Viña del Mar, Región de Valparaíso, Chile
Investigational Site Number : 1520008
Concepción, Región del Biobío, Chile
Investigational Site Number : 1560027
Beijing, , China
Investigational Site Number : 1560005
Changchun, , China
Investigational Site Number : 1560021
Chengde, , China
Investigational Site Number : 1560039
Chengdu, , China
Investigational Site Number : 1560028
Foshan, , China
Investigational Site Number : 1560010
Guangzhou, , China
Investigational Site Number : 1560033
Guangzhou, , China
Investigational Site Number : 1560037
Guiyang, , China
Investigational Site Number : 1560042
Hangzhou, , China
Investigational Site Number : 1560009
Hebei, , China
Investigational Site Number : 1560040
Hefei, , China
Investigational Site Number : 1560006
Hohhot, , China
Investigational Site Number : 1560007
Hohhot, , China
Investigational Site Number : 1560029
Huizhou, , China
Investigational Site Number : 1560011
Huizhou, , China
Investigational Site Number : 1560025
Jiazhuang, , China
Investigational Site Number : 1560034
Jinan, , China
Investigational Site Number : 1560038
Jinan, , China
Investigational Site Number : 1560030
Lanzhou, , China
Investigational Site Number : 1560018
Luoyang, , China
Investigational Site Number : 1560003
Nanchang, , China
Investigational Site Number : 1560014
Ningbo, , China
Investigational Site Number : 1560001
Shanghai, , China
Investigational Site Number : 1560043
Shanghai, , China
Investigational Site Number : 1560016
Shenyang, , China
Investigational Site Number : 1560019
Suzhou, , China
Investigational Site Number : 1560008
Suzhou, , China
Investigational Site Number : 1560017
Taiyuan, , China
Investigational Site Number : 1560035
Taiyuan, , China
Investigational Site Number : 1560002
Tianjin, , China
Investigational Site Number : 1560013
Tianjin, , China
Investigational Site Number : 1560022
Wuhan, , China
Investigational Site Number : 1560036
Xi'an, , China
Investigational Site Number : 1560032
Xi'an, , China
Investigational Site Number : 1560044
Xianyang, , China
Investigational Site Number : 1560012
Xuzhou, , China
Investigational Site Number : 1560047
Yangzhou, , China
Investigational Site Number : 1560023
Zhengzhou, , China
Investigational Site Number : 1560026
Zhengzhou, , China
Investigational Site Number : 1560045
Zigong, , China
Investigational Site Number : 2080001
Hvidovre, , Denmark
Investigational Site Number : 2080002
Vejle, , Denmark
Investigational Site Number : 2500007
Amiens, , France
Investigational Site Number : 2500004
Lyon, , France
Investigational Site Number : 2500003
Montpellier, , France
Investigational Site Number : 2500006
Paris, , France
Investigational Site Number : 2500005
Pessac, , France
Investigational Site Number : 2500001
Strasbourg, , France
Investigational Site Number : 2500002
Toulouse, , France
Investigational Site Number : 2760006
Ahrensburg, , Germany
Investigational Site Number : 2760002
Bendorf, , Germany
Investigational Site Number : 2760007
Berlin, , Germany
Investigational Site Number : 6420001
Düsseldorf, , Germany
Investigational Site Number : 2760004
Frankfurt, , Germany
Investigational Site Number : 2760008
Frankfurt, , Germany
Investigational Site Number : 2760001
Leipzig, , Germany
Investigational Site Number : 2760005
Mainz, , Germany
Investigational Site Number : 3480006
Debrecen, , Hungary
Investigational Site Number : 3480002
Gödöllő, , Hungary
Investigational Site Number : 3480003
Hajdúnánás, , Hungary
Investigational Site Number : 3480004
Mosonmagyaróvár, , Hungary
Investigational Site Number : 3480005
Pécs, , Hungary
Investigational Site Number : 3480001
Püspökladány, , Hungary
Investigational Site Number : 3760006
Haifa, , Israel
Investigational Site Number : 3760003
Jerusalem, , Israel
Investigational Site Number : 3760002
Jerusalem, , Israel
Investigational Site Number : 3760005
Petah Tikva, , Israel
Investigational Site Number : 3760001
Rehovot, , Israel
Investigational Site Number : 3760004
Tel Aviv, , Israel
Investigational Site Number : 3800008
Torette, Ancona, Italy
Investigational Site Number : 3800006
Monserrato, Cagliari, Italy
Investigational Site Number : 3800001
Cona, Ferrara, Italy
Investigational Site Number : 3800009
Genoa, Genova, Italy
Investigational Site Number : 3800004
Milan, Milano, Italy
Investigational Site Number : 3800003
Rozzano, Milano, Italy
Investigational Site Number : 3800010
Rome, Roma, Italy
Investigational Site Number : 3800012
Tradate, Varese, Italy
Investigational Site Number : 3800007
Bergamo, , Italy
Investigational Site Number : 3800005
Modena, , Italy
Investigational Site Number : 3800013
Palermo, , Italy
Investigational Site Number : 3800011
Reggio Emilia, , Italy
Investigational Site Number : 3920001
Ube, Yamaguchi, Japan
Investigational Site Number : 3920004
Tokyo, , Japan
Investigational Site Number : 6160005
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160001
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160008
Lodz, Lódzkie, Poland
Investigational Site Number : 6160002
Bialystok, Podlaskie Voivodeship, Poland
Investigational Site Number : 6160004
Chęciny, , Poland
Investigational Site Number : 6160009
Katowice, , Poland
Investigational Site Number : 6160003
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
Investigational Site Number : 6420002
Cluj-Napoca, , Romania
Investigational Site Number : 7100004
Benoni, , South Africa
Investigational Site Number : 7100005
Benoni, , South Africa
Investigational Site Number : 7100002
Cape Town, , South Africa
Investigational Site Number : 7100003
Durban, , South Africa
Investigational Site Number : 7100006
Durban, , South Africa
Investigational Site Number : 7100007
Johannesburg, , South Africa
Investigational Site Number : 7240005
Santiago de Compostela, A Coruña [La Coruña], Spain
Investigational Site Number : 7240010
Badalona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240009
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240015
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240017
Santander, Cantabria, Spain
Investigational Site Number : 7240016
Girona, Girona [Gerona], Spain
Investigational Site Number : 7240018
Benalmádena, Málaga, Spain
Investigational Site Number : 7240013
Madrid, , Spain
Investigational Site Number : 7240008
Madrid, , Spain
Investigational Site Number : 7240011
Madrid, , Spain
Investigational Site Number : 7240002
Madrid, , Spain
Investigational Site Number : 7240007
Madrid, , Spain
Investigational Site Number : 7240004
Málaga, , Spain
Investigational Site Number : 7240006
Málaga, , Spain
Investigational Site Number : 7240001
Palma, , Spain
Investigational Site Number : 7240014
Seville, , Spain
Investigational Site Number : 7520003
Gothenburg, , Sweden
Investigational Site Number : 7520002
Lund, , Sweden
Investigational Site Number : 7520001
Solna, , Sweden
Investigational Site Number : 1580002
Hualien City, , Taiwan
Investigational Site Number : 1580005
Kaohsiung City, , Taiwan
Investigational Site Number : 1580006
Taichung, , Taiwan
Investigational Site Number : 1580007
Taichung, , Taiwan
Investigational Site Number : 1580004
Taipei, , Taiwan
Investigational Site Number : 1580003
Taipei, , Taiwan
Investigational Site Number : 1580001
Taoyuan, , Taiwan
Investigational Site Number : 7920003
Kayseri, , Turkey (Türkiye)
Investigational Site Number : 7920002
Kırıkkale, , Turkey (Türkiye)
Investigational Site Number : 7920001
Mersin, , Turkey (Türkiye)
Investigational Site Number : 8260007
Corby, Northamptonshire, United Kingdom
Investigational Site Number : 8260006
Nottingham, Nottinghamshire, United Kingdom
Investigational Site Number : 8260008
Oxford, Oxfordshire, United Kingdom
Investigational Site Number : 8260005
Barnsley, , United Kingdom
Investigational Site Number : 8260003
Bradford, , United Kingdom
Investigational Site Number : 8260009
Hillingdon, , United Kingdom
Investigational Site Number : 8260001
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
Access external resources that provide additional context or updates about the study.
ACT18301 Plain Language Results Summary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-513959-33
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1301-3938
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACT18301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.