Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
Launched by SANOFI · Nov 4, 2024
Trial Information
Current as of July 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment called Lunsekimig (SAR443765) for adults with high-risk asthma. The goal is to see how well this treatment works compared to a placebo, which is a harmless substance that has no active ingredients. The study will include adults aged 18 to 80 who have been diagnosed with mild to moderate asthma and have had at least one asthma attack in the past year. Participants will not be eligible if they have other serious lung conditions or have recently needed emergency treatment for their asthma.
If you decide to participate, you can expect to be involved in the study for about 64 weeks, with a treatment time of up to 52 weeks. During this time, you will visit the study site 18 times to check your progress and monitor your health. The study is designed to be safe, and both you and the researchers won’t know if you are receiving Lunsekimig or the placebo, which helps ensure that the results are fair. This trial is currently recruiting participants, so if you think you might be eligible, it could be a good opportunity to contribute to asthma research and potentially benefit from a new treatment.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINA guidelines.
- • 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:
- Participants are excluded from the study if any of the following criteria apply:
- • 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.
About Sanofi
Sanofi is a global healthcare leader dedicated to empowering life through innovation in pharmaceuticals and vaccines. With a strong commitment to research and development, Sanofi focuses on addressing complex health challenges across various therapeutic areas, including diabetes, oncology, immunology, and rare diseases. The company leverages advanced science and technology to develop transformative therapies that improve patient outcomes. Through collaborative partnerships and a patient-centric approach, Sanofi strives to enhance global health and deliver sustainable solutions that meet the evolving needs of healthcare systems and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Austin, Texas, United States
Liège, , Belgium
Madrid, , Spain
Gent, , Belgium
Lund, , Sweden
Santiago, Reg Metropolitana De Santiago, Chile
Quillota, Valparaíso, Chile
Rozzano, Milano, Italy
Santiago, Reg Metropolitana De Santiago, Chile
Hvidovre, , Denmark
Bradford, , United Kingdom
Rosario, Santa Fe, Argentina
Mosonmagyaróvár, , Hungary
Poznan, Wielkopolskie, Poland
Mersin, , Turkey
Toulouse, , France
Santiago, Reg Metropolitana De Santiago, Chile
Lampasas, Texas, United States
Changchun, , China
Guelph, Ontario, Canada
Ann Arbor, Michigan, United States
Haifa, , Israel
Jerusalem, , Israel
Kaohsiung City, , Taiwan
Taipei City, , Taiwan
Taipei City, , Taiwan
Akdeniz, , Turkey
Boynton Beach, Florida, United States
Miami, Florida, United States
Buenos Aires, , Argentina
Boynton Beach, Florida, United States
Miami, Florida, United States
Dubois, Pennsylvania, United States
Kelowna, British Columbia, Canada
London, , United Kingdom
San Miguel De Tucumán, , Argentina
Buenos Aires, , Argentina
Jerusalem, , Israel
Talca, Maule, Chile
Buenos Aires, , Argentina
Gothenburg, , Sweden
Dubois, Pennsylvania, United States
Sherbrooke, Quebec, Canada
Barnsley, , United Kingdom
Shanghai, , China
Rehovot, , Israel
Surprise, Arizona, United States
Pensacola, Florida, United States
Mankato, Minnesota, United States
Edmond, Oklahoma, United States
North Vancouver, British Columbia, Canada
Corby, Northamptonshire, United Kingdom
Nottingham, , United Kingdom
Cutler Bay, Florida, United States
Silver Spring, Maryland, United States
Toledo, Ohio, United States
Stephenville, Texas, United States
Viña Del Mar, Valparaíso, Chile
Chengdu, , China
Ningbo, , China
Berazategui, Buenos Aires, Argentina
Surprise, Arizona, United States
La Jolla, California, United States
La Mesa, California, United States
North Hollywood, California, United States
San Mateo, California, United States
Davie, Florida, United States
Miami, Florida, United States
Plantation, Florida, United States
Champaign, Illinois, United States
Rockville, Maryland, United States
Desoto, Texas, United States
Mckinney, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Buenos Aires, , Argentina
Mendoza, , Argentina
Concepción, Biobío, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Beijing, , China
Chengde, , China
Guangzhou, , China
Guangzhou, , China
Hangzhou, , China
Huizhou, , China
Jinan, , China
Shenyang, , China
Suzhou, , China
Taiyuan, , China
Xuzhou, , China
Petah Tikva, , Israel
Tel Aviv, , Israel
Kayseri, , Turkey
Corby, Northamptonshire, United Kingdom
Barnsley, , United Kingdom
Nottingham, , United Kingdom
San Miguel De Tucumán, Tucumán, Argentina
Chandler, Arizona, United States
Tucson, Arizona, United States
Inverness, Florida, United States
Lady Lake, Florida, United States
Margate, Florida, United States
Oviedo, Florida, United States
Pembroke Pines, Florida, United States
Cordele, Georgia, United States
Boise, Idaho, United States
Rockville, Maryland, United States
Silver Spring, Maryland, United States
Hannibal, Missouri, United States
New York, New York, United States
Greenville, South Carolina, United States
Boerne, Texas, United States
Houston, Texas, United States
Buenos Aires, , Argentina
Corrientes, , Argentina
Mendoza, , Argentina
Mechelen, , Belgium
Stoney Creek, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Talcahuano, Biobío, Chile
Viña Del Mar, Valparaíso, Chile
Foshan, , China
Guiyang, , China
Hebei, , China
Hefei, , China
Hohhot, , China
Hohhot, , China
Huizhou, , China
Jiazhuang, , China
Jinan, , China
Lanzhou, , China
Luoyang, , China
Nanchang, , China
Shanghai, , China
Suzhou, , China
Tianjin, , China
Wuhan, , China
Xi An, , China
Xi An, , China
Xianyang, , China
Yangzhou, , China
Zhengzhou, , China
Zigong, , China
Bendorf, , Germany
Düsseldorf, , Germany
Leipzig, , Germany
Gödöllő, , Hungary
Hajdunanas, , Hungary
Püspökladány, , Hungary
Ostrowiec Swietokrzyski, Swietokrzyskie, Poland
Katowice, , Poland
Cluj Napoca, , Romania
Madrid, , Spain
Madrid, , Spain
Palma, , Spain
Kirikkale, , Turkey
Nottingham, Nottinghamshire, United Kingdom
Oxford, Oxfordshire, United Kingdom
London, , United Kingdom
Los Angeles, California, United States
Statesville, North Carolina, United States
San Marcos, Texas, United States
Sugar Land, Texas, United States
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
Buenos Aires, , Argentina
Santa Fe, , Argentina
Changchun, , China
Tianjin, , China
Xi'an, , China
Xi'an, , China
Vejle, , Denmark
Lyon, , France
Montpellier, , France
Pessac, , France
Santiago De Compostela, A Coruña [La Coruña], Spain
Badalona, Barcelona [Barcelona], Spain
Girona, Girona [Gerona], Spain
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Taichung, , Taiwan
Quillota, , Chile
Madrid, , Spain
Concepción, , Chile
Talcahuano, , Chile
Viña Del Mar, , Chile
Viña Del Mar, , Chile
Santiago De Compostela, , Spain
Badalona, , Spain
Girona, , Spain
Saraland, Alabama, United States
Sun City, Arizona, United States
Torrance, California, United States
Debary, Florida, United States
Saint Cloud, Florida, United States
Rochester, Minnesota, United States
Ajax, Ontario, Canada
Santiago, Reg Metropolitana De Santiago, Chile
Taiyuan, , China
Zhengzhou, , China
Amiens, , France
Strasbourg, , France
Mainz, , Germany
Debrecen, , Hungary
Pécs, , Hungary
Genoa, Genova, Italy
Milan, Milano, Italy
Rome, Roma, Italy
Ancona, , Italy
Bergamo, , Italy
Palermo, , Italy
Reggio Emilia, , Italy
Tradate, , Italy
Bialystok, Podlaskie, Poland
Barcelona, , Spain
Sevilla, , Spain
Taoyuan City, , Taiwan
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported