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Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma

NCT06676319 · Sanofi
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Official title
A Randomized, Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig (SAR443765) in Adult Participants With High-risk Asthma Who Are Not Currently Eligible for Biologic Treatment
About this study
This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma. 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.
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.
Study design
Enrollment target: 1147 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-11-07
Estimated completion: 2027-10-15
Last updated: 2026-04-16
Interventions
Drug: LunsekimigDrug: Short-Acting Beta Agonists (SABA)Drug: PlaceboDrug: Fluticasone/SalmeterolDrug: Budesonide/FormoterolDrug: Budesonide/Albuterol
Primary outcomes
  • Annualized rate of asthma exacerbation events (From baseline up to 52 weeks)
Sponsor
Sanofi · industry
Contacts & investigators
ContactTrial Transparency email recommended (Toll free for US & Canada) · contact · contact-us@sanofi.com · 800-633-1610
All locations (236)
The Center for Clinical Trials - Saraland- Site Number : 8400096Recruiting
Saraland, Alabama, United States
Chandler Clinical Research Trials- Site Number : 8400075Recruiting
Chandler, Arizona, United States
Epic Medical Research - Sun City- Site Number : 8400052Recruiting
Sun City, Arizona, United States
Tucson Clinical Research Institute- Site Number : 8400085Recruiting
Tucson, Arizona, United States
Ark Clinical Research- Site Number : 8400097Recruiting
Long Beach, California, United States
Downtown L.A. Research Center- Site Number : 8400080Recruiting
Los Angeles, California, United States
Carbon Health - North Hollywood - NoHo West- Site Number : 8400061Recruiting
North Hollywood, California, United States
Carbon Health - San Mateo - Hillsdale Mall- Site Number : 8400062Recruiting
San Mateo, California, United States
Stanford University Medical Center- Site Number : 8400108Recruiting
Stanford, California, United States
Modena Allergy And Asthma- Site Number : 8400068Recruiting
Torrance, California, United States
Howard University Hospital- Site Number : 8400107Recruiting
Washington D.C., District of Columbia, United States
Helix Biomedics- Site Number : 8400005Recruiting
Boynton Beach, Florida, United States
Beautiful Minds Clinical Research Center- Site Number : 8400019Recruiting
Cutler Bay, Florida, United States
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400082Recruiting
DeBary, Florida, United States
Alfa Medical Research- Site Number : 8400071Recruiting
Hollywood, Florida, United States
Royal Clinical Trials - Inverness- Site Number : 8400067Recruiting
Inverness, Florida, United States
Premier Medical Associates- Site Number : 8400077Recruiting
Lady Lake, Florida, United States
D&H Pompano Research Center- Site Number : 8400072Recruiting
Margate, Florida, United States
Research Institute of South Florida- Site Number : 8400023Recruiting
Miami, Florida, United States
Innovations Biotech- Site Number : 8400044Recruiting
Miami, Florida, United States
Tellabio International Research Services- Site Number : 8400083Recruiting
Pembroke Pines, Florida, United States
Avanza Medical Research Center- Site Number : 8400056Recruiting
Pensacola, Florida, United States
Hull and Hull Medical Specialists- Site Number : 8400079Recruiting
Plantation, Florida, United States
Ilumina Medical Research- Site Number : 8400095Recruiting
Saint Cloud, Florida, United States
Private Practice - Dr. David Kavtaradze- Site Number : 8400081Recruiting
Cordele, Georgia, United States
EmVenio Research - Riverdale- Site Number : 8400109Recruiting
Riverdale, Georgia, United States
Christie Clinic in Champaign on University- Site Number : 8400003Recruiting
Champaign, Illinois, United States
University of Kansas Medical Center (KUMC)- Site Number : 8400105Recruiting
Westwood, Kansas, United States
Velocity Clinical Research - Rockville (formerly Meridian Clinical Research)- Site Number : 8400036Recruiting
Rockville, Maryland, United States
Javara - Privia Medical Group - Silver Spring Lockwood- Site Number : 8400042Recruiting
Silver Spring, Maryland, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400014Recruiting
Ann Arbor, Michigan, United States
Clarkston Medical Group- Site Number : 8400054Recruiting
Clarkston, Michigan, United States
Javara - Mankato Clinic- Site Number : 8400001Recruiting
Mankato, Minnesota, United States
Mayo Clinic in Rochester - Minnesota- Site Number : 8400057Recruiting
Rochester, Minnesota, United States
Hannibal Regional Healthcare System- Site Number : 8400078Recruiting
Hannibal, Missouri, United States
Icahn School of Medicine at Mount Sinai (ISMMS) - Mount Sinai Doctors- Site Number : 8400069Recruiting
New York, New York, United States
Pioneer Clinical Research - New York- Site Number : 8400092Recruiting
New York, New York, United States
Piedmont Healthcare - Family Medicine- Site Number : 8400064Recruiting
Statesville, North Carolina, United States
Cleveland Clinic - Cleveland- Site Number : 8400106Recruiting
Cleveland, Ohio, United States
Asthma & Allergy Center - Toledo- Site Number : 8400020Recruiting
Toledo, Ohio, United States
OK Clinical Research- Site Number : 8400060Recruiting
Edmond, Oklahoma, United States
Clinical Research Associates of Central PA- Site Number : 8400013Recruiting
DuBois, Pennsylvania, United States
Thomas Jefferson University Hospital- Site Number : 8400110Recruiting
Philadelphia, Pennsylvania, United States
Allergic Disease and Asthma Center (ADAC)- Site Number : 8400070Recruiting
Greenville, South Carolina, United States
Orion Clinical ResearchRecruiting
Austin, Texas, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400015Recruiting
Boerne, Texas, United States
Epic Medical Research - De Soto- Site Number : 8400051Recruiting
DeSoto, Texas, United States
Axsendo Clinical Research - Houston- Site Number : 8400065Completed
Houston, Texas, United States
Metroplex Pulmonary and Sleep Center- Site Number : 8400012Recruiting
McKinney, Texas, United States
STAAMP Research - San Antonio- Site Number : 8400059Recruiting
San Antonio, Texas, United States
Bandera Family Health Care - San Antonio- Site Number : 8400049Recruiting
San Antonio, Texas, United States
Javara - San Marcos - Redwood Road- Site Number : 8400040Recruiting
San Marcos, Texas, United States
Simcare Medical Research- Site Number : 8400102Recruiting
Sugar Land, Texas, United States
Children's Wisconsin- Site Number : 8400073Recruiting
Milwaukee, Wisconsin, United States
Investigational Site Number : 0320007Recruiting
Berazategui, Buenos Aires, Argentina
Investigational Site Number : 0320011Recruiting
La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320013Recruiting
Lobos, Buenos Aires, Argentina
Investigational Site Number : 0320006Recruiting
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320010Recruiting
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320016Recruiting
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320003Recruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320005Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320012Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320002Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320001Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320004Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320008Recruiting
Corrientes, Argentina
Investigational Site Number : 0320014Recruiting
Mendoza, Argentina
Investigational Site Number : 0320015Recruiting
Mendoza, Argentina
Investigational Site Number : 0320009Recruiting
Santa Fe, Argentina
Investigational Site Number : 0560001Recruiting
Ghent, Belgium
Investigational Site Number : 0560003Recruiting
Liège, Belgium
Investigational Site Number : 0560002Recruiting
Mechelen, Belgium
Associacao Proar- Site Number : 0760002Recruiting
Salvador, Estado de Bahia, Brazil
Universidade Federal de Goias- Site Number : 0760011Recruiting
Goiânia, Goiás, Brazil
Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760006Recruiting
Curitiba, Paraná, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Incor - Instituto do Coracao- Site Number : 0760004Recruiting
São Paulo, Brazil
Investigational Site Number : 1240011Recruiting
Kelowna, British Columbia, Canada
Investigational Site Number : 1240012Recruiting
West Vancouver, British Columbia, Canada
Investigational Site Number : 1240013Recruiting
Ajax, Ontario, Canada
Investigational Site Number : 1240003Recruiting
Guelph, Ontario, Canada
Investigational Site Number : 1240006Recruiting
Stoney Creek, Ontario, Canada
Investigational Site Number : 1240008Recruiting
Toronto, Ontario, Canada
Investigational Site Number : 1240014Recruiting
Montreal, Quebec, Canada
Investigational Site Number : 1240002Recruiting
Sherbrooke, Quebec, Canada
Investigational Site Number : 1520008Recruiting
Concepción, Biobio, Chile
Investigational Site Number : 1520002Recruiting
Talca, Maule Region, Chile
Investigational Site Number : 1520009Recruiting
Lo Barnechea, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520010Recruiting
Recoleta, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520006Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520005Recruiting
Quillota, Valparaiso, Chile
Investigational Site Number : 1520004Recruiting
Viña del Mar, Valparaiso, Chile
Investigational Site Number : 1520007Recruiting
Viña del Mar, Valparaiso, Chile
Investigational Site Number : 1560027Recruiting
Beijing, China
Investigational Site Number : 1560005Recruiting
Changchun, China
Investigational Site Number : 1560021Recruiting
Chengde, China
Investigational Site Number : 1560039Recruiting
Chengdu, China
Investigational Site Number : 1560028Recruiting
Foshan, China
Investigational Site Number : 1560010Recruiting
Guangzhou, China
Investigational Site Number : 1560033Recruiting
Guangzhou, China
Investigational Site Number : 1560037Recruiting
Guiyang, China
Investigational Site Number : 1560042Recruiting
Hangzhou, China
Investigational Site Number : 1560009Recruiting
Hebei, China
Investigational Site Number : 1560040Recruiting
Hefei, China
Investigational Site Number : 1560006Recruiting
Hohhot, China
Investigational Site Number : 1560007Recruiting
Hohhot, China
Investigational Site Number : 1560029Recruiting
Huizhou, China
Investigational Site Number : 1560011Recruiting
Huizhou, China
Investigational Site Number : 1560025Recruiting
Jiazhuang, China
Investigational Site Number : 1560034Recruiting
Jinan, China
Investigational Site Number : 1560038Recruiting
Jinan, China
Investigational Site Number : 1560030Recruiting
Lanzhou, China
Investigational Site Number : 1560018Recruiting
Luoyang, China
Investigational Site Number : 1560003Recruiting
Nanchang, China
Investigational Site Number : 1560014Recruiting
Ningbo, China
Investigational Site Number : 1560001Recruiting
Shanghai, China
Investigational Site Number : 1560043Recruiting
Shanghai, China
Investigational Site Number : 1560016Recruiting
Shenyang, China
Investigational Site Number : 1560019Recruiting
Suzhou, China
Investigational Site Number : 1560008Recruiting
Suzhou, China
Investigational Site Number : 1560017Recruiting
Taiyuan, China
Investigational Site Number : 1560035Recruiting
Taiyuan, China
Investigational Site Number : 1560002Recruiting
Tianjin, China
Investigational Site Number : 1560013Recruiting
Tianjin, China
Investigational Site Number : 1560022Recruiting
Wuhan, China
Investigational Site Number : 1560036Recruiting
Xi'an, China
Investigational Site Number : 1560032Recruiting
Xi'an, China
Investigational Site Number : 1560044Recruiting
Xianyang, China
Investigational Site Number : 1560012Recruiting
Xuzhou, China
Investigational Site Number : 1560047Recruiting
Yangzhou, China
Investigational Site Number : 1560023Recruiting
Zhengzhou, China
Investigational Site Number : 1560026Recruiting
Zhengzhou, China
Investigational Site Number : 1560045Recruiting
Zigong, China
Investigational Site Number : 2080001Recruiting
Hvidovre, Denmark
Investigational Site Number : 2080002Recruiting
Vejle, Denmark
Investigational Site Number : 2500007Recruiting
Amiens, France
Investigational Site Number : 2500004Recruiting
Lyon, France
Investigational Site Number : 2500003Recruiting
Montpellier, France
Investigational Site Number : 2500005Recruiting
Pessac, France
Investigational Site Number : 2500001Recruiting
Strasbourg, France
Investigational Site Number : 2500002Recruiting
Toulouse, France
Investigational Site Number : 2760006Recruiting
Ahrensburg, Germany
Investigational Site Number : 2760002Recruiting
Bendorf, Germany
Investigational Site Number : 2760007Recruiting
Berlin, Germany
Investigational Site Number : 6420001Recruiting
Düsseldorf, Germany
Investigational Site Number : 2760004Recruiting
Frankfurt, Germany
Investigational Site Number : 2760008Recruiting
Frankfurt, Germany
Investigational Site Number : 2760001Recruiting
Leipzig, Germany
Investigational Site Number : 2760005Recruiting
Mainz, Germany
Investigational Site Number : 3480006Recruiting
Debrecen, Hungary
Investigational Site Number : 3480002Recruiting
Gödöllő, Hungary
Investigational Site Number : 3480003Recruiting
Hajdúnánás, Hungary
Investigational Site Number : 3480004Recruiting
Mosonmagyaróvár, Hungary
Investigational Site Number : 3480005Recruiting
Pécs, Hungary
Investigational Site Number : 3480001Recruiting
Püspökladány, Hungary
Investigational Site Number : 2500006Recruiting
Mumbai, India
Investigational Site Number : 3760006Recruiting
Haifa, Israel
Investigational Site Number : 3760003Recruiting
Jerusalem, Israel
Investigational Site Number : 3760002Recruiting
Jerusalem, Israel
Investigational Site Number : 3760005Recruiting
Petah Tikva, Israel
Investigational Site Number : 3760001Recruiting
Rehovot, Israel
Investigational Site Number : 3760004Recruiting
Tel Aviv, Israel
Investigational Site Number : 3800008Recruiting
Torette, Ancona, Italy
Investigational Site Number : 3800006Recruiting
Monserrato, Cagliari, Italy
Investigational Site Number : 3800001Recruiting
Cona, Ferrara, Italy
Investigational Site Number : 3800009Recruiting
Genoa, Genova, Italy
Investigational Site Number : 3800004Recruiting
Milan, Milano, Italy
Investigational Site Number : 3800003Recruiting
Rozzano, Milano, Italy
Investigational Site Number : 3800010Recruiting
Rome, Roma, Italy
Investigational Site Number : 3800012Recruiting
Tradate, Varese, Italy
Investigational Site Number : 3800007Recruiting
Bergamo, Italy
Investigational Site Number : 3800005Recruiting
Modena, Italy
Investigational Site Number : 3800013Recruiting
Palermo, Italy
Investigational Site Number : 3800011Recruiting
Reggio Emilia, Italy
Investigational Site Number : 3920002Recruiting
Shinagawa, Tokyo, Japan
Investigational Site Number : 3920001Recruiting
Ube, Yamaguchi, Japan
Investigational Site Number : 3920004Recruiting
Tokyo, Japan
Investigational Site Number : 4840001Recruiting
Guadalajara, Jalisco, Mexico
Investigational Site Number : 4840007Recruiting
Guadalajara, Jalisco, Mexico
Investigational Site Number : 4840005Recruiting
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840006Recruiting
San Juan del Río, Querétaro, Mexico
Investigational Site Number : 4840002Recruiting
Chihuahua City, Mexico
Investigational Site Number : 6160005Recruiting
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160001Recruiting
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160008Recruiting
Lodz, Lódzkie, Poland
Investigational Site Number : 6160002Recruiting
Bialystok, Podlaskie Voivodeship, Poland
Investigational Site Number : 6160004Recruiting
Chęciny, Poland
Investigational Site Number : 6160009Recruiting
Katowice, Poland
Investigational Site Number : 6160003Recruiting
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
Investigational Site Number : 6420002Recruiting
Cluj-Napoca, Romania
Investigational Site Number : 7100004Recruiting
Benoni, South Africa
Investigational Site Number : 7100005Recruiting
Benoni, South Africa
Investigational Site Number : 7100002Recruiting
Cape Town, South Africa
Investigational Site Number : 7100003Recruiting
Durban, South Africa
Investigational Site Number : 7100006Recruiting
Durban, South Africa
Investigational Site Number : 7100007Recruiting
Johannesburg, South Africa
Investigational Site Number : 7240005Recruiting
Santiago de Compostela, A Coruña [La Coruña], Spain
Investigational Site Number : 7240010Recruiting
Badalona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240009Recruiting
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240015Recruiting
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240017Recruiting
Santander, Cantabria, Spain
Investigational Site Number : 7240016Recruiting
Girona, Girona [Gerona], Spain
Investigational Site Number : 7240018Recruiting
Benalmádena, Málaga, Spain
Investigational Site Number : 7240013Recruiting
Madrid, Spain
Investigational Site Number : 7240008Recruiting
Madrid, Spain
Investigational Site Number : 7240011Recruiting
Madrid, Spain
Investigational Site Number : 7240002Recruiting
Madrid, Spain
Investigational Site Number : 7240007Recruiting
Madrid, Spain
Investigational Site Number : 7240004Recruiting
Málaga, Spain
Investigational Site Number : 7240006Recruiting
Málaga, Spain
Investigational Site Number : 7240001Recruiting
Palma, Spain
Investigational Site Number : 7240014Recruiting
Seville, Spain
Investigational Site Number : 7520003Recruiting
Gothenburg, Sweden
Investigational Site Number : 7520002Recruiting
Lund, Sweden
Investigational Site Number : 7520001Recruiting
Solna, Sweden
Investigational Site Number : 1580002Recruiting
Hualien City, Taiwan
Investigational Site Number : 1580005Recruiting
Kaohsiung City, Taiwan
Investigational Site Number : 1580006Recruiting
Taichung, Taiwan
Investigational Site Number : 1580007Recruiting
Taichung, Taiwan
Investigational Site Number : 1580004Recruiting
Taipei, Taiwan
Investigational Site Number : 1580003Recruiting
Taipei, Taiwan
Investigational Site Number : 1580001Recruiting
Taoyuan, Taiwan
Investigational Site Number : 7920003Recruiting
Kayseri, Turkey (Türkiye)
Investigational Site Number : 7920002Recruiting
Kirikkale, Turkey (Türkiye)
Investigational Site Number : 7920001Recruiting
Mersin, Turkey (Türkiye)
Investigational Site Number : 8260009Recruiting
Ruislip, Hillingdon, United Kingdom
Investigational Site Number : 8260007Recruiting
Corby, Northamptonshire, United Kingdom
Investigational Site Number : 8260006Recruiting
Nottingham, Nottinghamshire, United Kingdom
Investigational Site Number : 8260008Recruiting
Oxford, Oxfordshire, United Kingdom
Investigational Site Number : 8260005Recruiting
Barnsley, United Kingdom
Investigational Site Number : 8260003Recruiting
Bradford, United Kingdom
Investigational Site Number : 8260001Recruiting
London, United Kingdom
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma · TrialPath