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

June 30, 2026 updated by: Sanofi

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

556

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1121
        • Investigational Site Number : 0320005
      • Buenos Aires, Argentina, 1425
        • Investigational Site Number : 0320001
      • Buenos Aires, Argentina, 1425
        • Investigational Site Number : 0320004
      • Buenos Aires, Argentina, 1122
        • Investigational Site Number : 0320012
      • Buenos Aires, Argentina, 1414
        • Investigational Site Number : 0320002
      • Corrientes, Argentina, 3400
        • Investigational Site Number : 0320008
      • Mendoza, Argentina, 5500
        • Investigational Site Number : 0320015
      • Mendoza, Argentina, 5500
        • Investigational Site Number : 0320014
      • Santa Fe, Argentina, 3000
        • Investigational Site Number : 0320009
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, 1886
        • Investigational Site Number : 0320007
      • La Plata, Buenos Aires, Argentina, 1900
        • Investigational Site Number : 0320011
      • Lobos, Buenos Aires, Argentina, 7240
        • Investigational Site Number : 0320013
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320006
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320010
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320016
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Investigational Site Number : 0320003
  • Belgium
      • Liège, Belgium, 4000
        • Investigational Site Number : 0560003
      • Mechelen, Belgium, 2800
        • Investigational Site Number : 0560002
  • Brazil
      • São Paulo, Brazil, 05403-900
        • Incor - Instituto do Coracao- Site Number : 0760004
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40060-330
        • Associacao Proar- Site Number : 0760002
    • Goiás
      • Goiânia, Goiás, Brazil, 74605-020
        • Universidade Federal de Goias- Site Number : 0760011
    • Paraná
      • Curitiba, Paraná, Brazil, 80060-900
        • Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760006
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
      • Porto Alegre, Rio Grande do Sul, Brazil, 91010-006
        • WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 4N7
        • Investigational Site Number : 1240011
      • West Vancouver, British Columbia, Canada, V7T 2Z3
        • Investigational Site Number : 1240012
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Investigational Site Number : 1240013
      • Guelph, Ontario, Canada, N1h 6j2
        • Investigational Site Number : 1240003
      • Stoney Creek, Ontario, Canada, L8G 2V6
        • Investigational Site Number : 1240006
      • Toronto, Ontario, Canada, M4G 3E8
        • Investigational Site Number : 1240008
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Investigational Site Number : 1240014
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Investigational Site Number : 1240002
  • Chile
    • Biobio
      • Concepción, Biobio, Chile, 4070094
        • Investigational Site Number : 1520008
    • Maule Region
      • Talca, Maule Region, Chile, 3465584
        • Investigational Site Number : 1520002
    • Reg Metropolitana de Santiago
      • Lo Barnechea, Reg Metropolitana de Santiago, Chile, 7691236
        • Investigational Site Number : 1520009
      • Recoleta, Reg Metropolitana de Santiago, Chile, 8420000
        • Investigational Site Number : 1520010
      • Santiago, Reg Metropolitana de Santiago, Chile, 7500692
        • Investigational Site Number : 1520001
      • Santiago, Reg Metropolitana de Santiago, Chile, 7500698
        • Investigational Site Number : 1520003
      • Santiago, Reg Metropolitana de Santiago, Chile, 7500587
        • Investigational Site Number : 1520006
    • Valparaiso
      • Quillota, Valparaiso, Chile, 2260877
        • Investigational Site Number : 1520005
      • Viña del Mar, Valparaiso, Chile, 2540364
        • Investigational Site Number : 1520007
      • Viña del Mar, Valparaiso, Chile, 2531172
        • Investigational Site Number : 1520004
  • China
      • Beijing, China, 100029
        • Investigational Site Number : 1560027
      • Changchun, China, 130021
        • Investigational Site Number : 1560005
      • Chengde, China, 067020
        • Investigational Site Number : 1560021
      • Chengdu, China, 611130
        • Investigational Site Number : 1560039
      • Foshan, China, 528399
        • Investigational Site Number : 1560028
      • Guangzhou, China, 510000
        • Investigational Site Number : 1560010
      • Guangzhou, China, 510180
        • Investigational Site Number : 1560033
      • Guiyang, China, 550002
        • Investigational Site Number : 1560037
      • Hangzhou, China, 310005
        • Investigational Site Number : 1560042
      • Hebei, China, 050051
        • Investigational Site Number : 1560009
      • Hefei, China, 230032
        • Investigational Site Number : 1560040
      • Hohhot, China, 010050
        • Investigational Site Number : 1560006
      • Hohhot, China, 010070
        • Investigational Site Number : 1560007
      • Huizhou, China, 516001
        • Investigational Site Number : 1560029
      • Huizhou, China, 516002
        • Investigational Site Number : 1560011
      • Jiazhuang, China, 050000
        • Investigational Site Number : 1560025
      • Jinan, China, 250001
        • Investigational Site Number : 1560034
      • Jinan, China, 250014
        • Investigational Site Number : 1560038
      • Lanzhou, China, 730000
        • Investigational Site Number : 1560030
      • Luoyang, China, 471003
        • Investigational Site Number : 1560018
      • Nanchang, China, 330006
        • Investigational Site Number : 1560003
      • Ningbo, China, 315010
        • Investigational Site Number : 1560014
      • Shanghai, China, 200080
        • Investigational Site Number : 1560001
      • Shanghai, China, 200433
        • Investigational Site Number : 1560043
      • Shenyang, China, 110004
        • Investigational Site Number : 1560016
      • Suzhou, China, 215002
        • Investigational Site Number : 1560019
      • Suzhou, China, 215006
        • Investigational Site Number : 1560008
      • Taiyuan, China, 030001
        • Investigational Site Number : 1560017
      • Taiyuan, China, 030032
        • Investigational Site Number : 1560035
      • Tianjin, China, 300121
        • Investigational Site Number : 1560002
      • Tianjin, China, 300211
        • Investigational Site Number : 1560013
      • Wuhan, China, 430030
        • Investigational Site Number : 1560022
      • Xi'an, China, 710004
        • Investigational Site Number : 1560036
      • Xi'an, China, 710061
        • Investigational Site Number : 1560032
      • Xianyang, China, 712000
        • Investigational Site Number : 1560044
      • Xuzhou, China, 221006
        • Investigational Site Number : 1560012
      • Yangzhou, China, 225000
        • Investigational Site Number : 1560047
      • Zhengzhou, China, 450003
        • Investigational Site Number : 1560023
      • Zhengzhou, China, 450007
        • Investigational Site Number : 1560026
      • Zigong, China, 643000
        • Investigational Site Number : 1560045
  • Denmark
      • Hvidovre, Denmark, 2650
        • Investigational Site Number : 2080001
      • Vejle, Denmark, 7100
        • Investigational Site Number : 2080002
  • France
      • Amiens, France, 80000
        • Investigational Site Number : 2500007
      • Lyon, France, 69004
        • Investigational Site Number : 2500004
      • Montpellier, France, 34090
        • Investigational Site Number : 2500003
      • Paris, France, 75018
        • Investigational Site Number : 2500006
      • Pessac, France, 33604
        • Investigational Site Number : 2500005
      • Strasbourg, France, 67000
        • Investigational Site Number : 2500001
      • Toulouse, France, 31059
        • Investigational Site Number : 2500002
  • Germany
      • Ahrensburg, Germany, 22926
        • Investigational Site Number : 2760006
      • Bendorf, Germany, 56170
        • Investigational Site Number : 2760002
      • Berlin, Germany, 12159
        • Investigational Site Number : 2760007
      • Düsseldorf, Germany, 40225
        • Investigational Site Number : 6420001
      • Frankfurt, Germany, 60596
        • Investigational Site Number : 2760004
      • Frankfurt, Germany, 60596
        • Investigational Site Number : 2760008
      • Frankfurt am Main, Germany, 60389
        • Investigational Site Number : 2760003
      • Leipzig, Germany, 04347
        • Investigational Site Number : 2760001
      • Mainz, Germany, 55128
        • Investigational Site Number : 2760005
  • Hungary
      • Debrecen, Hungary, 4032
        • Investigational Site Number : 3480006
      • Gödöllő, Hungary, 2100
        • Investigational Site Number : 3480002
      • Hajdúnánás, Hungary, 4080
        • Investigational Site Number : 3480003
      • Mosonmagyaróvár, Hungary, 9200
        • Investigational Site Number : 3480004
      • Pécs, Hungary, 7635
        • Investigational Site Number : 3480005
      • Püspökladány, Hungary, 4150
        • Investigational Site Number : 3480001
  • Israel
      • Haifa, Israel, 3436212
        • Investigational Site Number : 3760006
      • Jerusalem, Israel, 9103102
        • Investigational Site Number : 3760003
      • Jerusalem, Israel, 9112001
        • Investigational Site Number : 3760002
      • Petah Tikva, Israel, 4941492
        • Investigational Site Number : 3760005
      • Rehovot, Israel, 7610001
        • Investigational Site Number : 3760001
      • Tel Aviv, Israel, 6423906
        • Investigational Site Number : 3760004
  • Italy
      • Bergamo, Italy, 24127
        • Investigational Site Number : 3800007
      • Modena, Italy, 41125
        • Investigational Site Number : 3800005
      • Palermo, Italy, 90127
        • Investigational Site Number : 3800013
      • Reggio Emilia, Italy, 42100
        • Investigational Site Number : 3800011
    • Ancona
      • Torette, Ancona, Italy, 60020
        • Investigational Site Number : 3800008
    • Cagliari
      • Monserrato, Cagliari, Italy, 09042
        • Investigational Site Number : 3800006
    • Ferrara
      • Cona, Ferrara, Italy, 44124
        • Investigational Site Number : 3800001
    • Genova
      • Genoa, Genova, Italy, 16132
        • Investigational Site Number : 3800009
    • Milano
      • Milan, Milano, Italy, 20122
        • Investigational Site Number : 3800004
      • Rozzano, Milano, Italy, 20089
        • Investigational Site Number : 3800003
    • Roma
      • Rome, Roma, Italy, 00168
        • Investigational Site Number : 3800010
    • Varese
      • Tradate (Va), Varese, Italy, 21049
        • Investigational Site Number : 3800012
  • Japan
      • Tokyo, Japan, 162-8666
        • Investigational Site Number : 3920004
    • Tokyo
      • Shinagawa, Tokyo, Japan, 142-8666
        • Investigational Site Number : 3920002
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Investigational Site Number : 3920001
  • Poland
      • Chęciny, Poland, 26-060
        • Investigational Site Number : 6160004
      • Katowice, Poland, 40-600
        • Investigational Site Number : 6160009
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-693
        • Investigational Site Number : 6160001
      • Poznan, Greater Poland Voivodeship, Poland, 60-309
        • Investigational Site Number : 6160005
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-044
        • Investigational Site Number : 6160002
    • Świętokrzyskie Voivodeship
      • Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
        • Investigational Site Number : 6160003
  • Romania
      • Cluj-Napoca, Romania, 400006
        • Investigational Site Number : 6420002
  • South Africa
      • Benoni, South Africa, 1500
        • Investigational Site Number : 7100004
      • Benoni, South Africa, 1500
        • Investigational Site Number : 7100005
      • Cape Town, South Africa, 7530
        • Investigational Site Number : 7100002
      • Durban, South Africa, 4001
        • Investigational Site Number : 7100006
      • Durban, South Africa, 3630
        • Investigational Site Number : 7100003
      • Johannesburg, South Africa, 1821
        • Investigational Site Number : 7100007
  • Spain
      • Madrid, Spain, 28041
        • Investigational Site Number : 7240002
      • Madrid, Spain, 28003
        • Investigational Site Number : 7240013
      • Madrid, Spain, 28007
        • Investigational Site Number : 7240008
      • Madrid, Spain, 28010
        • Investigational Site Number : 7240011
      • Madrid, Spain, 28046
        • Investigational Site Number : 7240007
      • Málaga, Spain, 29010
        • Investigational Site Number : 7240004
      • Málaga, Spain, 29010
        • Investigational Site Number : 7240006
      • Palma, Spain, 07120
        • Investigational Site Number : 7240001
      • Seville, Spain, 41012
        • Investigational Site Number : 7240014
    • A Coruña [La Coruña]
      • Santiago de Compostela, A Coruña [La Coruña], Spain, 15702
        • Investigational Site Number : 7240005
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Investigational Site Number : 7240010
      • Barcelona, Barcelona [Barcelona], Spain, 08017
        • Investigational Site Number : 7240009
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Investigational Site Number : 7240015
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Investigational Site Number : 7240017
    • Girona [Gerona]
      • Girona, Girona [Gerona], Spain, 17005
        • Investigational Site Number : 7240016
    • Málaga
      • Benalmádena, Málaga, Spain, 29631
        • Investigational Site Number : 7240018
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Investigational Site Number : 7520003
      • Lund, Sweden, 221 85
        • Investigational Site Number : 7520002
      • Solna, Sweden, 171 64
        • Investigational Site Number : 7520001
  • Taiwan
      • Hualien City, Taiwan, 970
        • Investigational Site Number : 1580002
      • Kaohsiung City, Taiwan, 807
        • Investigational Site Number : 1580005
      • Taichung, Taiwan, 404
        • Investigational Site Number : 1580006
      • Taichung, Taiwan, 407
        • Investigational Site Number : 1580007
      • Taipei, Taiwan, 100
        • Investigational Site Number : 1580004
      • Taipei, Taiwan, 110
        • Investigational Site Number : 1580003
      • Taoyuan City, Taiwan, 333
        • Investigational Site Number : 1580001
  • Turkey (Türkiye)
      • Kayseri, Turkey (Türkiye), 38039
        • Investigational Site Number : 7920003
      • Kirikkale, Turkey (Türkiye), 71100
        • Investigational Site Number : 7920002
      • Mersin, Turkey (Türkiye), 33070
        • Investigational Site Number : 7920001
  • United Kingdom
      • Barnsley, United Kingdom, S75 2EP
        • Investigational Site Number : 8260005
      • Bradford, United Kingdom, BD9 6RJ
        • Investigational Site Number : 8260003
      • London, United Kingdom, W1G 8HU
        • Investigational Site Number : 8260001
    • Hillingdon
      • Ruislip, Hillingdon, United Kingdom, HA4 8NX
        • Investigational Site Number : 8260009
    • Northamptonshire
      • Corby, Northamptonshire, United Kingdom, NN17 2UN
        • Investigational Site Number : 8260007
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Investigational Site Number : 8260006
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Investigational Site Number : 8260008
  • United States
    • Alabama
      • Saraland, Alabama, United States, 36571
        • The Center for Clinical Trials - Saraland- Site Number : 8400096
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Chandler Clinical Research Trials- Site Number : 8400075
      • Sun City, Arizona, United States, 85351
        • Epic Medical Research - Sun City- Site Number : 8400052
      • Tucson, Arizona, United States, 85712
        • Tucson Clinical Research Institute- Site Number : 8400085
    • California
      • Long Beach, California, United States, 90815
        • Ark Clinical Research- Site Number : 8400097
      • Los Angeles, California, United States, 90017
        • Downtown L.A. Research Center- Site Number : 8400080
      • North Hollywood, California, United States, 91606
        • Carbon Health - North Hollywood - NoHo West- Site Number : 8400061
      • San Mateo, California, United States, 94403
        • Carbon Health - San Mateo - Hillsdale Mall- Site Number : 8400062
      • Stanford, California, United States, 94305
        • Stanford University Medical Center- Site Number : 8400108
      • Torrance, California, United States, 90505
        • Modena Allergy And Asthma- Site Number : 8400068
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20060
        • Howard University Hospital- Site Number : 8400107
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Helix Biomedics- Site Number : 8400005
      • Cutler Bay, Florida, United States, 33157
        • Beautiful Minds Clinical Research Center- Site Number : 8400019
      • DeBary, Florida, United States, 32713
        • Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400082
      • Hollywood, Florida, United States, 33024
        • Alfa Medical Research- Site Number : 8400071
      • Inverness, Florida, United States, 34453
        • Royal Clinical Trials - Inverness- Site Number : 8400067
      • Lady Lake, Florida, United States, 32159
        • Premier Medical Associates- Site Number : 8400077
      • Margate, Florida, United States, 33063
        • D&H Pompano Research Center- Site Number : 8400072
      • Miami, Florida, United States, 33173
        • Research Institute of South Florida- Site Number : 8400023
      • Miami, Florida, United States, 33186
        • Innovations Biotech- Site Number : 8400044
      • Pembroke Pines, Florida, United States, 33025
        • Tellabio International Research Services- Site Number : 8400083
      • Pensacola, Florida, United States, 32503
        • Avanza Medical Research Center- Site Number : 8400056
      • Plantation, Florida, United States, 33324
        • Hull and Hull Medical Specialists- Site Number : 8400079
      • Saint Cloud, Florida, United States, 34769
        • Ilumina Medical Research- Site Number : 8400095
    • Georgia
      • Cordele, Georgia, United States, 31015
        • Private Practice - Dr. David Kavtaradze- Site Number : 8400081
      • Riverdale, Georgia, United States, 30274
        • EmVenio Research - Riverdale- Site Number : 8400109
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Christie Clinic in Champaign on University- Site Number : 8400003
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center- Site Number : 8400105
    • Maryland
      • Rockville, Maryland, United States, 20854
        • Velocity Clinical Research - Rockville (formerly Meridian Clinical Research)- Site Number : 8400036
      • Silver Spring, Maryland, United States, 20901
        • Javara - Privia Medical Group - Silver Spring Lockwood- Site Number : 8400042
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System - Ann Arbor- Site Number : 8400014
      • Clarkston, Michigan, United States, 48346
        • Clarkston Medical Group- Site Number : 8400054
    • Minnesota
      • Mankato, Minnesota, United States, 56001
        • Javara - Mankato Clinic- Site Number : 8400001
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester - Minnesota- Site Number : 8400057
    • Missouri
      • Hannibal, Missouri, United States, 63401
        • Hannibal Regional Healthcare System- Site Number : 8400078
    • New York
      • New York, New York, United States, 10011
        • Icahn School of Medicine at Mount Sinai (ISMMS) - Mount Sinai Doctors- Site Number : 8400069
      • New York, New York, United States, 10016
        • Pioneer Clinical Research - New York- Site Number : 8400092
    • North Carolina
      • Statesville, North Carolina, United States, 28625
        • Piedmont Healthcare - Family Medicine- Site Number : 8400064
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic - Cleveland- Site Number : 8400106
      • Toledo, Ohio, United States, 43617
        • Asthma & Allergy Center - Toledo- Site Number : 8400020
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • OK Clinical Research- Site Number : 8400060
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Clinical Research Associates of Central Pennsylvania- Site Number : 8400013
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital- Site Number : 8400110
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Allergic Disease and Asthma Center (ADAC)- Site Number : 8400070
    • Texas
      • Austin, Texas, United States, 78759
        • Orion Clinical Research
      • Boerne, Texas, United States, 78006
        • South Texas Medical Research Institute - TTS Research- Site Number : 8400015
      • DeSoto, Texas, United States, 75115
        • Epic Medical Research - De Soto- Site Number : 8400051
      • Houston, Texas, United States, 77058
        • Axsendo Clinical Research - Houston- Site Number : 8400065
      • McKinney, Texas, United States, 75069
        • Metroplex Pulmonary and Sleep Center- Site Number : 8400012
      • San Antonio, Texas, United States, 78229
        • STAAMP Research - San Antonio- Site Number : 8400059
      • San Antonio, Texas, United States, 78249
        • Bandera Family Health Care - San Antonio- Site Number : 8400049
      • San Marcos, Texas, United States, 78666
        • Javara - San Marcos - Redwood Road- Site Number : 8400040
      • Sugar Land, Texas, United States, 77478
        • Simcare Medical Research- Site Number : 8400102
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Wisconsin- Site Number : 8400073

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lunsekimig
Participants will receive lunsekimig (SC injection) every 4 weeks
Drug: Lunsekimig
Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection
Other Names:
  • SAR443765
Drug: Short-Acting Beta Agonists (SABA)
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
Drug: Fluticasone/Salmeterol
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation
Drug: Budesonide/Formoterol
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
Drug: Budesonide/Albuterol
Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation
Placebo Comparator: Placebo
Participants will receive placebo (SC injection) every 4 weeks
Drug: Short-Acting Beta Agonists (SABA)
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
Drug: Fluticasone/Salmeterol
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation
Drug: Budesonide/Formoterol
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
Drug: Budesonide/Albuterol
Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation
Drug: Placebo
Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized rate of asthma exacerbation events
Time Frame: From baseline up to 52 weeks
Asthma exacerbation event defined as: worsening of asthma requiring the use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit due to asthma and requiring the use of systemic corticosteroids or death due to asthma
From baseline up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in prebronchodilator (BD) forced expiratory volume in 1 second (FEV1)
Time Frame: From baseline to week 52
From baseline to week 52
Change from baseline in Asthma Control Questionnaire5 (ACQ-5) score
Time Frame: From baseline to week 52
The ACQ-5 is a questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. The ACQ-5 has five questions on the asthma symptoms and patients are asked to recall how their asthma has been during the previous week and to respond on a 7-point scale for each question (0 = no impairment, 6 = maximum impairment). The ACQ-5 score is the mean of the 5 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control.
From baseline to week 52
Change from baseline in FeNO level
Time Frame: From baseline to week 52
From baseline to week 52
Annualized rate of asthma exacerbations requiring hospitalization or emergency room or urgent care visit
Time Frame: From baseline to week 52
From baseline to week 52
Total systemic corticosteroid dose exposure
Time Frame: From baseline to week 52
From baseline to week 52
Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores
Time Frame: From baseline to week 52
From baseline to week 52
Change from baseline in the Asthma Daytime Symptom Diary (ADSD) daily morning and evening score
Time Frame: From baseline to week 52
From baseline to week 52
Serum lunsekimig concentrations
Time Frame: From baseline to week 56
From baseline to week 56
Incidence and titer of anti-drug antibodies (ADA) against lunsekimig
Time Frame: From baseline to week 56
From baseline to week 56
Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)
Time Frame: From baseline to week 56
From baseline to week 56
Annualized rate of loss of asthma control events (LOAC) events
Time Frame: From baseline to week 52

Annualized rate of LOAC events defined by 1 or more of the following criteria:

  • ≥30% reduction from baseline in morning PEF on 2 consecutive days
  • ≥6 additional reliever puffs of SABA in a 24-hour period (compared to baseline) on 2 consecutive days OR ≥4 additional puffs of low-dose budesonide/formoterol or budesonide/albuterol in a 24-hour period (compared to baseline) on 2 consecutive days
  • Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days
  • Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids (asthma exacerbation event)
  • Death due to asthma
From baseline to week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2024

Primary Completion (Estimated)

June 21, 2027

Study Completion (Estimated)

July 19, 2027

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT18301
  • 2024-513959-33 (Registry Identifier: CTIS)
  • U1111-1301-3938 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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