AzTrials
AzTrials

AsthmaPhase 2AIRLYMPUSNCT06676319

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

A Phase 2 study testing Lunsekimig, Short-Acting Beta Agonists (SABA) and Fluticasone/Salmeterol in people with Asthma, run by Sanofi at 221 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Asthma
What is being tested?
Lunsekimig, Short-Acting Beta Agonists (SABA) and Fluticasone/Salmeterol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
556 participants
Where
221 sitesin 22 countries
Study dates
7 Nov 2024to 19 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

221 sites in 22 countries.

221 sites in 22 countries

United States53 sites

  • University of Michigan Health System - Ann Arbor- Site Number : 8400014

    Ann Arbor, Michigan, 48109

  • Orion Clinical Research- Site Number : 8400084

    Austin, Texas, 78759

  • South Texas Medical Research Institute - TTS Research- Site Number : 8400015

    Boerne, Texas, 78006

  • Helix Biomedics- Site Number : 8400005

    Boynton Beach, Florida, 33435

  • Christie Clinic in Champaign on University- Site Number : 8400003

    Champaign, Illinois, 61820

  • Chandler Clinical Research Trials- Site Number : 8400075

    Chandler, Arizona, 85224

  • Clarkston Medical Group- Site Number : 8400054

    Clarkston, Michigan, 48346

  • Cleveland Clinic - Cleveland- Site Number : 8400106

    Cleveland, Ohio, 44195

  • Private Practice - Dr. David Kavtaradze- Site Number : 8400081

    Cordele, Georgia, 31015

  • Beautiful Minds Clinical Research Center- Site Number : 8400019

    Cutler Bay, Florida, 33157

  • Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400082

    DeBary, Florida, 32713

  • Epic Medical Research - De Soto- Site Number : 8400051

    DeSoto, Texas, 75115

  • Clinical Research Associates of Central Pennsylvania- Site Number : 8400013

    DuBois, Pennsylvania, 15801

  • OK Clinical Research- Site Number : 8400060

    Edmond, Oklahoma, 73034

  • Allergic Disease and Asthma Center (ADAC)- Site Number : 8400070

    Greenville, South Carolina, 29607

  • Hannibal Regional Healthcare System- Site Number : 8400078

    Hannibal, Missouri, 63401

  • Alfa Medical Research- Site Number : 8400071

    Hollywood, Florida, 33024

  • Axsendo Clinical Research - Houston- Site Number : 8400065

    Houston, Texas, 77058

  • Royal Clinical Trials - Inverness- Site Number : 8400067

    Inverness, Florida, 34453

  • University of Kansas Medical Center- Site Number : 8400105

    Kansas City, Kansas, 66160

  • Premier Medical Associates- Site Number : 8400077

    Lady Lake, Florida, 32159

  • Ark Clinical Research- Site Number : 8400097

    Long Beach, California, 90815

  • Downtown L.A. Research Center- Site Number : 8400080

    Los Angeles, California, 90017

  • Javara - Mankato Clinic- Site Number : 8400001

    Mankato, Minnesota, 56001

  • D&H Pompano Research Center- Site Number : 8400072

    Margate, Florida, 33063

  • Metroplex Pulmonary and Sleep Center- Site Number : 8400012

    McKinney, Texas, 75069

  • Research Institute of South Florida- Site Number : 8400023

    Miami, Florida, 33173

  • Innovations Biotech- Site Number : 8400044

    Miami, Florida, 33186

  • Children's Wisconsin- Site Number : 8400073

    Milwaukee, Wisconsin, 53226

  • Icahn School of Medicine at Mount Sinai (ISMMS) - Mount Sinai Doctors- Site Number : 8400069

    New York, New York, 10011

  • Pioneer Clinical Research - New York- Site Number : 8400092

    New York, New York, 10016

  • Carbon Health - North Hollywood - NoHo West- Site Number : 8400061

    North Hollywood, California, 91606

  • Tellabio International Research Services- Site Number : 8400083

    Pembroke Pines, Florida, 33025

  • Avanza Medical Research Center- Site Number : 8400056

    Pensacola, Florida, 32503

  • Thomas Jefferson University Hospital- Site Number : 8400110

    Philadelphia, Pennsylvania, 19107

  • EmVenio Research - Riverdale- Site Number : 8400109

    Riverdale, Georgia, 30274

  • Mayo Clinic in Rochester - Minnesota- Site Number : 8400057

    Rochester, Minnesota, 55905

  • Velocity Clinical Research - Rockville (formerly Meridian Clinical Research)- Site Number : 8400036

    Rockville, Maryland, 20854

  • Ilumina Medical Research- Site Number : 8400095

    Saint Cloud, Florida, 34769

  • STAAMP Research - San Antonio- Site Number : 8400059

    San Antonio, Texas, 78229

  • Bandera Family Health Care - San Antonio- Site Number : 8400049

    San Antonio, Texas, 78249

  • Javara - San Marcos - Redwood Road- Site Number : 8400040

    San Marcos, Texas, 78666

  • Carbon Health - San Mateo - Hillsdale Mall- Site Number : 8400062

    San Mateo, California, 94403

  • The Center for Clinical Trials - Saraland- Site Number : 8400096

    Saraland, Alabama, 36571

  • Javara - Privia Medical Group - Silver Spring Lockwood- Site Number : 8400042

    Silver Spring, Maryland, 20901

  • Stanford University Medical Center- Site Number : 8400108

    Stanford, California, 94305

  • Piedmont Healthcare - Family Medicine- Site Number : 8400064

    Statesville, North Carolina, 28625

  • Simcare Medical Research- Site Number : 8400102

    Sugar Land, Texas, 77478

  • Epic Medical Research - Sun City- Site Number : 8400052

    Sun City, Arizona, 85351

  • Asthma & Allergy Center - Toledo- Site Number : 8400020

    Toledo, Ohio, 43617

  • Modena Allergy And Asthma- Site Number : 8400068

    Torrance, California, 90505

  • Tucson Clinical Research Institute- Site Number : 8400085

    Tucson, Arizona, 85712

  • Howard University Hospital- Site Number : 8400107

    Washington D.C., District of Columbia, 20060

Other trials in United States

China37 sites

  • Investigational Site Number : 1560027

    Beijing, 100029

  • Investigational Site Number : 1560005

    Changchun, 130021

  • Investigational Site Number : 1560021

    Chengde, 067020

  • Investigational Site Number : 1560039

    Chengdu, 611130

  • Investigational Site Number : 1560028

    Foshan, 528399

  • Investigational Site Number : 1560010

    Guangzhou, 510000

  • Investigational Site Number : 1560033

    Guangzhou, 510180

  • Investigational Site Number : 1560037

    Guiyang, 550002

  • Investigational Site Number : 1560042

    Hangzhou, 310005

  • Investigational Site Number : 1560009

    Hebei, 050051

  • Investigational Site Number : 1560006

    Hohhot, 010050

  • Investigational Site Number : 1560007

    Hohhot, 010070

  • Investigational Site Number : 1560029

    Huizhou, 516001

  • Investigational Site Number : 1560011

    Huizhou, 516002

  • Investigational Site Number : 1560025

    Jiazhuang, 050000

  • Investigational Site Number : 1560034

    Jinan, 250001

  • Investigational Site Number : 1560038

    Jinan, 250014

  • Investigational Site Number : 1560030

    Lanzhou, 730000

  • Investigational Site Number : 1560018

    Luoyang, 471003

  • Investigational Site Number : 1560003

    Nanchang, 330006

  • Investigational Site Number : 1560014

    Ningbo, 315010

  • Investigational Site Number : 1560001

    Shanghai, 200080

  • Investigational Site Number : 1560043

    Shanghai, 200433

  • Investigational Site Number : 1560016

    Shenyang, 110004

  • Investigational Site Number : 1560019

    Suzhou, 215002

  • Investigational Site Number : 1560017

    Taiyuan, 030001

  • Investigational Site Number : 1560035

    Taiyuan, 030032

  • Investigational Site Number : 1560013

    Tianjin, 300211

  • Investigational Site Number : 1560022

    Wuhan, 430030

  • Investigational Site Number : 1560036

    Xi'an, 710004

  • Investigational Site Number : 1560032

    Xi'an, 710061

  • Investigational Site Number : 1560044

    Xianyang, 712000

  • Investigational Site Number : 1560012

    Xuzhou, 221006

  • Investigational Site Number : 1560047

    Yangzhou, 225000

  • Investigational Site Number : 1560023

    Zhengzhou, 450003

  • Investigational Site Number : 1560026

    Zhengzhou, 450007

  • Investigational Site Number : 1560045

    Zigong, 643000

Other trials in China

Argentina16 sites

  • Investigational Site Number : 0320007

    Berazategui, Buenos Aires, 1886

  • Investigational Site Number : 0320005

    Buenos Aires, 1121

  • Investigational Site Number : 0320012

    Buenos Aires, 1122

  • Investigational Site Number : 0320002

    Buenos Aires, 1414

  • Investigational Site Number : 0320001

    Buenos Aires, 1425

  • Investigational Site Number : 0320004

    Buenos Aires, 1425

  • Investigational Site Number : 0320008

    Corrientes, 3400

  • Investigational Site Number : 0320011

    La Plata, Buenos Aires, B1904CUL

  • Investigational Site Number : 0320013

    Lobos, Buenos Aires, 7240

  • Investigational Site Number : 0320014

    Mendoza, 5500

  • Investigational Site Number : 0320015

    Mendoza, 5500

  • Investigational Site Number : 0320006

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320010

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320016

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320003

    San Miguel de Tucumán, Tucumán Province, 4000

  • Investigational Site Number : 0320009

    Santa Fe, 3000

Other trials in Argentina

Spain15 sites

  • Investigational Site Number : 7240010

    Badalona, Barcelona [Barcelona], 08916

  • Investigational Site Number : 7240009

    Barcelona, Catalunya [Cataluña], 08017

  • Investigational Site Number : 7240015

    Barcelona, Catalunya [Cataluña], 08035

  • Investigational Site Number : 7240018

    Benalmádena, Málaga, 29631

  • Investigational Site Number : 7240016

    Girona, 17005

  • Investigational Site Number : 7240007

    Madrid, Madrid, Comunidad de, 28046

  • Investigational Site Number : 7240013

    Madrid, 28003

  • Investigational Site Number : 7240008

    Madrid, 28007

  • Investigational Site Number : 7240011

    Madrid, 28010

  • Investigational Site Number : 7240002

    Madrid, 28041

  • Investigational Site Number : 7240006

    Málaga, 29010

  • Investigational Site Number : 7240001

    Palma, 07120

  • Investigational Site Number : 7240017

    Santander, Cantabria, 39008

  • Investigational Site Number : 7240005

    Santiago de Compostela, A Coruña [La Coruña], 15702

  • Investigational Site Number : 7240014

    Seville, 41012

Other trials in Spain

Italy12 sites

  • Investigational Site Number : 3800007

    Bergamo, 24127

  • Investigational Site Number : 3800001

    Cona, Ferrara, 44124

  • Investigational Site Number : 3800009

    Genoa, Genova, 16132

  • Investigational Site Number : 3800004

    Milan, Milano, 20122

  • Investigational Site Number : 3800005

    Modena, 41125

  • Investigational Site Number : 3800006

    Monserrato, Cagliari, 09042

  • Investigational Site Number : 3800013

    Palermo, 90127

  • Investigational Site Number : 3800011

    Reggio Emilia, 42100

  • Investigational Site Number : 3800010

    Rome, Roma, 00168

  • Investigational Site Number : 3800003

    Rozzano, Milano, 20089

  • Investigational Site Number : 3800008

    Torette, Ancona, 60020

  • Investigational Site Number : 3800012

    Tradate (Va), 21049

Other trials in Italy

Chile10 sites

  • Investigational Site Number : 1520008

    Concepción, Biobio, 4070094

  • Investigational Site Number : 1520009

    Lo Barnechea, Reg Metropolitana de Santiago, 7691236

  • Investigational Site Number : 1520005

    Quillota, Valparaiso, 2260877

  • Investigational Site Number : 1520010

    Recoleta, Reg Metropolitana de Santiago, 8420000

  • Investigational Site Number : 1520006

    Santiago, Reg Metropolitana de Santiago, 7500587

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7500692

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7500698

  • Investigational Site Number : 1520002

    Talca, Maule Region, 3465584

  • Investigational Site Number : 1520004

    Viña del Mar, Valparaiso, 2531172

  • Investigational Site Number : 1520007

    Viña del Mar, Valparaiso, 2540364

Other trials in Chile

Canada8 sites

  • Investigational Site Number : 1240013

    Ajax, Ontario, L1S 2J5

  • Investigational Site Number : 1240003

    Guelph, Ontario, N1h 6j2

  • Investigational Site Number : 1240011

    Kelowna, British Columbia, V1Y 4N7

  • Investigational Site Number : 1240014

    Montreal, Quebec, H2X 3E4

  • Investigational Site Number : 1240002

    Sherbrooke, Quebec, J1H 5N4

  • Investigational Site Number : 1240006

    Stoney Creek, Ontario, L8G 2V6

  • Investigational Site Number : 1240008

    Toronto, Ontario, M4G 3E8

  • Investigational Site Number : 1240012

    West Vancouver, British Columbia, V7T 2Z3

Other trials in Canada

Germany8 sites

  • Investigational Site Number : 2760006

    Ahrensburg, 22926

  • Investigational Site Number : 2760002

    Bendorf, 56170

  • Investigational Site Number : 2760007

    Berlin, 12159

  • Investigational Site Number : 2760004

    Frankfurt, 60596

  • Investigational Site Number : 2760008

    Frankfurt, 60596

  • Investigational Site Number : 2760003

    Frankfurt am Main, 60389

  • Investigational Site Number : 2760001

    Leipzig, 04347

  • Investigational Site Number : 2760005

    Mainz, 55128

Other trials in Germany

France7 sites

  • Investigational Site Number : 2500007

    Amiens, 80000

  • Investigational Site Number : 2500004

    Lyon, 69004

  • Investigational Site Number : 2500003

    Montpellier, 34090

  • Investigational Site Number : 2500006

    Paris, 75018

  • Investigational Site Number : 2500005

    Pessac, 33604

  • Investigational Site Number : 2500001

    Strasbourg, 67000

  • Investigational Site Number : 2500002

    Toulouse, 31059

Other trials in France

Taiwan7 sites

  • Investigational Site Number : 1580002

    Hualien City, 970

  • Investigational Site Number : 1580005

    Kaohsiung City, 80756

  • Investigational Site Number : 1580006

    Taichung, 404

  • Investigational Site Number : 1580007

    Taichung, 407

  • Investigational Site Number : 1580004

    Taipei, 100

  • Investigational Site Number : 1580003

    Taipei, 110

  • Investigational Site Number : 1580001

    Taoyuan City, 333

Other trials in Taiwan

United Kingdom7 sites

  • Investigational Site Number : 8260005

    Barnsley, S75 2EP

  • Investigational Site Number : 8260003

    Bradford, BD9 6DA

  • Investigational Site Number : 8260007

    Corby, Northamptonshire, NN17 2UN

  • Investigational Site Number : 8260001

    London, W1G 8HU

  • Investigational Site Number : 8260006

    Nottingham, Nottinghamshire, NG7 2UH

  • Investigational Site Number : 8260008

    Oxford, Oxfordshire, OX3 9DU

  • Investigational Site Number : 8260009

    Ruislip, Hillingdon, HA4 8NX

Other trials in United Kingdom

Brazil6 sites

  • Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760006

    Curitiba, Paraná, 80060-900

  • Universidade Federal de Goias- Site Number : 0760011

    Goiânia, Goiás, 74605-020

  • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001

    Porto Alegre, Rio Grande do Sul, 90610-000

  • WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003

    Porto Alegre, Rio Grande do Sul, 91010-006

  • Associacao Proar- Site Number : 0760002

    Salvador, Estado de Bahia, 40060-330

  • Incor - Instituto do Coracao- Site Number : 0760004

    São Paulo, 05403-000

Other trials in Brazil

Hungary6 sites

  • Investigational Site Number : 3480006

    Debrecen, 4032

  • Investigational Site Number : 3480002

    Gödöllő, 2100

  • Investigational Site Number : 3480003

    Hajdúnánás, 4080

  • Investigational Site Number : 3480004

    Mosonmagyaróvár, 9200

  • Investigational Site Number : 3480005

    Pécs, 7635

  • Investigational Site Number : 3480001

    Püspökladány, 4150

Other trials in Hungary

Israel6 sites

  • Investigational Site Number : 3760006

    Haifa, 3436212

  • Investigational Site Number : 3760003

    Jerusalem, 9103102

  • Investigational Site Number : 3760002

    Jerusalem, 9112001

  • Investigational Site Number : 3760005

    Petah Tikva, 4941492

  • Investigational Site Number : 3760001

    Rehovot, 7610001

  • Investigational Site Number : 3760004

    Tel Aviv, 6423906

Other trials in Israel

Poland6 sites

  • Investigational Site Number : 6160002

    Bialystok, Podlaskie Voivodeship, 15-044

  • Investigational Site Number : 6160004

    Chęciny, 26-060

  • Investigational Site Number : 6160009

    Katowice, 40-600

  • Investigational Site Number : 6160003

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400

  • Investigational Site Number : 6160005

    Poznan, Greater Poland Voivodeship, 60-309

  • Investigational Site Number : 6160001

    Poznan, Greater Poland Voivodeship, 60-693

Other trials in Poland

South Africa6 sites

  • Investigational Site Number : 7100004

    Benoni, 1500

  • Investigational Site Number : 7100005

    Benoni, 1500

  • Investigational Site Number : 7100002

    Cape Town, 7530

  • Investigational Site Number : 7100003

    Durban, 3630

  • Investigational Site Number : 7100006

    Durban, 4001

  • Investigational Site Number : 7100007

    Johannesburg, 1821

Other trials in South Africa

Turkey (Türkiye)3 sites

  • Investigational Site Number : 7920003

    Kayseri, 38039

  • Investigational Site Number : 7920002

    Kirikkale, 71100

  • Investigational Site Number : 7920001

    Mersin, 33070

Other trials in Turkey (Türkiye)

Belgium2 sites

  • Investigational Site Number : 0560003

    Liège, 4000

  • Investigational Site Number : 0560002

    Mechelen, 2800

Other trials in Belgium

Denmark2 sites

  • Investigational Site Number : 2080001

    Hvidovre, 2650

  • Investigational Site Number : 2080002

    Vejle, 7100

Other trials in Denmark

Romania2 sites

  • Investigational Site Number : 6420001

    Bucharest, 011658

  • Investigational Site Number : 6420002

    Cluj-Napoca, 400006

Other trials in Romania

Japan1 site

  • Investigational Site Number : 3920001

    Ube, Yamaguchi, 755-8505

Other trials in Japan

Sweden1 site

  • Investigational Site Number : 7520002

    Lund, 221 85

Other trials in Sweden

About this study

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

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.

Read more

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.
Conditions
Asthma
Being tested
Lunsekimig, Short-Acting Beta Agonists (SABA), Placebo, Fluticasone/Salmeterol, Budesonide/Formoterol
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LunsekimigDrug

    Also called SAR443765

    Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection

  • Short-Acting Beta Agonists (SABA)Drug

    Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation

  • PlaceboDrug

    Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection

  • Fluticasone/SalmeterolDrug

    Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation

  • Budesonide/FormoterolDrug

    Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation

  • Budesonide/AlbuterolDrug

    Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation

Study groups in NCT06676319
Study groupRoleWhat they receive
LunsekimigExperimentalParticipants will receive lunsekimig (SC injection) every 4 weeks
Receives: Drug: Lunsekimig; Drug: Short-Acting Beta Agonists (SABA); Drug: Fluticasone/Salmeterol; Drug: Budesonide/Formoterol; Drug: Budesonide/Albuterol
PlaceboPlacebo comparatorParticipants will receive placebo (SC injection) every 4 weeks
Receives: Drug: Short-Acting Beta Agonists (SABA); Drug: Placebo; Drug: Fluticasone/Salmeterol; Drug: Budesonide/Formoterol; Drug: Budesonide/Albuterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized rate of asthma exacerbation events

    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

    Measured: From baseline up to 52 weeks

Secondary outcomes (11)

  1. Change from baseline in prebronchodilator (BD) forced expiratory volume in 1 second (FEV1)

    Measured: From baseline to week 52

  2. Change from baseline in Asthma Control Questionnaire5 (ACQ-5) score

    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.

    Measured: From baseline to week 52

  3. Change from baseline in FeNO level

    Measured: From baseline to week 52

  4. Annualized rate of loss of asthma control events (LOAC) events

    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

    Measured: From baseline to week 52

  5. Annualized rate of asthma exacerbations requiring hospitalization or emergency room or urgent care visit

    Measured: From baseline to week 52

  6. Total systemic corticosteroid dose exposure

    Measured: From baseline to week 52

  7. Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores

    Measured: From baseline to week 52

  8. Change from baseline in the Asthma Daytime Symptom Diary (ADSD) daily morning and evening score

    Measured: From baseline to week 52

  9. Serum lunsekimig concentrations

    Measured: From baseline to week 56

  10. Incidence and titer of anti-drug antibodies (ADA) against lunsekimig

    Measured: From baseline to week 56

  11. Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)

    Measured: From baseline to week 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2024
  2. Study start7 Nov 2024
  3. Primary completion21 Jun 2027 (estimated)
  4. Study completion19 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
556 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06676319
Sponsor's protocol ID
ACT18301
Other IDs
2024-513959-33, U1111-1301-3938
Acronym
AIRLYMPUS
Status last verified
Sep 2026
First submitted
4 Nov 2024
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lunsekimig, Short-Acting Beta Agonists (SABA) and Fluticasone/Salmeterol in people with Asthma, run by Sanofi at 221 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 221 sites in United States, China, Argentina, Spain, Italy and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized rate of asthma exacerbation events (time frame: From baseline up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06676319.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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