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

Last updated: April 29, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

2

Condition

Asthma

Treatment

Fluticasone/salmeterol

Short-Acting Beta Agonists (SABA)

Lunsekimig

Clinical Study ID

NCT06676319
ACT18301
2024-513959-33
  • Ages 18-80
  • All Genders

Study 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 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

Inclusion Criteria:

  • Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINAguidelines.

  • 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 FunctionInitiative [GLI] standards) at Screening (Visit 1).

Exclusion

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 emergencytreatment or hospitalization, or treatment with systemic steroids within 1 monthprior to the Screening (Visit 1) (counting from the date of completion of treatmentfor asthma exacerbation).

  • Participants who have experienced an upper or lower respiratory tract infectionwithin the 4 weeks prior to Screening (Visit 1).

  • Known history of, or suspected, significant current immunosuppression, includinghistory of invasive opportunistic or helminthic infections despite infectionresolution or otherwise recurrent infections of abnormal frequency or prolongedduration.

  • Evidence of any infection requiring systemic anti-infective treatment within 2 weeksbefore Screening (Visit 1) or during the screening period. Significant viralinfections within 2 weeks before Screening (Visit 1) or during the screening periodeven if the participant has not received systemic antiviral treatment (eg, influenzareceiving only symptomatic treatment).

  • Participants with active tuberculosis (TB), latent TB, a history of incompletelytreated TB, suspected extrapulmonary TB infection, or who are at high risk ofcontracting TB (such as close contact with individuals with active TB), or receivedBacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1).

  • Severe concomitant illness that would in the Investigator's opinion inhibit theparticipant's participation in the study, including for example, but not limited to,hypertension, renal disease, neurological conditions, heart failure, and pulmonarydisease.

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical study.

Study Design

Total Participants: 1000
Treatment Group(s): 5
Primary Treatment: Fluticasone/salmeterol
Phase: 2
Study Start date:
November 07, 2024
Estimated Completion Date:
November 12, 2027

Connect with a study center

  • Investigational Site Number : 0320006

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320003

    San Miguel de Tucumán, Tucumán 4000
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320001

    Buenos Aires, 1425
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320002

    Buenos Aires, 1414
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320004

    Buenos Aires, 1425
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320012

    Buenos Aires, 1122
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320008

    Corrientes, 3400
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320014

    Mendoza, 5500
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320015

    Mendoza, 5500
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0560001

    Gent, 9000
    Belgium

    Active - Recruiting

  • Investigational Site Number : 0560003

    Liège, 4000
    Belgium

    Active - Recruiting

  • Investigational Site Number : 0560002

    Mechelen, 2800
    Belgium

    Active - Recruiting

  • Investigational Site Number : 1240011

    Kelowna, British Columbia V1Y 4N7
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240012

    North Vancouver, British Columbia V7M 1R9
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240003

    Guelph, Ontario N1H 6J2
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240006

    Stoney Creek, Ontario L8G 2V6
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240008

    Toronto, Ontario M4G 3E8
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240014

    Montreal, Quebec H2X 3E4
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240002

    Sherbrooke, Quebec J1H 5N4
    Canada

    Active - Recruiting

  • Investigational Site Number : 1520008

    Concepción, Biobío 4070094
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520011

    Talcahuano, Biobío 2687000
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520002

    Talca, Maule 3465584
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana De Santiago 7500692
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana De Santiago 7500698
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520006

    Santiago, Reg Metropolitana De Santiago 7500587
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520009

    Santiago, Reg Metropolitana De Santiago 7691236
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520005

    Quillota, Valparaíso 2260877
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520007

    Viña Del Mar, Valparaíso 2540364
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520004

    Viña del Mar, Valparaíso 2530946
    Chile

    Active - Recruiting

  • Investigational Site Number : 1560027

    Beijing, 100029
    China

    Active - Recruiting

  • Investigational Site Number : 1560005

    Changchun, 130021
    China

    Active - Recruiting

  • Investigational Site Number : 1560021

    Chengde, 067400
    China

    Active - Recruiting

  • Investigational Site Number : 1560039

    Chengdu, 611130
    China

    Active - Recruiting

  • Investigational Site Number : 1560028

    Foshan, 528399
    China

    Active - Recruiting

  • Investigational Site Number : 1560010

    Guangzhou, 510000
    China

    Active - Recruiting

  • Investigational Site Number : 1560033

    Guangzhou, 510180
    China

    Active - Recruiting

  • Investigational Site Number : 1560037

    Guiyang, 550002
    China

    Active - Recruiting

  • Investigational Site Number : 1560042

    Hangzhou, 310005
    China

    Active - Recruiting

  • Investigational Site Number : 1560009

    Hebei, 050051
    China

    Active - Recruiting

  • Investigational Site Number : 1560040

    Hefei, 230032
    China

    Active - Recruiting

  • Investigational Site Number : 1560006

    Hohhot, 010050
    China

    Active - Recruiting

  • Investigational Site Number : 1560007

    Hohhot, 010070
    China

    Active - Recruiting

  • Investigational Site Number : 1560011

    Huizhou, 516002
    China

    Active - Recruiting

  • Investigational Site Number : 1560029

    Huizhou, 516001
    China

    Active - Recruiting

  • Investigational Site Number : 1560025

    Jiazhuang, 050000
    China

    Active - Recruiting

  • Investigational Site Number : 1560034

    Jinan, 250001
    China

    Active - Recruiting

  • Investigational Site Number : 1560038

    Jinan, 250014
    China

    Active - Recruiting

  • Investigational Site Number : 1560030

    Lanzhou,
    China

    Active - Recruiting

  • Investigational Site Number : 1560018

    Luoyang, 471003
    China

    Active - Recruiting

  • Investigational Site Number : 1560003

    Nanchang, 330006
    China

    Active - Recruiting

  • Investigational Site Number : 1560014

    Ningbo, 315010
    China

    Active - Recruiting

  • Investigational Site Number : 1560001

    Shanghai, 200080
    China

    Active - Recruiting

  • Investigational Site Number : 1560043

    Shanghai, 200433
    China

    Active - Recruiting

  • Investigational Site Number : 1560016

    Shenyang, 110004
    China

    Active - Recruiting

  • Investigational Site Number : 1560008

    Suzhou, 215006
    China

    Active - Recruiting

  • Investigational Site Number : 1560019

    Suzhou, 215004
    China

    Active - Recruiting

  • Investigational Site Number : 1560017

    Taiyuan, 030001
    China

    Active - Recruiting

  • Investigational Site Number : 1560013

    Tianjin, 300211
    China

    Active - Recruiting

  • Investigational Site Number : 1560022

    Wuhan, 430030
    China

    Active - Recruiting

  • Investigational Site Number : 1560032

    Xi An, 710061
    China

    Active - Recruiting

  • Investigational Site Number : 1560036

    Xi An, 710004
    China

    Active - Recruiting

  • Investigational Site Number : 1560044

    Xianyang, 712099
    China

    Active - Recruiting

  • Investigational Site Number : 1560012

    Xuzhou, 221006
    China

    Active - Recruiting

  • Investigational Site Number : 1560047

    Yangzhou, 225000
    China

    Active - Recruiting

  • Investigational Site Number : 1560026

    Zhengzhou, 450007
    China

    Active - Recruiting

  • Investigational Site Number : 1560045

    Zigong, 643000
    China

    Active - Recruiting

  • Investigational Site Number : 2760002

    Bendorf, 56170
    Germany

    Active - Recruiting

  • Investigational Site Number : 6420001

    Düsseldorf, 40225
    Germany

    Active - Recruiting

  • Investigational Site Number : 2760001

    Leipzig, 04347
    Germany

    Active - Recruiting

  • Investigational Site Number : 3480002

    Gödöllő, 2100
    Hungary

    Active - Recruiting

  • Investigational Site Number : 3480003

    Hajdunanas, 4080
    Hungary

    Active - Recruiting

  • Investigational Site Number : 3480001

    Püspökladány, 4150
    Hungary

    Active - Recruiting

  • Investigational Site Number : 3760006

    Haifa, 3436212
    Israel

    Active - Recruiting

  • Investigational Site Number : 3760002

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Investigational Site Number : 3760003

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Investigational Site Number : 3760005

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Investigational Site Number : 3760001

    Rehovot, 7610001
    Israel

    Active - Recruiting

  • Investigational Site Number : 3760004

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Investigational Site Number : 6160003

    Ostrowiec Swietokrzyski, Swietokrzyskie 27-400
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160009

    Katowice, 40-600
    Poland

    Active - Recruiting

  • Investigational Site Number : 6420002

    Cluj-Napoca, 400006
    Romania

    Active - Recruiting

  • Investigational Site Number : 7240008

    Madrid, 28007
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240011

    Madrid, 28010
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240001

    Palma, 07120
    Spain

    Active - Recruiting

  • Investigational Site Number : 7520003

    Gothenburg, 413 45
    Sweden

    Active - Recruiting

  • Investigational Site Number : 7920001

    Akdeniz, 33070
    Turkey

    Active - Recruiting

  • Investigational Site Number : 7920003

    Kayseri, 38039
    Turkey

    Active - Recruiting

  • Investigational Site Number : 7920002

    Kirikkale, 71100
    Turkey

    Active - Recruiting

  • Investigational Site Number : 8260007

    Corby, Northamptonshire NN17 2UN
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 8260006

    Nottingham, Nottinghamshire NG7 2UH
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 8260008

    Oxford, Oxfordshire OX3 9DU
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 8260005

    Barnsley, S75 2EP
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 8260003

    Bradford, BD9 6RJ
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 8260001

    London, W1G 8HU
    United Kingdom

    Active - Recruiting

  • Chandler Clinical Research Trials- Site Number : 8400075

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Epic Medical Research - Surprise- Site Number : 8400052

    Surprise, Arizona 85378
    United States

    Active - Recruiting

  • Epic Medical Research- Site Number : 8400052

    Surprise, Arizona 85378
    United States

    Active - Recruiting

  • Tucson Clinical Research Institute - Site number: 8400085

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • Modena Allergy + Asthma- Site Number : 8400021

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Velocity Clinical Research - San Diego- Site Number : 8400024

    La Mesa, California 91942
    United States

    Active - Recruiting

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

    North Hollywood, California 91606
    United States

    Active - Recruiting

  • Carbon Health - San Mateo CA Urgent Care & Primary Care- Site Number : 8400062

    San Mateo, California 94403
    United States

    Active - Recruiting

  • Helix Biomedics, LLC Site Number : 8400005

    Boynton Beach, Florida 33435
    United States

    Active - Recruiting

  • Helix Biomedics- Site Number : 8400005

    Boynton Beach, Florida 33435
    United States

    Active - Recruiting

  • Beautiful Minds Clinical Research Center- Site Number : 8400019

    Cutler Bay, Florida 33157
    United States

    Active - Recruiting

  • Alfa Medical Research- Site Number : 8400071

    Davie, Florida 33024
    United States

    Active - Recruiting

  • Royal Clinical Trials- Site Number : 8400067

    Inverness, Florida 34453
    United States

    Active - Recruiting

  • Premier Medical Associates- Site Number : 8400077

    Lady Lake, Florida 32159
    United States

    Active - Recruiting

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

    Margate, Florida 33063
    United States

    Active - Recruiting

  • Innovations Biotech Site Number : 8400044

    Miami, Florida 33186
    United States

    Active - Recruiting

  • Innovations Biotech- Site Number : 8400044

    Miami, Florida 33186
    United States

    Active - Recruiting

  • Research Institute of South Florida- Site Number : 8400023

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Oviedo Medical Research - Site number: 8400091

    Oviedo, Florida 32765
    United States

    Active - Recruiting

  • Tellabio International Research Services- Site Number : 8400083

    Pembroke Pines, Florida 33025
    United States

    Active - Recruiting

  • Avanza Medical Research Center- Site Number : 8400056

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Private Practice - Dr. Frank Hull - Plantation- Site Number : 8400079

    Plantation, Florida 33324
    United States

    Active - Recruiting

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

    Cordele, Georgia 31015
    United States

    Active - Recruiting

  • Treasure Valley Medical Research- Site Number : 8400004

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Christie Clinic on University- Site Number : 8400003

    Champaign, Illinois 61820
    United States

    Active - Recruiting

  • Velocity Clinical Research - Rockville- Site Number : 8400036

    Rockville, Maryland 20854
    United States

    Active - Recruiting

  • Velocity Clinical Research, Rockville- Site Number : 8400036

    Rockville, Maryland 20854
    United States

    Active - Recruiting

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

    Silver Spring, Maryland 20901
    United States

    Active - Recruiting

  • Javara Inc/Privia Medical Group, PLLC- Site Number : 8400042

    Silver Spring, Maryland 20901
    United States

    Active - Recruiting

  • Javara - Mankato Clinic- Site Number : 8400001

    Mankato, Minnesota 56001
    United States

    Active - Recruiting

  • Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 8400078

    Hannibal, Missouri 63401-6890
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai - Mount Sinai Health System- Site Number : 8400069

    New York, New York 10029
    United States

    Active - Recruiting

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

    Toledo, Ohio 43617
    United States

    Active - Recruiting

  • OK Clinical Research- Site Number : 8400060

    Edmond, Oklahoma 73034
    United States

    Active - Recruiting

  • Clinical Research Associates of Central PA - Dubois- Site Number : 8400013

    DuBois, Pennsylvania 15801
    United States

    Active - Recruiting

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

    DuBois, Pennsylvania 15801
    United States

    Active - Recruiting

  • ADAC Research, PA- Site Number : 8400070

    Greenville, South Carolina 29607
    United States

    Active - Recruiting

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

    Boerne, Texas 78006
    United States

    Active - Recruiting

  • Epic Medical Research- Site Number : 8400051

    DeSoto, Texas 75115
    United States

    Active - Recruiting

  • Axsendo Clinical Research of Houston- Site Number : 8400065

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Metroplex Pulmonary and Sleep Center- Site Number : 8400012

    McKinney, Texas 75069
    United States

    Active - Recruiting

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

    San Antonio, Texas 78249
    United States

    Active - Recruiting

  • STAAMP Research LLC- Site Number : 8400059

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Javara Inc/Privia Medical Group North Texas, PLLC- Site Number : 8400038

    Stephenville, Texas 76401
    United States

    Active - Recruiting

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