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

Last updated: March 19, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

2

Condition

Asthma

Treatment

Placebo

Budesonide/formoterol

Short-Acting Beta Agonists (SABA)

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: Placebo
Phase: 2
Study Start date:
November 07, 2024
Estimated Completion Date:
November 12, 2027

Connect with a study center

  • 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 : 0320014

    Mendoza, 5500
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320003

    San Miguel de Tucumán, 4000
    Argentina

    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 : 1240002

    Sherbrooke, Quebec J1H 5N4
    Canada

    Active - Recruiting

  • Investigational Site Number : 1520008

    Concepción, Biobío 4070094
    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 : 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 : 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 : 1560010

    Guangzhou, 510000
    China

    Active - Recruiting

  • Investigational Site Number : 1560033

    Guangzhou, 510180
    China

    Active - Recruiting

  • Investigational Site Number : 1560042

    Hangzhou, 310005
    China

    Active - Recruiting

  • Investigational Site Number : 1560029

    Huizhou, 516001
    China

    Active - Recruiting

  • Investigational Site Number : 1560034

    Jinan, 250001
    China

    Active - Recruiting

  • Investigational Site Number : 1560014

    Ningbo, 315010
    China

    Active - Recruiting

  • Investigational Site Number : 1560001

    Shanghai, 200080
    China

    Active - Recruiting

  • Investigational Site Number : 1560016

    Shenyang, 110004
    China

    Active - Recruiting

  • Investigational Site Number : 1560008

    Suzhou, 215006
    China

    Active - Recruiting

  • Investigational Site Number : 1560017

    Taiyuan, 030001
    China

    Active - Recruiting

  • Investigational Site Number : 1560012

    Xuzhou, 221006
    China

    Active - Recruiting

  • Investigational Site Number : 3760006

    Haifa, 3436212
    Israel

    Active - Recruiting

  • Investigational Site Number : 3760002

    Jerusalem, 9112001
    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 : 7920001

    Akdeniz, 33070
    Turkey

    Active - Recruiting

  • Investigational Site Number : 7920003

    Kayseri, 38039
    Turkey

    Active - Recruiting

  • Investigational Site Number : 8260007

    Corby, Northamptonshire NN17 2UN
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 8260005

    Barnsley, S75 2EP
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 8260001

    London, W1T 6AH
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 8260006

    Nottingham, NG7 2UH
    United Kingdom

    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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Epic Medical Research- Site Number : 8400051

    DeSoto, Texas 75115
    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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