Loading clinical trials...

Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT06676319•Sanofi

View on ClinicalTrials.gov

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 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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (240)

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

Saraland, Alabama, United States

Chandler Clinical Research Trials- Site Number : 8400075

Chandler, Arizona, United States

Epic Medical Research - Sun City- Site Number : 8400052

Sun City, Arizona, United States

Tucson Clinical Research Institute- Site Number : 8400085

Tucson, Arizona, United States

Modena Allergy + Asthma- Site Number : 8400021

La Jolla, California, United States

Velocity Clinical Research - San Diego- Site Number : 8400024

La Mesa, California, United States

Ark Clinical Research- Site Number : 8400097

Long Beach, California, United States

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

Los Angeles, California, United States

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

North Hollywood, California, United States

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

San Mateo, California, United States

Key Dates

Start Date

November 7, 2024

Primary Completion Date

September 17, 2027

Completion Date

October 15, 2027

Last Updated

February 11, 2026

Enrollment

1,147

ESTIMATED participants

Conditions

Asthma

Interventions

Lunsekimig

DRUG

Short-Acting Beta Agonists (SABA)

DRUG

Placebo

DRUG

Fluticasone/Salmeterol

DRUG

Budesonide/Formoterol

DRUG

Budesonide/Albuterol

DRUG

Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610 contact-us@sanofi.com

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

View study

RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma