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ACTIVE NOT RECRUITING

NCT06676319

PHASE2

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

Sponsor: 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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

556

Start Date

2024-11-07

Completion Date

2027-07-19

Last Updated

2026-09-22

Healthy Volunteers

Conditions

Asthma

Interventions

DRUG

Lunsekimig

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

DRUG

Short-Acting Beta Agonists (SABA)

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

DRUG

Placebo

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

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

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 (221)

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

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

Stanford University Medical Center- Site Number : 8400108

Stanford, California, United States

Modena Allergy And Asthma- Site Number : 8400068

Torrance, California, United States

Howard University Hospital- Site Number : 8400107

Washington D.C., District of Columbia, United States

Helix Biomedics- Site Number : 8400005

Boynton Beach, Florida, United States

Beautiful Minds Clinical Research Center- Site Number : 8400019

Cutler Bay, Florida, United States

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

DeBary, Florida, United States

Alfa Medical Research- Site Number : 8400071

Hollywood, Florida, United States

Royal Clinical Trials - Inverness- Site Number : 8400067

Inverness, Florida, United States

Premier Medical Associates- Site Number : 8400077

Lady Lake, Florida, United States

D&H Pompano Research Center- Site Number : 8400072

Margate, Florida, United States

Research Institute of South Florida- Site Number : 8400023

Miami, Florida, United States

Innovations Biotech- Site Number : 8400044

Miami, Florida, United States

Tellabio International Research Services- Site Number : 8400083

Pembroke Pines, Florida, United States

Avanza Medical Research Center- Site Number : 8400056

Pensacola, Florida, United States

Ilumina Medical Research- Site Number : 8400095

Saint Cloud, Florida, United States

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

Cordele, Georgia, United States

EmVenio Research - Riverdale- Site Number : 8400109

Riverdale, Georgia, United States

Christie Clinic in Champaign on University- Site Number : 8400003

Champaign, Illinois, United States

University of Kansas Medical Center- Site Number : 8400105

Kansas City, Kansas, United States

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

Rockville, Maryland, United States

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

Silver Spring, Maryland, United States

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

Ann Arbor, Michigan, United States

Clarkston Medical Group- Site Number : 8400054

Clarkston, Michigan, United States

Javara - Mankato Clinic- Site Number : 8400001

Mankato, Minnesota, United States

Mayo Clinic in Rochester - Minnesota- Site Number : 8400057

Rochester, Minnesota, United States

Hannibal Regional Healthcare System- Site Number : 8400078

Hannibal, Missouri, United States

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

New York, New York, United States

Pioneer Clinical Research - New York- Site Number : 8400092

New York, New York, United States

Piedmont Healthcare - Family Medicine- Site Number : 8400064

Statesville, North Carolina, United States

Cleveland Clinic - Cleveland- Site Number : 8400106

Cleveland, Ohio, United States

Asthma & Allergy Center - Toledo- Site Number : 8400020

Toledo, Ohio, United States

OK Clinical Research- Site Number : 8400060

Edmond, Oklahoma, United States

Clinical Research Associates of Central Pennsylvania- Site Number : 8400013

DuBois, Pennsylvania, United States

Thomas Jefferson University Hospital- Site Number : 8400110

Philadelphia, Pennsylvania, United States

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

Greenville, South Carolina, United States

Orion Clinical Research- Site Number : 8400084

Austin, Texas, United States

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

Boerne, Texas, United States

Epic Medical Research - De Soto- Site Number : 8400051

DeSoto, Texas, United States

Axsendo Clinical Research - Houston- Site Number : 8400065

Houston, Texas, United States

Metroplex Pulmonary and Sleep Center- Site Number : 8400012

McKinney, Texas, United States

STAAMP Research - San Antonio- Site Number : 8400059

San Antonio, Texas, United States

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

San Antonio, Texas, United States

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

San Marcos, Texas, United States

Simcare Medical Research- Site Number : 8400102

Sugar Land, Texas, United States

Children's Wisconsin- Site Number : 8400073

Milwaukee, Wisconsin, United States

Investigational Site Number : 0320007

Berazategui, Buenos Aires, Argentina

Investigational Site Number : 0320013

Lobos, Buenos Aires, Argentina

Investigational Site Number : 0320006

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320010

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320016

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320003

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number : 0320005

Buenos Aires, Argentina

Investigational Site Number : 0320012

Buenos Aires, Argentina

Investigational Site Number : 0320002

Buenos Aires, Argentina

Investigational Site Number : 0320001

Buenos Aires, Argentina

Investigational Site Number : 0320004

Buenos Aires, Argentina

Investigational Site Number : 0320008

Corrientes, Argentina

Investigational Site Number : 0320011

La Plata, Buenos Aires, Argentina

Investigational Site Number : 0320014

Mendoza, Argentina

Investigational Site Number : 0320015

Mendoza, Argentina

Investigational Site Number : 0320009

Santa Fe, Argentina

Investigational Site Number : 0560003

Liège, Belgium

Investigational Site Number : 0560002

Mechelen, Belgium

Associacao Proar- Site Number : 0760002

Salvador, Estado de Bahia, Brazil

Universidade Federal de Goias- Site Number : 0760011

Goiânia, Goiás, Brazil

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

Curitiba, Paraná, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003

Porto Alegre, Rio Grande do Sul, Brazil

Incor - Instituto do Coracao- Site Number : 0760004

São Paulo, Brazil

Investigational Site Number : 1240011

Kelowna, British Columbia, Canada

Investigational Site Number : 1240012

West Vancouver, British Columbia, Canada

Investigational Site Number : 1240013

Ajax, Ontario, Canada

Investigational Site Number : 1240003

Guelph, Ontario, Canada

Investigational Site Number : 1240006

Stoney Creek, Ontario, Canada

Investigational Site Number : 1240008

Toronto, Ontario, Canada

Investigational Site Number : 1240014

Montreal, Quebec, Canada

Investigational Site Number : 1240002

Sherbrooke, Quebec, Canada

Investigational Site Number : 1520008

Concepción, Biobio, Chile

Investigational Site Number : 1520002

Talca, Maule Region, Chile

Investigational Site Number : 1520009

Lo Barnechea, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520010

Recoleta, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520006

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520005

Quillota, Valparaiso, Chile

Investigational Site Number : 1520004

Viña del Mar, Valparaiso, Chile

Investigational Site Number : 1520007

Viña del Mar, Valparaiso, Chile

Investigational Site Number : 1560027

Beijing, China

Investigational Site Number : 1560005

Changchun, China

Investigational Site Number : 1560021

Chengde, China

Investigational Site Number : 1560039

Chengdu, China

Investigational Site Number : 1560028

Foshan, China

And 121 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (221)