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Clinical Trials in China / NCT06676319
Active, not recruiting Phase 2

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

NCT06676319 · tracked via the Priya Life Science China tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2024-11-07
Last updated
2026-07-01

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

Lunsekimig →Short-Acting Beta Agonists (SABA)PlaceboFluticasone/SalmeterolBudesonide/Formoterol →Budesonide/Albuterol

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

Short-Acting Beta Agonists (SABA): Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation

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

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

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

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

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 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (230)

FacilityCityRegionStatus
The Center for Clinical Trials - Saraland- Site Number : 8400096 Saraland Alabama
Chandler Clinical Research Trials- Site Number : 8400075 Chandler Arizona
Epic Medical Research - Sun City- Site Number : 8400052 Sun City Arizona
Tucson Clinical Research Institute- Site Number : 8400085 Tucson Arizona
Ark Clinical Research- Site Number : 8400097 Long Beach California
Downtown L.A. Research Center- Site Number : 8400080 Los Angeles California
Carbon Health - North Hollywood - NoHo West- Site Number : 8400061 North Hollywood California
Carbon Health - San Mateo - Hillsdale Mall- Site Number : 8400062 San Mateo California
Stanford University Medical Center- Site Number : 8400108 Stanford California
Modena Allergy And Asthma- Site Number : 8400068 Torrance California
Howard University Hospital- Site Number : 8400107 Washington D.C. District of Columbia
Helix Biomedics- Site Number : 8400005 Boynton Beach Florida
Beautiful Minds Clinical Research Center- Site Number : 8400019 Cutler Bay Florida
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400082 DeBary Florida
Alfa Medical Research- Site Number : 8400071 Hollywood Florida
Royal Clinical Trials - Inverness- Site Number : 8400067 Inverness Florida
Premier Medical Associates- Site Number : 8400077 Lady Lake Florida
D&H Pompano Research Center- Site Number : 8400072 Margate Florida
Research Institute of South Florida- Site Number : 8400023 Miami Florida
Innovations Biotech- Site Number : 8400044 Miami Florida
Tellabio International Research Services- Site Number : 8400083 Pembroke Pines Florida
Avanza Medical Research Center- Site Number : 8400056 Pensacola Florida
Hull and Hull Medical Specialists- Site Number : 8400079 Plantation Florida
Ilumina Medical Research- Site Number : 8400095 Saint Cloud Florida
Private Practice - Dr. David Kavtaradze- Site Number : 8400081 Cordele Georgia
EmVenio Research - Riverdale- Site Number : 8400109 Riverdale Georgia
Christie Clinic in Champaign on University- Site Number : 8400003 Champaign Illinois
University of Kansas Medical Center- Site Number : 8400105 Kansas City Kansas
Velocity Clinical Research - Rockville (formerly Meridian Clinical Research)- Site Number : 8400036 Rockville Maryland
Javara - Privia Medical Group - Silver Spring Lockwood- Site Number : 8400042 Silver Spring Maryland
University of Michigan Health System - Ann Arbor- Site Number : 8400014 Ann Arbor Michigan
Clarkston Medical Group- Site Number : 8400054 Clarkston Michigan
Javara - Mankato Clinic- Site Number : 8400001 Mankato Minnesota
Mayo Clinic in Rochester - Minnesota- Site Number : 8400057 Rochester Minnesota
Hannibal Regional Healthcare System- Site Number : 8400078 Hannibal Missouri
Icahn School of Medicine at Mount Sinai (ISMMS) - Mount Sinai Doctors- Site Number : 8400069 New York New York
Pioneer Clinical Research - New York- Site Number : 8400092 New York New York
Piedmont Healthcare - Family Medicine- Site Number : 8400064 Statesville North Carolina
Cleveland Clinic - Cleveland- Site Number : 8400106 Cleveland Ohio
Asthma & Allergy Center - Toledo- Site Number : 8400020 Toledo Ohio

+ 190 more sites — see the full list on the official registry below.

On this site

📄 Advair (fluticasone/salmeterol) drug profile → 📄 Symbicort (budesonide/formoterol) drug profile →

More Sanofi trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06676319 on ClinicalTrials.gov ↗ ← All trials in China