NCT06676319

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,147 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-11-07
• Primary completion: 2027-09-17
• Completion: 2027-10-15
• First posted: 2024-11-06
• Last updated: 2026-04-16

Locations

236 sites across 24 countries: United States, Argentina, Belgium, Brazil, Canada, Chile, China, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Romania, South Africa, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study