Clinical Trial

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

Study acronym: AIRLYMPUS
Active, Not Recruiting Phase 2
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.
Protocol Amendment History 6 changes
critical Trial status changed: RECRUITING → ACTIVE_NOT_RECRUITING 2026-07-02
notable Enrollment reduced: 1147 -> 556 participants 2026-07-02
notable Primary completion moved earlier: 2027-09-17 -> 2027-06-21 2026-07-02
minor Completion moved earlier: 2027-10-15 -> 2027-07-19 2026-07-02
notable Trial sites reduced: 236 -> 230 locations 2026-05-28
notable Trial sites reduced: 241 -> 236 locations 2026-04-17
Trial Details
NCT Number NCT06676319
Lead Sponsor Sanofi
Conditions Asthma
Enrollment 556 participants
Start Date 2024-11-07
Primary Completion 2027-06-21 (estimated)
Study Completion 2027-07-19 (estimated)
Updated on ClinicalTrials.gov 2026-07-01