ASTHMA
Study Protocol
To investigate the efficacy, safety, and tolerability of subcutaneous lunsekimg (SAR443765) in adult participants with high-risk asthma who are not currently eligible for biologic treatment.
Study Duration
64 WEEKS
INCLUSION CRITERIA
dults 18–80 years
Physician-diagnosed mild to moderate asthma for ≥12 months (per GINA)
Daily asthma maintenance therapy for ≥1 month prior, including:
o ICS <500 μg/day fluticasone propionate or
o ICS <800 μg/day budesonide or equivalent
o With or without LABA≥1 asthma exacerbation in the past year, with at least one occurring while on low-dose ICS (as above)
FeNO ≥50 ppb at screening AND ≥20 ppb at baseline
Blood eosinophils ≥300 cells/μL at screening
BMI 18.5–40 kg/m²
All sexes eligible; effective contraception required