SIMCARE MEDICAL RESEARCH

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