Dose-Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma (AIRCULES)

STUDY OVERVIEW

This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study by Sanofi is designed to evaluate the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig in adult participants aged 18 to 80 years with moderate-to-severe asthma.

STUDY GOALS

The goal of this study is to evaluate the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig in adults aged 18 to 80 with moderate-to-severe asthma.

LOCATION

El Paso, Texas: Western Sky Medical Research

INCLUSION CRITERIA

  • Diagnosed with moderate-to-severe asthma for at least 12 months, following GINA guidelines Steps 4 and 5.

  • Currently on moderate-to-high doses of inhaled corticosteroids (ICS) with 1-2 additional controller medications for at least 3 months, with a stable dose for at least 1 month before Visit 1.

  • Experienced at least one asthma exacerbation in the past year while on moderate-to-high doses of ICS.

  • ACQ-5 score greater than 1.5 at Screening (Visit 1).

exclusion criteria

  • Having chronic obstructive lung diseases or other lung diseases affecting lung function, or any diagnosed pulmonary or systemic disease.

  • Current smoker, former smoker who quit within the last 6 months, history of more than 10 pack-years, or active vaping/smoking of marijuana within the last 6 months.

  • Asthma worsening that required emergency treatment, hospitalization, or systemic steroids within 1 month prior to Screening.

  • Upper or lower respiratory tract infection within 4 weeks prior to Screening.

  • Chronic OCS users with a history of serious infection requiring hospitalization within the last 12 months before Randomization (Visit 2).

  • Active, latent, or incompletely treated tuberculosis, high risk of contracting TB, or recent BCG vaccination within 12 weeks before Screening.

  • Severe concomitant illnesses that could interfere with study participation, such as hypertension, renal disease, neurological conditions, heart failure, and pulmonary disease.

For more information, visit ClinicalTrials.gov.