This is a randomised, placebo-controlled, double-blind study to assess the efficacy and safety of Atuliflapon administered once daily over a 12-week treatment period to adult participants with moderate to severe uncontrolled asthma.
The study will enroll participants with moderate to severe uncontrolled asthma who are on low-dose inhaled corticosteroid (ICS) - a long-acting beta-agonist (LABA) or medium-to-high-dose ICS with or without LABA background treatment. The study will be initiated by Lead-in pharmacokinetics (PK) cohort in asthma participants. Participant will be randomised globally, including participants in Lead-in PK cohort (2 arms) and in Part 1 of the study (2 arms). In the Lead-in PK cohort, participants will be randomised to Atuliflapon or placebo (recruitment completed). In Part 1 of the study, participants will be stratified by geographical region, and grouped based on high or low levels of biomarker at screening (Visit 1).
Randomised participants will receive Atuliflapon
Randomised participants will receive matching placebo to Atuliflapon.
Bahía Blanca, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
CABA, Argentina
Capital Federal, Argentina
Ciudad Capital, Argentina
Ciudad de Buenos Aire, Argentina
Concepción del Uruguay, Argentina
Córdoba, Argentina
Florida, Argentina
Godoy Cruz, Argentina
La Plata, Argentina
La Plata, Argentina
Lobos, Argentina
Mar del Plata, Argentina
Mar del Plata, Argentina
Mendoza, Argentina
Mendoza, Argentina
Mendoza, Argentina
Pilar, Argentina
Quilmes, Argentina
Ramos Mejía, Argentina
Rosario, Argentina
San Juan Bautista, Argentina
San Miguel de Tucumán, Argentina
Santa Fe, Argentina