Last updated 33 days ago

Study to Assess the Efficacy and Safety of Atuliflapon in Moderate-to-Severe Uncontrolled Asthma

666 patients around the world
Available in Mexico, United States, Spain
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 randmised globally, includig particpants in Lead-in PK cohort and in Part 1 of the study. 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 based on high or low levels of biomarker at screening (Visit 1) and randomised 1:1 to Atuliflapon or placebo. An event-driven interim analysis will be performed once 30 participants with at least 1 CompEx (Composite endpoint for Exacerbations) event are observed in the group having high levels of biomarker.
AstraZeneca
666Patients around the world
This study is for people with
Asthma
Requirements for the patient
To 80 Years
All Gender
Medical requirements
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