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

Asthma Clinical Trial

Official title:
A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of Atuliflapon Given Orally Once Daily for Twelve Weeks in Adults With Moderate to Severe Uncontrolled Asthma

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05251259
Study type Interventional
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Status Recruiting
Phase Phase 2
Start date January 27, 2022
Completion date January 29, 2025
View Details
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