AZD1419 Ph2a Study

Summary

Ph2a study planned to be run at approximately 16-18 sites in 4 EU countries (Denmark, Hungary, Poland and Sweden) enrolling approximately 170 patients to ensure 70 randomized patients with eosinophilic, moderate to severe asthma. The patients will receive 13 once weekly inhaled doses of the study drug. Treatment is initiated on top of their ICS/LABA controller medication, which is then tapered down and withdrawn during a period of 3 weeks and during the last 3 weeks of treatment the study drug is given as monotherapy. SABA is used as reliever medication during the whole study period. Primary endpoint is Loss of asthma control. When the endpoint is met, patients will resume their ICS/LABA, will be followed for an additional 4 weeks and will thereafter discontinue the study.

Timeline

Start

2016-10-12

Primary completion

2018-09-25

Completion

2018-09-25

Outcome

Missed primary endpoint

registry analysis (other test); AZD1419 vs Placebo; p = 0.5722; Hazard Ratio (HR) 1.05 (95% CI 0.59 to 1.87); Regression, Cox; note: 1-sided p-value NCT02898662 ↗

Drugs

Indications