Efficacy and Safety Study of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.

Phase 3 Completed 894 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations: * patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population) * patients with inadequately controlled severe asthma (overall study population) Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).

Timeline

Start: 2015-12-11
Primary completion: 2019-10-21
Completion: 2019-11-04

Outcome

Missed primary endpoint

registry analysis (superiority test); QAW039 150 mg vs Placebo; p = 0.800; rate ratio 1.04 (95% CI 0.77 to 1.41) NCT02555683 ↗

registry analysis (superiority test); QAW039 450 mg vs Placebo; p = 0.510; Rate Ratio 0.83 (95% CI 0.61 to 1.14) NCT02555683 ↗

paper INTERPRETATION: Although neither trial showed a statistically significant reduction in asthma exacerbations after adjusting for multiple testing PMID 32979986 ↗

Publications

Brightling CE, Gaga M, Inoue H, Li J, Maspero J, Wenzel S, Maitra S, Lawrence D, Brockhaus F, Lehmann T, Brindicci C, Knorr B, Bleecker ER. Effectiveness of fevipiprant in reducing exacerbations in patients with severe asthma (LUSTER-1 and LUSTER-2): two phase 3 randomised controlled trials. Lancet Respir Med. 2021 Jan;9(1):43-56. doi: 10.1016/S2213-2600(20)30412-4. Epub 2020 Sep 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	fevipiprant	Small molecule	150 mg	—
Subject	fevipiprant	Small molecule	450 mg	—