Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment
Status:
Terminated
Trial end date:
2020-03-16
Target enrollment:
Participant gender:
Summary
This study was a 2-treatment period, randomized, multicenter parallel-group study. The
overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039)
(Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma
(GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with
moderate-to- severe asthma.
The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily
and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5
standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with
moderate-to-severe asthma. The study included 2 cohorts of patients:
1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies
with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred
to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration
of exposure, and
2. New patients who had not previously participated in a study of QAW039, permitting an
increase in the number of patients with long-term exposure to QAW039.
By including these 2 categories of patients, the total number of patients treated with QAW039
as well as the duration of exposure to QAW039 treatment was substantially increased,
supporting evaluation of the safety profile of QAW039.