CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 877 enrolled
Drug / intervention
QAW039 +2 moredrug
Likely dose
QAW039 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02563067
NCT02563067Phase 3Completed
CompareCT.gov

A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.

Novartis Pharmaceuticals·interventional·Posted Sep 29, 2015·Updated May 3, 2021

In Brief

A Phase 3 clinical trial evaluating QAW039 and Placebo for Asthma. Completed, enrolled 877 participants across 163 sites in 19 countries.

Detailed Summary

This study aimed to determine the efficacy and safety of QAW039 and QAW039 450 mg compared to 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 (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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Canada, Czechia, Greece, India, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, Netherlands, Russia, Serbia, Slovakia, South Africa, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 29, 2015
Enrollment StartDec 3, 2015
Primary CompletionJul 4, 2019
Study CompletionAug 2, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.8 years ago

Interventions

QAW039drug

QAW039 150 mg once daily

QAW039drug

QAW039 450 mg once daily

Placebodrug

Placebo once daily