CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 894 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/NCT02555683
NCT02555683Phase 3Completed
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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 21, 2015·Updated May 18, 2020

In Brief

A Phase 3 clinical trial evaluating QAW039 and Placebo for Asthma. Completed, enrolled 894 participants across 233 sites in 27 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Australia, Austria, Belgium, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, Ireland, Latvia, Lithuania, Philippines, Poland, Romania, Singapore, Spain, Switzerland, United Kingdom, United States, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 21, 2015
Enrollment StartDec 11, 2015
Primary CompletionOct 21, 2019
Study CompletionNov 4, 2019
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.8 years ago

Interventions

QAW039drug

QAW039 150 mg once daily

QAW039drug

QAW039 450 mg once daily

Placebodrug

Placebo once daily