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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT02555683

Public ClinicalTrials.gov record NCT02555683. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 8:48 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02555683
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
894 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 11, 2015 (Actual)
Primary completion
Oct 21, 2019 (Actual)
Completion
Nov 4, 2019 (Actual)
Last update posted
Oct 7, 2026

2015 – 2019

United States locations

U.S. sites
55
U.S. states
21
U.S. cities
52
Facility City State ZIP Site status
Novartis Investigative Site Birmingham Alabama 35209 —
Novartis Investigative Site Birmingham Alabama 35249 —
Novartis Investigative Site Gilbert Arizona 85234 —
Novartis Investigative Site Litchfield Park Arizona 85340 —
Novartis Investigative Site Peoria Arizona 85381 —
Novartis Investigative Site Little Rock Arkansas 72209 —
Novartis Investigative Site Hawaiian Gardens California 90716 —
Novartis Investigative Site Newport Beach California 92663 —
Novartis Investigative Site Redondo Beach California 90277 —
Novartis Investigative Site Riverside California 92506 —
Novartis Investigative Site Torrance California 90503 —
Novartis Investigative Site Westminster California 92683 —
Novartis Investigative Site New Haven Connecticut 06520 —
Novartis Investigative Site Brandon Florida 33511 —
Novartis Investigative Site New Smyrna Beach Florida 32168 —
Novartis Investigative Site Orlando Florida 32803 —
Novartis Investigative Site Orlando Florida 32806 —
Novartis Investigative Site Ormond Beach Florida 32174 —
Novartis Investigative Site Sebring Florida 33870 —
Novartis Investigative Site Winter Park Florida 32789 —
Novartis Investigative Site Gainesville Georgia 30501 —
Novartis Investigative Site Marietta Georgia 30060 —
Novartis Investigative Site Crowley Louisiana 70526 —
Novartis Investigative Site Zachary Louisiana 70791 —
Novartis Investigative Site Bangor Maine 04401 —
Novartis Investigative Site Gaithersburg Maryland 20878 —
Novartis Investigative Site White Marsh Maryland 21162 —
Novartis Investigative Site Livonia Michigan 48152 —
Novartis Investigative Site Ypsilanti Michigan 48197 —
Novartis Investigative Site Picayune Mississippi 39466 —
Novartis Investigative Site Bellevue Nebraska 68123 —
Novartis Investigative Site Lincoln Nebraska 68510 —
Novartis Investigative Site Omaha Nebraska 68131 —
Novartis Investigative Site Corning New York 14830 —
Novartis Investigative Site New York New York 10016 —
Novartis Investigative Site Charlotte North Carolina 28277 —
Novartis Investigative Site Gastonia North Carolina 28054 —
Novartis Investigative Site Monroe North Carolina 28112 —
Novartis Investigative Site New Bern North Carolina 28562 —
Novartis Investigative Site Whiteville North Carolina 28472 —
Novartis Investigative Site Wilmington North Carolina 28401 —
Novartis Investigative Site Winston-Salem North Carolina 27103 —
Novartis Investigative Site Canton Ohio 44718 —
Novartis Investigative Site Cincinnati Ohio 45231 —
Novartis Investigative Site Maumee Ohio 43537 —
Novartis Investigative Site Oklahoma City Oklahoma 73120 —
Novartis Investigative Site Jefferson Hills Pennsylvania 15025 —
Novartis Investigative Site Pittsburgh Pennsylvania 15213 —
Novartis Investigative Site East Providence Rhode Island 02941 —
Novartis Investigative Site Boerne Texas 78006 —
Novartis Investigative Site McKinney Texas 75069 —
Novartis Investigative Site Plano Texas 75093 —
Novartis Investigative Site San Antonio Texas 78229 —
Novartis Investigative Site San Antonio Texas 78251 —
Novartis Investigative Site Fairfax Virginia 22030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 179 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02555683, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 7, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02555683 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →