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QAW039 once daily for 28 days

Phase 2

Persistent Asthma | Small molecule | Respiratory |Novartis AG|Trials Updated: Dec 19, 2020

QAW039 once daily for 28 days target and mechanism

ModalitySmall molecule

Also known as QAW039 capsules once daily for 28 days

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment170

FDA Designations

No designations recorded

QAW039 once daily for 28 days clinical trials

QAW039 once daily for 28 days · 1 trial · 1 indication

Phase 2 1
NCT01253603Efficacy, Safety, and Pharmacokinetics of QAW039Persistent Asthma
COMPLETED170 Analytics
PHASE2COMPLETED
Efficacy, Safety, and Pharmacokinetics of QAW039
Persistent AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo.
28 days

Secondary Endpoints

To assess the safety of a 28 day administration of QAW039 compared to placebo, measured by vital signs, laboratory evaluations and electrocardiograms.
28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALQAW039 capsules once daily for 28 days
2EXPERIMENTALPlacebo to QAW039 capsules once daily for 28 days
3EXPERIMENTALFluticasone propionate inhaler twice daily for 28 days

Interventions

NameTypeDescription
QAW039 capsules once daily for 28 daysDRUG -
Placebo to QAW039 capsules once daily for 28 daysDRUG -
Fluticasone propionate inhaler twice daily for 28 daysDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Patients with a medical history of mild to moderate persistent allergic asthma. * Patients must weigh at least 45 kg to participate in the study, and must have abody mass index (BMI) of \>17 kg/m2. * Female patients must be surgically sterilized, postmenopausal or using a doub...

Countries:United StatesBelgiumGermanyRomaniaSouth Korea
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Frequently asked questions about QAW039 once daily for 28 days

What is QAW039 once daily for 28 days?

QAW039 once daily for 28 days is an investigational small molecule developed by Novartis AG for persistent asthma. It was studied as an oral capsule taken once daily over a 28-day treatment period in a Phase 2 clinical trial. It is not an approved therapy and remains in clinical development.

What is QAW039 once daily for 28 days used for?

QAW039 once daily for 28 days was studied for the treatment of persistent asthma in adults. The Phase 2 trial enrolled patients with persistent asthma across the United States, Belgium, Germany, Romania, and South Korea. It is investigational and has not been approved for any indication.

Who is developing QAW039 once daily for 28 days?

Novartis AG (ticker NVS) is the developer of QAW039 once daily for 28 days. The company sponsored the Phase 2 trial evaluating the oral small molecule in persistent asthma. Novartis is the sole developer identified for this asset.

What phase is QAW039 once daily for 28 days in?

QAW039 once daily for 28 days is in Phase 2 development. The single completed trial, NCT01253603, was a Phase 2 study in persistent asthma. The drug is investigational and has not received FDA approval.

What clinical trials is QAW039 once daily for 28 days in?

QAW039 once daily for 28 days has been evaluated in one completed Phase 2 trial, NCT01253603, titled Efficacy, Safety, and Pharmacokinetics of QAW039. The randomized, double-blind, controlled study enrolled 170 adults with persistent asthma across five countries. No active trials are ongoing.

Is QAW039 once daily for 28 days the same as QAW039 capsules once daily for 28 days?

Yes, QAW039 once daily for 28 days is also known as QAW039 capsules once daily for 28 days. Both names refer to the same oral small molecule formulation developed by Novartis AG for persistent asthma. The capsule form was administered once daily over 28 days in the Phase 2 trial.