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QAW039 once daily for 28 days

Phase 2

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

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

Clinical trial landscape

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 used for?

QAW039 is an investigational small molecule being studied for the treatment of persistent asthma. It is administered once daily for 28 days. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does QAW039 target?

The molecular target of QAW039 has not been disclosed in available information. The drug is a small molecule being evaluated for its efficacy, safety, and pharmacokinetics in patients with persistent asthma.

Who makes QAW039?

QAW039 is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's potential in treating persistent asthma.

What phase is QAW039 in?

QAW039 is in Phase 2 clinical development. A Phase 2 trial has been completed, which evaluated the drug's efficacy, safety, and pharmacokinetics in patients with persistent asthma. The drug remains investigational and is not yet approved.

What clinical trials is QAW039 in?

QAW039 has been studied in one completed Phase 2 clinical trial with the identifier NCT01253603. This randomized, double-blind, controlled trial enrolled 170 participants with persistent asthma across the United States, Belgium, Germany, Romania, and South Korea.