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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment170
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01253603Efficacy, Safety, and Pharmacokinetics of QAW039PHASE2 COMPLETED 170Nov 1, 2010Sep 1, 2011Dec 19, 202026 United States, Belgium +3
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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 — 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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