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QAV680

Phase 2

Seasonal Allergic Rhinitis | Small molecule | Other |Novartis AG|Last Updated: Nov 18, 2016

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00784732A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure ChamberPHASE2 COMPLETED 44 — — Sep 1, 2008Dec 1, 2008Nov 18, 20161 Canada
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Study Endpoints
Primary Endpoints
Total Nasal Symptom Score (TNSS) over the last 2 hours of exposure in the EEC Percentage nasal lavage eosinophil count post EEC
TNSS: 6-8h during EEC exposure on Day 10
Secondary Endpoints
Measure of nasal cytokines (ECP, IL-5, IL-13, PGD2, Eotaxin)
After 8h exposure in EEC
Absolute eosinophil count from nasal lavage collected
During exposure in EEC
Nasal airway patency assessed by acoustic rhinometry during exposure in the EEC
During exposure in EEC
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
QAV680DRUG -
Mometasone FuroateDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Positive skin prick test to ragweed allergen * FEV1 must be ≥80% predicted value at screening and prior to entry into EEC on Day -2. * Patients must weigh at least 50 kg, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2. * Non-smokers and ex-smokers (≤1...

Countries:Canada
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