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VAK694

Phase 2

Allergic Rhinitis | Monoclonal antibody | Other |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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00929968Safety, Tolerability and Pharmacokinetics of Multiple Doses of VAK694 in Atopic Subjects With Seasonal RhinitisPHASE2 COMPLETED 35Jun 1, 2009 -Dec 19, 20202 United States, Canada
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Study Endpoints
Primary Endpoints
To assess the safety and tolerability of prolonged administration of multiple intravenous doses of VAK694 as well as the preliminary efficacy of multiple intravenous doses of VAK694 in atopic subjects
12 weeks
Secondary Endpoints
To evaluate pharmacokinetics of multiple intravenous doses of VAK694 in atopic subjects
12 weeks
Change in serum levels of total and antigen specific IgE and total and antigen specific IgG
12 weeks
Immunogenicity of multiple intravenous doses of VAK694
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Placebo to VAK694PLACEBO_COMPARATOR -
VAK694EXPERIMENTAL -
Fluticasone propionateACTIVE_COMPARATOR -
Interventions
NameTypeDescription
PlaceboBIOLOGICAL -
VAK694BIOLOGICAL -
FluticasoneDRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Male and female subjects between ages of 18 to 60 in good health * History of atopy for at least 2 years and positive skin prick test to ragweed allergen Exclusion criteria: * History of asthma treated with corticosteroids * Smokers with a smoking history of \> 10 pack/years...

Countries:United StatesCanada
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Competitive Landscape -Allergic Rhinitis 4 trials