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VAK694; Alutard Avanz SQ

Phase 2

Seasonal Allergic Rhinitis | Small molecule | Other |Novartis AG|Last Updated: Mar 21, 2017

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-BlindCONTROLLED
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01018693A Study to Determine the Capacity of VAK694 When Combined With Allergen Immunotherapy to Bring About Specific Immune TolerancePHASE2 COMPLETED 37 — — Nov 1, 2009Oct 1, 2011Mar 21, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Intra-dermal late phase response to allergen Measure: Wheal diameter
10-12 months
Secondary Endpoints
To evaluate the immunomodulatory activity of VAK694 Measure: IgE/IgG, Th1/Th2 cytokine expression, Treg induction
10-12 months
To assess the effects of VAK694 combined with SCIT on the symptoms of seasonal allergic rhinitis Measure: mini-Respiratory Quality of Life Questionnaire (RQLQm) and visual analogue scale (VAS)
10-12 months
To preliminarily assess the ability of VAK694 to reduce the side-effects of subcutaneous immunotherapy Measure: Frequency and severity of local and systemic reactions to immunotherapy
10-12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VAK694 AND Immunotherapy (alutard)EXPERIMENTAL -
: VAK694 placebo AND Immunotherapy (alutard)EXPERIMENTAL -
VAK694 placebo AND Immunotherapy (alutard) placeboEXPERIMENTAL -
Interventions
NameTypeDescription
VAK694; Alutard Avanz SQDRUG -
VAK694 placebo infusion; Alutard Avanz SQDRUG -
VAK694 placebo infusion; SalineDRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * History of atopy, defined as a history of seasonal allergic rhinitis for at least 2 years (in relation to the grass pollen allergy season), and evidence of atopy, defined as a positive skin prick test (wheal difference allergen - negative control at least 3 mm) to grass pollen...

Countries:United Kingdom
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