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VAK694; Alutard Avanz SQ

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

VAK694; Alutard Avanz SQ · 1 trial · 1 indication

Phase 2 1
NCT01018693A Study to Determine the Capacity of VAK694 When Combined With Allergen Immunotherapy to Bring About Specific Immune ToleranceSeasonal Allergic Rhinitis
COMPLETED37 Analytics
PHASE2COMPLETED
A Study to Determine the Capacity of VAK694 When Combined With Allergen Immunotherapy to Bring About Specific Immune Tolerance
Seasonal Allergic RhinitisUnlock trial analytics

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 to 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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Frequently asked questions about VAK694; Alutard Avanz SQ

What is VAK694 used for?

VAK694 is an investigational small molecule being studied for the treatment of seasonal allergic rhinitis. It is being evaluated in combination with allergen immunotherapy to bring about specific immune tolerance. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes VAK694?

VAK694 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical trials for seasonal allergic rhinitis.

What phase is VAK694 in?

VAK694 is in Phase 2 clinical development. It is an investigational drug for seasonal allergic rhinitis and has not been approved by the FDA or other regulatory agencies. One Phase 2 trial has been completed, and the drug remains under investigation.

What clinical trials is VAK694 in?

VAK694 has one completed Phase 2 clinical trial registered as NCT01018693. This study, titled 'A Study to Determine the Capacity of VAK694 When Combined With Allergen Immunotherapy to Bring About Specific Immune Tolerance,' enrolled 37 participants with seasonal allergic rhinitis in the United Kingdom.

Is VAK694 the same as Alutard Avanz SQ?

Yes, VAK694 is also known as Alutard Avanz SQ. Both names refer to the same investigational drug being developed by Novartis AG for seasonal allergic rhinitis. The drug is currently in Phase 2 clinical development.