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VAK694

Phase 2

Allergic Rhinitis | Monoclonal antibody | Respiratory |Novartis AG|Last Updated: Dec 21, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

VAK694 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00929968Safety, Tolerability and Pharmacokinetics of Multiple Doses of VAK694 in Atopic Subjects With Seasonal RhinitisAllergic Rhinitis
COMPLETED35 Analytics
PHASE2COMPLETED
Safety, Tolerability and Pharmacokinetics of Multiple Doses of VAK694 in Atopic Subjects With Seasonal Rhinitis
Allergic RhinitisUnlock trial analytics

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
Number of patients with adverse events
100 days

Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs

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 -
VAK694 PlaceboPLACEBO_COMPARATORVAK694 placebo was administered as a one hour intravenous infusion
QAX576EXPERIMENTALQAX576 was administered intravenously as a 2 hour infusion
QAX576 placeboPLACEBO_COMPARATORQAX576 placebo was administered as a 2 hour intravenous infusion

Interventions

NameTypeDescription
PlaceboBIOLOGICAL -
VAK694BIOLOGICAL -
FluticasoneDRUG -
VAK694 placeboDRUGIntravenous infusion
QAX576DRUGIntravenous infusion
QAX576 placeboDRUGIntravenous infusion
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Eligibility Criteria

Age Range18 Years to 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

Frequently asked questions about VAK694

What is VAK694 used for?

VAK694 is an investigational monoclonal antibody being developed by Novartis AG for the treatment of asthma and allergic rhinitis. It has been studied in clinical trials for these respiratory conditions, though it remains in clinical development and is not yet approved.

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 company has conducted clinical trials to evaluate the safety and efficacy of this investigational monoclonal antibody.

What phase is VAK694 in?

VAK694 has completed a Phase 2 clinical trial for allergic rhinitis and a Phase 1 trial for asthma. It is an investigational drug still in clinical development, and it has not been approved by regulatory authorities for any indication.

What clinical trials is VAK694 in?

VAK694 has been studied in two completed clinical trials. NCT00929968 was a Phase 2 study in 35 subjects with seasonal allergic rhinitis in the United States and Canada. NCT01568762 was a Phase 1 study in 50 patients with asthma in the United States.

How does VAK694 work?

VAK694 is a monoclonal antibody, a type of biologic drug designed to target specific molecules involved in disease processes. However, its specific molecular target has not been disclosed in available information, so its exact mechanism of action is not publicly detailed.