A Study to Determine the Capacity of VAK694 When Combined With Allergen Immunotherapy to Bring About Specific Immune Tolerance
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Randomized, Double-blind, Placebo-controlled Trial to Determine the Capacity of VAK694 to Elicit Long Term Immune Tolerance When Combined With Subcutaneous Allergen Immunotherapy for the Treatment of Seasonal Allergic Rhinitis
Actual Study Start Date
Primary Completion Date
Study Completion Date
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Intra-dermal late phase response to allergen Measure: Wheal diameter [ Time Frame: 10-12 months ]
Secondary Outcome Measures
To evaluate the immunomodulatory activity of VAK694 Measure: IgE/IgG, Th1/Th2 cytokine expression, Treg induction [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 10-12 months ]
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Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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 allergen at screening.
Male or female subjects aged between 18 and 60 years (inclusive)
Female subjects must be of non-childbearing potential
Subjects must weigh at least 50 kg with a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive)
Treatment with intranasal corticosteroids within 28 days prior to the first dose.
History of asthma with treatment with inhaled or systemic corticosteroids within 6 months of the first dose.
History of COPD.
Any exposure to human monoclonal or polyclonal antibodies.
Any allergy immunotherapy within 3 years prior to screening.
Any prior grass pollen allergy immunotherapy.
FEV1 < 70% of predicted at screening or baseline.
Other protocol-defined inclusion/exclusion criteria may apply