A Study to Determine the Capacity of VAK694 When Combined With Allergen Immunotherapy to Bring About Specific Immune Tolerance

Study Overview
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Brief Summary
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The purpose of the study is to determine whether VAK694 when combined with subcutaneous immunotherapy leads to long term immune tolerance to allergen in individuals with seasonal allergic rhinitis.

Official Title
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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

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: VAK694; Alutard Avanz SQ
* Drug: VAK694 placebo infusion; Alutard Avanz SQ
* Drug: VAK694 placebo infusion; Saline


Participation Criteria
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Eligibility Criteria
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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 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) Informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VAK694 AND Immunotherapy (alutard)<br> | Drug: VAK694; Alutard Avanz SQ<br> <br> |
| Experimental: : VAK694 placebo AND Immunotherapy (alutard)<br> | Drug: VAK694 placebo infusion; Alutard Avanz SQ<br> <br> |
| Experimental: VAK694 placebo AND Immunotherapy (alutard) placebo<br> | Drug: VAK694 placebo infusion; Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-dermal late phase response to allergen Measure: Wheal diameter |  | 10-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seasonal allergic rhinitis,, late phase response,, alutard avanz,, immunotherapy,, visual analogue scale,, mini rhinitis quality of life,, immune modulation