A Study to Determine the Capacity of VAK694 When Combined With Allergen Immunotherapy to Bring About Specific Immune Tolerance
Phase 2
Completed
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Drug: VAK694; Alutard Avanz SQDrug: VAK694 placebo infusion; Alutard Avanz SQDrug: VAK694 placebo infusion; Saline
- Registration Number
- NCT01018693
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VAK694 AND Immunotherapy (alutard) VAK694; Alutard Avanz SQ - : VAK694 placebo AND Immunotherapy (alutard) VAK694 placebo infusion; Alutard Avanz SQ - VAK694 placebo AND Immunotherapy (alutard) placebo VAK694 placebo infusion; Saline -
- Primary Outcome Measures
Name Time Method Intra-dermal late phase response to allergen Measure: Wheal diameter 10-12 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Investigator Site
🇬🇧London, United Kingdom