Clinical trial NCT01018693: A Study to Determine the Capacity of VAK694 When Combined With Allergen Immunotherapy to Bring About Specific Immune Tolerance
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Keywords: Seasonal allergic rhinitis,
late phase response,
alutard avanz,
immunotherapy,
visual analogue scale,
mini rhinitis quality of life,
immune modulation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intra-dermal late phase response to allergen Measure: Wheal diameter
timeFrame: 10-12 months
Secondary outcomes:
measure: To evaluate the immunomodulatory activity of VAK694 Measure: IgE/IgG, Th1/Th2 cytokine expression, Treg induction
timeFrame: 10-12 months
measure: 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)
timeFrame: 10-12 months
measure: 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
timeFrame: 10-12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: