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

Novartis

Status and phase: Completed; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: VAK694 placebo infusion; Saline; Drug: VAK694; Alutard Avanz SQ; Drug: VAK694 placebo infusion; Alutard Avanz SQ

Study type: Interventional

Funder types: Industry

Identifiers

NCT01018693

CVAK694A2205

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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37 participants in 3 patient groups

VAK694 AND Immunotherapy (alutard)

Experimental group

Treatment:

Drug: VAK694; Alutard Avanz SQ

: VAK694 placebo AND Immunotherapy (alutard)

Experimental group

Treatment:

Drug: VAK694 placebo infusion; Alutard Avanz SQ

VAK694 placebo AND Immunotherapy (alutard) placebo

Experimental group

Treatment:

Drug: VAK694 placebo infusion; Saline