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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-10-31

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.

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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VAK694 AND Immunotherapy (alutard)

Group Type EXPERIMENTAL

VAK694; Alutard Avanz SQ

Intervention Type DRUG

: VAK694 placebo AND Immunotherapy (alutard)

Group Type EXPERIMENTAL

VAK694 placebo infusion; Alutard Avanz SQ

Intervention Type DRUG

VAK694 placebo AND Immunotherapy (alutard) placebo

Group Type EXPERIMENTAL

VAK694 placebo infusion; Saline

Intervention Type DRUG

Interventions

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VAK694; Alutard Avanz SQ

Intervention Type DRUG

VAK694 placebo infusion; Alutard Avanz SQ

Intervention Type DRUG

VAK694 placebo infusion; Saline

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No