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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01018693

Enrollment

Registered

2009-11-25

Start date

2009-11-30

Completion date

2011-10-31

Last updated

2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

Keywords

Seasonal allergic rhinitis,, late phase response,, alutard avanz,, immunotherapy,, visual analogue scale,, mini rhinitis quality of life,, immune modulation

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.

Interventions

DRUGVAK694; Alutard Avanz SQ

DRUGVAK694 placebo infusion; Alutard Avanz SQ

DRUGVAK694 placebo infusion; Saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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/

Design outcomes

Primary

Measure	Time frame
Intra-dermal late phase response to allergen Measure: Wheal diameter	10-12 months

Secondary

Measure	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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026