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OpenTrials
Completed

NCT Number: NCT01018693

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

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigator Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VAK694; Alutard Avanz SQ

Drug

VAK694 placebo infusion; Alutard Avanz SQ

Drug

VAK694 placebo infusion; Saline

Drug

Primary outcomes

  1. Intra-dermal late phase response to allergen Measure: Wheal diameter

    Time frame: 10-12 months

Secondary outcomes

  1. To evaluate the immunomodulatory activity of VAK694 Measure: IgE/IgG, Th1/Th2 cytokine expression, Treg induction

    Time frame: 10-12 months

  2. 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)

    Time frame: 10-12 months

  3. 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

    Time frame: 10-12 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 25, 2009
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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