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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01018693
First received: November 24, 2009
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: VAK694; Alutard Avanz SQ
Drug: VAK694 placebo infusion; Alutard Avanz SQ
Drug: VAK694 placebo infusion; Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Intra-dermal late phase response to allergen Measure: Wheal diameter [ Time Frame: 10-12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the immunomodulatory activity of VAK694 Measure: IgE/IgG, Th1/Th2 cytokine expression, Treg induction [ Time Frame: 10-12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: November 2009
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VAK694 AND Immunotherapy (alutard) Drug: VAK694; Alutard Avanz SQ
Experimental: : VAK694 placebo AND Immunotherapy (alutard) Drug: VAK694 placebo infusion; Alutard Avanz SQ
Experimental: VAK694 placebo AND Immunotherapy (alutard) placebo Drug: VAK694 placebo infusion; Saline

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018693

Locations
United Kingdom
Novartis Investigator Site
London, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01018693     History of Changes
Other Study ID Numbers: CVAK694A2205
Study First Received: November 24, 2009
Last Updated: April 23, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Seasonal allergic rhinitis,
late phase response,
alutard avanz,
immunotherapy,
visual analogue scale,
mini rhinitis quality of life,
immune modulation

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 28, 2014