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

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018693
• Other study ID #: CVAK694A2205
• Status: Completed
• Phase: Phase 2
• First received: November 24, 2009
• Last updated: March 17, 2017
• Start date: November 2009
• Est. completion date: October 2011

Study information

• Verified date: March 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• VAK694; Alutard Avanz SQ

• VAK694 placebo infusion; Alutard Avanz SQ

• VAK694 placebo infusion; Saline

Locations

Country	Name	City	State
United Kingdom	Novartis Investigator Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-dermal late phase response to allergen Measure: Wheal diameter		10-12 months
Secondary	To evaluate the immunomodulatory activity of VAK694 Measure: IgE/IgG, Th1/Th2 cytokine expression, Treg induction		10-12 months
Secondary	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
Secondary	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

External Links

•   Results for CVAK694A2205from Novartis Clinical Trials Website