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

NCT01018693 | Completed Phase 2

• 1 other identifier: CVAK694A2205
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  10-12 months

Secondary Outcomes (3)

• 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

Study Arms (3)

VAK694 AND Immunotherapy (alutard)

EXPERIMENTAL

Drug: VAK694; Alutard Avanz SQ

: VAK694 placebo AND Immunotherapy (alutard)

EXPERIMENTAL

Drug: VAK694 placebo infusion; Alutard Avanz SQ

VAK694 placebo AND Immunotherapy (alutard) placebo

EXPERIMENTAL

Drug: VAK694 placebo infusion; Saline

Interventions

VAK694; Alutard Avanz SQ DRUG

VAK694 AND Immunotherapy (alutard)

VAK694 placebo infusion; Alutard Avanz SQ DRUG

: VAK694 placebo AND Immunotherapy (alutard)

VAK694 placebo infusion; Saline DRUG

VAK694 placebo AND Immunotherapy (alutard) placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigator Site

London, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 21, 2017

Record last verified: 2017-03

Locations

GB (1)