Back to results

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

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

VAK694; Alutard Avanz SQ

VAK694 placebo infusion; Alutard Avanz SQ

VAK694 placebo infusion; Saline

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Seasonal allergic rhinitis,, late phase response,, alutard avanz,, immunotherapy,, visual analogue scale,, mini rhinitis quality of life,, immune modulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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/exclusion criteria may apply

Sites / Locations

Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

VAK694 AND Immunotherapy (alutard)

: VAK694 placebo AND Immunotherapy (alutard)

VAK694 placebo AND Immunotherapy (alutard) placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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)

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

Full Information

NCT ID

NCT01018693

First Posted

November 24, 2009

Last Updated

March 17, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01018693

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

November 2009 (Actual)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Allergic Rhinitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VAK694 AND Immunotherapy (alutard)

Arm Type

Experimental

Arm Title

: VAK694 placebo AND Immunotherapy (alutard)

Arm Type

Experimental

Arm Title

VAK694 placebo AND Immunotherapy (alutard) placebo

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

VAK694; Alutard Avanz SQ

Intervention Type

Drug

Intervention Name(s)

VAK694 placebo infusion; Alutard Avanz SQ

Intervention Type

Drug

Intervention Name(s)

VAK694 placebo infusion; Saline

Primary Outcome Measure Information:

Title

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

Time Frame

10-12 months

Secondary Outcome Measure Information:

Title

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

Time Frame

10-12 months

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigator Site

City

London

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://www.hayfeverlondon.net

Description

Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs