ToleroMune Grass Follow on Study

Study Overview
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Brief Summary
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Grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy. The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed all dosing visits in study TG002 approximately two years after the start of treatment.

Detailed Description
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This is a follow-up study to a multi-centre, randomised, double-blind, placebo controlled, parallel group clinical study (TG002) which evaluated the efficacy, safety and tolerability of three doses of ToleroMune Grass versus placebo in grass allergic subjects. Subjects who completed TG002 in calendar year 2012 will undergo a further single exposure to grass allergens in an EEU.

Official Title
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An Optional Follow-Up Study to Evaluate the Continued Efficacy of ToleroMune Grass in Grass Allergic Subjects Following Challenge With Grass Allergen in an Environmental Exposure Unit.

Conditions
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Rhinoconjunctivitis, Grass Allergy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously randomised into study TG002, and completed all treatment visits and PTC during calendar year 2012 Exclusion Criteria: Partly controlled and uncontrolled asthama History of anaphylaxis to grass allergen FEV1 <80% of predicted Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquilizers or psychoactuve drugs Symptoms of a clinically relevant illness Subjects who cannot tolerate allergen challenge in the EEU

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TG002 Subjects<br>Subjects previously randomised in study TG002 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Rhinoconjunctivitis Symptom Scores |  | 32 months post first dose in TG002 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grass Specific Immunoglobulin A (IgA) |  | 32 months post first dose in TG002 | 
| Grass Specific Immunoglobulin E (IgE) |  | 32 months post first dose in TG002 | 
| Grass Specific Immunoglobulin G Isotype 4 (IgG4) |  | 32 months post first dose in TG002 | 
| Skin Prick Weal Diameter |  | 32 months post first dose in TG002 | 
| Adverse Events |  | 32 months post first dose in TG002 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Grass Allergy, Rhinoconjunctivitis, Environmental Exposure Unit, Immunotherapy, ToleroMune Grass