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 one year after the start of treatment.

Detailed Description
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Subjects who completed all dosing visits and the post treatment challenge (PTC) in study TG002 will be invited to attend the Screening Visit for TG002a. Subjects will attend for 4 visits to the EEU on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later.

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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Grass Allergy, Rhinoconjunctivitis

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

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 Score |  | Eighteen months post first dose in TG002 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom scores for nasal and non nasal symptoms |  | Eighteen months post first dose in TG002 | 
| Skin prick wheal diameter |  | Eighteen months post first dose in TG002 | 
| Peak Nasal Inspiratory Flow |  | Eighteen months post first dose in TG002 | 
| Grass specific IgA |  | Eighteen months post first dose in TG002 | 
| Grass specific IgE |  | Eighteen months post first dose in TG002 | 
| Grass specific IgG4 |  | Eighteen months post first dose in TG002 | 
| Adverse Events |  | Eighteen 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