ToleroMune Grass Exposure Unit 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. This study will look at the efficacy, safety and tolerability of three doses of ToleroMune Grass in grass allergic subjects following challenge with with grass in an Environmental Exposure Unit (EEU).

Detailed Description
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This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis. The efficacy of ToleroMune Grass will be explored in subjects using an EEU (Environmental Exposure Unit). The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 16 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEU at least 3 days before randomisation. In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of four groups and will receive treatment every 2 weeks (±2 days) for 14 weeks. In Period 3, Post Treatment Challenge will consist of 4 visits to the EEU about 25 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.

Official Title
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A Double-blind, Randomised, Placebo-controlled Study to Evaluate Three Doses 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

Intervention / Treatment
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* Biological: ToleroMune Grass
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Male or female, aged 18-65 years. Minimum 2-year documented history of rhinoconjunctivitis on exposure to grass. Positive skin prick test to grass allergen. Minimum qualifying rhinoconjunctivitis symptom scores Exclusion criteria History of asthma. A history of anaphylaxis to grassallergen. Subjects with an FEV1 <80% of predicted. Subjects who cannot tolerate baseline challenge in the EEU. Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension). A history of severe drug allergy, severe angioedema or anaphylactic reaction to food. A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment).

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Intradermal injection, 1 x 8 administrations 2 weeks apart | Biological: Placebo<br>* Intradermal injection 1 x 8 administrations 2 weeks apart<br>|
| Experimental: ToleroMune Grass Dose 1<br>Intradermal injection 1 x 8 administrations 2 weeks apart | Biological: ToleroMune Grass<br>* Intradermal injection 1 x 8 administrations 2 weeks apart<br>|
| Experimental: ToleroMune Grass Dose 2<br>Intradermal injection 1 x 8 administrations 2 weeks apart | Biological: ToleroMune Grass<br>* Intradermal injection 1 x 8 administrations 2 weeks apart<br>|
| Experimental: ToleroMune Grass Dose 3<br>Intradermal injection 1 x 8 administrations 2 weeks apart | Biological: ToleroMune Grass<br>* Intradermal injection 1 x 8 administrations 2 weeks apart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Rhinoconjunctivitis Symptom Score |  | Upto 25 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom scores for nasal and non nasal symptoms |  | Upto 25 weeks | 
| Skin prick testing |  | Upto 25 weeks | 
| Peak Nasal Inspiratory Flow |  | Up to 25 weeks | 
| Grass specific IgA |  | Upto 26 weeks | 
| Grass specific IgE |  | Upto 26 weeks | 
| Grass specific IgG4 |  | Up to 26 weeks | 
| Adverse Events |  | Up tp 26 weeks | 

 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