ToleroMune Ragweed Exposure Chamber Study

Study Overview
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Brief Summary
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It is believe that ragweed is the primary cause of autumn allergies and 87% of patients with ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of ragweed allergy. This study will look at the efficacy, safety and tolerability of two doses of ToleroMune Ragweed in ragweed allergic subjects following challenge with ragweed in an EEC.

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 Ragweed in ragweed allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of ToleroMune Ragweed will be explored in subjects using an(Environmental Exposure Chamber)EEC. The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 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 EEC 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 five 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 EEC 18-22 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 Two Doses of ToleroMune Ragweed in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber

Conditions
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Ragweed Allergy

Intervention / Treatment
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* Biological: ToleroMune Ragweed
* 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 ragweed. [Subjects may also have controlled asthma Positive skin prick test to ragweed allergen. Minimum qualifying rhinoconjunctivitis symptom scores Exclusion criteria History of asthma. A history of anaphylaxis to ragweed allergen. Subjects with an FEV1 <70% of predicted. Subjects who cannot tolerate baseline challenge in the EEC. 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> | Biological: Placebo<br>* Intradermal injection, 1x8 administrations 2 weeks apart<br>|
| Experimental: ToleroMune Ragweed Regimen 1<br> | Biological: ToleroMune Ragweed<br>* Intradermal injection 1 x8 administrations 2 weeks apart<br>|
| Experimental: ToleroMune Ragweed Regimen 2<br> | Biological: ToleroMune Ragweed<br>* Intradermal injection 1 x8 administrations 2 weeks apart<br>|
| Experimental: ToleroMune Ragweed Regimen 3<br> | Biological: ToleroMune Ragweed<br>* Intradermal injection 1 x8 administrations 2 weeks apart<br>|
| Experimental: ToleroMune Ragweed Regimen 4<br> | Biological: ToleroMune Ragweed<br>* Intradermal injection 1 x8 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 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom scores for ocular and nasal symptoms |  | Upto 22 weeks | 
| Acoustic Rhinometry |  | Upto 22 weeks | 
| Skin prick testing |  | Baseline and final follow up | 
| Ragweed specific IgE |  | At baseline and at follow up | 
| Ragweed specific IgA |  | At baseline and follow up | 
| Ragweed specific IgG4 |  | At baseline and at follow up | 
| Adverse Events |  | Upto 23 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ragweed allergy, Rhinoconjunctivitis, Exposure chamber, Immunotherapy, ToleroMune Ragweed