ToleroMune Ragweed Follow up Study

Study Overview
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Brief Summary
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Ragweed is the primary cause of autumn allergies. The ragweed season begins in mid-August. In the third National Health and Nutrition Examination Surveys54.3% of the population had positive test responses to one or more allergens, with the prevalence for short ragweed being 26.2% The purpose of this observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to ragweed allergen in the EEC among subjects who completed all dosing visits and the post treatment challenge (PTC) visit in study TR002 approximately one year after the start of treatment.

Detailed Description
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Subjects who were randomised in study TR002 and who completed all dosing visits and the PTC will be invited to attend the Screening Visit for TR002B. Subjects will attend the EEC for 4 visits on successive days. Following the final EEC visit a follow-up visit will be performed 3-10 days later.

Official Title
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An Optional One Year Follow-up Study to Evaluate the Continued Efficacy of ToleroMune Ragweed in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber.

Conditions
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Ragweed Allergy, Rhinoconjunctivitis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Previously randomised into study TR002 and completed all treatment visits and the PTC. Exclusion Criteria History of asthma (a diagnosis of asthma in childhood may be allowed). Subjects with an FEV1 <70% of predicted. Subjects being treated with beta-blockers. Developed a significant disease, disorder or inability to communicate, since completing study TR002 which, in the opinion of the Sponsor's medical representative, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study.

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 |
| --- | --- |
| Placebo<br>Subjects previously randomised to placebo in TR002 | Biological: Placebo<br>* No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.<br>|
| ToleroMune Ragweed Regimen 1<br>Subjects previously randomised to receive ToleroMune Ragweed regimen 1 in study TR002 | Biological: ToleroMune Ragweed<br>* No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.<br>|
| ToleroMune Ragweed Regimen 2<br>Subject previously randomised to receive ToleroMune Ragweed regimen 2 in study TR002 | Biological: ToleroMune Ragweed<br>* No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.<br>|
| ToleroMune Ragweed regimen 3<br>Subject previously randomised to receive ToleroMune Ragweed regimen 3 in study TR002 | Biological: ToleroMune Ragweed<br>* No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.<br>|
| ToleroMune Ragweed regimen 4<br>Subjects previously randomised to receive ToleroMune Ragweed regimen 4 in study TR002 | Biological: ToleroMune Ragweed<br>* No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Rhinoconjunctivitis Symptom Score |  | 48-54 weeks after the start of treatment in TR002 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total nasal and non-nasal symptom scores |  | 48-54 weeks after the start of treatment in TR002 | 
| Change in Immunoglobulin A (IgA) |  | 50-56 weeks after the start of treatment in Tr002 | 
| Change in Immunoglobulin E (IgE) |  | 50-56 weeks after the start of treatment in Tr002 | 
| Change in Immunoglobulin G4 (IgG4) |  | 50-56 weeks after the start of treatment in Tr002 | 
| Adverse Events |  | 50-56 weeks after the start of treatment in TR002 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ragweed allergy, ToleroMune ragweed, immunotherapy