Evaluating the Efficacy of Ragweed-SPIRE Following Exposure to Ragweed Allergen in an Environmental Exposure Chamber

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Ragweed-SPIRE is safe and effective at reducing allergy symptoms in people who suffer from allergy to Ragweed pollen

Official Title
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A Double-Blind, Randomised, Placebo-Controlled Study to Evaluate Three Dose Regimens of Ragweed-SPIRE in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Biological: Ragweed-SPIRE
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18-65 years. Reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two seasons. Minimum qualifying rhinoconjunctivitis symptom scores Ragweed-specific Immunoglobulin E (IgE) > 0.70 kU/L. Exclusion Criteria: Subjects with a history of ragweed pollen induced asthma A history of anaphylaxis to ragweed allergen. FEV1 < 80 % of predicted. Subjects who cannot tolerate Baseline Challenge in the EEC. Subjects for whom administration of epinephrine is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension). History of immunopathological diseases (e.g. multiple sclerosis) that in the opinion of the Investigator or the Sponsor could interfere with the results obtained from the study. 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ragweed-SPIRE 1<br>Ragweed SPIRE regimen 1 given 2 weeks apart | Biological: Ragweed-SPIRE<br> <br> |
| Experimental: Ragweed-SPIRE 2<br>Ragweed-SPIRE regimen 2 given 2 weeks apart | Biological: Ragweed-SPIRE<br> <br> |
| Experimental: Ragweed-SPIRE 3<br>Ragweed-SPIRE regimen 3 given 2 weeks apart | Biological: Ragweed-SPIRE<br> <br> |
| Placebo Comparator: Placebo<br>Placebo given 2 weeks apart | Biological: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) |  | Between Baseline and approximately 25 weeks after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) - all timepoints |  | Between Baseline and approximately 25 weeks after randomisation | 
| Change from Baseline in mean Total Nasal Symptom Score (TNSS) |  | Aproximately 25 weeks after randomisation | 
| Change from Baseline in mean Total Non Nasal Symptom Scores (TNNSS) |  | Approximately 25 weeks after randomisation | 
| Number of Participants with Adverse Events as a Measure of Safety and tolerability |  | Approximately 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhinoconjunctivitis, Rhinitis, Seasonal, Ragweed, Allergy