Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults

Study Overview
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Brief Summary
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The purpose of this study is to find out if a new investigational vaccine, TOLAMBA™, is safe and effective in reducing the symptoms of ragweed allergy.

Detailed Description
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Ragweed allergy is the most common seasonal allergy in North America. Allergen immunotherapy is a therapeutic option for patients who have allergy symptoms that cannot be adequately controlled by avoidance of the allergen or medication. It may also be appropriate for those who cannot tolerate their medications due to side effects or have difficulties with medication compliance. This study compares the safety and efficacy of two different dosing regimens of TOLAMBA™ with placebo in reducing the symptoms of ragweed-allergic adults over two consecutive ragweed pollen seasons. Comparison(s): Subject-rated allergy symptoms of subjects treated with TOLAMBA™ dose-intense regimen or TOLAMBA™ lower-dose regimen, compared with subjects treated with placebo.

Official Title
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A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Dose-Regimen Study of the Efficacy and Safety of TOLAMBA™ in Ragweed-Allergic Rhinitis Adults

Conditions
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Rhinitis, Allergic, Seasonal

Intervention / Treatment
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* Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate
* Biological: Histamine base


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a history of ragweed allergic rhinitis (hayfever) during at least the last 2 consecutive seasons that has required treatment with antihistamines, decongestants and/or nasal steroids, but where symptom relief has been incomplete Is willing to stay in their ragweed area during the historical peak period of the local ragweed season, and willing to travel for no more than 2 weeks (cumulative time) outside of their ragweed area during the entire season Exclusion Criteria: Has had any hospital admissions for asthma Has smoked within the past year, or has a ≥10-pack per year smoking history Has had any previous immunotherapy with ragweed pollen extract, or was in a previous clinical trial with TOLAMBA™ Has used Xolair within the past 12 months Has a history of anaphylaxis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>TOLAMBA™ dose-intense regimen | Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate<br>* Escalating doses, 6 weekly subcutaneous (under the skin) injections<br>* Other names: TOLAMBA™;|
| Experimental: 2<br>TOLAMBA™ lower-dose regimen | Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate<br>* Escalating doses, 6 weekly subcutaneous (under the skin) injections<br>* Other names: TOLAMBA™;|
| Placebo Comparator: 3<br> | Biological: Histamine base<br>* Escalating doses, 6 weekly subcutaneous (under the skin) injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season. |  | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ragweed, Allergy, Allergic, Rhinitis, Hay Fever, Seasonal, Treatment, Immunotherapy, Vaccine