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| Name | Class |
|---|---|
| Adiga Life Sciences, Inc. | INDUSTRY |
| Cetero Research, San Antonio | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Subjects previously randomised to placebo in TR002 |
| |
| ToleroMune Ragweed Regimen 1 | Subjects previously randomised to receive ToleroMune Ragweed regimen 1 in study TR002 |
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| ToleroMune Ragweed Regimen 2 | Subject previously randomised to receive ToleroMune Ragweed regimen 2 in study TR002 |
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| ToleroMune Ragweed regimen 3 | Subject previously randomised to receive ToleroMune Ragweed regimen 3 in study TR002 |
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| ToleroMune Ragweed regimen 4 | Subjects previously randomised to receive ToleroMune Ragweed regimen 4 in study TR002 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | No further medication to be administered in this study. Intervention refers to treatment received in Study TR002. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Rhinoconjunctivitis Symptom Score | 48-54 weeks after the start of treatment in TR002 |
| 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 | |
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Inclusion Criteria
Exclusion Criteria
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Subjects previously randomised in study TR002 and completed all dosing visits and the Post Treatment Challenge (PTC).
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| Name | Affiliation | Role |
|---|---|---|
| Peter Couroux, MD | Cetero Research, San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cetero Research | Mississauga | Ontario | L4W 1N2 | Canada |
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| ToleroMune Ragweed | Biological | No further medication to be administered in this study. Intervention refers to treatment received in Study 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 |