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| Name | Class |
|---|---|
| Adiga Life Sciences, Inc. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ragweed-SPIRE 1 | Experimental | Ragweed SPIRE regimen 1 given 2 weeks apart |
|
| Ragweed-SPIRE 2 | Experimental | Ragweed-SPIRE regimen 2 given 2 weeks apart |
|
| Ragweed-SPIRE 3 | Experimental | Ragweed-SPIRE regimen 3 given 2 weeks apart |
|
| Placebo | Placebo Comparator | Placebo given 2 weeks apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ragweed-SPIRE | Biological |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) | Between Baseline and approximately 25 weeks after randomisation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piyush Patel, MD | Inflamax Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanata Allergy Services | Kanata | Ontario | K2L 3C8 | Canada | ||
| KGK Synergize Inc |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D012220 | Rhinitis |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Biological |
|
| 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 |
| London |
| Ontario |
| N6A 5R8 |
| Canada |
| Inflamax Research | Mississauga | Ontario | L8P 0A1 | Canada |
| Taunton Health Centre | Oshawa | Ontario | L1H 7K4 | Canada |
| Windsor Allergy Asthma Associates | Windsor | Ontario | N8X 2G1 | Canada |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |