Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00537355 | An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber | PHASE2 | COMPLETED | 271 | — | — | Sep 1, 2007 | May 1, 2008 | Apr 16, 2019 | 6 | Canada |
| Arm | Type | Description |
|---|---|---|
| TOLAMBA™ | ACTIVE_COMPARATOR | - |
| Histamine | SHAM_COMPARATOR | Histamine simulates mild redness/swelling effect seen with active comparator, TOLAMBA™. Prevents study staff from easily identifying subjects who received active comparator. |
| Name | Type | Description |
|---|---|---|
| Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate | BIOLOGICAL | 6 weekly subcutaneous injections (escalating doses of 3 mcg to 30 mcg) |
| Histamine | DRUG | 6 weekly subcutaneous injections (escalating doses of 0.22 mcg to 1.1 mcg) |
Inclusion Criteria: * Is willing and able to give signed informed consent, and must have provided this consent. * Has a clinical history of seasonal allergic rhinitis with seasonal nasal allergy symptoms during each of the last 2 ragweed allergy seasons. * Has documentation of a positive skin test ...