Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rBet v 1 · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | Placebo |
| 2 | EXPERIMENTAL | 12.5 µg rBet v 1 |
| 3 | EXPERIMENTAL | 25 µg rBet v 1 |
| 4 | EXPERIMENTAL | 50 µg rBet v 1 |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | One sublingual tablet of matching placebo daily during approximately 5.5 months |
| rBet v 1 | BIOLOGICAL | One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months |
Inclusion Criteria: * Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the last 2 pollen seasons * Sensitisation to birch pollen as demonstrated, at screening, by a positive SPT to birch pollen with wheal diameter greater than 3 mm and specific IgE levels \> 0.70 kU/L (bir...