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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04709575 | Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis | PHASE3 | COMPLETED | 353 | — | — | Jan 14, 2021 | Aug 24, 2021 | Oct 27, 2022 | 37 | United States, Belgium +3 |
| NCT05430919 | Efficacy of the Anti-Bet v 1 Monoclonal Antibodies (Given Subcutaneously) to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen in Adult Participants | PHASE2 | COMPLETED | 217 | — | — | Aug 15, 2022 | Jul 31, 2023 | Nov 19, 2024 | 3 | Canada |
The average CSMS will be calculated based on daily symptom score and daily medication score recorded over the duration of the birch pollen season (BPS). CSMS is calculated by adding the Daily Medication Score (DMS) and Total Symptom Score (TSS) together, with scores ranging between 0 (none) and 38 (severe).
TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.
| Arm | Type | Description |
|---|---|---|
| REGN5713-5714-5715 | EXPERIMENTAL | REGN5713-5714-5715 administered subcutaneously |
| Placebo Only | PLACEBO_COMPARATOR | Placebo matching REGN5713-5714-5715 administered subcutaneously |
| REGN5713-5715 | EXPERIMENTAL | 2-mAb |
| REGN5715 | EXPERIMENTAL | 1-mAb |
| Matching Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| REGN5713 | DRUG | Administered subcutaneously |
| REGN5714 | DRUG | Administered subcutaneously |
| REGN5715 | DRUG | Administered subcutaneously |
| Placebo | DRUG | Placebo that replaces REGN5713-5714-5715 |
Key Inclusion Criteria 1. Documented or participant-reported history of birch pollen-triggered allergic rhinitis symptoms, with or without conjunctivitis, for at least 2 years 2. Positive Skin prick test (SPT) with birch pollen extract in the screening period, as defined in the protocol 3. Positive...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Polyrizon Ltd. | PLRZ | 1 | NA | Undisclosed |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | — | Undisclosed |