drugset / Trial / 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
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Primary objective: To assess the efficacy of a single dose of the anti- Bet v 1 monoclonal antibodies (mAb(s ) in the reduction of allergic nasal symptoms during an out-of-season birch allergen environmental exposure unit (EEU) challenge in participants receiving REGN5713-5714-5715 versus placebo (Part A)
Timeline
- Start
- 2022-08-15
- Primary completion
- 2023-07-31
- Completion
- 2023-07-31
Outcome
Met primary endpoint
registry analysis (superiority test); REGN5713-5714-5715 900 mg vs Placebo; p <0.0001; Least Squares (LS) Mean Difference -2.31 (95% CI -3.229 to -1.385); ANCOVA NCT05430919 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | REGN5713 | Monoclonal antibody | — | Subcutaneous |
| Subject | REGN5715 | Monoclonal antibody | — | Subcutaneous |
| Subject | UMESOLERBART | Monoclonal antibody | — | Subcutaneous |