Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis

Summary

The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus placebo.

Timeline

Start

2021-01-14

Primary completion

2021-08-24

Completion

2021-08-24

Outcome

Met primary endpoint

registry analysis (superiority test); REGN5713-5714-5715 vs Placebo Only; p = 0.0497; linear mixed-effect model -0.995 (95% CI -1.9886 to -0.0011); LS Mean Difference NCT04709575 ↗

release “The initial Phase 3 study in birch allergic patients with allergic rhinoconjunctivitis met its primary endpoint” regeneron.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	REGN5713	Monoclonal antibody	—	Subcutaneous
Subject	REGN5715	Monoclonal antibody	—	Subcutaneous
Subject	UMESOLERBART	Monoclonal antibody	—	Subcutaneous

Indications