Phase 3 Study Testing REGN5713 and REGN5715 Antibodies for Treating Eye Allergy from Birch Pollen in Teens and Adults

What this Trial Is About

Researchers are studying two experimental drugs, REGN5713 and REGN5715, to see if they can reduce eye allergy signs and symptoms caused by birch tree pollen allergy. This Phase 3 study compares how safe and effective these drugs are when given alone or together, versus a placebo. It also explores side effects, drug levels in the blood, and whether the body develops antibodies against the drugs that could affect their action or cause side effects. Participants will be randomly assigned to receive REGN5713 alone, REGN5715 alone, both drugs together, or a placebo. The study drugs are administered according to the study protocol. The trial uses a double-masked, placebo-controlled design to fairly compare the effects of these treatments on allergic conjunctivitis symptoms. The study includes a Conjunctival Allergen Challenge CAC to test drug effects at specific time points. During the study, participants will be monitored for eye itch and redness scores, nasal symptoms, and skin prick test changes. Blood samples will be taken to measure drug concentrations and antibody responses. Side effects and serious adverse events are carefully recorded up to Day 113. Assessments occur at baseline and multiple post-CAC time points, with the main outcome measured on Day 8. The study runs from January 2026 until June 2027, involving adolescent and adult participants aged 12 and older.

Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen Allergy