350 Participants Needed

REGN5713 + REGN5715 for Allergic Eye

CT
Overseen ByClinical Trials Administrator
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Regeneron Pharmaceuticals
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is researching 2 experimental drugs, REGN5713 and REGN5715. The study drugs will be either of these drugs given alone (either REGN5713 or REGN5715) or given together (REGN5713 and REGN5715) to reduce eye allergy signs and symptoms due to birch tree pollen allergy.

The aim of the study is to see how safe and effective the study drugs are at lowering eye allergy signs and symptoms compared with placebo.

The study will also evaluate whether the combination (REGN5713-5715) has different effectiveness than REGN5713 or REGN5715 alone.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drugs

* How much of the study drugs is in the blood at different times

* Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)

Who Is on the Research Team?

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adolescents and adults with birch pollen allergy who have specific positive tests for this allergy. They must show allergic eye symptoms when exposed to birch pollen. People cannot join if they don't meet the required test criteria.

Inclusion Criteria

I am allergic to birch.
I am allergic to birch pollen, confirmed by tests.
I have a positive calcium score.
See 1 more

What Are the Treatments Tested in This Trial?

Interventions

  • REGN5713
  • REGN5715

Trial Overview

The study is testing two experimental drugs, REGN5713 and REGN5715, alone or in combination, against a placebo. It aims to determine their safety and effectiveness in reducing eye allergy symptoms caused by birch tree pollen.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: REGN5715Experimental Treatment1 Intervention
Group II: REGN5713-5715Experimental Treatment2 Interventions
Group III: REGN5713Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School