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Monoclonal Antibodies

REGN5713-5715 for Allergic Conjunctivitis

Phase 3
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 22 and 113
Awards & highlights
Pivotal Trial

Summary

This trial is testing two new drugs, REGN5713 and REGN5715, combined as REGN5713-5715, to help reduce eye allergy symptoms caused by birch tree pollen

Who is the study for?
Adults with a history of moderate to severe birch pollen allergy for at least 2 years, bothersome eye symptoms during birch season, and positive tests for specific allergic responses (skin prick test and immunoglobulin E) can join. Those who don't meet the screening criteria or have conditions that might interfere with the study are excluded.
What is being tested?
The trial is testing REGN5713-5715, a combination of two experimental drugs aimed at reducing eye allergy symptoms from birch pollen compared to a placebo—a treatment lookalike without active medicine. It will also measure drug levels in blood and check if the body develops antibodies against it.
What are the potential side effects?
Possible side effects include reactions where the drug is administered, general discomfort or changes in how your body functions due to immune response. The exact side effects aren't listed but typically involve local or systemic allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 22 and 113
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 22 and 113 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ocular itch score in response to birch allergen challenge
Secondary study objectives
Change in birch tSPT
Change in oak tSPT
Ciliary redness score in response to birch allergen challenge
+7 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: REGN5713-5715Experimental Treatment2 Interventions
Participants will be randomized 1:1
Group II: PlaceboPlacebo Group1 Intervention
Participants will be randomized 1:1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
REGN5713
2022
Completed Phase 3
~570
REGN5715
2022
Completed Phase 3
~570

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
671 Previous Clinical Trials
385,774 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
284 Previous Clinical Trials
254,867 Total Patients Enrolled
~33 spots leftby Apr 2025
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