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

Regeneron Pharmaceuticals

Status and phase: Not yet enrolling; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: REGN5713; Drug: REGN5715; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07309432

R5713-5715-ALG-2556

Details and patient eligibility

About

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)

Enrollment: 350 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Positive SPT to birch allergen extract
2. Positive allergen specific Immunoglobulin E (sIgE) tests for birch and Bet v 1
3. Positive CAC criteria

Key Exclusion Criteria:

1. Significant and/or severe environmental allergies causing symptoms (outside of the challenge setting) that are expected to interfere with study assessments
2. Presence of any ophthalmic disease/abnormality/condition that may interfere with study assessments, affect the study outcomes or negatively impact participant safety
3. A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment more than twice within prior 12 months or once within 3 months prior to screening visit 1 or has been hospitalized or has attended the Emergency Room/Urgent Care facility for asthma in the 12 months prior to screening

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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350 participants in 4 patient groups, including a placebo group

REGN5713-5715

Experimental group

Treatment:

Drug: REGN5715

Drug: REGN5713

REGN5713

Experimental group

Treatment:

Drug: REGN5713

REGN5715

Experimental group

Treatment:

Drug: REGN5715

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo