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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Conjunctivitis; Allergic Rhinitis

Treatments: Drug: Placebo; Drug: REGN5715; Drug: REGN5713; Drug: REGN5714

Study type: Interventional

Funder types: Industry

Identifiers

NCT04709575

R5713-5714-5715-ALG-2001

2020-004094-52 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 353 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

1. Documented or participant-reported history of birch pollen-triggered allergic rhinitis symptoms, with or without conjunctivitis, for at least 2 years
2. Positive Skin prick test (SPT) with birch pollen extract in the screening period, as defined in the protocol
3. Positive Allergen-specific IgE (sIgE) tests for birch pollen and Bet v 1 in the screening period, as defined in the protocol
4. Willing and able to comply with clinic visits and study-related procedures

Key Exclusion Criteria:

1. Participation in a prior REGN5713-5714-5715 clinical trial
2. Recurrent or chronic rhinitis or sinusitis not associated with birch pollen season, or due to daily contact with other allergens causing symptoms that are expected to coincide with birch pollen season, as assessed by the investigator
3. Participants who anticipate major changes in allergen exposure in their home or work environments that are expected to coincide with the study assessments as assessed by the investigator
4. Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections (at the discretion of the investigator) within 4 weeks prior to screening visit. Participants may be re-evaluated for eligibility after symptoms resolve
5. Documentation of active SARS-CoV-2 infection, as defined in the protocol
6. A clinical history of asthma with 2 or more asthma exacerbations requiring hospitalizations or systemic corticosteroids in the previous year
7. History of birch allergy immunotherapy as defined in the protocol
8. Use of anti-IgE or other biological therapy in treatment of asthma or allergy within 6 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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353 participants in 2 patient groups, including a placebo group

REGN5713-5714-5715

Experimental group

Description:

REGN5713-5714-5715 administered subcutaneously

Treatment:

Drug: REGN5715

Drug: REGN5714

Drug: REGN5713

Placebo Only

Placebo Comparator group

Description:

Placebo matching REGN5713-5714-5715 administered subcutaneously

Treatment:

Drug: Placebo