A study to investigate the efficacy of Anti-Bet v 1 Monoclonal Antibodies in reducing symptoms of seasonal allergic rhinitis

Phase 1

• Conditions: Birch Pollen Allergy; MedDRA version: 20.1Level: LLTClassification code 10066093Term: Birch pollen allergySystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-004094-52-DK
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-07
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 353

Inclusion Criteria

1. Documented or subject-reported history of birch pollen-triggered allergic rhinitis symptoms, with or without conjunctivitis, for at least 2 years
2. Positive SPT with birch pollen extract in the screening period, as defined in 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

NOTE: Other protocol defined inclusion criteria apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 353
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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. Subjects who anticipate major changes in allergen exposure in their home or work environments that are expected to coincide with study assessments, per investigator discretion
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. Subjects may be re-evaluated for eligibility after symptoms resolve
5. Documentation of active SARS-CoV-2 infection
Note: A subject with a documented, positive PCR or serology test for SARS-CoV-2 may
be enrolled, provided that the subject has:
• Recovered from COVID-19 (all COVID-19-related symptoms and major clinical
findings which can potentially affect the safety of the patient should be resolved to
baseline), and
• Had 2 negative results from a health authority-authorized nucleic acid amplification
(PCR) test for COVID-19 taken at least 48 hours apart
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 exclusion criteria apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified