Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis
NCT ID: NCT04709575
Last Updated: 2022-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
353 participants
INTERVENTIONAL
2021-01-14
2021-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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REGN5713-5714-5715
REGN5713-5714-5715 administered subcutaneously
REGN5713
Administered subcutaneously
REGN5714
Administered subcutaneously
REGN5715
Administered subcutaneously
Placebo Only
Placebo matching REGN5713-5714-5715 administered subcutaneously
Placebo
Placebo that replaces REGN5713-5714-5715
Interventions
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REGN5713
Administered subcutaneously
REGN5714
Administered subcutaneously
REGN5715
Administered subcutaneously
Placebo
Placebo that replaces REGN5713-5714-5715
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron Study Site
Bangor, Maine, United States
Regeneron Study Site
Baltimore, Maryland, United States
Regeneron Study Site
Plymouth, Minnesota, United States
Regeneron Study Site
Columbia, Missouri, United States
Regeneron Study Site
St Louis, Missouri, United States
Regeneron Study Site
Missoula, Montana, United States
Regeneron Study Site
Verona, New Jersey, United States
Regeneron Study Site
Great Neck, New York, United States
Regeneron Study Site
Cincinnati, Ohio, United States
Regeneron Study Site
Toledo, Ohio, United States
Regeneron Study Site
Portland, Oregon, United States
Regeneron Study Site
Pittsburgh, Pennsylvania, United States
Regeneron Study Site
Lincoln, Rhode Island, United States
Regeneron Study Site
Greenfield, Wisconsin, United States
Regeneron Study Site
Ghent, Oost-Vlaanderen, Belgium
Regeneron Study Site
Leuven, Vlaams Brabant, Belgium
Regeneron Study Site
Kingston, Ontario, Canada
Regeneron Study Site
London, Ontario, Canada
Regeneron Study Site
Ottawa, Ontario, Canada
Regeneron Study Site
Toronto, Ontario, Canada
Regeneron Study Site
Toronto, Ontario, Canada
Regeneron Study Site
Toronto, Ontario, Canada
Regeneron Study Site
Trois-Rivières, Quebec, Canada
Regeneron Study Site
Québec, , Canada
Regeneron Study Site
Hvidovre, Capital, Denmark
Regeneron Study Site
Hellerup, Copenhagen Surroundings, Denmark
Regeneron Study Site
Vejle, South Jutland, Denmark
Regeneron Study Site
Heidelberg, Baden-Wurttemberg, Germany
Regeneron Study Site
Stuttgart, Baden-Wurttemberg, Germany
Regeneron Study Site
Dreieich, Hesse, Germany
Regeneron Study Site
Wiesbaden, Hesse, Germany
Regeneron Study Site
Duisburg, North Rhine-Westphalia, Germany
Regeneron Study Site
Düsseldorf, North Rhine-Westphalia, Germany
Regeneron Study Site
Dresden, Saxony, Germany
Regeneron Study Site
Berlin, , Germany
Regeneron Study Site
Berlin, , Germany
Regeneron Study Site
Hamburg, , Germany
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-004094-52
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R5713-5714-5715-ALG-2001
Identifier Type: -
Identifier Source: org_study_id
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