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

Last updated: September 30, 2022
Sponsor: Regeneron Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Allergy

Nasal Obstruction

Eye Disorders/infections

Treatment

N/A

Clinical Study ID

NCT04709575
R5713-5714-5715-ALG-2001
2020-004094-52
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria

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

Exclusion

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, ordue to daily contact with other allergens causing symptoms that are expected tocoincide with birch pollen season, as assessed by the investigator
  3. Participants who anticipate major changes in allergen exposure in their home or workenvironments that are expected to coincide with the study assessments as assessed bythe investigator
  4. Persistent chronic or recurring acute infection requiring treatment with antibiotics,antivirals, or antifungals, or any untreated respiratory infections (at the discretionof the investigator) within 4 weeks prior to screening visit. Participants may bere-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 requiringhospitalizations 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 6months prior to screening NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Study Design

Total Participants: 353
Study Start date:
January 14, 2021
Estimated Completion Date:
August 24, 2021

Connect with a study center

  • Regeneron Study Site

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • Regeneron Study Site

    Leuven, Vlaams Brabant 3000
    Belgium

    Site Not Available

  • Regeneron Study Site

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • Regeneron Study Site

    London, Ontario N5W 6A2
    Canada

    Site Not Available

  • Regeneron Study Site

    Ottawa, Ontario K1G 6C6
    Canada

    Site Not Available

  • Regeneron Study Site

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • Regeneron Study Site

    Trois-Rivieres, Quebec G8T 7A1
    Canada

    Site Not Available

  • Regeneron Study Site

    Quebec, G1V 4M6
    Canada

    Site Not Available

  • Regeneron Study Site

    Hvidovre, Capital 2650
    Denmark

    Site Not Available

  • Regeneron Study Site

    Hellerup, Copenhagen Surroundings 2900
    Denmark

    Site Not Available

  • Regeneron Study Site

    Vejle, South Jutland 7100
    Denmark

    Site Not Available

  • Regeneron Study Site

    Heidelberg, Baden-Wurttemberg 69120
    Germany

    Site Not Available

  • Regeneron Study Site

    Stuttgart, Baden-Wurttemberg 70374
    Germany

    Site Not Available

  • Regeneron Study Site

    Dreieich, Hessen 63303
    Germany

    Site Not Available

  • Regeneron Study Site

    Wiesbaden, Hessen 65183
    Germany

    Site Not Available

  • Regeneron Study Site

    Duisburg, Nordrhein-Westfalen 47051
    Germany

    Site Not Available

  • Regeneron Study Site

    Dusseldorf, North Rhine-Westphalia 40225
    Germany

    Site Not Available

  • Regeneron Study Site

    Dresden, Sachsen 01139
    Germany

    Site Not Available

  • Regeneron Study Site

    Berlin, 10117
    Germany

    Site Not Available

  • Regeneron Study Site

    Hamburg, 22549
    Germany

    Site Not Available

  • Regeneron Study Site

    Bangor, Maine 04401
    United States

    Site Not Available

  • Regeneron Study Site

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Regeneron Study Site

    Plymouth, Minnesota 55441
    United States

    Site Not Available

  • Regeneron Study Site

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Regeneron Study Site

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Regeneron Study Site

    Missoula, Montana 59808
    United States

    Site Not Available

  • Regeneron Study Site

    Verona, New Jersey 07044
    United States

    Site Not Available

  • Regeneron Study Site

    Great Neck, New York 11021
    United States

    Site Not Available

  • Regeneron Study Site

    Cincinnati, Ohio 45231
    United States

    Site Not Available

  • Regeneron Study Site

    Toledo, Ohio 43617
    United States

    Site Not Available

  • Regeneron Study Site

    Portland, Oregon 97202
    United States

    Site Not Available

  • Regeneron Study Site

    Pittsburgh, Pennsylvania 15241
    United States

    Site Not Available

  • Regeneron Study Site

    Lincoln, Rhode Island 02865
    United States

    Site Not Available

  • Regeneron Study Site

    Greenfield, Wisconsin 53228
    United States

    Site Not Available

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