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

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ClinicalTrials.gov Identifier: NCT04709575
Recruitment Status : Active, not recruiting
First Posted : January 14, 2021
Last Update Posted : June 25, 2021
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Conjunctivitis Drug: REGN5713 Drug: REGN5714 Drug: REGN5715 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 353 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Anti-Bet v 1 Monoclonal Antibodies to Reduce Symptoms of Seasonal Allergic Rhinitis
Actual Study Start Date : January 14, 2021
Estimated Primary Completion Date : August 24, 2021
Estimated Study Completion Date : August 24, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Experimental: REGN5713-5714-5715
REGN5713-5714-5715 administered subcutaneously
Drug: REGN5713
Administered subcutaneously

Drug: REGN5714
Administered subcutaneously

Drug: REGN5715
Administered subcutaneously

Placebo Comparator: Placebo Only
Placebo matching REGN5713-5714-5715 administered subcutaneously
Drug: Placebo
Placebo that replaces REGN5713-5714-5715




Primary Outcome Measures :
  1. Combined symptom and medication score (CSMS) in participants who receive a single dose of REGN5713-5714-5715 versus placebo [ Time Frame: Until the end of Birch Pollen Season, up to Week 16 ]
    CSMS is calculated by adding the Daily Medication Score (DMS) and Total Symptom Score (TSS) together, with scores ranging between 0 (none) and 38 (severe).


Secondary Outcome Measures :
  1. Total symptom score (TSS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 versus placebo [ Time Frame: Until the end of Birch Pollen Season, up to Week 16 ]
    TSS is a combined score of TOSS and TNSS. TNSS and TOSS are scored as in part 1 each for a combined TSS of 0 (none) to 18 (severe)

  2. Total nasal symptom score (TNSS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 versus placebo [ Time Frame: Until the end of Birch Pollen Season, up to Week 16 ]
    Total nasal symptom score (TNSS) is from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a Likert scale ranging from 0 (none) to 3 (severe) for congestion, itching, and rhinorrhea, and from 0 (none) to 3 (5 or more sneezes) for sneezing.

  3. Total ocular symptom score (TOSS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 versus placebo [ Time Frame: Until the end of Birch Pollen Season, up to Week 16 ]
    Total ocular symptom score is 0 to 6 and is based on itching/redness/gritty feeling and tearing/watering; each of the 2 symptoms is graded 0 (absent), 1 (mild), 2 (moderate), and 3 (severe)

  4. Daily medication score (DMS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 versus placebo [ Time Frame: Until the end of Birch Pollen Season, up to Week 16 ]
    The Daily Medication Score (DMS) is calculated by adding points for each pre-specified medication taken as follows: desloratadine 5 mg 6 points/dose; maximum daily score 6 points, olopatadine 1 mg/mL each drop 1.5 points/drop; maximum daily score 6 points, mometasone furoate 50 ug/dose 2.0 points/spray; maximum daily score 8 points). The scale is 0 (minimum) to 20 (maximum)

  5. Incidence of Treatment-Emergent Adverse Events (TEAEs) throughout the study [ Time Frame: Up to Day 127 ]
  6. Incidence of Serious TEAEs throughout the study [ Time Frame: Up to Day 127 ]
  7. Change from baseline to the end of study in birch SPT mean wheal diameter in participants who receive a single dose of REGN5713-5714-5715 versus placebo [ Time Frame: Baseline through Day 127 ]
  8. Percent change from baseline to the end of study in birch SPT mean wheal diameter in participants who receive a single dose of REGN5713-5714-5715 versus placebo [ Time Frame: Baseline through Day 127 ]
  9. Serum concentration of REGN5713 over the study duration [ Time Frame: Up to Day 127 ]
  10. Serum concentration of REGN5714 over the study duration [ Time Frame: Up to Day 127 ]
  11. Serum concentration of REGN5715 over the study duration [ Time Frame: Up to Day 127 ]
  12. Incidence of treatment emergent anti-drug antibodies to REGN5713 throughout the study [ Time Frame: Up to Day 127 ]
  13. Incidence of treatment emergent anti-drug antibodies to REGN5714 throughout the study [ Time Frame: Up to Day 127 ]
  14. Incidence of treatment emergent anti-drug antibodies to REGN5715 throughout the study [ Time Frame: Up to Day 127 ]
  15. Number of "Well Days" [ Time Frame: Until the end of Birch Pollen Season, up to Week 16 ]
    "Well Days" are defined as days when rescue medication is not utilized and the Total symptom score (TSS) is ≤2/18



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04709575


Locations
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United States, Maine
Regeneron Study Site
Bangor, Maine, United States, 04401
United States, Maryland
Regeneron Study Site
Baltimore, Maryland, United States, 21224
United States, Minnesota
Regeneron Study Site
Plymouth, Minnesota, United States, 55441
United States, Missouri
Regeneron Study Site
Columbia, Missouri, United States, 65212
Regeneron Study Site
Saint Louis, Missouri, United States, 63141
United States, Montana
Regeneron Study Site
Missoula, Montana, United States, 59808
United States, New Jersey
Regeneron Study Site
Verona, New Jersey, United States, 07044
United States, New York
Regeneron Study Site
Great Neck, New York, United States, 11021
United States, Ohio
Regeneron Study Site
Cincinnati, Ohio, United States, 45231
Regeneron Study Site
Toledo, Ohio, United States, 43617
United States, Oregon
Regeneron Study Site
Portland, Oregon, United States, 97202
United States, Pennsylvania
Regeneron Study Site
Pittsburgh, Pennsylvania, United States, 15241
United States, Rhode Island
Regeneron Study Site
Lincoln, Rhode Island, United States, 02865
United States, Wisconsin
Regeneron Study Site
Greenfield, Wisconsin, United States, 53228
Belgium
Regeneron Study Site
Gent, Oost-Vlaanderen, Belgium, 9000
Regeneron Study Site
Leuven, Vlaams Brabant, Belgium, 3000
Canada, Ontario
Regeneron Study Site
Kingston, Ontario, Canada, K7L 2V7
Regeneron Study Site
London, Ontario, Canada, N5W 6A2
Regeneron Study Site
Ottawa, Ontario, Canada, K1G 6C6
Regeneron Study Site
Toronto, Ontario, Canada, M4V 1R2
Regeneron Study Site
Toronto, Ontario, Canada, M5B 1W8
Regeneron Study Site
Toronto, Ontario, Canada, M5G 1E2
Canada, Quebec
Regeneron Study Site
Trois-Rivieres, Quebec, Canada, G8T 7A1
Canada
Regeneron Study Site
Quebec, Canada, G1V 4M6
Denmark
Regeneron Study Site
Hvidovre, Capital, Denmark, 2650
Regeneron Study Site
Hellerup, Copenhagen Surroundings, Denmark, 2900
Regeneron Study Site
Vejle, South Jutland, Denmark, 7100
Germany
Regeneron Study Site
Heidelberg, Baden-Wurttemberg, Germany, 69120
Regeneron Study Site
Stuttgart, Baden-Wurttemberg, Germany, 70374
Regeneron Study Site
Dreieich, Hessen, Germany, 63303
Regeneron Study Site
Wiesbaden, Hessen, Germany, 65183
Regeneron Study Site
Duisburg, Nordrhein-Westfalen, Germany, 47051
Regeneron Study Site
Dusseldorf, North Rhine-Westphalia, Germany, 40225
Regeneron Study Site
Dresden, Sachsen, Germany, 01139
Regeneron Study Site
Berlin, Germany, 10117
Regeneron Study Site
Berlin, Germany, 14050
Regeneron Study Site
Hamburg, Germany, 22549
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04709575    
Other Study ID Numbers: R5713-5714-5715-ALG-2001
2020-004094-52 ( EudraCT Number )
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: June 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Birch Allergy
Additional relevant MeSH terms:
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Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Conjunctivitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Immune System Diseases
Conjunctival Diseases
Eye Diseases