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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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04709575
Collaborator
(none)
353
Enrollment
37
Locations
2
Arms
7.3
Actual Duration (Months)
9.5
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Jan 14, 2021
Actual Primary Completion Date :
Aug 24, 2021
Actual Study Completion Date :
Aug 24, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Combined symptom and medication score (CSMS) in participants who receive a single dose of REGN5713-5714-5715 versus placebo [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 [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 [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 [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 [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 [Up to Day 127]

  6. Incidence of Serious TEAEs throughout the study [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 [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 [Baseline through Day 127]

  9. Serum concentration of REGN5713 over the study duration [Up to Day 127]

  10. Serum concentration of REGN5714 over the study duration [Up to Day 127]

  11. Serum concentration of REGN5715 over the study duration [Up to Day 127]

  12. Incidence of treatment emergent anti-drug antibodies to REGN5713 throughout the study [Up to Day 127]

  13. Incidence of treatment emergent anti-drug antibodies to REGN5714 throughout the study [Up to Day 127]

  14. Incidence of treatment emergent anti-drug antibodies to REGN5715 throughout the study [Up to Day 127]

  15. Number of "Well Days" [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Regeneron Study Site Bangor Maine United States 04401
2 Regeneron Study Site Baltimore Maryland United States 21224
3 Regeneron Study Site Plymouth Minnesota United States 55441
4 Regeneron Study Site Columbia Missouri United States 65212
5 Regeneron Study Site Saint Louis Missouri United States 63141
6 Regeneron Study Site Missoula Montana United States 59808
7 Regeneron Study Site Verona New Jersey United States 07044
8 Regeneron Study Site Great Neck New York United States 11021
9 Regeneron Study Site Cincinnati Ohio United States 45231
10 Regeneron Study Site Toledo Ohio United States 43617
11 Regeneron Study Site Portland Oregon United States 97202
12 Regeneron Study Site Pittsburgh Pennsylvania United States 15241
13 Regeneron Study Site Lincoln Rhode Island United States 02865
14 Regeneron Study Site Greenfield Wisconsin United States 53228
15 Regeneron Study Site Gent Oost-Vlaanderen Belgium 9000
16 Regeneron Study Site Leuven Vlaams Brabant Belgium 3000
17 Regeneron Study Site Kingston Ontario Canada K7L 2V7
18 Regeneron Study Site London Ontario Canada N5W 6A2
19 Regeneron Study Site Ottawa Ontario Canada K1G 6C6
20 Regeneron Study Site Toronto Ontario Canada M4V 1R2
21 Regeneron Study Site Toronto Ontario Canada M5B 1W8
22 Regeneron Study Site Toronto Ontario Canada M5G 1E2
23 Regeneron Study Site Trois-Rivieres Quebec Canada G8T 7A1
24 Regeneron Study Site Quebec Canada G1V 4M6
25 Regeneron Study Site Hvidovre Capital Denmark 2650
26 Regeneron Study Site Hellerup Copenhagen Surroundings Denmark 2900
27 Regeneron Study Site Vejle South Jutland Denmark 7100
28 Regeneron Study Site Heidelberg Baden-Wurttemberg Germany 69120
29 Regeneron Study Site Stuttgart Baden-Wurttemberg Germany 70374
30 Regeneron Study Site Dreieich Hessen Germany 63303
31 Regeneron Study Site Wiesbaden Hessen Germany 65183
32 Regeneron Study Site Duisburg Nordrhein-Westfalen Germany 47051
33 Regeneron Study Site Dusseldorf North Rhine-Westphalia Germany 40225
34 Regeneron Study Site Dresden Sachsen Germany 01139
35 Regeneron Study Site Berlin Germany 10117
36 Regeneron Study Site Berlin Germany 14050
37 Regeneron Study Site Hamburg Germany 22549

Sponsors and Collaborators

  • Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04709575
Other Study ID Numbers:
  • R5713-5714-5715-ALG-2001
  • 2020-004094-52
First Posted:
Jan 14, 2021
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Conjunctivitis

Study Results

No Results Posted as of Nov 9, 2021