Efficacy of the Anti-Bet v 1 Monoclonal Antibodies (Given Subcutaneously) to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen in Adult Participants

A Two-Part Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of the Anti-Bet v 1 Monoclonal Antibodies to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen

Primary objective: To assess the efficacy of a single dose of the anti- Bet v 1 monoclonal antibodies (mAb(s ) in the reduction of allergic nasal symptoms during an out-of-season birch allergen environmental exposure unit (EEU) challenge in participants receiving REGN5713-5714-5715 versus placebo (Part A)

Study Overview

• Status: Completed
• Conditions: Conjunctivitis; Allergic Rhinitis
• Intervention / Treatment: Other: Placebo; Drug: REGN5713; Drug: REGN5714; Drug: REGN5715

Detailed Description

The study consists of Part A and Part B. All participants will be asked to complete both Part A and Part B of the study. The study lasts for a total duration of up to approximately 46 weeks (including up to a 10-week screening period). Part A of the study lasts up to approximately 28 weeks (including the screening period). Part B of the study starts after completion of Part A and lasts up to approximately 18 weeks (including an approximately 4-week follow-up period after end of birch pollen season (BPS)), dependent on the start and end times of the natural BPS.

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Health Research Institute
    • Mississauga, Ontario, Canada, L4W 1A4
      • Inflamax Research Limited DBA Cliantha Research
  • Quebec
    • Quebec City, Quebec, Canada, G1V4W2
      • Clinique Specialisee en Allergie de la Capitale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

1. Documented or participant-reported history of birch tree pollen-triggered allergic-rhinitis (AR) symptoms with or without conjunctivitis (for at least 2 seasons)
2. Positive Skin prick test (SPT) with birch tree pollen extract (mean wheal diameter at least 5 mm greater than a negative control) in screening period
3. Positive allergen-specific immunoglobulin E (sIgE) tests for birch tree pollen and Bet v 1 (≥0.7 kUa/L) in screening period
4. Demonstrated TNSS ≥ 6 out of 12 on at least 2 time points during the birch EEU exposure challenge in screening period

Key Exclusion Criteria:

1. Participation in a prior REGN5713-5714-5715 clinical trial and received REGN5713-5714-5715 antibodies (receipt of placebo in a previous trial is allowed)
2. Significant rhinitis, sinusitis, significant and/or severe allergies not associated with the birch pollen season, or due to daily contact with other non-birch related allergens causing symptoms that are expected to coincide or potentially interfere with the study EEU assessments or with the birch pollen season, as assessed by the investigator
3. Participants who anticipate major changes in allergen exposure during the birch pollen season that are expected to coincide with study assessments or planned travel that is expected to interfere with the study assessments, as assessed by the investigator (eg. anticipated travel during planned EEU sessions or birch pollen season)
4. Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening visit 1. Patients may be re-evaluated for eligibility after resolution of symptoms and specified duration.
5. History of significant, recurrent sinusitis, defined as at least 3 episodes requiring antibiotic treatment per year for the last 2 years
6. Abnormal lung function as judged by the investigator with Forced Expiratory Volume (FEV1) <75% of predicted at screening or randomization
7. A clinical history of moderate to severe asthma, uncontrolled asthma, global initiative for asthma [GINA] steps 3 to 5, history of life-threatening asthma, asthma exacerbations due to tree pollen allergy within 2 prior seasons, >2 asthma exacerbations requiring systemic steroids in past 12 months, asthma related emergency care or hospitalization within 12 months prior to screening, as defined in the protocol.
8. History of birch or other tree allergen immunotherapy in the 3 years prior to screening.
9. Use of anti-IgE or other biological therapy (including but not limited to anti IL-5, anti IL-4) that interferes with type 2 disease within 6 months prior to screening visit 1.
10. Allergen-specific immunotherapy with any allergen other than birch or other trees at screening.
11. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease,
12. Any malignancy within the past 5 years, except for basal cell or squamous epithelial cell carcinomas of the skin or carcinoma in situ of the cervix or anus that have been resected, with no evidence of local recurrence or metastatic disease for 3 years.

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Matching Placebo	Other: Placebo; Administered SC
Experimental: REGN5713-5714-5715; 3-mAb	Drug: REGN5713; Administered subcutaneously (SC); Drug: REGN5714; Administered SC; Drug: REGN5715; Administered SC
Experimental: REGN5713-5715; 2-mAb	Other: Placebo; Administered SC; Drug: REGN5713; Administered subcutaneously (SC); Drug: REGN5715; Administered SC
Experimental: REGN5715; 1-mAb	Other: Placebo; Administered SC; Drug: REGN5715; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean of Total Nasal Symptom Score [TNSS (2 to 6 hours)] during a birch allergen environmental exposure unit (EEU) challenge	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean of TNSS (2 to 6 hours) during out-of-season birch allergen EEU challenges for 3-mAb only	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Days 57 and 85
Mean of Total Ocular Symptom Score (TOSS) (2 to 6 hours) during out-of-season birch allergen EEU challenges	The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).	Days 29, 57 and 85
Mean of Total Symptom Score (TSS) (2 to 6 hours) during out-of-season birch allergen EEU challenges	The TSS is calculated by adding the TNSS and TOSS together, for a combined TSS of 0 to 18.	Days 29, 57 and 85
Change from pre-treatment baseline in TNSS (2 to 6 hours) during out-of-season birch allergen EEU challenges	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Days 29, 57 and 85
Change from pre-treatment baseline in TOSS (2 to 6 hours) during out-of-season birch allergen EEU challenges	The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).	Days 29, 57 and 85
Change from pre-treatment baseline in TSS (2 to 6 hours) during out-of-season birch allergen EEU challenges	The TSS is calculated by adding the TNSS and TOSS together, for a combined TSS of 0 to 18.	Days 29, 57 and 85
Percent change from pre-treatment baseline in TNSS (2 to 6 hours) during out-of-season birch allergen EEU challenges	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Days 29, 57 and 85
Percent change from pre-treatment baseline in TOSS (2 to 6 hours) during out-of-season birch allergen EEU challenges	The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).	Days 29, 57 and 85
Percent change from pre-treatment baseline in TSS (2 to 6 hours) during out-of-season birch allergen EEU challenges	The TSS is calculated by adding the TNSS and TOSS together, for a combined TSS of 0 to 18.	Days 29, 57 and 85
Change from pre-treatment baseline in the birch (and related allergens) titrated Skin Prick Test (SPT) mean wheal diameter Area under the Curve (AUC)	Skin prick test using serial dilutions of birch and related allergens will be evaluated as a percent change from baseline AUC.	Days 29, 57, 85 and 127
Percent change from pre-treatment baseline in the birch (and related allergens) titrated SPT mean wheal diameter AUC	Skin prick test using serial dilutions of birch and related allergens will be evaluated as a percent change from baseline AUC.	Days 29, 57, 85 and 127
Mean of TNSS (2 to 6 hours) during out-of-season oak allergen EEU challenge	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Day 36
Mean of TOSS (2 to 6 hours) during out-of-season oak allergen EEU challenge	The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).	Day 36
Mean of TSS (2 to 6 hours) during out-of-season oak allergen EEU challenge	The TSS is calculated by adding the TNSS and TOSS together, for a combined TSS of 0 to 18.	Day 36
Change from pre-treatment baseline in TNSS (2 to 6 hours) during an oak allergen EEU in subpopulation of oak-allergic participants	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Day 36
Change from pre-treatment baseline in TOSS (2 to 6 hours) during an oak allergen EEU in subpopulation of oak-allergic participants	The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).	Day 36
Change from pre-treatment baseline in TSS (2 to 6 hours) during an oak allergen EEU in subpopulation of oak-allergic participants	The TSS is calculated by adding the TNSS and TOSS together, for a combined TSS of 0 to 18.	Day 36
Percent change from pre-treatment baseline in TNSS (2 to 6 hours) during an oak allergen EEU in subpopulation of oak-allergic participants	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Day 36
Percent change from pre-treatment baseline in TOSS (2 to 6 hours) during an oak allergen EEU in subpopulation of oak-allergic participants	The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).	Day 36
Percent change from pre-treatment baseline in TSS (2 to 6 hours) during an oak allergen EEU in subpopulation of oak-allergic participants	The TSS is calculated by adding the TNSS and TOSS together, for a combined TSS of 0 to 18.	Day 36
Proportion of participants achieving different degrees of clinical responses will be compared across TNSS (2 to 6 hours) response threshold	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Days 29, 57 and 85
Proportion of participants achieving different degrees of clinical responses will be compared across TOSS (2 to 6 hours) response threshold	The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).	Days 29, 57 and 85
Proportion of participants achieving different degrees of clinical responses will be compared across TSS (2 to 6 hours) response threshold	The TSS is calculated by adding the TNSS and TOSS together, for a combined TSS of 0 to 18.	Days 29, 57 and 85
Proportion of participants achieving different degrees of responses in the birch (and related allergens) titrated SPT mean wheal diameter AUC will be compared across different response thresholds	Skin prick test using serial dilutions of birch and related allergens will be evaluated as a percent change from baseline AUC.	Days 29, 57 and 85
Mean of TNSS (2 to 6 hours) during the peak-season birch allergen EEU challenge	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Up to 253 Days
Mean of TOSS (2 to 6 hours) during the peak-season birch allergen EEU challenge	The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).	Up to 253 Days
Mean of TSS (2 to 6 hours) during the peak-season birch allergen EEU challenge	The TSS is calculated by adding the TNSS and TOSS together, for a combined TSS of 0 to 18.	Up to 253 Days
Daily Combined Symptom and Medication Score (CSMS) averaged during the BPS	The CSMS is defined as Total Symptom Score (TSS) plus Daily Medication Score (DMS).	Up to 253 Days
Daily TSS averaged during the BPS	The TSS is calculated by adding the TNSS and TOSS together, for a combined TSS of 0 to 18.	Up to 253 Days
Daily TNSS averaged during the BPS	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Up to 253 Days
Daily TOSS averaged during the BPS	The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).	Up to 253 Days
Daily Medication Score (DMS) averaged during the BPS	For the DMS, oral antihistamine 6 points/dose; maximum daily score 6 points, ocular antihistamine 1.5 points/drop; maximum daily score 6 points, intranasal corticosteroid 2.0 points/spray; maximum daily score 8 points). The maximum DMS score is 20.	Up to 253 Days
Daily CSMS averaged during the peak BPS	The CSMS is defined as Total Symptom Score (TSS) plus Daily Medication Score (DMS).	Up to 253 Days
Daily TSS averaged during the peak BPS	The TSS is calculated by adding the TNSS and TOSS together, for a combined TSS of 0 to 18.	Up to 253 Days
Daily TNSS averaged during the peak BPS	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Up to 253 Days
Daily TOSS averaged during the peak BPS	The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).	Up to 253 Days
DMS averaged during the peak BPS	For the DMS, oral antihistamine 6 points/dose; maximum daily score 6 points, ocular antihistamine 1.5 points/drop; maximum daily score 6 points, intranasal corticosteroid 2.0 points/spray; maximum daily score 8 points). The maximum DMS score is 20.	Up to 253 Days
Change from baseline in CSMS averaged during the BPS	The CSMS is defined as Total Symptom Score (TSS) plus Daily Medication Score (DMS).	Up to 253 Days
Change from baseline in TSS averaged during the BPS	The TSS is calculated by adding the TNSS and TOSS together, for a combined TSS of 0 to 18.	Up to 253 Days
Change from baseline in TNSS averaged during the BPS	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Up to 253 Days
Change from baseline in TOSS averaged during the BPS	The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).	Up to 253 Days
Change from baseline in DMS averaged during the BPS	For the DMS, oral antihistamine 6 points/dose; maximum daily score 6 points, ocular antihistamine 1.5 points/drop; maximum daily score 6 points, intranasal corticosteroid 2.0 points/spray; maximum daily score 8 points). The maximum DMS score is 20.	Up to 253 Days
Change from baseline in CSMS averaged during the peak BPS	The CSMS is defined as Total Symptom Score (TSS) plus Daily Medication Score (DMS).	Up to 253 Days
Change from baseline in TSS averaged during the peak BPS	The TSS is calculated by adding the TNSS and TOSS together, for a combined TSS of 0 to 18.	Up to 253 Days
Change from baseline in TNSS averaged during the peak BPS	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Up to 253 Days
Change from baseline in TOSS averaged during the peak BPS	The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).	Up to 253 Days
Change from baseline in DMS averaged during the peak BPS	For the DMS, oral antihistamine 6 points/dose; maximum daily score 6 points, ocular antihistamine 1.5 points/drop; maximum daily score 6 points, intranasal corticosteroid 2.0 points/spray; maximum daily score 8 points). The maximum DMS score is 20.	Up to 253 Days
Percentage change from baseline in CSMS averaged during the BPS	The CSMS is defined as Total Symptom Score (TSS) plus Daily Medication Score (DMS).	Up to 253 Days
Percentage change from baseline in TSS averaged during the BPS	The TSS is calculated by adding the TNSS and TOSS together, for a combined TSS of 0 to 18.	Up to 253 Days
Percentage change from baseline in TNSS averaged during the BPS	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Up to 253 Days
Percentage change from baseline in TOSS averaged during the BPS	The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).	Up to 253 Days
Percentage change from baseline in DMS averaged during the BPS	For the DMS, oral antihistamine 6 points/dose; maximum daily score 6 points, ocular antihistamine 1.5 points/drop; maximum daily score 6 points, intranasal corticosteroid 2.0 points/spray; maximum daily score 8 points). The maximum DMS score is 20.	Up to 253 Days
Percentage change from baseline in CSMS averaged during the peak BPS	The CSMS is defined as Total Symptom Score (TSS) plus Daily Medication Score (DMS).	Up to 253 Days
Percentage change from baseline in TSS averaged during the peak BPS	The TSS is calculated by adding the TNSS and TOSS together, for a combined TSS of 0 to 18.	Up to 253 Days
Percentage change from baseline in TNSS averaged during the peak BPS	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Up to 253 Days
Percentage change from baseline in TOSS averaged during the peak BPS	The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).	Up to 253 Days
Percentage change from baseline in DMS averaged during the peak BPS	For the DMS, oral antihistamine 6 points/dose; maximum daily score 6 points, ocular antihistamine 1.5 points/drop; maximum daily score 6 points, intranasal corticosteroid 2.0 points/spray; maximum daily score 8 points). The maximum DMS score is 20.	Up to 253 Days
Change from pre-treatment baseline to end-of-season visits in the birch (and related allergens) titrated SPT mean wheal diameter AUC	Skin prick test using serial dilutions of birch and related allergens will be evaluated as a percent change from baseline AUC.	Up to 253 Days
Change from pre-treatment baseline to end-of-study visits in the birch (and related allergens) titrated SPT mean wheal diameter AUC	Skin prick test using serial dilutions of birch and related allergens will be evaluated as a percent change from baseline AUC.	Up to 253 Days
Percent change from pre-treatment baseline to end-of-season visits in the birch (and related allergens) titrated SPT mean wheal diameter AUC	Skin prick test using serial dilutions of birch and related allergens will be evaluated as a percent change from baseline AUC.	Up to 253 Days
Percent change from pre-treatment baseline to end-of-study visits in the birch (and related allergens) titrated SPT mean wheal diameter AUC	Skin prick test using serial dilutions of birch and related allergens will be evaluated as a percent change from baseline AUC.	Up to 253 Days
Mean of the total Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) score during BPS	The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items with 1-week recall on the RQLQ(S) in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function. Higher scores indicated more health-related quality of life impairment (lower scores were better).	Up to 253 Days
Mean of the total Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) score during peak BPS	The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items with 1-week recall on the RQLQ(S) in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function. Higher scores indicated more health-related quality of life impairment (lower scores were better).	Up to 253 Days
RQLQ(S) averaged during the BPS	The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items with 1-week recall on the RQLQ(S) in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal /eye symptoms, practical problems, and emotional function. Higher scores indicated more health-related quality of life impairment (lower scores were better).	Up to 253 Days
RQLQ(S) averaged during the peak BPS	The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items with 1-week recall on the RQLQ(S) in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal /eye symptoms, practical problems, and emotional function. Higher scores indicated more health-related quality of life impairment (lower scores were better).	Up to 253 Days
Change from baseline in the average RQLQ(S) score during BPS	The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items with 1-week recall on the RQLQ(S) in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal /eye symptoms, practical problems, and emotional function. Higher scores indicated more health-related quality of life impairment (lower scores were better).	Up to 253 Days
Change from baseline in the average RQLQ(S) score during peak BPS	The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items with 1-week recall on the RQLQ(S) in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal /eye symptoms, practical problems, and emotional function. Higher scores indicated more health-related quality of life impairment (lower scores were better).	Up to 253 Days
Percent change from baseline in the average RQLQ(S) score during BPS	The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items with 1-week recall on the RQLQ(S) in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal /eye symptoms, practical problems, and emotional function. Higher scores indicated more health-related quality of life impairment (lower scores were better).	Up to end of BPS, Up to 127 Days
Percent change from baseline in the total RQLQ[S]) score during peak BPS	The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items with 1-week recall on the RQLQ(S) in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal /eye symptoms, practical problems, and emotional function. Higher scores indicated more health-related quality of life impairment (lower scores were better).	Up to 253 Days
Incidence rates of Serious TEAEs through end of study		Up to 253 Days
Serum concentration of REGN5713 over the study duration		Up to 253 Days
Serum concentration of REGN5714 over the study duration		Up to 253 Days
Serum concentration of REGN5715 over the study duration		Up to 253 Days
Incidence of anti-drug antibodies (ADA) to REGN5713 over time		Up to 253 Days
Incidence of ADA to REGN5714 over time		Up to 253 Days
Incidence of ADA to REGN5715 over time		Up to 253 Days
Titers of anti-drug antibodies (ADA) to REGN5713 over time		Up to 253 Days
Titers of ADA to REGN5714 over time		Up to 253 Days
Titers of ADA to REGN5715 over time		Up to 253 Days
Mean of TNSS (2 to 6 hours) during out-of-season birch allergen EEU challenges except for 3-mAb vs Placebo at Day 29	The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.	Days 29, 57 and 85
Incidence rates of Treatment-Emergent Adverse Events (TEAEs) over the study duration		Up to 253 Days

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Skin Prick Test; Subcutaneous immunotherapy; Birch Allergy; Birch Pollen Season; Monoclonal antibody(ies); Oak Pollen Season
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Conjunctival Diseases; Rhinitis; Rhinitis, Allergic; Conjunctivitis
• Other Study ID Numbers: R5713-5714-5715-ALG-21111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• IPD Sharing 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.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes