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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05430919

Enrollment

217

Registered

2022-06-24

Start date

2022-08-15

Completion date

2023-07-31

Last updated

2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis, Conjunctivitis

Keywords

Birch Allergy, Birch Pollen Season, Monoclonal antibody(ies), Oak Pollen Season, Subcutaneous immunotherapy, Skin Prick Test

Brief summary

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)

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.

Interventions

DRUGREGN5713

Administered subcutaneously (SC)

DRUGREGN5714

Administered SC

DRUGREGN5715

Administered SC

OTHERPlacebo

Administered SC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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/

Design outcomes

Primary

Measure	Time frame	Description
Mean Total Nasal Symptom Score (TNSS) (2 to 6 Hours) During Out-of-season Birch Allergen Environmental Exposure Unit (EEU) Challenge (REGN5713-5714-5715 vs. Placebo) at Day 29	Day 29 from randomization (Out-of-season)	TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.

Secondary

Measure	Time frame	Description
Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 57 and Day 85, from randomization (Out-of-season)	TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.
Mean Total Ocular Symptom Score (TOSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29	Day 29 from randomization (Out-of-season)	TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome.
Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 57 and Day 85, from randomization (Out-of-season)	TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome.
Mean Total Symptom Score (TSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29	Day 29 from randomization (Out-of-season)	TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome
Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85	Day 57 and Day 85, from randomization (Out-of-season)	TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome
Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29, Day 57 and Day 85, from randomization (Out-of-season)	TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.
Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29, Day 57 and Day 85, from randomization (Out-of-season)	TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome.
Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29, Day 57 and Day 85, from randomization (Out-of-season)	TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome
Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29, Day 57 and Day 85, from randomization (Out-of-season)	TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.
Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29, Day 57 and Day 85, from randomization (Out-of-season)	TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome.
Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85	Day 29, Day 57 and Day 85, from randomization (Out-of-season)	TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome
Change From Pre-treatment Baseline in the Birch Titrated Skin Prick Test (SPT) Mean Wheal Diameter Area Under the Curve (AUC) at Day 29	Day 29 from randomization (Out-of-season)	Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 57 and Day 85, from randomization (Out-of-season)	Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127	Day 127 from randomization	Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 225 from randomization (end-of-season) and Day 253 from randomization (end of study)	Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 29	Day 29 from randomization (Out-of-season)	Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 57 and Day 85, from randomization (Out-of-season)	Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127	Day 127 from randomization	Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 225 from randomization (end-of-season) and Day 253 from randomization (end of study)	Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36	Day 36 from randomization (Out-of-season)	TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome.
Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	Day 36 from randomization (Out-of-season)	TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome.
Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	Day 36 from randomization (Out-of-season)	TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome.
Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 29, Day 57 and Day 85, from randomization (Out-of-season)	TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.
Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 29, Day 57 and Day 85, from randomization (Out-of-season)	TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome.
Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 29, Day 57 and Day 85, from randomization (Out-of-season)	TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome.
Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 29, Day 57 and Day 85, from randomization (Out-of-season)	Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190	Day 190 from randomization (In-season); Timing may vary based on local season	Peak season EEU is an in-season challenge corresponding to approximate timing of the anticipated peak BPS; TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome.
Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	Up to 253 days from randomization (during BPS)	TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS & TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for each pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS & TSS higher score indicates worse outcome). Daily TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of birch pollen season presented.
Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	Up to 253 days from randomization (during peak BPS)	TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS & TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for each pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS & TSS higher score indicates worse outcome). Daily TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of peak birch pollen season presented.
Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	Up to 253 days from randomization (during BPS)	TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS & TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS & TSS; Higher score indicates worse outcome. Change from pre-treatment baseline in TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of birch pollen season presented.
Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	Up to 253 days from randomization (during peak BPS)	TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS & TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS & TSS; Higher score indicates worse outcome. Change from pre-treatment baseline in TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of peak birch pollen season presented.
Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	Up to 253 days from randomization (during BPS)	TNSS range from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS range from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS range from 0 (none) to 18 (severe): Sum of TNSS & TOSS; Higher score indicates worse outcome. DMS range from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS range from 0 to 38 (max): Sum of DMS & TSS; Higher score indicates worse outcome. Percent change from pre-treatment baseline in TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of birch pollen season presented.
Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	Up to 253 days from randomization (during peak BPS)	TNSS range from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on Likert scale from 0 (none) to 3 (severe);Higher score indicates worse outcome. TOSS range from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering;Higher score indicates worse outcome. TSS range from 0 (none) to 18 (severe): Sum of TNSS & TOSS;Higher score indicates worse outcome. DMS range from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS range from 0 to 38 (max): Sum of DMS & TSS;Higher score indicates worse outcome. Percent change from pre-treatment baseline in TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of peak birch pollen season presented.
Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) Score Averaged During BPS	Up to 253 days from randomization (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 in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Overall RQLQ(S) score averaged over duration of birch pollen season presented.
Standardized RQLQ(S) Score Averaged During Peak BPS	Up to 253 days from randomization (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 in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Overall RQLQ(S) score averaged over duration of peak birch pollen season presented.
Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS	Up to 253 days from randomization (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 in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Change from pre-treatment baseline averaged over duration of birch pollen season presented.
Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS	Up to 253 days from randomization (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 in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Change from pre-treatment baseline averaged over duration of peak birch pollen season presented.
Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS	Up to 253 days from randomization (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 in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Percent change from pre-treatment baseline averaged over duration of birch pollen season presented.
Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS	Up to 253 days from randomization (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 in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Percent change from pre-treatment baseline averaged over duration of peak birch pollen season presented.
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) Over the Study Duration	Up to 253 Days	—
Number of Participants With Any Treatment-Emergent Serious AE (TESAE) Over the Study Duration	Up to 253 Days	—
Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 29	Day 29 from randomization (Out-of-season)	TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.
Serum Concentration of REGN5714 Over the Study Duration	Up to Week 36	—
Serum Concentration of REGN5715 Over the Study Duration	Up to Week 36	—
Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time	Up to Week 36	—
Number of Participants With ADA to REGN5714 Over Time	Up to Week 36	—
Number of Participants With ADA to REGN5715 Over Time	Up to Week 36	—
Serum Concentration of REGN5713 Over the Study Duration	Up to Week 36	—

Countries

Canada

Participant flow

Pre-assignment details

847 participants were screened, of which 217 were randomized

Participants by arm

Arm	Count
Placebo Matching placebo	55
REGN5715 300 mg 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714	55
REGN5713-5715 600 mg 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714	52
REGN5713-5714-5715 900 mg 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb)	55
Total	217

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Lost to Follow-up	0	1	0	0
Overall Study	Protocol Violation	0	0	1	0
Overall Study	Withdrawal by Subject	3	0	0	1

Baseline characteristics

Characteristic	Placebo	REGN5715 300 mg	REGN5713-5715 600 mg	REGN5713-5714-5715 900 mg	Total
Age, Continuous	43.8 Years STANDARD_DEVIATION 13.72	40.1 Years STANDARD_DEVIATION 11.15	40.3 Years STANDARD_DEVIATION 10.87	42.6 Years STANDARD_DEVIATION 12.56	41.7 Years STANDARD_DEVIATION 12.17
Birch allergen EEU Mean Total Nasal Symptom Score (TNSS) (0 - 12) (2-6 Hours)	7.36 Scores on a Scale STANDARD_DEVIATION 2.489	7.84 Scores on a Scale STANDARD_DEVIATION 2.479	7.29 Scores on a Scale STANDARD_DEVIATION 2.414	7.71 Scores on a Scale STANDARD_DEVIATION 2.549	7.55 Scores on a Scale STANDARD_DEVIATION 2.477
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants	5 Participants	6 Participants	5 Participants	21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants	47 Participants	46 Participants	49 Participants	191 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	3 Participants	0 Participants	1 Participants	5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	7 Participants	6 Participants	8 Participants	12 Participants	33 Participants
Race (NIH/OMB) Black or African American	6 Participants	5 Participants	5 Participants	5 Participants	21 Participants
Race (NIH/OMB) More than one race	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	0 Participants	1 Participants	2 Participants	5 Participants
Race (NIH/OMB) White	39 Participants	43 Participants	37 Participants	36 Participants	155 Participants
Sex: Female, Male Female	30 Participants	27 Participants	22 Participants	34 Participants	113 Participants
Sex: Female, Male Male	25 Participants	28 Participants	30 Participants	21 Participants	104 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 55	0 / 55	0 / 51	0 / 55
other Total, other adverse events	23 / 55	19 / 55	20 / 51	19 / 55
serious Total, serious adverse events	0 / 55	0 / 55	0 / 51	0 / 55

Outcome results

Primary

Mean Total Nasal Symptom Score (TNSS) (2 to 6 Hours) During Out-of-season Birch Allergen Environmental Exposure Unit (EEU) Challenge (REGN5713-5714-5715 vs. Placebo) at Day 29

Time frame: Day 29 from randomization (Out-of-season)

Population: Randomized participants in only the REGN5713-5714-5715 and placebo arms were assessed for this endpoint. Missing values were imputed using multiple imputation (MI) method.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Mean Total Nasal Symptom Score (TNSS) (2 to 6 Hours) During Out-of-season Birch Allergen Environmental Exposure Unit (EEU) Challenge (REGN5713-5714-5715 vs. Placebo) at Day 29	4.40 Scores on a Scale	Standard Error 0.377
Placebo	Mean Total Nasal Symptom Score (TNSS) (2 to 6 Hours) During Out-of-season Birch Allergen Environmental Exposure Unit (EEU) Challenge (REGN5713-5714-5715 vs. Placebo) at Day 29	6.71 Scores on a Scale	Standard Error 0.38

p-value: <0.000195% CI: [-3.229, -1.385]ANCOVA

Secondary

Change From Pre-treatment 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 in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Change from pre-treatment baseline averaged over duration of birch pollen season presented.

Time frame: Up to 253 days from randomization (during BPS)

Population: Randomized participants who received a second dose of the study drug

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS	-0.11 Scores on a Scale	Standard Error 0.205
Placebo	Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS	-0.11 Scores on a Scale	Standard Error 0.215
Placebo	Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS	0.02 Scores on a Scale	Standard Error 0.197
Placebo	Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS	0.20 Scores on a Scale	Standard Error 0.189

Secondary

Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS

Time frame: Up to 253 days from randomization (during peak BPS)

Population: Randomized participants who received a second dose of the study drug

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS	-0.04 Scores on a Scale	Standard Error 0.229
Placebo	Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS	0.05 Scores on a Scale	Standard Error 0.239
Placebo	Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS	0.16 Scores on a Scale	Standard Error 0.22
Placebo	Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS	0.54 Scores on a Scale	Standard Error 0.215

Secondary

Change From Pre-treatment Baseline in the Birch Titrated Skin Prick Test (SPT) Mean Wheal Diameter Area Under the Curve (AUC) at Day 29

Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.

Time frame: Day 29 from randomization (Out-of-season)

Population: All randomized participants

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in the Birch Titrated Skin Prick Test (SPT) Mean Wheal Diameter Area Under the Curve (AUC) at Day 29	-5.396 millimeter (mm)	Standard Error 0.2822
Placebo	Change From Pre-treatment Baseline in the Birch Titrated Skin Prick Test (SPT) Mean Wheal Diameter Area Under the Curve (AUC) at Day 29	-4.743 millimeter (mm)	Standard Error 0.3243
Placebo	Change From Pre-treatment Baseline in the Birch Titrated Skin Prick Test (SPT) Mean Wheal Diameter Area Under the Curve (AUC) at Day 29	-3.266 millimeter (mm)	Standard Error 0.2983
Placebo	Change From Pre-treatment Baseline in the Birch Titrated Skin Prick Test (SPT) Mean Wheal Diameter Area Under the Curve (AUC) at Day 29	-0.507 millimeter (mm)	Standard Error 0.2946

Secondary

Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127

Time frame: Day 127 from randomization

Population: Randomized participants with Day 127 visit (intended to be pre-season) at least 12 weeks post-randomization

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127	-3.980 millimeter (mm)	Standard Error 0.3673
Placebo	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127	-3.590 millimeter (mm)	Standard Error 0.3907
Placebo	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127	-2.485 millimeter (mm)	Standard Error 0.3539
Placebo	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127	0.058 millimeter (mm)	Standard Error 0.3481

Secondary

Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253

Time frame: Day 225 from randomization (end-of-season) and Day 253 from randomization (end of study)

Population: Among randomized participants that received a second dose of study drug, the number of participants analyzed is the number of participants with a baseline measurement and post-baseline measurement. The number analyzed for each timepoint is the number of participants with available observed data that were analyzed at that timepoint.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 225	-5.435 millimeter (mm)	Standard Error 0.3648
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 253	-4.752 millimeter (mm)	Standard Error 0.3184
Placebo	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 253	-4.546 millimeter (mm)	Standard Error 0.3329
Placebo	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 225	-4.587 millimeter (mm)	Standard Error 0.4578
Placebo	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 225	-3.263 millimeter (mm)	Standard Error 0.3983
Placebo	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 253	-2.802 millimeter (mm)	Standard Error 0.3113
Placebo	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 225	-0.715 millimeter (mm)	Standard Error 0.3984
Placebo	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 253	-0.759 millimeter (mm)	Standard Error 0.3007

Secondary

Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85

Time frame: Day 57 and Day 85, from randomization (Out-of-season)

Population: The overall Number of Participants Analyzed is the total number of randomized participants in each treatment group. The Number Analyzed for each timepoint is the number of participants with available observed data that were analyzed at that timepoint.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 57	-5.110 millimeter (mm)	Standard Error 0.2878
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 85	-4.418 millimeter (mm)	Standard Error 0.3218
Placebo	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 85	-4.241 millimeter (mm)	Standard Error 0.3199
Placebo	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 57	-4.693 millimeter (mm)	Standard Error 0.2976
Placebo	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 57	-3.052 millimeter (mm)	Standard Error 0.2837
Placebo	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 85	-1.757 millimeter (mm)	Standard Error 0.3166
Placebo	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 57	-0.054 millimeter (mm)	Standard Error 0.2789
Placebo	Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 85	0.016 millimeter (mm)	Standard Error 0.293

Secondary

Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85

Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-3.04 Scores on a Scale	Standard Error 0.511
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-3.14 Scores on a Scale	Standard Error 0.371
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-3.14 Scores on a Scale	Standard Error 0.458
Placebo	Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-3.52 Scores on a Scale	Standard Error 0.411
Placebo	Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-3.17 Scores on a Scale	Standard Error 0.506
Placebo	Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-3.71 Scores on a Scale	Standard Error 0.471
Placebo	Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-2.03 Scores on a Scale	Standard Error 0.451
Placebo	Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-2.27 Scores on a Scale	Standard Error 0.373
Placebo	Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-2.27 Scores on a Scale	Standard Error 0.499
Placebo	Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-0.84 Scores on a Scale	Standard Error 0.376
Placebo	Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-1.50 Scores on a Scale	Standard Error 0.466
Placebo	Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-1.31 Scores on a Scale	Standard Error 0.445

Secondary

Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36

TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome.

Time frame: Day 36 from randomization (Out-of-season)

Population: The Number of Participants Analyzed is the number of participants allergic to oak with a baseline measurement and post-baseline measurement in each treatment group. The Number Analyzed for each scale is the number of participants with available observed data for that scale.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TNSS	-2.63 Scores on a Scale	Standard Error 0.561
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TSS	-3.97 Scores on a Scale	Standard Error 0.804
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TOSS	-1.33 Scores on a Scale	Standard Error 0.28
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TNSS	-2.89 Scores on a Scale	Standard Error 0.57
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TSS	-4.04 Scores on a Scale	Standard Error 0.817
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TOSS	-1.14 Scores on a Scale	Standard Error 0.284
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TOSS	-1.41 Scores on a Scale	Standard Error 0.256
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TNSS	-2.38 Scores on a Scale	Standard Error 0.516
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TSS	-3.79 Scores on a Scale	Standard Error 0.738
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TNSS	-1.83 Scores on a Scale	Standard Error 0.538
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TSS	-2.53 Scores on a Scale	Standard Error 0.771
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TOSS	-0.65 Scores on a Scale	Standard Error 0.27

Secondary

Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS

TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS & TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS & TSS; Higher score indicates worse outcome. Change from pre-treatment baseline in TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of birch pollen season presented.

Time frame: Up to 253 days from randomization (during BPS)

Population: The Number of Participants Analyzed is the number of participants who received a second dose of the study drug. The Number Analyzed for each scale is the number of participants with available observed data for that scale.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	DMS	0.78 Scores on a Scale	Standard Error 0.439
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TOSS	0.54 Scores on a Scale	Standard Error 0.199
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	CSMS	2.733 Scores on a Scale	Standard Error 0.8912
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TSS	1.93 Scores on a Scale	Standard Error 0.595
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TNSS	1.38 Scores on a Scale	Standard Error 0.422
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TSS	2.03 Scores on a Scale	Standard Error 0.625
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	DMS	0.83 Scores on a Scale	Standard Error 0.457
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	CSMS	2.891 Scores on a Scale	Standard Error 0.9352
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TOSS	0.60 Scores on a Scale	Standard Error 0.21
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TNSS	1.44 Scores on a Scale	Standard Error 0.443
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TSS	2.18 Scores on a Scale	Standard Error 0.582
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TNSS	1.57 Scores on a Scale	Standard Error 0.413
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TOSS	0.61 Scores on a Scale	Standard Error 0.195
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	DMS	0.98 Scores on a Scale	Standard Error 0.426
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	CSMS	3.158 Scores on a Scale	Standard Error 0.871
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	DMS	1.68 Scores on a Scale	Standard Error 0.408
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TOSS	1.06 Scores on a Scale	Standard Error 0.188
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TNSS	2.05 Scores on a Scale	Standard Error 0.399
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TSS	3.10 Scores on a Scale	Standard Error 0.563
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	CSMS	4.775 Scores on a Scale	Standard Error 0.8433

Secondary

Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS

TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS & TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS & TSS; Higher score indicates worse outcome. Change from pre-treatment baseline in TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of peak birch pollen season presented.

Time frame: Up to 253 days from randomization (during peak BPS)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	DMS	0.88 Scores on a Scale	Standard Error 0.504
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TOSS	0.69 Scores on a Scale	Standard Error 0.23
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	CSMS	3.376 Scores on a Scale	Standard Error 1.0154
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TSS	2.48 Scores on a Scale	Standard Error 0.679
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TNSS	1.79 Scores on a Scale	Standard Error 0.483
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TSS	2.62 Scores on a Scale	Standard Error 0.705
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	DMS	1.11 Scores on a Scale	Standard Error 0.517
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	CSMS	3.736 Scores on a Scale	Standard Error 1.0525
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TOSS	0.77 Scores on a Scale	Standard Error 0.238
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TNSS	1.86 Scores on a Scale	Standard Error 0.502
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TSS	2.40 Scores on a Scale	Standard Error 0.659
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TNSS	1.71 Scores on a Scale	Standard Error 0.469
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TOSS	0.70 Scores on a Scale	Standard Error 0.223
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	DMS	1.04 Scores on a Scale	Standard Error 0.485
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	CSMS	3.434 Scores on a Scale	Standard Error 0.9842
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	DMS	1.93 Scores on a Scale	Standard Error 0.463
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TOSS	1.32 Scores on a Scale	Standard Error 0.214
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TNSS	2.66 Scores on a Scale	Standard Error 0.452
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TSS	3.97 Scores on a Scale	Standard Error 0.635
Placebo	Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	CSMS	5.880 Scores on a Scale	Standard Error 0.95

Secondary

Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85

TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome.

Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-1.11 Scores on a Scale	Standard Error 0.202
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-1.15 Scores on a Scale	Standard Error 0.243
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-1.41 Scores on a Scale	Standard Error 0.231
Placebo	Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-1.26 Scores on a Scale	Standard Error 0.222
Placebo	Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-1.09 Scores on a Scale	Standard Error 0.241
Placebo	Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-1.37 Scores on a Scale	Standard Error 0.237
Placebo	Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-100 Scores on a Scale	Standard Error 0.227
Placebo	Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-0.87 Scores on a Scale	Standard Error 0.202
Placebo	Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-1.14 Scores on a Scale	Standard Error 0.238
Placebo	Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-0.44 Scores on a Scale	Standard Error 0.204
Placebo	Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-0.54 Scores on a Scale	Standard Error 0.223
Placebo	Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-0.47 Scores on a Scale	Standard Error 0.225

Secondary

Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85

TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome

Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-4.24 Scores on a Scale	Standard Error 0.543
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-4.20 Scores on a Scale	Standard Error 0.71
REGN5713-5714-5715 900 mg	Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-4.55 Scores on a Scale	Standard Error 0.652
Placebo	Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-4.76 Scores on a Scale	Standard Error 0.6
Placebo	Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-4.26 Scores on a Scale	Standard Error 0.703
Placebo	Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-5.08 Scores on a Scale	Standard Error 0.671
Placebo	Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-3.02 Scores on a Scale	Standard Error 0.642
Placebo	Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-3.14 Scores on a Scale	Standard Error 0.545
Placebo	Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-3.39 Scores on a Scale	Standard Error 0.693
Placebo	Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-1.26 Scores on a Scale	Standard Error 0.55
Placebo	Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-2.06 Scores on a Scale	Standard Error 0.648
Placebo	Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-1.78 Scores on a Scale	Standard Error 0.634

Secondary

Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)

TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS & TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for each pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS & TSS higher score indicates worse outcome). Daily TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of birch pollen season presented.

Time frame: Up to 253 days from randomization (during BPS)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	DMS	0.84 Scores on a Scale	Standard Error 0.439
REGN5713-5714-5715 900 mg	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	TOSS	1.09 Scores on a Scale	Standard Error 0.199
REGN5713-5714-5715 900 mg	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	CSMS	5.350 Scores on a Scale	Standard Error 0.8912
REGN5713-5714-5715 900 mg	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	TSS	4.48 Scores on a Scale	Standard Error 0.595
REGN5713-5714-5715 900 mg	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	TNSS	3.38 Scores on a Scale	Standard Error 0.422
Placebo	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	TSS	4.59 Scores on a Scale	Standard Error 0.625
Placebo	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	DMS	0.89 Scores on a Scale	Standard Error 0.457
Placebo	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	CSMS	5.509 Scores on a Scale	Standard Error 0.9352
Placebo	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	TOSS	1.15 Scores on a Scale	Standard Error 0.21
Placebo	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	TNSS	3.44 Scores on a Scale	Standard Error 0.443
Placebo	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	TSS	4.73 Scores on a Scale	Standard Error 0.582
Placebo	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	TNSS	3.57 Scores on a Scale	Standard Error 0.413
Placebo	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	TOSS	1.16 Scores on a Scale	Standard Error 0.195
Placebo	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	DMS	1.05 Scores on a Scale	Standard Error 0.426
Placebo	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	CSMS	5.776 Scores on a Scale	Standard Error 0.871
Placebo	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	DMS	1.74 Scores on a Scale	Standard Error 0.408
Placebo	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	TOSS	1.62 Scores on a Scale	Standard Error 0.188
Placebo	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	TNSS	4.05 Scores on a Scale	Standard Error 0.399
Placebo	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	TSS	5.65 Scores on a Scale	Standard Error 0.563
Placebo	Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)	CSMS	7.392 Scores on a Scale	Standard Error 0.8433

Secondary

Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS

TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS & TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for each pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS & TSS higher score indicates worse outcome). Daily TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of peak birch pollen season presented.

Time frame: Up to 253 days from randomization (during peak BPS)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	TSS	5.03 Scores on a Scale	Standard Error 0.679
REGN5713-5714-5715 900 mg	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	DMS	0.94 Scores on a Scale	Standard Error 0.504
REGN5713-5714-5715 900 mg	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	CSMS	5.997 Scores on a Scale	Standard Error 1.0154
REGN5713-5714-5715 900 mg	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	TOSS	1.24 Scores on a Scale	Standard Error 0.23
REGN5713-5714-5715 900 mg	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	TNNS	3.79 Scores on a Scale	Standard Error 0.483
Placebo	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	TOSS	1.32 Scores on a Scale	Standard Error 0.238
Placebo	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	DMS	1.18 Scores on a Scale	Standard Error 0.517
Placebo	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	TSS	5.18 Scores on a Scale	Standard Error 0.705
Placebo	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	TNNS	3.87 Scores on a Scale	Standard Error 0.502
Placebo	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	CSMS	6.357 Scores on a Scale	Standard Error 1.0525
Placebo	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	TSS	4.96 Scores on a Scale	Standard Error 0.659
Placebo	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	TNNS	3.71 Scores on a Scale	Standard Error 0.469
Placebo	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	TOSS	1.25 Scores on a Scale	Standard Error 0.223
Placebo	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	DMS	1.11 Scores on a Scale	Standard Error 0.485
Placebo	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	CSMS	6.055 Scores on a Scale	Standard Error 0.9842
Placebo	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	DMS	1.99 Scores on a Scale	Standard Error 0.463
Placebo	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	TNNS	4.67 Scores on a Scale	Standard Error 0.452
Placebo	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	TOSS	1.87 Scores on a Scale	Standard Error 0.214
Placebo	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	TSS	6.53 Scores on a Scale	Standard Error 0.635
Placebo	Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS	CSMS	8.501 Scores on a Scale	Standard Error 0.95

Secondary

Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85

Time frame: Day 57 and Day 85, from randomization (Out-of-season)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 57	4.47 Scores on a Scale	Standard Error 0.458
REGN5713-5714-5715 900 mg	Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 85	4.61 Scores on a Scale	Standard Error 0.511
Placebo	Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 85	4.48 Scores on a Scale	Standard Error 0.506
Placebo	Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 57	3.89 Scores on a Scale	Standard Error 0.471
Placebo	Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 57	5.58 Scores on a Scale	Standard Error 0.451
Placebo	Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 85	5.38 Scores on a Scale	Standard Error 0.499
Placebo	Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 57	6.29 Scores on a Scale	Standard Error 0.445
Placebo	Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 85	6.14 Scores on a Scale	Standard Error 0.466

Secondary

Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 29

Time frame: Day 29 from randomization (Out-of-season)

Population: Randomized participants in only the REGN5713-5715, REGN5715 and placebo arms were assessed for this endpoint. Missing values were imputed using multiple imputation (MI) method.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 29	4.06 Scores on a Scale	Standard Error 0.406
Placebo	Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 29	5.20 Scores on a Scale	Standard Error 0.393
Placebo	Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 29	6.71 Scores on a Scale	Standard Error 0.38

p-value: <0.000195% CI: [-3.634, -1.658]ANCOVA

p-value: 0.002395% CI: [-2.478, -0.539]ANCOVA

Secondary

Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36

Time frame: Day 36 from randomization (Out-of-season)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36	TSS	6.64 Scores on a Scale	Standard Error 0.804
REGN5713-5714-5715 900 mg	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36	TNSS	4.79 Scores on a Scale	Standard Error 0.561
REGN5713-5714-5715 900 mg	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36	TOSS	1.86 Scores on a Scale	Standard Error 0.28
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36	TOSS	2.05 Scores on a Scale	Standard Error 0.284
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36	TNSS	4.53 Scores on a Scale	Standard Error 0.57
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36	TSS	6.57 Scores on a Scale	Standard Error 0.817
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36	TSS	6.82 Scores on a Scale	Standard Error 0.738
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36	TNSS	5.04 Scores on a Scale	Standard Error 0.516
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36	TOSS	1.78 Scores on a Scale	Standard Error 0.256
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36	TOSS	2.54 Scores on a Scale	Standard Error 0.27
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36	TNSS	5.59 Scores on a Scale	Standard Error 0.538
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36	TSS	8.08 Scores on a Scale	Standard Error 0.771

Secondary

Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190

Peak season EEU is an in-season challenge corresponding to approximate timing of the anticipated peak BPS; TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome.

Time frame: Day 190 from randomization (In-season); Timing may vary based on local season

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190	TSS	6.39 Scores on a Scale	Standard Error 0.692
REGN5713-5714-5715 900 mg	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190	TNSS	4.49 Scores on a Scale	Standard Error 0.497
REGN5713-5714-5715 900 mg	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190	TOSS	1.90 Scores on a Scale	Standard Error 0.246
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190	TOSS	1.85 Scores on a Scale	Standard Error 0.257
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190	TNSS	4.41 Scores on a Scale	Standard Error 0.52
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190	TSS	6.26 Scores on a Scale	Standard Error 0.724
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190	TSS	6.92 Scores on a Scale	Standard Error 0.69
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190	TNSS	5.07 Scores on a Scale	Standard Error 0.497
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190	TOSS	1.83 Scores on a Scale	Standard Error 0.245
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190	TOSS	2.68 Scores on a Scale	Standard Error 0.232
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190	TNSS	6.69 Scores on a Scale	Standard Error 0.469
Placebo	Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190	TSS	9.36 Scores on a Scale	Standard Error 0.653

Secondary

Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85

Time frame: Day 57 and Day 85, from randomization (Out-of-season)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 57	1.63 Scores on a Scale	Standard Error 0.231
REGN5713-5714-5715 900 mg	Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 85	1.90 Scores on a Scale	Standard Error 0.243
Placebo	Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 85	1.96 Scores on a Scale	Standard Error 0.241
Placebo	Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 57	1.66 Scores on a Scale	Standard Error 0.237
Placebo	Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 57	2.04 Scores on a Scale	Standard Error 0.227
Placebo	Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 85	1.91 Scores on a Scale	Standard Error 0.238
Placebo	Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 57	2.57 Scores on a Scale	Standard Error 0.225
Placebo	Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85	Day 85	2.51 Scores on a Scale	Standard Error 0.223

Secondary

Mean Total Ocular Symptom Score (TOSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29

Time frame: Day 29 from randomization (Out-of-season)

Population: All randomized participants. Missing values were imputed using multiple imputation (MI) method.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Mean Total Ocular Symptom Score (TOSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29	1.81 Scores on a Scale	Standard Error 0.202
Placebo	Mean Total Ocular Symptom Score (TOSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29	1.69 Scores on a Scale	Standard Error 0.217
Placebo	Mean Total Ocular Symptom Score (TOSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29	2.01 Scores on a Scale	Standard Error 0.207
Placebo	Mean Total Ocular Symptom Score (TOSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29	2.48 Scores on a Scale	Standard Error 0.202

Secondary

Mean Total Symptom Score (TSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29

TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome

Time frame: Day 29 from randomization (Out-of-season)

Population: All randomized participants. Missing values were imputed using multiple imputation (MI) method.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Mean Total Symptom Score (TSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29	6.22 Scores on a Scale	Standard Error 0.549
Placebo	Mean Total Symptom Score (TSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29	5.76 Scores on a Scale	Standard Error 0.592
Placebo	Mean Total Symptom Score (TSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29	7.21 Scores on a Scale	Standard Error 0.572
Placebo	Mean Total Symptom Score (TSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29	9.20 Scores on a Scale	Standard Error 0.553

Secondary

Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85

TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome

Time frame: Day 57 and Day 85, from randomization (Out-of-season)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85	Day 57	6.09 Scores on a Scale	Standard Error 0.652
REGN5713-5714-5715 900 mg	Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85	Day 85	6.49 Scores on a Scale	Standard Error 0.71
Placebo	Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85	Day 85	6.44 Scores on a Scale	Standard Error 0.703
Placebo	Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85	Day 57	5.57 Scores on a Scale	Standard Error 0.671
Placebo	Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85	Day 57	7.62 Scores on a Scale	Standard Error 0.642
Placebo	Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85	Day 85	7.30 Scores on a Scale	Standard Error 0.693
Placebo	Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85	Day 57	8.86 Scores on a Scale	Standard Error 0.634
Placebo	Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85	Day 85	8.63 Scores on a Scale	Standard Error 0.648

Secondary

Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds

Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	4 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	15 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	17 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	3 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	13 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	7 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	9 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	7 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	2 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	14 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	7 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	27 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	13 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	1 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	31 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	26 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	15 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	6 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	21 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	11 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	23 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	31 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	13 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	30 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	10 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	18 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	26 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	7 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	6 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	40 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	30 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	15 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	23 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	31 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	17 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	9 Participants

Secondary

Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds

Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	5 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	17 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	18 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	7 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	22 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	10 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	13 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	9 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	8 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	22 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	10 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	26 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	18 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	6 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	34 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	30 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	21 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	10 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	25 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	12 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	20 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	29 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	20 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	26 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	14 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	19 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	24 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	11 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	20 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	38 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	30 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	20 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	28 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	31 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	27 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	16 Participants

Secondary

Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds

TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome.

Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	13 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	18 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	7 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	3 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	8 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	7 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	3 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	15 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	4 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	15 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	2 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	13 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	30 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	4 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	25 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	7 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	14 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	29 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	11 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	29 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	25 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	18 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	23 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	23 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	14 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	8 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	29 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	8 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	22 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	32 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	32 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	21 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	11 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	40 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	16 Participants
Placebo	Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	9 Participants

Secondary

Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds

Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	11 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	1 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	1 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	1 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	0 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	5 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	1 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	5 Participants
REGN5713-5714-5715 900 mg	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	0 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	12 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	2 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	17 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	1 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	34 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	1 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	9 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	29 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	0 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	21 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	27 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	31 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	11 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	34 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	24 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	4 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	8 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	35 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 85 Participants with a percent reduction of at least 25% or greater	32 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 29 Participants with a percent reduction of at least 75% or greater	19 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 29 Participants with a percent reduction of at least 50% or greater	41 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 29 Participants with a percent reduction of at least 25% or greater	50 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 57 Participants with a percent reduction of at least 75% or greater	12 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 57 Participants with a percent reduction of at least 25% or greater	40 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 85 Participants with a percent reduction of at least 75% or greater	8 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 85 Participants with a percent reduction of at least 50% or greater	25 Participants
Placebo	Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds	Day 57 Participants with a percent reduction of at least 50% or greater	25 Participants

Secondary

Number of Participants With ADA to REGN5714 Over Time

Time frame: Up to Week 36

Population: Randomized and treated participants who received REGN5714 during the study

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With ADA to REGN5714 Over Time	Negative	53 Participants
Placebo	Number of Participants With ADA to REGN5714 Over Time	Low Titer (<1000) Treatment Emergent Response	1 Participants
Placebo	Number of Participants With ADA to REGN5714 Over Time	Moderate Titer (1000 to 10000) Treatment Emergent Response	0 Participants
Placebo	Number of Participants With ADA to REGN5714 Over Time	High Titer (>10000) Treatment Emergent Response	0 Participants

Secondary

Number of Participants With ADA to REGN5715 Over Time

Time frame: Up to Week 36

Population: Randomized and treated participants who received REGN5715 during the study

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
REGN5713-5714-5715 900 mg	Number of Participants With ADA to REGN5715 Over Time	Negative	53 Participants
REGN5713-5714-5715 900 mg	Number of Participants With ADA to REGN5715 Over Time	Low Titer (<1000) Treatment Emergent Response	1 Participants
REGN5713-5714-5715 900 mg	Number of Participants With ADA to REGN5715 Over Time	Moderate Titer (1000 to 10000) Treatment Emergent Response	0 Participants
REGN5713-5714-5715 900 mg	Number of Participants With ADA to REGN5715 Over Time	High Titer (>10000) Treatment Emergent Response	0 Participants
Placebo	Number of Participants With ADA to REGN5715 Over Time	High Titer (>10000) Treatment Emergent Response	0 Participants
Placebo	Number of Participants With ADA to REGN5715 Over Time	Negative	50 Participants
Placebo	Number of Participants With ADA to REGN5715 Over Time	Moderate Titer (1000 to 10000) Treatment Emergent Response	0 Participants
Placebo	Number of Participants With ADA to REGN5715 Over Time	Low Titer (<1000) Treatment Emergent Response	1 Participants
Placebo	Number of Participants With ADA to REGN5715 Over Time	High Titer (>10000) Treatment Emergent Response	0 Participants
Placebo	Number of Participants With ADA to REGN5715 Over Time	Low Titer (<1000) Treatment Emergent Response	1 Participants
Placebo	Number of Participants With ADA to REGN5715 Over Time	Moderate Titer (1000 to 10000) Treatment Emergent Response	0 Participants
Placebo	Number of Participants With ADA to REGN5715 Over Time	Negative	53 Participants

Secondary

Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time

Time frame: Up to Week 36

Population: Randomized and treated participants who received REGN5713 during the study

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time	Low Titer (<1000) Treatment Emergent Response	0 Participants
Placebo	Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time	Negative	51 Participants
Placebo	Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time	Moderate Titer (1000 to 10000) Treatment Emergent Response	0 Participants
Placebo	Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time	High Titer (>10000) Treatment Emergent Response	0 Participants
Placebo	Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time	High Titer (>10000) Treatment Emergent Response	0 Participants
Placebo	Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time	Moderate Titer (1000 to 10000) Treatment Emergent Response	0 Participants
Placebo	Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time	Negative	54 Participants
Placebo	Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time	Low Titer (<1000) Treatment Emergent Response	0 Participants

Secondary

Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) Over the Study Duration

Time frame: Up to 253 Days

Population: Randomized participants who receive any study drug, regardless of the amount of treatment administered

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
REGN5713-5714-5715 900 mg	Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) Over the Study Duration	26 Participants
Placebo	Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) Over the Study Duration	23 Participants
Placebo	Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) Over the Study Duration	23 Participants
Placebo	Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) Over the Study Duration	25 Participants

Secondary

Number of Participants With Any Treatment-Emergent Serious AE (TESAE) Over the Study Duration

Time frame: Up to 253 Days

Population: Randomized participants who receive any study drug, regardless of the amount of treatment administered

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
REGN5713-5714-5715 900 mg	Number of Participants With Any Treatment-Emergent Serious AE (TESAE) Over the Study Duration	0 Participants
Placebo	Number of Participants With Any Treatment-Emergent Serious AE (TESAE) Over the Study Duration	0 Participants
Placebo	Number of Participants With Any Treatment-Emergent Serious AE (TESAE) Over the Study Duration	0 Participants
Placebo	Number of Participants With Any Treatment-Emergent Serious AE (TESAE) Over the Study Duration	0 Participants

Secondary

Percent Change From Pre-treatment 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 in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Percent change from pre-treatment baseline averaged over duration of birch pollen season presented.

Time frame: Up to 253 days from randomization (during BPS)

Population: Randomized participants who received a second dose of the study drug

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS	-32.68 Percentage of Change	Standard Error 16.904
Placebo	Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS	-22.84 Percentage of Change	Standard Error 17.78
Placebo	Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS	-12.70 Percentage of Change	Standard Error 16.298
Placebo	Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS	2.06 Percentage of Change	Standard Error 15.598

Secondary

Percent Change From Pre-treatment 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 in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Percent change from pre-treatment baseline averaged over duration of peak birch pollen season presented.

Time frame: Up to 253 days from randomization (during peak BPS)

Population: Randomized participants who received a second dose of the study drug

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS	-27.67 Percentage of Change	Standard Error 19.22
Placebo	Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS	-9.90 Percentage of Change	Standard Error 20
Placebo	Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS	-1.67 Percentage of Change	Standard Error 18.446
Placebo	Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS	29.24 Percentage of Change	Standard Error 17.972

Secondary

Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127

Time frame: Day 127 from randomization

Population: Randomized participants with Day 127 visit (intended to be pre-season) at least 12 weeks post-randomization

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127	-49.10 Percentage of Change	Standard Error 5.715
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127	-44.38 Percentage of Change	Standard Error 6.079
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127	-29.13 Percentage of Change	Standard Error 5.506
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127	9.30 Percentage of Change	Standard Error 5.416

Secondary

Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253

Time frame: Day 225 from randomization (end-of-season) and Day 253 from randomization (end of study)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 225	-72.42 Percentage of Change	Standard Error 5.621
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 253	-62.71 Percentage of Change	Standard Error 5.01
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 253	-60.89 Percentage of Change	Standard Error 5.238
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 225	-57.83 Percentage of Change	Standard Error 7.054
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 225	-36.74 Percentage of Change	Standard Error 6.136
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 253	-30.98 Percentage of Change	Standard Error 4.898
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 225	-6.70 Percentage of Change	Standard Error 6.138
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253	Day 253	-5.41 Percentage of Change	Standard Error 4.732

Secondary

Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 29

Time frame: Day 29 from randomization (Out-of-season)

Population: All randomized participants

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 29	-66.50 Percentage of Change	Standard Error 4.036
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 29	-59.32 Percentage of Change	Standard Error 4.689
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 29	-38.14 Percentage of Change	Standard Error 4.217
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 29	-3.31 Percentage of Change	Standard Error 4.223

p-value: <0.000195% CI: [-73.411, -52.95]ANCOVA

p-value: <0.000195% CI: [-66.806, -45.204]ANCOVA

p-value: <0.000195% CI: [-45.304, -24.343]ANCOVA

Secondary

Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85

Time frame: Day 57 and Day 85, from randomization (Out-of-season)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 57	-64.45 Percentage of Change	Standard Error 4.917
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 85	-54.36 Percentage of Change	Standard Error 5.108
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 85	-54.43 Percentage of Change	Standard Error 5.079
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 57	-59.19 Percentage of Change	Standard Error 5.084
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 57	-37.04 Percentage of Change	Standard Error 4.847
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 85	-18.38 Percentage of Change	Standard Error 5.026
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 57	8.07 Percentage of Change	Standard Error 4.765
Placebo	Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85	Day 85	7.85 Percentage of Change	Standard Error 4.651

Secondary

Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85

Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-41.94 Percentage of Change	Standard Error 7.683
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-44.35 Percentage of Change	Standard Error 5.099
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-42.98 Percentage of Change	Standard Error 6.508
Placebo	Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-48.26 Percentage of Change	Standard Error 6.689
Placebo	Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-46.86 Percentage of Change	Standard Error 5.645
Placebo	Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-39.22 Percentage of Change	Standard Error 7.607
Placebo	Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-28.94 Percentage of Change	Standard Error 7.505
Placebo	Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-27.88 Percentage of Change	Standard Error 5.132
Placebo	Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-29.48 Percentage of Change	Standard Error 6.407
Placebo	Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-11.65 Percentage of Change	Standard Error 6.318
Placebo	Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-4.10 Percentage of Change	Standard Error 5.173
Placebo	Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-13.99 Percentage of Change	Standard Error 7.003

Secondary

Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36

Time frame: Day 36 from randomization (Out-of-season)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TNSS	-35.18 Percentage of Change	Standard Error 7.448
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TSS	-38.98 Percentage of Change	Standard Error 7.471
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TOSS	-52.74 Percentage of Change	Standard Error 9.947
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TNSS	-34.95 Percentage of Change	Standard Error 7.572
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TSS	-33.81 Percentage of Change	Standard Error 7.59
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TOSS	-32.95 Percentage of Change	Standard Error 10.097
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TOSS	-49.39 Percentage of Change	Standard Error 9.113
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TNSS	-30.36 Percentage of Change	Standard Error 6.848
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TSS	-35.14 Percentage of Change	Standard Error 6.858
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TNSS	-20.46 Percentage of Change	Standard Error 7.144
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TSS	-19.25 Percentage of Change	Standard Error 7.167
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36	TOSS	-15.45 Percentage of Change	Standard Error 9.589

Secondary

Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS

TNSS range from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS range from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS range from 0 (none) to 18 (severe): Sum of TNSS & TOSS; Higher score indicates worse outcome. DMS range from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS range from 0 to 38 (max): Sum of DMS & TSS; Higher score indicates worse outcome. Percent change from pre-treatment baseline in TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of birch pollen season presented.

Time frame: Up to 253 days from randomization (during BPS)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	DMS	-17.06 Percentage of Change	Standard Error 43.686
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TOSS	-2.85 Percentage of Change	Standard Error 18.48
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	CSMS	147.47 Percentage of Change	Standard Error 65.846
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TSS	126.46 Percentage of Change	Standard Error 42.83
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TNSS	86.55 Percentage of Change	Standard Error 32.12
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TSS	128.85 Percentage of Change	Standard Error 45.018
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	DMS	-15.13 Percentage of Change	Standard Error 45.431
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	CSMS	187.32 Percentage of Change	Standard Error 69.092
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TOSS	-0.66 Percentage of Change	Standard Error 19.426
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TNSS	81.60 Percentage of Change	Standard Error 33.741
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TSS	147.59 Percentage of Change	Standard Error 41.886
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TNSS	112.71 Percentage of Change	Standard Error 31.414
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TOSS	2.78 Percentage of Change	Standard Error 18.078
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	DMS	2.66 Percentage of Change	Standard Error 42.367
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	CSMS	219.64 Percentage of Change	Standard Error 64.352
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	DMS	70.85 Percentage of Change	Standard Error 40.614
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TOSS	44.16 Percentage of Change	Standard Error 17.452
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TNSS	120.74 Percentage of Change	Standard Error 30.384
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	TSS	177.04 Percentage of Change	Standard Error 40.526
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS	CSMS	263.58 Percentage of Change	Standard Error 62.302

Secondary

Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS

TNSS range from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on Likert scale from 0 (none) to 3 (severe);Higher score indicates worse outcome. TOSS range from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering;Higher score indicates worse outcome. TSS range from 0 (none) to 18 (severe): Sum of TNSS & TOSS;Higher score indicates worse outcome. DMS range from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS range from 0 to 38 (max): Sum of DMS & TSS;Higher score indicates worse outcome. Percent change from pre-treatment baseline in TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of peak birch pollen season presented.

Time frame: Up to 253 days from randomization (during peak BPS)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	DMS	-7.34 Percentage of Change	Standard Error 50.188
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TOSS	9.74 Percentage of Change	Standard Error 21.416
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	CSMS	164.04 Percentage of Change	Standard Error 76.371
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TSS	143.52 Percentage of Change	Standard Error 48.745
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TNSS	103.41 Percentage of Change	Standard Error 36.254
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TSS	165.35 Percentage of Change	Standard Error 50.606
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	DMS	13.02 Percentage of Change	Standard Error 51.51
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	CSMS	246.04 Percentage of Change	Standard Error 79.156
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TOSS	14.03 Percentage of Change	Standard Error 22.233
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TNSS	110.33 Percentage of Change	Standard Error 37.612
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TSS	157.81 Percentage of Change	Standard Error 47.273
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TNSS	121.50 Percentage of Change	Standard Error 35.16
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TOSS	10.21 Percentage of Change	Standard Error 20.773
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	DMS	8.63 Percentage of Change	Standard Error 48.254
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	CSMS	227.73 Percentage of Change	Standard Error 74.021
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	DMS	95.84 Percentage of Change	Standard Error 46.109
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TOSS	68.18 Percentage of Change	Standard Error 19.993
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TNSS	166.54 Percentage of Change	Standard Error 33.905
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	TSS	234.84 Percentage of Change	Standard Error 45.601
Placebo	Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS	CSMS	340.82 Percentage of Change	Standard Error 71.451

Secondary

Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85

Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-44.15 Percentage of Change	Standard Error 7.729
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-53.08 Percentage of Change	Standard Error 7.932
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-46.38 Percentage of Change	Standard Error 9.206
Placebo	Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-44.70 Percentage of Change	Standard Error 8.147
Placebo	Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-40.40 Percentage of Change	Standard Error 8.504
Placebo	Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-32.54 Percentage of Change	Standard Error 9.117
Placebo	Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-29.90 Percentage of Change	Standard Error 7.731
Placebo	Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-35.02 Percentage of Change	Standard Error 7.795
Placebo	Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-39.16 Percentage of Change	Standard Error 8.997
Placebo	Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 57	-11.64 Percentage of Change	Standard Error 7.725
Placebo	Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 85	-12.17 Percentage of Change	Standard Error 8.431
Placebo	Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85	Day 29	-8.40 Percentage of Change	Standard Error 7.807

Secondary

Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85

TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome

Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85	Day 29	-44.33 Percentage of Change	Standard Error 5.274
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85	Day 85	42.74 Percentage of Change	Standard Error 7.252
REGN5713-5714-5715 900 mg	Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85	Day 57	-45.49 Percentage of Change	Standard Error 6.283
Placebo	Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85	Day 29	-44.97 Percentage of Change	Standard Error 5.83
Placebo	Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85	Day 85	-37.11 Percentage of Change	Standard Error 7.186
Placebo	Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85	Day 57	-46.81 Percentage of Change	Standard Error 6.46
Placebo	Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85	Day 57	-30.21 Percentage of Change	Standard Error 6.182
Placebo	Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85	Day 29	-27.50 Percentage of Change	Standard Error 5.298
Placebo	Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85	Day 85	-31.64 Percentage of Change	Standard Error 7.084
Placebo	Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85	Day 29	-4.18 Percentage of Change	Standard Error 5.347
Placebo	Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85	Day 85	-13.55 Percentage of Change	Standard Error 6.621
Placebo	Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85	Day 57	-10.55 Percentage of Change	Standard Error 6.11

Secondary

Serum Concentration of REGN5713 Over the Study Duration

Time frame: Up to Week 36

Population: Randomized and treated participants who received REGN5713 and contributed to each timepoint

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Baseline	0 mg/L	Standard Deviation 0
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 22	1.42 mg/L	Standard Deviation 1.27
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 12	4.72 mg/L	Standard Deviation 2.37
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 27	16.9 mg/L	Standard Deviation 5.54
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 8	7.10 mg/L	Standard Deviation 2.69
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 32	6.11 mg/L	Standard Deviation 3.1
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 18	2.18 mg/L	Standard Deviation 1.8
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 36	2.88 mg/L	Standard Deviation 1.47
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 4	15.2 mg/L	Standard Deviation 4.72
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 36	4.18 mg/L	Standard Deviation 3.02
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Baseline	0 mg/L	Standard Deviation 0
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 4	16.2 mg/L	Standard Deviation 5.23
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 8	8.12 mg/L	Standard Deviation 3.59
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 12	5.25 mg/L	Standard Deviation 3.09
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 18	2.84 mg/L	Standard Deviation 2.6
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 22	2.04 mg/L	Standard Deviation 2.36
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 27	20.8 mg/L	Standard Deviation 8.4
Placebo	Serum Concentration of REGN5713 Over the Study Duration	Week 32	6.52 mg/L	Standard Deviation 3.56

Secondary

Serum Concentration of REGN5714 Over the Study Duration

Time frame: Up to Week 36

Population: Randomized and treated participants who received REGN5714 and contributed to each timepoint

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Serum Concentration of REGN5714 Over the Study Duration	Baseline	0 mg/L	Standard Deviation 0
Placebo	Serum Concentration of REGN5714 Over the Study Duration	Week 4	22.3 mg/L	Standard Deviation 5.96
Placebo	Serum Concentration of REGN5714 Over the Study Duration	Week 8	13.1 mg/L	Standard Deviation 4.36
Placebo	Serum Concentration of REGN5714 Over the Study Duration	Week 12	9.01 mg/L	Standard Deviation 3.7
Placebo	Serum Concentration of REGN5714 Over the Study Duration	Week 18	5.34 mg/L	Standard Deviation 3.69
Placebo	Serum Concentration of REGN5714 Over the Study Duration	Week 22	3.95 mg/L	Standard Deviation 3.45
Placebo	Serum Concentration of REGN5714 Over the Study Duration	Week 27	29.0 mg/L	Standard Deviation 9.51
Placebo	Serum Concentration of REGN5714 Over the Study Duration	Week 32	11.9 mg/L	Standard Deviation 4.92
Placebo	Serum Concentration of REGN5714 Over the Study Duration	Week 36	7.90 mg/L	Standard Deviation 4.1

Secondary

Serum Concentration of REGN5715 Over the Study Duration

Time frame: Up to Week 36

Population: Randomized and treated participants who received REGN5715 and contributed to each timepoint

Arm	Measure	Group	Value (MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Serum Concentration of REGN5715 Over the Study Duration	Week 12	8.30 mg/L	Standard Deviation 3.42
REGN5713-5714-5715 900 mg	Serum Concentration of REGN5715 Over the Study Duration	Week 36	5.83 mg/L	Standard Deviation 2.42
REGN5713-5714-5715 900 mg	Serum Concentration of REGN5715 Over the Study Duration	Week 22	3.02 mg/L	Standard Deviation 2.2
REGN5713-5714-5715 900 mg	Serum Concentration of REGN5715 Over the Study Duration	Week 18	4.75 mg/L	Standard Deviation 3.27
REGN5713-5714-5715 900 mg	Serum Concentration of REGN5715 Over the Study Duration	Baseline	0 mg/L	Standard Deviation 0
REGN5713-5714-5715 900 mg	Serum Concentration of REGN5715 Over the Study Duration	Week 32	9.60 mg/L	Standard Deviation 4.09
REGN5713-5714-5715 900 mg	Serum Concentration of REGN5715 Over the Study Duration	Week 8	11.1 mg/L	Standard Deviation 3.35
REGN5713-5714-5715 900 mg	Serum Concentration of REGN5715 Over the Study Duration	Week 4	20.6 mg/L	Standard Deviation 5.94
REGN5713-5714-5715 900 mg	Serum Concentration of REGN5715 Over the Study Duration	Week 27	22.7 mg/L	Standard Deviation 8.4
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 18	4.51 mg/L	Standard Deviation 2.86
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Baseline	0 mg/L	Standard Deviation 0
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 4	21.5 mg/L	Standard Deviation 5.54
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 8	12.3 mg/L	Standard Deviation 3.63
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 12	8.73 mg/L	Standard Deviation 3.38
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 22	3.12 mg/L	Standard Deviation 2.16
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 27	24.4 mg/L	Standard Deviation 6.95
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 32	10.7 mg/L	Standard Deviation 4.26
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 36	6.16 mg/L	Standard Deviation 2.1
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 8	14.8 mg/L	Standard Deviation 4.96
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Baseline	0 mg/L	Standard Deviation 0
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 27	29.3 mg/L	Standard Deviation 9.29
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 4	26.7 mg/L	Standard Deviation 9.37
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 36	8.21 mg/L	Standard Deviation 4.21
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 18	5.92 mg/L	Standard Deviation 4.17
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 12	10.4 mg/L	Standard Deviation 4.28
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 32	12.2 mg/L	Standard Deviation 4.93
Placebo	Serum Concentration of REGN5715 Over the Study Duration	Week 22	4.29 mg/L	Standard Deviation 3.77

Secondary

Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) Score Averaged 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 in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Overall RQLQ(S) score averaged over duration of birch pollen season presented.

Time frame: Up to 253 days from randomization (during BPS)

Population: Randomized participants who received a second dose of the study drug

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) Score Averaged During BPS	0.98 Scores on a Scale	Standard Error 0.205
Placebo	Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) Score Averaged During BPS	0.98 Scores on a Scale	Standard Error 0.215
Placebo	Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) Score Averaged During BPS	1.11 Scores on a Scale	Standard Error 0.197
Placebo	Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) Score Averaged During BPS	1.29 Scores on a Scale	Standard Error 0.189

Secondary

Standardized RQLQ(S) Score Averaged 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 in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Overall RQLQ(S) score averaged over duration of peak birch pollen season presented.

Time frame: Up to 253 days from randomization (during peak BPS)

Population: Randomized participants who received a second dose of the study drug

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
REGN5713-5714-5715 900 mg	Standardized RQLQ(S) Score Averaged During Peak BPS	1.04 Scores on a Scale	Standard Error 0.229
Placebo	Standardized RQLQ(S) Score Averaged During Peak BPS	1.14 Scores on a Scale	Standard Error 0.239
Placebo	Standardized RQLQ(S) Score Averaged During Peak BPS	1.25 Scores on a Scale	Standard Error 0.22
Placebo	Standardized RQLQ(S) Score Averaged During Peak BPS	1.62 Scores on a Scale	Standard Error 0.215

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Mean Total Nasal Symptom Score (TNSS) (2 to 6 Hours) During Out-of-season Birch Allergen Environmental Exposure Unit (EEU) Challenge (REGN5713-5714-5715 vs. Placebo) at Day 29

Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS

Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS

Change From Pre-treatment Baseline in the Birch Titrated Skin Prick Test (SPT) Mean Wheal Diameter Area Under the Curve (AUC) at Day 29

Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127

Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253

Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85

Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85

Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36

Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS

Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS

Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85

Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85

Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)

Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS

Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85

Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 29

Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36

Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190

Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85

Mean Total Ocular Symptom Score (TOSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29

Mean Total Symptom Score (TSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29

Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85

Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds

Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds

Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds

Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds

Number of Participants With ADA to REGN5714 Over Time

Number of Participants With ADA to REGN5715 Over Time

Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time

Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) Over the Study Duration

Number of Participants With Any Treatment-Emergent Serious AE (TESAE) Over the Study Duration

Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS

Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS

Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127

Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253

Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 29

Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85

Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85

Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36

Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS

Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS

Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85

Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85

Serum Concentration of REGN5713 Over the Study Duration

Serum Concentration of REGN5714 Over the Study Duration

Serum Concentration of REGN5715 Over the Study Duration

Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) Score Averaged During BPS

Standardized RQLQ(S) Score Averaged During Peak BPS