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CompletedNCT05430919Updated Nov 19, 2024Results posted

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 Phase 2 interventional study of REGN5713 and REGN5714 in Allergic Rhinitis and Conjunctivitis, sponsored by Regeneron Pharmaceuticals. Completed at 3 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-19.

Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
217
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Allergic Rhinitis
  • Conjunctivitis

Keywords

  • Birch Allergy
  • Birch Pollen Season
  • Monoclonal antibody(ies)
  • Oak Pollen Season
  • Subcutaneous immunotherapy
  • Skin Prick Test
03

In context

Rhinitis, Allergic

717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.

This study's enrollment of 217 is above the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.

Browse Rhinitis, Allergic studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.

Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.

Browse Regeneron Pharmaceuticals studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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 (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 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 cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease,
  12. Any 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 disease for 3 years.

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
217 participants (actual)

Study arms

  • Experimental
    REGN5713-5714-5715

    3-mAb

    Drug: REGN5713 · Drug: REGN5714 · Drug: REGN5715

  • Experimental
    REGN5713-5715

    2-mAb

    Drug: REGN5713 · Drug: REGN5715 · Other: Placebo

  • Experimental
    REGN5715

    1-mAb

    Drug: REGN5715 · Other: Placebo

  • Placebo comparator
    Matching Placebo

    Other: Placebo

Interventions

  • DrugREGN5713

    Administered subcutaneously (SC)

  • DrugREGN5714

    Administered SC

  • DrugREGN5715

    Administered SC

  • OtherPlacebo

    Administered SC

06

What researchers measure

Primary outcomes

  1. 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

    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.

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

Secondary outcomes

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

    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.

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

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

    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.

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

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

    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 from randomization (Out-of-season)

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

  5. 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)

  6. 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)

  7. 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

    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.

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

  8. 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)

  9. 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)

  10. 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

    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.

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

  11. 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

    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)

  12. 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)

  13. 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)

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

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

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

    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 127 from randomization

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

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

  17. Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter 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)

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

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

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

    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 127 from randomization

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

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

  21. Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season 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)

  22. 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)

  23. Percent 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)

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

    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.

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

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

    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)

  26. 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)

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

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

  28. 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

  29. 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)

  30. 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)

  31. 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)

  32. 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)

  33. 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)

  34. 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)

  35. 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)

  36. 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)

  37. 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)

  38. 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). 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)

  39. 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)

  40. 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)

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

    Time frame: Up to 253 Days

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

    Time frame: Up to 253 Days

  43. Serum Concentration of REGN5713 Over the Study Duration

    Time frame: Up to Week 36

  44. Serum Concentration of REGN5714 Over the Study Duration

    Time frame: Up to Week 36

  45. Serum Concentration of REGN5715 Over the Study Duration

    Time frame: Up to Week 36

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

    Time frame: Up to Week 36

  47. Number of Participants With ADA to REGN5714 Over Time

    Time frame: Up to Week 36

  48. Number of Participants With ADA to REGN5715 Over Time

    Time frame: Up to Week 36

07

Results

Posted Nov 19, 2024

Participant flow

Participant flow — Overall Study
MilestonePlaceboREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mg
Started55555255
Completed52545154
Not completed3111
Withdrew: Protocol violation0010
Withdrew: Lost to follow-up0100
Withdrew: Withdrawal by subject3001

Outcome measures

PrimaryMean 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

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.

Time frame:
Day 29 from randomization (Out-of-season)
Reported as:
Least squares mean · Scores on a Scale
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
Scores on a ScaleREGN5713-5714-5715 900 mgPlacebo
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 294.40 ± 0.3776.71 ± 0.380
Statistical analysis
  • REGN5713-5714-5715 900 mg vs Placebo · ANCOVA · p = <0.0001 · Least squares (ls) mean difference: -2.31 · 95% CI -3.229 to -1.385REGN5713-5714-5715 900 mg vs. Placebo, Day 29
SecondaryMean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 29

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.

Time frame:
Day 29 from randomization (Out-of-season)
Reported as:
Least squares mean · Scores on a Scale
Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 29
Scores on a ScaleREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 294.06 ± 0.4065.20 ± 0.3936.71 ± 0.380
Statistical analysis
  • REGN5713-5715 600 mg vs Placebo · ANCOVA · p = <0.0001 · Ls mean difference: -2.65 · 95% CI -3.634 to -1.658REGN5713-5715 600 mg vs. Placebo, Day 29
  • REGN5715 300 mg vs Placebo · ANCOVA · p = 0.0023 · Ls mean difference: -1.51 · 95% CI -2.478 to -0.539REGN5715 300 mg vs. Placebo, Day 29
SecondaryMean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85

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.

Time frame:
Day 57 and Day 85, from randomization (Out-of-season)
Reported as:
Least squares mean · Scores on a Scale
Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Day 574.47 ± 0.4583.89 ± 0.4715.58 ± 0.4516.29 ± 0.445
Day 854.61 ± 0.5114.48 ± 0.5065.38 ± 0.4996.14 ± 0.466
SecondaryMean Total Ocular Symptom Score (TOSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29

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 from randomization (Out-of-season)
Reported as:
Least squares mean · Scores on a Scale
Mean Total Ocular Symptom Score (TOSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Mean Total Ocular Symptom Score (TOSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 291.81 ± 0.2021.69 ± 0.2172.01 ± 0.2072.48 ± 0.202
SecondaryMean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 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 57 and Day 85, from randomization (Out-of-season)
Reported as:
Least squares mean · Scores on a Scale
Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Day 571.63 ± 0.2311.66 ± 0.2372.04 ± 0.2272.57 ± 0.225
Day 851.90 ± 0.2431.96 ± 0.2411.91 ± 0.2382.51 ± 0.223
SecondaryMean 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)
Reported as:
Least squares mean · Scores on a Scale
Mean Total Symptom Score (TSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Mean Total Symptom Score (TSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 296.22 ± 0.5495.76 ± 0.5927.21 ± 0.5729.20 ± 0.553
SecondaryMean 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)
Reported as:
Least squares mean · Scores on a Scale
Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Day 576.09 ± 0.6525.57 ± 0.6717.62 ± 0.6428.86 ± 0.634
Day 856.49 ± 0.7106.44 ± 0.7037.30 ± 0.6938.63 ± 0.648
SecondaryChange From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85

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.

Time frame:
Day 29, Day 57 and Day 85, from randomization (Out-of-season)
Reported as:
Least squares mean · Scores on a Scale
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
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Day 29-3.14 ± 0.371-3.52 ± 0.411-2.27 ± 0.373-0.84 ± 0.376
Day 57-3.14 ± 0.458-3.71 ± 0.471-2.03 ± 0.451-1.31 ± 0.445
Day 85-3.04 ± 0.511-3.17 ± 0.506-2.27 ± 0.499-1.50 ± 0.466
SecondaryChange 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)
Reported as:
Least squares mean · Scores on a Scale
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
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Day 29-1.11 ± 0.202-1.26 ± 0.222-0.87 ± 0.202-0.44 ± 0.204
Day 57-1.41 ± 0.231-1.37 ± 0.237-100 ± 0.227-0.47 ± 0.225
Day 85-1.15 ± 0.243-1.09 ± 0.241-1.14 ± 0.238-0.54 ± 0.223
SecondaryChange 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)
Reported as:
Least squares mean · Scores on a Scale
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
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Day 29-4.24 ± 0.543-4.76 ± 0.600-3.14 ± 0.545-1.26 ± 0.550
Day 57-4.55 ± 0.652-5.08 ± 0.671-3.02 ± 0.642-1.78 ± 0.634
Day 85-4.20 ± 0.710-4.26 ± 0.703-3.39 ± 0.693-2.06 ± 0.648
SecondaryPercent 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

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.

Time frame:
Day 29, Day 57 and Day 85, from randomization (Out-of-season)
Reported as:
Least squares mean · Percentage of Change
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
Percentage of ChangeREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Day 29-44.35 ± 5.099-46.86 ± 5.645-27.88 ± 5.132-4.10 ± 5.173
Day 57-42.98 ± 6.508-48.26 ± 6.689-29.48 ± 6.407-11.65 ± 6.318
Day 85-41.94 ± 7.683-39.22 ± 7.607-28.94 ± 7.505-13.99 ± 7.003
SecondaryPercent 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)
Reported as:
Least squares mean · Percentage of Change
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
Percentage of ChangeREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Day 29-44.15 ± 7.729-40.40 ± 8.504-29.90 ± 7.731-8.40 ± 7.807
Day 57-53.08 ± 7.932-44.70 ± 8.147-35.02 ± 7.795-11.64 ± 7.725
Day 85-46.38 ± 9.206-32.54 ± 9.117-39.16 ± 8.997-12.17 ± 8.431
SecondaryPercent 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)
Reported as:
Least squares mean · Percentage of Change
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
Percentage of ChangeREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Day 29-44.33 ± 5.274-44.97 ± 5.830-27.50 ± 5.298-4.18 ± 5.347
Day 57-45.49 ± 6.283-46.81 ± 6.460-30.21 ± 6.182-10.55 ± 6.110
Day 8542.74 ± 7.252-37.11 ± 7.186-31.64 ± 7.084-13.55 ± 6.621
SecondaryChange 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)
Reported as:
Least squares mean · millimeter (mm)
Change From Pre-treatment Baseline in the Birch Titrated Skin Prick Test (SPT) Mean Wheal Diameter Area Under the Curve (AUC) at Day 29
millimeter (mm)REGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
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 ± 0.2822-4.743 ± 0.3243-3.266 ± 0.2983-0.507 ± 0.2946
SecondaryChange From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85

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 57 and Day 85, from randomization (Out-of-season)
Reported as:
Least squares mean · millimeter (mm)
Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85
millimeter (mm)REGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Day 57-5.110 ± 0.2878-4.693 ± 0.2976-3.052 ± 0.2837-0.054 ± 0.2789
Day 85-4.418 ± 0.3218-4.241 ± 0.3199-1.757 ± 0.31660.016 ± 0.2930
SecondaryChange From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127

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 127 from randomization
Reported as:
Least squares mean · millimeter (mm)
Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127
millimeter (mm)REGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127-3.980 ± 0.3673-3.590 ± 0.3907-2.485 ± 0.35390.058 ± 0.3481
SecondaryChange From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253

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 225 from randomization (end-of-season) and Day 253 from randomization (end of study)
Reported as:
Least squares mean · millimeter (mm)
Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253
millimeter (mm)REGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Day 225-5.435 ± 0.3648-4.587 ± 0.4578-3.263 ± 0.3983-0.715 ± 0.3984
Day 253-4.752 ± 0.3184-4.546 ± 0.3329-2.802 ± 0.3113-0.759 ± 0.3007
SecondaryPercent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter 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)
Reported as:
Least squares mean · Percentage of Change
Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 29
Percentage of ChangeREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 29-66.50 ± 4.036-59.32 ± 4.689-38.14 ± 4.217-3.31 ± 4.223
Statistical analysis
  • REGN5713-5714-5715 900 mg vs Placebo · ANCOVA · p = <0.0001 · Ls mean difference: -63.18 · 95% CI -73.411 to -52.950REGN5713-5714-5715 900 mg vs. Placebo, Day 29
  • REGN5713-5715 600 mg vs Placebo · ANCOVA · p = <0.0001 · Ls mean difference: -56.01 · 95% CI -66.806 to -45.204REGN5713-5715 600 mg vs. Placebo, Day 29
  • REGN5715 300 mg vs Placebo · ANCOVA · p = <0.0001 · Ls mean difference: -34.82 · 95% CI -45.304 to -24.343REGN5715 300 mg vs. Placebo, Day 29
SecondaryPercent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85

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 57 and Day 85, from randomization (Out-of-season)
Reported as:
Least squares mean · Percentage of Change
Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85
Percentage of ChangeREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Day 57-64.45 ± 4.917-59.19 ± 5.084-37.04 ± 4.8478.07 ± 4.765
Day 85-54.36 ± 5.108-54.43 ± 5.079-18.38 ± 5.0267.85 ± 4.651
SecondaryPercent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127

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 127 from randomization
Reported as:
Least squares mean · Percentage of Change
Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127
Percentage of ChangeREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127-49.10 ± 5.715-44.38 ± 6.079-29.13 ± 5.5069.30 ± 5.416
SecondaryPercent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253

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 225 from randomization (end-of-season) and Day 253 from randomization (end of study)
Reported as:
Least squares mean · Percentage of Change
Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253
Percentage of ChangeREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Day 225-72.42 ± 5.621-57.83 ± 7.054-36.74 ± 6.136-6.70 ± 6.138
Day 253-62.71 ± 5.010-60.89 ± 5.238-30.98 ± 4.898-5.41 ± 4.732
SecondaryMean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season 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)
Reported as:
Least squares mean · Scores on a Scale
Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
TNSS4.79 ± 0.5614.53 ± 0.5705.04 ± 0.5165.59 ± 0.538
TOSS1.86 ± 0.2802.05 ± 0.2841.78 ± 0.2562.54 ± 0.270
TSS6.64 ± 0.8046.57 ± 0.8176.82 ± 0.7388.08 ± 0.771
SecondaryChange 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)
Reported as:
Least squares mean · Scores on a Scale
Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
TNSS-2.63 ± 0.561-2.89 ± 0.570-2.38 ± 0.516-1.83 ± 0.538
TOSS-1.33 ± 0.280-1.14 ± 0.284-1.41 ± 0.256-0.65 ± 0.270
TSS-3.97 ± 0.804-4.04 ± 0.817-3.79 ± 0.738-2.53 ± 0.771
SecondaryPercent 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)
Reported as:
Least squares mean · Percentage of Change
Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36
Percentage of ChangeREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
TNSS-35.18 ± 7.448-34.95 ± 7.572-30.36 ± 6.848-20.46 ± 7.144
TOSS-52.74 ± 9.947-32.95 ± 10.097-49.39 ± 9.113-15.45 ± 9.589
TSS-38.98 ± 7.471-33.81 ± 7.590-35.14 ± 6.858-19.25 ± 7.167
SecondaryNumber of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds

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.

Time frame:
Day 29, Day 57 and Day 85, from randomization (Out-of-season)
Reported as:
Count of participants · Participants
Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds
ParticipantsPlaceboREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mg
Day 29 Participants with a percent reduction of at least 75% or greater21119
Day 29 Participants with a percent reduction of at least 50% or greater7132323
Day 29 Participants with a percent reduction of at least 25% or greater13313140
Day 57 Participants with a percent reduction of at least 75% or greater36136
Day 57 Participants with a percent reduction of at least 50% or greater7142117
Day 57 Participants with a percent reduction of at least 25% or greater15273031
Day 85 Participants with a percent reduction of at least 75% or greater47107
Day 85 Participants with a percent reduction of at least 50% or greater9151815
Day 85 Participants with a percent reduction of at least 25% or greater17262630
SecondaryNumber of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds

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)
Reported as:
Count of participants · Participants
Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds
ParticipantsPlaceboREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mg
Day 29 Participants with a percent reduction of at least 75% or greater861216
Day 29 Participants with a percent reduction of at least 50% or greater10182028
Day 29 Participants with a percent reduction of at least 25% or greater22342938
Day 57 Participants with a percent reduction of at least 75% or greater7102020
Day 57 Participants with a percent reduction of at least 50% or greater9222527
Day 57 Participants with a percent reduction of at least 25% or greater17262631
Day 85 Participants with a percent reduction of at least 75% or greater5101411
Day 85 Participants with a percent reduction of at least 50% or greater13211920
Day 85 Participants with a percent reduction of at least 25% or greater18302430
SecondaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds
ParticipantsPlaceboREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mg
Day 29 Participants with a percent reduction of at least 75% or greater321111
Day 29 Participants with a percent reduction of at least 50% or greater7132321
Day 29 Participants with a percent reduction of at least 25% or greater13302940
Day 57 Participants with a percent reduction of at least 75% or greater34149
Day 57 Participants with a percent reduction of at least 50% or greater7152322
Day 57 Participants with a percent reduction of at least 25% or greater15252932
Day 85 Participants with a percent reduction of at least 75% or greater4788
Day 85 Participants with a percent reduction of at least 50% or greater8141816
Day 85 Participants with a percent reduction of at least 25% or greater18292532
SecondaryNumber of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds

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, Day 57 and Day 85, from randomization (Out-of-season)
Reported as:
Count of participants · Participants
Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds
ParticipantsPlaceboREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mg
Day 29 Participants with a percent reduction of at least 75% or greater11819
Day 29 Participants with a percent reduction of at least 50% or greater1122441
Day 29 Participants with a percent reduction of at least 25% or greater11343550
Day 57 Participants with a percent reduction of at least 75% or greater01412
Day 57 Participants with a percent reduction of at least 50% or greater192725
Day 57 Participants with a percent reduction of at least 25% or greater5293440
Day 85 Participants with a percent reduction of at least 75% or greater00118
Day 85 Participants with a percent reduction of at least 50% or greater122125
Day 85 Participants with a percent reduction of at least 25% or greater5173132
SecondaryMean 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
Reported as:
Least squares mean · Scores on a Scale
Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
TNSS4.49 ± 0.4974.41 ± 0.5205.07 ± 0.4976.69 ± 0.469
TOSS1.90 ± 0.2461.85 ± 0.2571.83 ± 0.2452.68 ± 0.232
TSS6.39 ± 0.6926.26 ± 0.7246.92 ± 0.6909.36 ± 0.653
SecondaryDaily 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)
Reported as:
Least squares mean · Scores on a Scale
Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
TNSS3.38 ± 0.4223.44 ± 0.4433.57 ± 0.4134.05 ± 0.399
TOSS1.09 ± 0.1991.15 ± 0.2101.16 ± 0.1951.62 ± 0.188
TSS4.48 ± 0.5954.59 ± 0.6254.73 ± 0.5825.65 ± 0.563
DMS0.84 ± 0.4390.89 ± 0.4571.05 ± 0.4261.74 ± 0.408
CSMS5.350 ± 0.89125.509 ± 0.93525.776 ± 0.87107.392 ± 0.8433
SecondaryDaily 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)
Reported as:
Least squares mean · Scores on a Scale
Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
TNNS3.79 ± 0.4833.87 ± 0.5023.71 ± 0.4694.67 ± 0.452
TOSS1.24 ± 0.2301.32 ± 0.2381.25 ± 0.2231.87 ± 0.214
TSS5.03 ± 0.6795.18 ± 0.7054.96 ± 0.6596.53 ± 0.635
DMS0.94 ± 0.5041.18 ± 0.5171.11 ± 0.4851.99 ± 0.463
CSMS5.997 ± 1.01546.357 ± 1.05256.055 ± 0.98428.501 ± 0.9500
SecondaryChange 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)
Reported as:
Least squares mean · Scores on a Scale
Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
TNSS1.38 ± 0.4221.44 ± 0.4431.57 ± 0.4132.05 ± 0.399
TOSS0.54 ± 0.1990.60 ± 0.2100.61 ± 0.1951.06 ± 0.188
TSS1.93 ± 0.5952.03 ± 0.6252.18 ± 0.5823.10 ± 0.563
DMS0.78 ± 0.4390.83 ± 0.4570.98 ± 0.4261.68 ± 0.408
CSMS2.733 ± 0.89122.891 ± 0.93523.158 ± 0.87104.775 ± 0.8433
SecondaryChange 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)
Reported as:
Least squares mean · Scores on a Scale
Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
TNSS1.79 ± 0.4831.86 ± 0.5021.71 ± 0.4692.66 ± 0.452
TOSS0.69 ± 0.2300.77 ± 0.2380.70 ± 0.2231.32 ± 0.214
TSS2.48 ± 0.6792.62 ± 0.7052.40 ± 0.6593.97 ± 0.635
DMS0.88 ± 0.5041.11 ± 0.5171.04 ± 0.4851.93 ± 0.463
CSMS3.376 ± 1.01543.736 ± 1.05253.434 ± 0.98425.880 ± 0.9500
SecondaryPercent 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)
Reported as:
Least squares mean · Percentage of Change
Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS
Percentage of ChangeREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
TNSS86.55 ± 32.12081.60 ± 33.741112.71 ± 31.414120.74 ± 30.384
TOSS-2.85 ± 18.480-0.66 ± 19.4262.78 ± 18.07844.16 ± 17.452
TSS126.46 ± 42.830128.85 ± 45.018147.59 ± 41.886177.04 ± 40.526
DMS-17.06 ± 43.686-15.13 ± 45.4312.66 ± 42.36770.85 ± 40.614
CSMS147.47 ± 65.846187.32 ± 69.092219.64 ± 64.352263.58 ± 62.302
SecondaryPercent 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)
Reported as:
Least squares mean · Percentage of Change
Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS
Percentage of ChangeREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
TNSS103.41 ± 36.254110.33 ± 37.612121.50 ± 35.160166.54 ± 33.905
TOSS9.74 ± 21.41614.03 ± 22.23310.21 ± 20.77368.18 ± 19.993
TSS143.52 ± 48.745165.35 ± 50.606157.81 ± 47.273234.84 ± 45.601
DMS-7.34 ± 50.18813.02 ± 51.5108.63 ± 48.25495.84 ± 46.109
CSMS164.04 ± 76.371246.04 ± 79.156227.73 ± 74.021340.82 ± 71.451
SecondaryStandardized 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)
Reported as:
Least squares mean · Scores on a Scale
Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) Score Averaged During BPS
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) Score Averaged During BPS0.98 ± 0.2050.98 ± 0.2151.11 ± 0.1971.29 ± 0.189
SecondaryStandardized 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)
Reported as:
Least squares mean · Scores on a Scale
Standardized RQLQ(S) Score Averaged During Peak BPS
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Standardized RQLQ(S) Score Averaged During Peak BPS1.04 ± 0.2291.14 ± 0.2391.25 ± 0.2201.62 ± 0.215
SecondaryChange 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)
Reported as:
Least squares mean · Scores on a Scale
Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS-0.11 ± 0.205-0.11 ± 0.2150.02 ± 0.1970.20 ± 0.189
SecondaryChange 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). 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)
Reported as:
Least squares mean · Scores on a Scale
Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS
Scores on a ScaleREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS-0.04 ± 0.2290.05 ± 0.2390.16 ± 0.2200.54 ± 0.215
SecondaryPercent 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)
Reported as:
Least squares mean · Percentage of Change
Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS
Percentage of ChangeREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS-32.68 ± 16.904-22.84 ± 17.780-12.70 ± 16.2982.06 ± 15.598
SecondaryPercent 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)
Reported as:
Least squares mean · Percentage of Change
Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS
Percentage of ChangeREGN5713-5714-5715 900 mgREGN5713-5715 600 mgREGN5715 300 mgPlacebo
Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS-27.67 ± 19.220-9.90 ± 20.000-1.67 ± 18.44629.24 ± 17.972
SecondaryNumber of Participants With Any Treatment-Emergent Adverse Event (TEAE) Over the Study Duration
Time frame:
Up to 253 Days
Reported as:
Count of participants · Participants
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) Over the Study Duration
ParticipantsPlaceboREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mg
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) Over the Study Duration26232325
SecondaryNumber of Participants With Any Treatment-Emergent Serious AE (TESAE) Over the Study Duration
Time frame:
Up to 253 Days
Reported as:
Count of participants · Participants
Number of Participants With Any Treatment-Emergent Serious AE (TESAE) Over the Study Duration
ParticipantsPlaceboREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mg
Number of Participants With Any Treatment-Emergent Serious AE (TESAE) Over the Study Duration0000
SecondarySerum Concentration of REGN5713 Over the Study Duration
Time frame:
Up to Week 36
Reported as:
Mean · mg/L
Serum Concentration of REGN5713 Over the Study Duration
mg/LREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mg
Baseline—0 ± 00 ± 0
Week 4—15.2 ± 4.7216.2 ± 5.23
Week 8—7.10 ± 2.698.12 ± 3.59
Week 12—4.72 ± 2.375.25 ± 3.09
Week 18—2.18 ± 1.802.84 ± 2.60
Week 22—1.42 ± 1.272.04 ± 2.36
Week 27—16.9 ± 5.5420.8 ± 8.40
Week 32—6.11 ± 3.106.52 ± 3.56
Week 36—2.88 ± 1.474.18 ± 3.02
SecondarySerum Concentration of REGN5714 Over the Study Duration
Time frame:
Up to Week 36
Reported as:
Mean · mg/L
Serum Concentration of REGN5714 Over the Study Duration
mg/LREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mg
Baseline——0 ± 0
Week 4——22.3 ± 5.96
Week 8——13.1 ± 4.36
Week 12——9.01 ± 3.70
Week 18——5.34 ± 3.69
Week 22——3.95 ± 3.45
Week 27——29.0 ± 9.51
Week 32——11.9 ± 4.92
Week 36——7.90 ± 4.10
SecondarySerum Concentration of REGN5715 Over the Study Duration
Time frame:
Up to Week 36
Reported as:
Mean · mg/L
Serum Concentration of REGN5715 Over the Study Duration
mg/LREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mg
Baseline0 ± 00 ± 00 ± 0
Week 420.6 ± 5.9421.5 ± 5.5426.7 ± 9.37
Week 811.1 ± 3.3512.3 ± 3.6314.8 ± 4.96
Week 128.30 ± 3.428.73 ± 3.3810.4 ± 4.28
Week 184.75 ± 3.274.51 ± 2.865.92 ± 4.17
Week 223.02 ± 2.203.12 ± 2.164.29 ± 3.77
Week 2722.7 ± 8.4024.4 ± 6.9529.3 ± 9.29
Week 329.60 ± 4.0910.7 ± 4.2612.2 ± 4.93
Week 365.83 ± 2.426.16 ± 2.108.21 ± 4.21
SecondaryNumber of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time
Time frame:
Up to Week 36
Reported as:
Count of participants · Participants
Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time
ParticipantsREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mg
Negative—5154
Low Titer (<1000) Treatment Emergent Response—00
Moderate Titer (1000 to 10000) Treatment Emergent Response—00
High Titer (>10000) Treatment Emergent Response—00
SecondaryNumber of Participants With ADA to REGN5714 Over Time
Time frame:
Up to Week 36
Reported as:
Count of participants · Participants
Number of Participants With ADA to REGN5714 Over Time
ParticipantsREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mg
Negative——53
Low Titer (<1000) Treatment Emergent Response——1
Moderate Titer (1000 to 10000) Treatment Emergent Response——0
High Titer (>10000) Treatment Emergent Response——0
SecondaryNumber of Participants With ADA to REGN5715 Over Time
Time frame:
Up to Week 36
Reported as:
Count of participants · Participants
Number of Participants With ADA to REGN5715 Over Time
ParticipantsREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mg
Negative535053
Low Titer (<1000) Treatment Emergent Response111
Moderate Titer (1000 to 10000) Treatment Emergent Response000
High Titer (>10000) Treatment Emergent Response000

Adverse events

Collected over From the time of signing the informed consent form (ICF) up to Day 260. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/55 (0%)0/55 (0%)23/55 (41.8%)
REGN5715 300 mg0/55 (0%)0/55 (0%)19/55 (34.5%)
REGN5713-5715 600 mg0/51 (0%)0/51 (0%)20/51 (39.2%)
REGN5713-5714-5715 900 mg0/55 (0%)0/55 (0%)19/55 (34.5%)
Most frequent other events
Showing 10 of 15
Most frequent other events
EventPlaceboREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mg
HeadacheNervous system disorders8/554/5510/517/55
Upper respiratory tract infectionInfections and infestations3/558/555/513/55
COVID-19Infections and infestations4/553/555/512/55
Oropharyngeal painRespiratory, thoracic and mediastinal disorders5/552/552/510/55
Injection site erythemaGeneral disorders2/551/554/512/55
Injection related reactionInjury, poisoning and procedural complications0/554/551/510/55
Back painMusculoskeletal and connective tissue disorders3/551/551/514/55
NauseaGastrointestinal disorders4/551/550/511/55
Injection site pruritusGeneral disorders3/550/553/511/55
PresyncopeNervous system disorders3/553/552/512/55

Baseline characteristics

Age, Continuous
Age, Continuous(Years)PlaceboREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mgTotal
Mean43.8 ± 13.7240.1 ± 11.1540.3 ± 10.8742.6 ± 12.5641.7 ± 12.17
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mgTotal
Female30272234113
Male25283021104
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mgTotal
Hispanic or Latino556521
Not Hispanic or Latino49474649191
Unknown or Not Reported13015
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mgTotal
American Indian or Alaska Native01001
Asian7681233
Native Hawaiian or Other Pacific Islander00000
Black or African American655521
White39433736155
More than one race10102
Unknown or Not Reported20125
Birch allergen EEU Mean Total Nasal Symptom Score (TNSS) (0 - 12) (2-6 Hours)
Birch allergen EEU Mean Total Nasal Symptom Score (TNSS) (0 - 12) (2-6 Hours)(Scores on a Scale)PlaceboREGN5715 300 mgREGN5713-5715 600 mgREGN5713-5714-5715 900 mgTotal
Mean7.36 ± 2.4897.84 ± 2.4797.29 ± 2.4147.71 ± 2.5497.55 ± 2.477
08

Study locations

3 sites
  • Kingston General Health Research Institute
    Kingston, Ontario K7L 2V7, Canada
  • Inflamax Research Limited DBA Cliantha Research
    Mississauga, Ontario L4W 1A4, Canada
  • Clinique Specialisee en Allergie de la Capitale
    Quebec City, Quebec G1V4W2, Canada
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.

Access criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

Data sharing details ↗ · vivli.org

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05430919
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Jun 24, 2022
Start date
Aug 15, 2022
Primary completion
Jul 31, 2023
Completion
Jul 31, 2023
Results posted
Nov 19, 2024
Last update
Nov 19, 2024

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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