| Primary | Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo | The average CSMS will be calculated based on daily symptom score and daily medication score recorded over the duration of the birch pollen season (BPS). CSMS is calculated by adding the Daily Medication Score (DMS) and Total Symptom Score (TSS) together, with scores ranging between 0 (none) and 38 (severe). | All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Until the end of Birch Pollen Season, up to Week 16 | | | | ID | Title | Description |
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| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously | | OG001 | Placebo Only | Placebo matching REGN5713-5714-5715 administered subcutaneously |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0007.503± 0.6545
- OG0018.498± 0.6534
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | LS Mean Difference | | 0.0497 | | linear mixed-effect model | -0.995 | | | 2-Sided | 95 | -1.9886 | -0.0011 | | | | | Superiority | | |
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| Secondary | Total Symptom Score (TSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo | TSS is a combined score of TOSS and TNSS. TNSS and TOSS are scored as in part 1 each for a combined TSS of 0 (none) to 18 (severe) | All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Until the end of Birch Pollen Season, up to Week 16 | | | | ID | Title | Description |
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| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously | | OG001 | Placebo Only | Placebo matching REGN5713-5714-5715 administered subcutaneously |
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| Secondary | Total Nasal Symptom Score (TNSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo | Total nasal symptom score (TNSS) is from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a Likert scale ranging from 0 (none) to 3 (severe) for congestion, itching, and rhinorrhea, and from 0 (none) to 3 (5 or more sneezes) for sneezing. | All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Until the end of Birch Pollen Season, up to Week 16 | | | | ID | Title | Description |
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| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously | | OG001 | Placebo Only | Placebo matching REGN5713-5714-5715 administered subcutaneously |
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| Secondary | Total Ocular Symptom Score (TOSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo | Total ocular symptom score is 0 to 6 and is based on itching/redness/gritty feeling and tearing/watering; each of the 2 symptoms is graded 0 (absent), 1 (mild), 2 (moderate), and 3 (severe) | All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Until the end of Birch Pollen Season, up to Week 16 | | | | ID | Title | Description |
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| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously | | OG001 | Placebo Only | Placebo matching REGN5713-5714-5715 administered subcutaneously |
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| Secondary | Daily Medication Score (DMS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo | The Daily Medication Score (DMS) is calculated by adding points for each pre-specified medication taken as follows: desloratadine 5 mg 6 points/dose; maximum daily score 6 points, olopatadine 1 mg/mL each drop 1.5 points/drop; maximum daily score 6 points, mometasone furoate 50 ug/dose 2.0 points/spray; maximum daily score 8 points). The scale is 0 (minimum) to 20 (maximum) | All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season | Posted | | Least Squares Mean | Standard Error | Score on a Scale | | Until the end of Birch Pollen Season, up to Week 16 | | | | ID | Title | Description |
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| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously | | OG001 | Placebo Only | Placebo matching REGN5713-5714-5715 administered subcutaneously |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Throughout the Study | Number of participants with any Treatment Emergent Adverse Events (TEAEs) from participating in study | All participants in Safety Analysis Set (SAF) who received study drug and were recorded, if symptoms were displayed or not | Posted | | Number | | Count of Participants | | Up to Day 127 | | | | ID | Title | Description |
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| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously | | OG001 | Placebo Only | Placebo matching REGN5713-5714-5715 administered subcutaneously |
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| Secondary | Number of Participants With Serious TEAEs Throughout the Study | Number of participants with any Serious Treatment Emergent Adverse Events (TEAEs) from participating in study | All participants in Safety Analysis Set (SAF) who received study drug and were recorded, if symptoms were displayed or not | Posted | | Number | | Count of Participants | | Up to Day 127 | | | | ID | Title | Description |
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| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously | | OG001 | Placebo Only | Placebo matching REGN5713-5714-5715 administered subcutaneously |
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| Secondary | Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo | Number of participants who showed change from baseline to the end of the study in Birch Skin Prick Test (SPT) Mean Wheal Diameter, in participants who received REGN5713-5714-5715 compared to placebo | All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season | Posted | | Least Squares Mean | Standard Error | millimeters | | Baseline through Day 127 | | | | ID | Title | Description |
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| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously | | OG001 | Placebo Only | Placebo matching REGN5713-5714-5715 administered subcutaneously |
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| Secondary | Percent Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo | | All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season | Posted | | Least Squares Mean | Standard Error | Percentage | | Baseline through Day 127 | | | | ID | Title | Description |
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| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously | | OG001 | Placebo Only | Placebo matching REGN5713-5714-5715 administered subcutaneously |
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| Secondary | Serum Concentration of REGN5713 Over the Study Duration | | All randomized and treated participants who recorded and contributed to each timepoint (+/- 14 days) | Posted | | Mean | Standard Deviation | mg/L | | Day 0, Day 56, Day 112 | | | | ID | Title | Description |
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| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously |
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| Secondary | Serum Concentration of REGN5714 Over the Study Duration | | All randomized and treated participants who recorded and contributed to each timepoint (+/- 14 days) | Posted | | Mean | Standard Deviation | mg/L | | Up to Day 127 | | | | ID | Title | Description |
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| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously |
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| Secondary | Serum Concentration of REGN5715 Over the Study Duration | | All randomized and treated participants who recorded and contributed to each timepoint (+/- 14 days) | Posted | | Mean | Standard Deviation | mg/L | | Up to Day 127 | | | | ID | Title | Description |
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| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously |
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| Secondary | Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5713 Throughout the Study | Percentage of participants who developed antibodies to intervention provided during study | All randomized and treated participants who recorded and contributed to each timepoint (+/- 14 days) | Posted | | Number | | Percentage of Participants | | Up to Day 127 | | | | ID | Title | Description |
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| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously | | OG001 | Placebo Only | Placebo matching REGN5713-5714-5715 administered subcutaneously |
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| Secondary | Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5714 Throughout the Study | Percentage of participants who developed antibodies to intervention provided during study | All randomized and treated participants who recorded and contributed to each timepoint (+/- 14 days) | Posted | | Number | | Percentage of Participants | | Up to Day 127 | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously | | OG001 | Placebo Only | Placebo matching REGN5713-5714-5715 administered subcutaneously |
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| Secondary | Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5715 Throughout the Study | Percentage of participants who developed antibodies to intervention provided during study | All randomized and treated participants who recorded and contributed to each timepoint (+/- 14 days) | Posted | | Number | | Percentage of Participants | | Up to Day 127 | | | | ID | Title | Description |
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| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously | | OG001 | Placebo Only | Placebo matching REGN5713-5714-5715 administered subcutaneously |
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| Secondary | Number of "Well Days" | "Well Days" are defined as days when rescue medication is not utilized and the Total symptom score (TSS) is ≤2/18 | All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season | Posted | | Least Squares Mean | Standard Error | Days | | Until the end of Birch Pollen Season, up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 | REGN5713-5714-5715 administered subcutaneously | | OG001 | Placebo Only | Placebo matching REGN5713-5714-5715 administered subcutaneously |
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