| Primary | Mean Total Nasal Symptom Score (TNSS) (2 to 6 Hours) During Out-of-season Birch Allergen Environmental Exposure Unit (EEU) Challenge (REGN5713-5714-5715 vs. Placebo) at Day 29 | 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. | Randomized participants in only the REGN5713-5714-5715 and placebo arms were assessed for this endpoint. Missing values were imputed using multiple imputation (MI) method. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Day 29 from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | Placebo | |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0004.40± 0.377
- OG0016.71± 0.380
|
|
| | 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 |
|---|
| | ANCOVA | | <0.0001 | | Least Squares (LS) Mean Difference | -2.31 | | | 2-Sided | 95 | -3.229 | -1.385 | | | REGN5713-5714-5715 900 mg vs. Placebo, Day 29 | | Superiority | | |
|
| Secondary | 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. | Randomized participants in only the REGN5713-5715, REGN5715 and placebo arms were assessed for this endpoint. Missing values were imputed using multiple imputation (MI) method. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Day 29 from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG001 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG002 | Placebo | |
| |
| Secondary | 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. | The overall "Number of Participants Analyzed" is the total number of randomized participants in each treatment group. The "Number Analyzed" for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Day 57 and Day 85, from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG003 |
|
| Secondary | 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. | All randomized participants. Missing values were imputed using multiple imputation (MI) method. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Day 29 from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG003 | Placebo | |
|
| Secondary | 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. | The overall "Number of Participants Analyzed" is the total number of randomized participants in each treatment group. The "Number Analyzed" for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Day 57 and Day 85, from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG003 |
|
| Secondary | Mean Total Symptom Score (TSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29 | TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome | All randomized participants. Missing values were imputed using multiple imputation (MI) method. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Day 29 from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG003 | Placebo | |
| |
| Secondary | Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85 | TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome | The overall "Number of Participants Analyzed" is the total number of randomized participants in each treatment group. The "Number Analyzed" for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Day 57 and Day 85, from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG003 | Placebo | |
|
| Secondary | Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85 | 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. | The overall "Number of Participants Analyzed" is the total number of randomized participants in each treatment group. The "Number Analyzed" for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | |
|
| Secondary | Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85 | TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. | The overall "Number of Participants Analyzed" is the total number of randomized participants in each treatment group. The "Number Analyzed" for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | |
|
| Secondary | Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85 | TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome | The overall "Number of Participants Analyzed" is the total number of randomized participants in each treatment group. The "Number Analyzed" for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG003 | Placebo |
|
| Secondary | Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85 | 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. | The overall "Number of Participants Analyzed" is the total number of randomized participants in each treatment group. The "Number Analyzed" for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Least Squares Mean | Standard Error | Percentage of Change | | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | |
|
| Secondary | Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85 | 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. | The overall "Number of Participants Analyzed" is the total number of randomized participants in each treatment group. The "Number Analyzed" for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Least Squares Mean | Standard Error | Percentage of Change | | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | |
|
| Secondary | Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85 | TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome | The overall "Number of Participants Analyzed" is the total number of randomized participants in each treatment group. The "Number Analyzed" for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Least Squares Mean | Standard Error | Percentage of Change | | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG003 | Placebo |
|
| Secondary | Change From Pre-treatment Baseline in the Birch Titrated Skin Prick Test (SPT) Mean Wheal Diameter Area Under the Curve (AUC) at Day 29 | Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters [mm] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized. | All randomized participants | Posted | | Least Squares Mean | Standard Error | millimeter (mm) | | Day 29 from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG003 |
|
| Secondary | 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. | The overall "Number of Participants Analyzed" is the total number of randomized participants in each treatment group. The "Number Analyzed" for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Least Squares Mean | Standard Error | millimeter (mm) | | Day 57 and Day 85, from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 |
|
| Secondary | 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. | Randomized participants with Day 127 visit (intended to be pre-season) at least 12 weeks post-randomization | Posted | | Least Squares Mean | Standard Error | millimeter (mm) | | Day 127 from randomization | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG003 |
|
| Secondary | 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. | Among randomized participants that received a second dose of study drug, the number of participants analyzed is the number of participants with a baseline measurement and post-baseline measurement. The number analyzed for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Least Squares Mean | Standard Error | millimeter (mm) | | Day 225 from randomization (end-of-season) and Day 253 from randomization (end of study) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg |
|
| Secondary | 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. | All randomized participants | Posted | | Least Squares Mean | Standard Error | Percentage of Change | | Day 29 from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG003 | Placebo |
|
| Secondary | 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. | The overall "Number of Participants Analyzed" is the total number of randomized participants in each treatment group. The "Number Analyzed" for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Least Squares Mean | Standard Error | Percentage of Change | | Day 57 and Day 85, from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 |
|
| Secondary | 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. | Randomized participants with Day 127 visit (intended to be pre-season) at least 12 weeks post-randomization | Posted | | Least Squares Mean | Standard Error | Percentage of Change | | Day 127 from randomization | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG003 |
|
| Secondary | 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. | Among randomized participants that received a second dose of study drug, the number of participants analyzed is the number of participants with a baseline measurement and post-baseline measurement. The number analyzed for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Least Squares Mean | Standard Error | Percentage of Change | | Day 225 from randomization (end-of-season) and Day 253 from randomization (end of study) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg |
|
| Secondary | 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. | The "Number of Participants Analyzed" is the number of participants allergic to oak with a baseline measurement and post-baseline measurement in each treatment group. The "Number Analyzed" for each scale is the number of participants with available observed data for that scale. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Day 36 from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 |
|
| Secondary | Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36 | TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome. | The "Number of Participants Analyzed" is the number of participants allergic to oak with a baseline measurement and post-baseline measurement in each treatment group. The "Number Analyzed" for each scale is the number of participants with available observed data for that scale. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Day 36 from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 |
|
| Secondary | 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. | The "Number of Participants Analyzed" is the number of participants allergic to oak with a baseline measurement and post-baseline measurement in each treatment group. The "Number Analyzed" for each scale is the number of participants with available observed data for that scale. | Posted | | Least Squares Mean | Standard Error | Percentage of Change | | Day 36 from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 |
|
| Secondary | 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. | The overall "Number of Participants Analyzed" is the total number of randomized participants in each treatment group. The "Number Analyzed" for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Count of Participants | | Participants | | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | | | OG001 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG002 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG003 | REGN5713-5714-5715 900 mg |
|
| Secondary | 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. | The overall "Number of Participants Analyzed" is the total number of randomized participants in each treatment group. The "Number Analyzed" for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Count of Participants | | Participants | | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | | | OG001 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG002 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG003 | REGN5713-5714-5715 900 mg |
|
| Secondary | Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds | TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome. | The overall "Number of Participants Analyzed" is the total number of randomized participants in each treatment group. The "Number Analyzed" for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Count of Participants | | Participants | | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | | | OG001 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG002 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG003 | REGN5713-5714-5715 900 mg | |
|
| Secondary | 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. | The overall "Number of Participants Analyzed" is the total number of randomized participants in each treatment group. The "Number Analyzed" for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Posted | | Count of Participants | | Participants | | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | | | OG001 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG002 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 |
|
| Secondary | Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190 | Peak season EEU is an in-season challenge corresponding to approximate timing of the anticipated peak BPS; TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome. | The "Number of Participants Analyzed" is the number of participants who received a second dose of the study drug. The "Number Analyzed" for each scale is the number of participants with available observed data for that scale. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Day 190 from randomization (In-season); Timing may vary based on local season | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 |
|
| Secondary | Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS) | TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS & TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for each pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS & TSS higher score indicates worse outcome). Daily TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of birch pollen season presented. | The "Number of Participants Analyzed" is the number of participants who received a second dose of the study drug. The "Number Analyzed" for each scale is the number of participants with available observed data for that scale. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Up to 253 days from randomization (during BPS) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 |
|
| Secondary | Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS | TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS & TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for each pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS & TSS higher score indicates worse outcome). Daily TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of peak birch pollen season presented. | The "Number of Participants Analyzed" is the number of participants who received a second dose of the study drug. The "Number Analyzed" for each scale is the number of participants with available observed data for that scale. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Up to 253 days from randomization (during peak BPS) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg |
|
| Secondary | Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS | TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on a Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS & TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS & TSS; Higher score indicates worse outcome. Change from pre-treatment baseline in TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of birch pollen season presented. | The "Number of Participants Analyzed" is the number of participants who received a second dose of the study drug. The "Number Analyzed" for each scale is the number of participants with available observed data for that scale. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Up to 253 days from randomization (during BPS) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 |
|
| Secondary | Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS | TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS & TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS & TSS; Higher score indicates worse outcome. Change from pre-treatment baseline in TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of peak birch pollen season presented. | The "Number of Participants Analyzed" is the number of participants who received a second dose of the study drug. The "Number Analyzed" for each scale is the number of participants with available observed data for that scale. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Up to 253 days from randomization (during peak BPS) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 |
|
| Secondary | Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS | TNSS range from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS range from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering; Higher score indicates worse outcome. TSS range from 0 (none) to 18 (severe): Sum of TNSS & TOSS; Higher score indicates worse outcome. DMS range from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS range from 0 to 38 (max): Sum of DMS & TSS; Higher score indicates worse outcome. Percent change from pre-treatment baseline in TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of birch pollen season presented. | The "Number of Participants Analyzed" is the number of participants who received a second dose of the study drug. The "Number Analyzed" for each scale is the number of participants with available observed data for that scale. | Posted | | Least Squares Mean | Standard Error | Percentage of Change | | Up to 253 days from randomization (during BPS) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 |
|
| Secondary | Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS | TNSS range from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, & runny nose, & sneezing) graded on Likert scale from 0 (none) to 3 (severe);Higher score indicates worse outcome. TOSS range from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling & tearing/watering;Higher score indicates worse outcome. TSS range from 0 (none) to 18 (severe): Sum of TNSS & TOSS;Higher score indicates worse outcome. DMS range from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS range from 0 to 38 (max): Sum of DMS & TSS;Higher score indicates worse outcome. Percent change from pre-treatment baseline in TNSS, TOSS, TSS, DMS & CSMS each averaged over duration of peak birch pollen season presented. | The "Number of Participants Analyzed" is the number of participants who received a second dose of the study drug. The "Number Analyzed" for each scale is the number of participants with available observed data for that scale. | Posted | | Least Squares Mean | Standard Error | Percentage of Change | | Up to 253 days from randomization (during peak BPS) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 |
|
| Secondary | Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) Score Averaged During BPS | The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Overall RQLQ(S) score averaged over duration of birch pollen season presented. | Randomized participants who received a second dose of the study drug | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Up to 253 days from randomization (during BPS) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 |
|
| Secondary | Standardized RQLQ(S) Score Averaged During Peak BPS | The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Overall RQLQ(S) score averaged over duration of peak birch pollen season presented. | Randomized participants who received a second dose of the study drug | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Up to 253 days from randomization (during peak BPS) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5715 300 mg |
|
| Secondary | Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS | The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Change from pre-treatment baseline averaged over duration of birch pollen season presented. | Randomized participants who received a second dose of the study drug | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Up to 253 days from randomization (during BPS) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 |
|
| Secondary | 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. | Randomized participants who received a second dose of the study drug | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Up to 253 days from randomization (during peak BPS) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 |
|
| Secondary | Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS | The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Percent change from pre-treatment baseline averaged over duration of birch pollen season presented. | Randomized participants who received a second dose of the study drug | Posted | | Least Squares Mean | Standard Error | Percentage of Change | | Up to 253 days from randomization (during BPS) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 |
|
| Secondary | Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS | The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Percent change from pre-treatment baseline averaged over duration of peak birch pollen season presented. | Randomized participants who received a second dose of the study drug | Posted | | Least Squares Mean | Standard Error | Percentage of Change | | Up to 253 days from randomization (during peak BPS) | | | | ID | Title | Description |
|---|
| OG000 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 |
|
| Secondary | Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) Over the Study Duration | | Randomized participants who receive any study drug, regardless of the amount of treatment administered | Posted | | Count of Participants | | Participants | | Up to 253 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | | | OG001 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG002 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG003 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) |
| |
| Secondary | Number of Participants With Any Treatment-Emergent Serious AE (TESAE) Over the Study Duration | | Randomized participants who receive any study drug, regardless of the amount of treatment administered | Posted | | Count of Participants | | Participants | | Up to 253 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | | | OG001 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG002 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG003 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) |
| |
| Secondary | Serum Concentration of REGN5713 Over the Study Duration | | Randomized and treated participants who received REGN5713 and contributed to each timepoint | Posted | | Mean | Standard Deviation | mg/L | | Up to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) |
| |
| Secondary | Serum Concentration of REGN5714 Over the Study Duration | | Randomized and treated participants who received REGN5714 and contributed to each timepoint | Posted | | Mean | Standard Deviation | mg/L | | Up to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) |
| |
| Secondary | Serum Concentration of REGN5715 Over the Study Duration | | Randomized and treated participants who received REGN5715 and contributed to each timepoint | Posted | | Mean | Standard Deviation | mg/L | | Up to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) |
| |
| Secondary | Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time | | Randomized and treated participants who received REGN5713 during the study | Posted | | Count of Participants | | Participants | | Up to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) |
| |
| Secondary | Number of Participants With ADA to REGN5714 Over Time | | Randomized and treated participants who received REGN5714 during the study | Posted | | Count of Participants | | Participants | | Up to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) |
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| Secondary | Number of Participants With ADA to REGN5715 Over Time | | Randomized and treated participants who received REGN5715 during the study | Posted | | Count of Participants | | Participants | | Up to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | REGN5715 300 mg | 1-monoclonal antibody (mAb) REGN5715 300 mg plus placebo to replace REGN5713-5714 | | OG001 | REGN5713-5715 600 mg | 2-monoclonal antibody (mAb) cocktail REGN5713-5715 600 mg (300 mg per mAb) plus placebo to replace REGN5714 | | OG002 | REGN5713-5714-5715 900 mg | 3-monoclonal antibody (mAb) cocktail REGN5713-5714-5715 900 mg (300 mg per mAb) |
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