| Primary | Time to Early Asthmatic Response (EAR) Upon Controlled Cat Allergen Challenge in an Environmental Exposure Unit (EEU) on Day 8 | Time to EAR was defined as the time to a ≥20% reduction in FEV1 or when the participant voluntarily departed the EEU due to clinically significant allergic and/or asthmatic symptoms. | Full analysis set: included all randomized participants who received any investigational product and had completed the Day 8 Cat Allergen Challenge. | Posted | | Median | 95% Confidence Interval | Minutes | | Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received a single dose of matching placebo | | OG001 | REGN1908-1909 600 mg | Participants received a single 600 mg dose of REGN1908-1909 |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00051(33.92 to 70.70)
- OG001NA(130.87 to NA)The median time to EAR could not be estimated in the REGN1908-1909 arm at the day 8 visit since a majority of participants were able to tolerate the full 4 hours of cat allergen exposure, the maximum time allowed in the EEU per protocol, without experiencing an EAR (censored at 4 hours)
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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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| | Cox Proportional Hazard | | = 0.0083 | | Hazard Ratio (HR) | 0.36 | | | 2-Sided | 95 | 0.17 | 0.77 | | | | | Superiority | | |
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| Secondary | Time to EAR Upon Controlled Cat Allergen Challenge in an EEU on Days 29, 57, and 85 | Time to EAR was defined as the time to a ≥20% reduction in FEV1 or when the participant voluntarily departed the EEU due to clinically significant allergic and/or asthmatic symptoms | Full analysis set: included all randomized participants who received any investigational product and had completed the Day 8 Cat Allergen Challenge. Here "n" = number of evaluable participants analyzed at each time point | Posted | | Median | 95% Confidence Interval | Minutes | | Days 29, 57 and 85 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received a single dose of matching placebo | | OG001 | REGN1908-1909 600 mg | Participants received a single 600 mg dose of REGN1908-1909 |
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| Secondary | Percent Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85 | The AUC was analyzed by mixed-effect model repeated measures (MMRM) with the treatment, time, treatment-by-time interaction, and day of challenge as factors and baseline FEV1 AUC as a continuous covariate. | Full analysis set; Here 'n' = number of evaluable participants analyzed at each time point. For each participant at each controlled cat allergen challenge, AUC was calculated over the time period of 0 to 2 hours, with last observation carried forward used to impute values out to 2 hours if the patients remained in EEU for less than 2 hours. The AUCs were calculated using the trapezoidal rule and were normalized by dividing by the length of time (2 hours). | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Days 8, 29, 57, and 85 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received a single dose of matching placebo | | OG001 | REGN1908-1909 600 mg | Participants received a single 600 mg dose of REGN1908-1909 |
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| Secondary | Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85 | The AUC was analyzed by mixed-effect model repeated measures (MMRM) with the treatment, time, treatment-by-time interaction, and day of challenge as factors and baseline FEV1 AUC as a continuous covariate. | Full analysis set; Here "n" = number of evaluable participants analyzed at each time point. For each participant at each controlled cat allergen challenge, AUC was calculated over the time period of 0 to 2 hours, with last observation carried forward used to impute values out to 2 hours if the patients remained in EEU for less than 2 hours. The AUCs were calculated using the trapezoidal rule and were normalized by dividing by the length of time (2 hours). | Posted | | Least Squares Mean | Standard Error | Liters (L) | | Days 8, 29, 57, and 85 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received a single dose of matching placebo | | OG001 | REGN1908-1909 600 mg | Participants received a single 600 mg dose of REGN1908-1909 |
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| Secondary | Change From Baseline in the Normalized AUC of Patient-Assessed Nasal Symptoms Induced by a Controlled Cat Allergen Challenge Over the Exposure Interval to the Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85 | Individual nasal symptoms, including rhinorrhea, nasal congestion, nasal itching, and sneezing were evaluated on a 4-point Likert scale (0, none; 1, mild; 2, moderate; and 3, severe) and combined to give the Total Nasal Symptom Score (TNSS) with a maximum score of 12. Scale range is 0-12. The higher the score, the more severe the symptoms. | Full analysis set; Here 'n' = number of evaluable participants analyzed at each time point. For each participant at each controlled cat allergen challenge, AUC was calculated over the time period of 0 to 2 hours, with last observation carried forward used to impute values out to 2 hours if participants remained in EEU for less than 2 hours. AUCs were calculated using trapezoidal rule and were normalized by dividing by the length of time (2 hours). | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Days 8, 29, 57 and 85 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received a single dose of matching placebo | | OG001 | REGN1908-1909 600 mg | Participants received a single 600 mg dose of REGN1908-1909 |
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| Secondary | Change From Baseline in the Normalized AUC in Patient-Assessed Ocular Symptoms Induced by a Controlled Cat Allergen Challenge Over the Exposure Interval to the Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85 | Individual ocular symptoms for itching/burning, redness, swelling/puffiness, and tearing/watery eyes were evaluated on a 4-point Likert scale (0, none; 1, mild; 2, moderate; and 3, severe) and combined to give the TOSS, with a maximum score of 12. Score range is 0-12. The higher the score, the more severe the symptoms. | Full analysis set; Here 'n' = number of evaluable participants analyzed at each time point. For each participant at each controlled cat allergen challenge, AUC was calculated over the time period of 0 to 2 hours, with last observation carried forward used to impute values out to 2 hours if participants remained in EEU for less than 2 hours. AUCs were calculated using trapezoidal rule and were normalized by dividing by the length of time (2 hours). | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Days 8, 29, 57 and 85 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received a single dose of matching placebo | | OG001 | REGN1908-1909 600 mg | Participants received a single 600 mg dose of REGN1908-1909 |
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| Secondary | Mean Change From Baseline in Cat Allergen Quantity as Experienced by Participants During Exposure on Days 8, 29, 57, and 85 | Cat Allergen Exposure Tolerated in ng = Minute Ventilation (L/min) x Allergen Concentration (ng/m3) x Time in EEU (minutes), where 1 L/min = 0.001 m3/min. The change in cat allergen quantity (tolerated exposure) from the baseline Cat Allergen Challenge, will be analyzed using a similar MMRM model with treatment, visit and treatment by-visit interaction as factors and the cat allergen quantity tolerated in the baseline Controlled Cat Allergen Challenge as a covariate. | Full analysis set: included all randomized participants who received any investigational product and had completed the Day 8 Cat Allergen Challenge; Here "n" = number of evaluable participants analyzed at each time point | Posted | | Least Squares Mean | Standard Error | Nanograms (ng) | | Days 8, 29, 57 and 85 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received a single dose of matching placebo | | OG001 | REGN1908-1909 600 mg | Participants received a single 600 mg dose of REGN1908-1909 |
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| Secondary | Percent Change in Cat Allergen Quantity as Experienced by Participants During Exposure on Days 8, 29, 57, and 85 | Cat Allergen Exposure Tolerated in ng = Minute Ventilation (L/min) x Allergen Concentration (ng/m3) x Time in EEU (minutes), where 1 L/min = 0.001 m3/min. The change in cat allergen quantity (tolerated exposure) from the baseline Cat Allergen Challenge, will be analyzed using a similar MMRM model with treatment, visit and treatment by-visit interaction as factors and the cat allergen quantity tolerated in the baseline Controlled Cat Allergen Challenge as a covariate. | Full analysis set: included all randomized participants who received any investigational product and had completed the Day 8 Cat Allergen Challenge; Here "n" = number of evaluable participants analyzed at each time point | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Days 8, 29, 57 and 85 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received a single dose of matching placebo | | OG001 | REGN1908-1909 600 mg | Participants received a single 600 mg dose of REGN1908-1909 |
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| Secondary | Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study | Adverse events and serious adverse events were collected from the time of informed consent signature and then at each visit until the end of the study with the exception of symptoms that occurred in response to the EEU within 24 hours following the EEU. | Safety Analysis Set (SAF): included all participants who received any investigational product and were analyzed as treated. | Posted | | Number | | Events | | Baseline to 16 weeks | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received a single dose of matching placebo | | OG001 | REGN1908-1909 600 mg | Participants received a single 600 mg dose of REGN1908-1909 |
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