| Primary | Daily Combined Symptom and Medication Score (CSMS) Averaged Over Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | 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). | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Weeks 48 to 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Daily Total Nasal Symptom Score (TNSS) Averaged Over the Last 12 Weeks of Treatment Period in Patients Who Receive REGN1908-1909 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. | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Weeks 48 to 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change From Pre-treatment Baseline in Average CSMS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Weeks 48 to 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change From Pre-treatment Baseline in Average TNSS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Weeks 48 to 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Daily Total Symptom Score (TSS) Averaged Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 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) | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Weeks 48 to 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change From Pre-treatment Baseline in Average TSS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Weeks 48 to 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change From Baseline to the End of Treatment in Cat Skin Prick Test (SPT) Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo | | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Week 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Daily CSMS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | The combined symptom and medication score (CSMS) is defined as the daily combined allergic rhinitis and conjunctivitis total symptom score (TSS: calculated as the sum of total nasal symptom score [TNSS] and total ocular symptom score [TOSS]) plus daily medication score (DMS). Scores ranging between 0 (none) and 38 (severe). | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | Weeks 0 to 12 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Daily TNSS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing. | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS | Posted | | Least Squares Mean | Standard Error | Average Score | | Weeks 0 to 12 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change From Pre-treatment Baseline in Average CSMS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | The combined symptom and medication score (CSMS) is defined as the daily combined allergic rhinitis and conjunctivitis total symptom score (TSS: calculated as the sum of total nasal symptom score [TNSS] and total ocular symptom score [TOSS]) plus daily medication score (DMS). | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS. | Posted | | Mean | Standard Deviation | Percent Change | | Weeks 0 to 12 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change From Pre-treatment Baseline in Average TNSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing. | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS. | Posted | | Mean | Standard Deviation | Percent Change | | Weeks 0 to 12 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change From Pre-treatment Baseline in Average TSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Total symptom score (TSS: calculated as the sum of TNSS and total ocular symptom score [TOSS]) plus daily medication score (DMS). | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS. | Posted | | Mean | Standard Deviation | Percent | | Weeks 0 to 12 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Daily TSS Score Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Total symptom score (TSS: calculated as the sum of TNSS and total ocular symptom score [TOSS]) plus daily medication score (DMS). | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS. | Posted | | Mean | Standard Deviation | Average Score | | Weeks 0 to 12 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change From Pre-treatment Baseline in Average TOSS, Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 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) | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS. | Posted | | Mean | Standard Deviation | Percent Change | | Weeks 0 to 12 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Daily TOSS Averaged Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 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) | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Weeks 48 to 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change From Pre-treatment Baseline in Average TOSS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 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) | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Weeks 48 to 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change in Forced Expiratory Volume (FEV)1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo | In-clinic spirometry on all patients to determine FEV1 (forced expiratory volume in 1 second) in liters (L). | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS. | Posted | | Mean | Standard Deviation | Percent Change | | Baseline to week 12 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change in FEV1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo | In-clinic spirometry on all patients to determine FEV1 (forced expiratory volume in 1 second) in liters (L). | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Baseline to week 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo | The full analysis set (FAS) includes all randomized participants; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS. | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Baseline to week 72 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Daily Number of Nighttime Awakenings Averaged Over the Initial 12 Weeks of the Treatment Period in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo | | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS. | Posted | | Mean | Standard Deviation | Nighttime awakenings/Day | | Weeks 0 to 12 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Number of Participants With Adverse Event of Special Interests (AESIs) Throughout the Study | | | Posted | | Number | | Participants | | Weeks 0 to 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Throughout the Study | | | Posted | | Number | | Participants | | Weeks 0 to 60 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | | | Posted | | Number | | Participants | | Weeks 0 to 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Total REGN1908 Concentration in Serum Over the Study Duration | | Each PK analysis includes all treated participants who received any amount of study drug (active, [SAF]) and had at least 1 non-missing result of each respective analyte following the first dose of study drug. The PKAS is based on the actual treatment received (as treated) rather than as randomized. Placebo participants were not analyzed. | Posted | | Mean | Standard Deviation | mg/L | | Weeks 0 to 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Total REGN1909 Concentration in Serum Over the Study Duration | | Each PK analysis includes all treated participants who received any amount of study drug (active, [SAF]) and had at least 1 non-missing result of each respective analyte following the first dose of study drug. The PKAS is based on the actual treatment received (as treated) rather than as randomized. Placebo participants were not analyzed. | Posted | | Mean | Standard Deviation | mg/L | | Weeks 0 to 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Incidence of Treatment-emergent Anti-drug Antibodies (ADAs) to REGN1908 Throughout the Study | | The AAS is defined for each study drug separately and includes all treated participants who received any amount of study drug (active or placebo, [SAF]) and had at least 1 non-missing ADA result following the first dose of study drug or placebo. The AAS is based on the actual treatment received (as treated) rather than as randomized. | Posted | | Count of Participants | | Participants | | Weeks 0 to 72 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Incidence of Treatment-emergent ADAs to REGN1909 Throughout the Study | | The AAS is defined for each study drug separately and includes all treated participants who received any amount of study drug (active or placebo, [SAF]) and had at least 1 non-missing ADA result following the first dose of study drug or placebo. The AAS is based on the actual treatment received (as treated) rather than as randomized. | Posted | | Count of Participants | | Participants | | Weeks 0 to 72 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo (up to Week 12) | | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS. | Posted | | Mean | Standard Deviation | Percent Change | | Baseline to week 12 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 12) | | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS | Posted | | Mean | Standard Deviation | Percent Change | | Baseline to week 12 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 60) | | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Baseline to week 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Change From Baseline to Week 60 in Rhinoconjunctivitis Quality of Life Questionnaire for Ages 12+ (RQLQ(S)+12) in Participants Who Received REGN1908-1909 Versus Placebo | The RQLQ had 25 questions in 6 domains (nose symptoms, eye symptoms, practical problems, activity limitation, non-hay fever symptoms and emotional function). Participants recalled how they have been during the previous week and responded to each question on a 7-point scale. The overall RQLQ score was the mean of all 25 responses and the individual domain scores were the means of the items in those domains. The RQLQ(S) responses are based on a 7-point Likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled). | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Baseline to week 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Daily Medication Score (DMS) Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo | The Daily Medication Score (DMS) was calculated by adding points for each pre-specified medication. Participants will be asked to record their daily rescue medication use using an e-diary, including which medications and the amount of these prespecified medications. The scale is 0 (minimum) to 20 (maximum) | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS. | Posted | | Mean | Standard Deviation | Score on a scale | | Weeks 0 to 12 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | DMS Averaged Over the Last 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo | | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Weeks 48 to 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Percent Change From Pre-treatment Baseline in Average DMS Averaged Over the Last 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo | | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Weeks 48 to 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Asthma Daily Symptom (ADS) Score, Averaged Over the Initial 12 Weeks of the Treatment Period Using Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo | The total daily asthma symptom score is a participant-reported outcome concerning the occurrence of asthma symptoms and their effect on a patient's daily activities and sleep. It is composed of two parts: daytime (five items) and nighttime (four items), both scored ordinally. Higher scores indicate more severe symptoms. The ADSD score will be based on 6 patient-reported symptoms (difficulty breathing, wheezing, shortness of breath, chest tightness, chest pain, and cough at their worst using an 11-point numeric rating scale (NRS) ranging from 0 ('None') to 10 ('As bad as you can imagine'). | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS | Posted | | Mean | Standard Deviation | Score on a scale | | Weeks 0 to 12 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | ADS Score Averaged Over the Last 12 Weeks of the Treatment Period Using ADSD and the ANSD in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (Weeks 48 to 60) | | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Weeks 48 to 60 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Daily TOSS Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo | The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe). | The full analysis set (FAS) includes all randomized patrticipants; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS. | Posted | | Mean | Standard Deviation | Score on a scale | | Weeks 0 to 12 | | | | ID | Title | Description |
|---|
| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Change From Baseline to Week 60 in Asthma Control Questionnaire 5 Question Version (ACQ-5) in Participant With Asthma Who Receive REGN1908-1909 Versus Placebo | The ACQ-5 had 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control. | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Baseline to week 60 | | | | ID | Title | Description |
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| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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| Secondary | Daily Number of Nighttime Awakenings Averaged Over the Last 12 Weeks of the Treatment Period in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo (Weeks 48 to 60) | | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | Posted | | | | | | Weeks 48 to 60 | | | | ID | Title | Description |
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| OG000 | REGN1908-1909 | Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | | OG001 | Placebo | Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations |
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