| Primary | Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24 | The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The 24-week TNSS was analyzed using the analysis of covariance (ANCOVA) model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms. | Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a Scale | | Week 24 | | | | ID | Title | Description |
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| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. | | OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. | | OG002 | Placebo | Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0003.83(2.94 to 4.72)
- OG0015.47(4.55 to 6.39)
- OG0027.45(6.57 to 8.33)
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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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| | ANCOVA | | <0.001 | | Difference in Least Squares Means (LSM) | -3.62 | | | 2-Sided | 95 | -4.85 | -2.39 | | | Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group. | | Superiority or Other | | | | |
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| Secondary | Average TNSS During EEC Challenge Session at Week 16 | The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The Week 16 TNSS was analyzed using the ANCOVA model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms. | Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a Scale | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. | | OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. |
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| Secondary | Average TNSS During EEC Challenge Session at Week 8 | The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The Week 8 TNSS was analyzed using the ANCOVA model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms. | Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a Scale | | Week 8 | | | | ID | Title | Description |
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| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. | | OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. |
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| Secondary | Average Total Symptom Score (TSS [TNSS + TOSS]) During EEC Challenge Session at Week 24 | The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 24 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms. | Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a Scale | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. | | OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. |
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| Secondary | Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 16 | The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 16 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms. | Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a Scale | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. | | OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. |
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| Secondary | Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 8 | The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 8 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms. | Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a Scale | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. | | OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. |
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| Secondary | Average Total Ocular Symptom Score (TOSS) During EEC Challenge Session at Week 24 | The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 24 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms. | Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a Scale | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. | | OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. |
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| Secondary | Average TOSS During EEC Challenge Session at Week 16 | The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 16 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms. | Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a Scale | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. | | OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. |
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| Secondary | Average TOSS During EEC Challenge Session at Week 8 | The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 8 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms. | Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a Scale | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. | | OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. |
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| Secondary | HDM-specific Immunoglobulin E (IgE) Levels at Week 8 | Dermatophagoides pteronyssinus (D. pteronyssinus) and Dermatophagoides farinae (D. farinae) serum IgE levels were measured using the Immunocap® assay at Week 8. IgE levels were expressed in Log 10 scale kilo units/Liter (kU/L). Analysis was based on the analysis of variance parametric (ANOVA) model with treatment as the fixed effect and reported as mean IgE with a standard deviation. | Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint | Posted | | Mean | Standard Deviation | Log 10 kU/L | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. | | OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. | | OG002 | Placebo | Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. |
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| Secondary | HDM-specific Immunoglobulin G4 (IgG4) Levels at Week 8 | D. pteronyssinus and D. farinae serum IgG4 levels were measured using the Immunocap® assay at Week 8. IgG4 levels were expressed in Log 10 scale milligrams/Liter (mg/L). Analysis was based on the ANOVA model with treatment as the fixed effect and reported as mean IgG4 with a standard deviation. | Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint | Posted | | Mean | Standard Deviation | Log 10 mg/L | | Week 8 | | | | ID | Title | Description |
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| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. | | OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. | | OG002 | Placebo | Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. |
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| Secondary | Change From Baseline in HDM-specific IgE Levels at Week 8 | D. pteronyssinus and D. farinae serum IgE levels were measured using the Immunocap® assay at baseline and Week 8. IgE levels were expressed in Log 10 scale kU/L. Mean Week 8 IgE levels were compared to the mean IgE levels at baseline. Analysis was based on the ANOVA model with treatment as the fixed effect and reported as a least squares mean with 95% confidence interval. | Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint | Posted | | Least Squares Mean | 95% Confidence Interval | Log 10 kU/L | | Baseline and Week 8 | | | | ID | Title | Description |
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| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. | | OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. | | OG002 | Placebo | Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. |
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| Secondary | Change From Baseline in HDM-specific IgG4 Levels at Week 8 | D. pteronyssinus and D. farinae serum IgG4 levels were measured using the Immunocap® assay at baseline and Week 8. IgG4 levels were expressed in Log 10 scale mg/L. Mean Week 8 IgG4 levels were compared to the mean IgG4 levels at baseline. Analysis was based on the ANOVA model with treatment as the fixed effect and reported as a least squares mean with 95% confidence interval. | Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint | Posted | | Least Squares Mean | 95% Confidence Interval | Log 10 mg/L | | Time Frame: Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. | | OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. | | OG002 | Placebo | Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. |
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| Secondary | Percentage of Participants Who Experienced At Least One Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. | All Participants as Treated including all randomized participants who received at least one dose of study treatment | Posted | | Number | | Percentage of participants | | From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks) | | | | ID | Title | Description |
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| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. | | OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. |
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| Secondary | Percentage of Participants Who Discontinued Study Drug Due to an AE | The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment. | All Participants as Treated including all randomized participants who received at least one dose of study treatment | Posted | | Number | | Percentage of Participants | | From first dose to last dose of treatment (Up to 24 weeks) | | | | ID | Title | Description |
|---|
| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. | | OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. | | OG002 | Placebo | Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. |
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