Trial Outcomes & Findings for A Dose-Ranging Study of the Safety and Effectiveness of MK-8237 in the Treatment of House Dust Mite (HDM) Induced Allergic Rhinitis/Rhinoconjunctivitis in Adults (MK-8237-003/P07627) (NCT NCT01644617)
NCT ID: NCT01644617
Last Updated: 2017-09-15
Results Overview
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.
COMPLETED
PHASE2
124 participants
Week 24
2017-09-15
Participant Flow
Participants must have had a clinical history of allergic rhinitis/rhinoconjunctivitis (with or without asthma) to house dust of 1 year duration or more and determined to be sensitized to Dermatophagoides pteronyssinus and/or Dermatophagoides farina by skin prick test and immunoglobulin E levels. Other inclusion and exclusion criteria applied.
Participant milestones
| Measure |
MK-8237 12 Development Units (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.
|
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.
|
Placebo
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
41
|
41
|
|
Overall Study
COMPLETED
|
36
|
36
|
34
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
7
|
Reasons for withdrawal
| Measure |
MK-8237 12 Development Units (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.
|
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.
|
Placebo
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
3
|
0
|
6
|
Baseline Characteristics
A Dose-Ranging Study of the Safety and Effectiveness of MK-8237 in the Treatment of House Dust Mite (HDM) Induced Allergic Rhinitis/Rhinoconjunctivitis in Adults (MK-8237-003/P07627)
Baseline characteristics by cohort
| Measure |
MK-8237 12 Development Units (DU)
n=42 Participants
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.
|
MK-8237 6 DU
n=41 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=41 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.5 Years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
26.7 Years
STANDARD_DEVIATION 7.0 • n=107 Participants
|
26.6 Years
STANDARD_DEVIATION 6.1 • n=206 Participants
|
26.9 Years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
58 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: 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
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.
Outcome measures
| Measure |
MK-8237 12 DU
n=36 Participants
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.
|
MK-8237 6 DU
n=36 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=34 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24
|
3.83 Score on a Scale
Interval 2.94 to 4.72
|
5.47 Score on a Scale
Interval 4.55 to 6.39
|
7.45 Score on a Scale
Interval 6.57 to 8.33
|
SECONDARY outcome
Timeframe: Week 16Population: 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
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.
Outcome measures
| Measure |
MK-8237 12 DU
n=39 Participants
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.
|
MK-8237 6 DU
n=36 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=38 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Average TNSS During EEC Challenge Session at Week 16
|
4.82 Score on a Scale
Interval 4.07 to 5.56
|
5.67 Score on a Scale
Interval 4.83 to 6.5
|
6.90 Score on a Scale
Interval 6.13 to 7.67
|
SECONDARY outcome
Timeframe: Week 8Population: 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
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.
Outcome measures
| Measure |
MK-8237 12 DU
n=40 Participants
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.
|
MK-8237 6 DU
n=39 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=39 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Average TNSS During EEC Challenge Session at Week 8
|
5.34 Score on a Scale
Interval 4.53 to 6.15
|
6.16 Score on a Scale
Interval 5.55 to 6.78
|
6.71 Score on a Scale
Interval 6.13 to 7.28
|
SECONDARY outcome
Timeframe: Week 24Population: 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
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.
Outcome measures
| Measure |
MK-8237 12 DU
n=36 Participants
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.
|
MK-8237 6 DU
n=36 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=34 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Average Total Symptom Score (TSS [TNSS + TOSS]) During EEC Challenge Session at Week 24
|
4.43 Score on a Scale
Interval 3.2 to 5.66
|
6.62 Score on a Scale
Interval 5.48 to 7.77
|
9.27 Score on a Scale
Interval 7.98 to 10.57
|
SECONDARY outcome
Timeframe: Week 16Population: 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
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.
Outcome measures
| Measure |
MK-8237 12 DU
n=39 Participants
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.
|
MK-8237 6 DU
n=36 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=38 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 16
|
5.95 Score on a Scale
Interval 4.92 to 6.99
|
7.21 Score on a Scale
Interval 6.05 to 8.37
|
8.58 Score on a Scale
Interval 7.46 to 9.69
|
SECONDARY outcome
Timeframe: Week 8Population: 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
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.
Outcome measures
| Measure |
MK-8237 12 DU
n=40 Participants
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.
|
MK-8237 6 DU
n=39 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=39 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 8
|
6.51 Score on a Scale
Interval 5.52 to 7.51
|
7.65 Score on a Scale
Interval 6.81 to 8.48
|
8.48 Score on a Scale
Interval 7.56 to 9.39
|
SECONDARY outcome
Timeframe: Week 24Population: 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
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.
Outcome measures
| Measure |
MK-8237 12 DU
n=36 Participants
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.
|
MK-8237 6 DU
n=36 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=34 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Average Total Ocular Symptom Score (TOSS) During EEC Challenge Session at Week 24
|
0.61 Score on a Scale
Interval 0.21 to 1.0
|
1.10 Score on a Scale
Interval 0.68 to 1.53
|
1.87 Score on a Scale
Interval 1.35 to 2.4
|
SECONDARY outcome
Timeframe: Week 16Population: 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
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.
Outcome measures
| Measure |
MK-8237 12 DU
n=39 Participants
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.
|
MK-8237 6 DU
n=36 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=38 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Average TOSS During EEC Challenge Session at Week 16
|
1.14 Score on a Scale
Interval 0.72 to 1.55
|
1.54 Score on a Scale
Interval 1.05 to 2.03
|
1.67 Score on a Scale
Interval 1.22 to 2.12
|
SECONDARY outcome
Timeframe: Week 8Population: 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
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.
Outcome measures
| Measure |
MK-8237 12 DU
n=40 Participants
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.
|
MK-8237 6 DU
n=39 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=39 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Average TOSS During EEC Challenge Session at Week 8
|
1.18 Score on a Scale
Interval 0.86 to 1.5
|
1.45 Score on a Scale
Interval 1.08 to 1.83
|
1.79 Score on a Scale
Interval 1.36 to 2.22
|
SECONDARY outcome
Timeframe: Week 8Population: 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
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.
Outcome measures
| Measure |
MK-8237 12 DU
n=40 Participants
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.
|
MK-8237 6 DU
n=39 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=39 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
HDM-specific Immunoglobulin E (IgE) Levels at Week 8
D. pteronyssinus
|
1.77 Log 10 kU/L
Standard Deviation 0.67
|
1.64 Log 10 kU/L
Standard Deviation 0.53
|
1.25 Log 10 kU/L
Standard Deviation 0.54
|
|
HDM-specific Immunoglobulin E (IgE) Levels at Week 8
D. farinae
|
1.80 Log 10 kU/L
Standard Deviation 0.67
|
1.69 Log 10 kU/L
Standard Deviation 0.53
|
1.31 Log 10 kU/L
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Week 8Population: 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
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.
Outcome measures
| Measure |
MK-8237 12 DU
n=40 Participants
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.
|
MK-8237 6 DU
n=39 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=39 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
HDM-specific Immunoglobulin G4 (IgG4) Levels at Week 8
D. pteronyssinus
|
-0.31 Log 10 mg/L
Standard Deviation 0.40
|
-0.33 Log 10 mg/L
Standard Deviation 0.31
|
-0.57 Log 10 mg/L
Standard Deviation 0.11
|
|
HDM-specific Immunoglobulin G4 (IgG4) Levels at Week 8
D. farinae
|
-0.32 Log 10 mg/L
Standard Deviation 0.47
|
-0.31 Log 10 mg/L
Standard Deviation 0.41
|
-0.62 Log 10 mg/L
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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
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.
Outcome measures
| Measure |
MK-8237 12 DU
n=40 Participants
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.
|
MK-8237 6 DU
n=39 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=39 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in HDM-specific IgE Levels at Week 8
D. pteronyssinus
|
0.63 Log 10 kU/L
Interval 0.51 to 0.75
|
0.50 Log 10 kU/L
Interval 0.41 to 0.59
|
0.08 Log 10 kU/L
Interval 0.03 to 0.12
|
|
Change From Baseline in HDM-specific IgE Levels at Week 8
D. farinae
|
0.59 Log 10 kU/L
Interval 0.48 to 0.7
|
0.46 Log 10 kU/L
Interval 0.38 to 0.55
|
0.07 Log 10 kU/L
Interval 0.03 to 0.11
|
SECONDARY outcome
Timeframe: Time Frame: Baseline and Week 8Population: 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
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.
Outcome measures
| Measure |
MK-8237 12 DU
n=40 Participants
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.
|
MK-8237 6 DU
n=39 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=39 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in HDM-specific IgG4 Levels at Week 8
D. pteronyssinus
|
0.23 Log 10 mg/L
Interval 0.13 to 0.33
|
0.19 Log 10 mg/L
Interval 0.12 to 0.25
|
-0.00 Log 10 mg/L
Interval -0.01 to 0.01
|
|
Change From Baseline in HDM-specific IgG4 Levels at Week 8
D. farinae
|
0.32 Log 10 mg/L
Interval 0.22 to 0.41
|
0.24 Log 10 mg/L
Interval 0.16 to 0.32
|
-0.01 Log 10 mg/L
Interval -0.03 to 0.01
|
SECONDARY outcome
Timeframe: From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)Population: All Participants as Treated including all randomized participants who received at least one dose of study treatment
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.
Outcome measures
| Measure |
MK-8237 12 DU
n=42 Participants
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.
|
MK-8237 6 DU
n=41 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=41 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Experienced At Least One Adverse Event (AE)
|
90.5 Percentage of participants
|
87.8 Percentage of participants
|
78.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From first dose to last dose of treatment (Up to 24 weeks)Population: All Participants as Treated including all randomized participants who received at least one dose of study treatment
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.
Outcome measures
| Measure |
MK-8237 12 DU
n=42 Participants
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.
|
MK-8237 6 DU
n=41 Participants
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=41 Participants
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Drug Due to an AE
|
7.1 Percentage of Participants
|
0.0 Percentage of Participants
|
14.6 Percentage of Participants
|
Adverse Events
MK-8237 12 Development Units (DU)
MK-8237 6 DU
Placebo
Serious adverse events
| Measure |
MK-8237 12 Development Units (DU)
n=42 participants at risk
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.
|
MK-8237 6 DU
n=41 participants at risk
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=41 participants at risk
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/42 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
0.00%
0/41 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
2.4%
1/41 • Number of events 1 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
Other adverse events
| Measure |
MK-8237 12 Development Units (DU)
n=42 participants at risk
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.
|
MK-8237 6 DU
n=41 participants at risk
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
Placebo
n=41 participants at risk
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear pruritus
|
7.1%
3/42 • Number of events 3 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
2.4%
1/41 • Number of events 1 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
0.00%
0/41 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
9.5%
4/42 • Number of events 6 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
4.9%
2/41 • Number of events 2 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
0.00%
0/41 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Lip swelling
|
19.0%
8/42 • Number of events 9 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
4.9%
2/41 • Number of events 2 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
2.4%
1/41 • Number of events 2 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Oedema mouth
|
23.8%
10/42 • Number of events 10 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
24.4%
10/41 • Number of events 10 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
0.00%
0/41 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Oral pruritus
|
14.3%
6/42 • Number of events 7 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
14.6%
6/41 • Number of events 6 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
0.00%
0/41 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
|
Infections and infestations
Influenza
|
7.1%
3/42 • Number of events 3 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
7.3%
3/41 • Number of events 5 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
7.3%
3/41 • Number of events 3 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
|
Infections and infestations
Nasopharyngitis
|
28.6%
12/42 • Number of events 16 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
22.0%
9/41 • Number of events 11 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
19.5%
8/41 • Number of events 8 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
|
Nervous system disorders
Headache
|
16.7%
7/42 • Number of events 9 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
14.6%
6/41 • Number of events 9 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
19.5%
8/41 • Number of events 13 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
3/42 • Number of events 3 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
4.9%
2/41 • Number of events 2 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
2.4%
1/41 • Number of events 1 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
7/42 • Number of events 11 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
19.5%
8/41 • Number of events 13 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
31.7%
13/41 • Number of events 22 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.5%
4/42 • Number of events 5 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
9.8%
4/41 • Number of events 4 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
4.9%
2/41 • Number of events 2 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
11.9%
5/42 • Number of events 5 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
17.1%
7/41 • Number of events 8 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
14.6%
6/41 • Number of events 7 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
2.4%
1/42 • Number of events 1 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
7.3%
3/41 • Number of events 3 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
4.9%
2/41 • Number of events 2 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
52.4%
22/42 • Number of events 26 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
34.1%
14/41 • Number of events 15 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
0.00%
0/41 • From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse events collected for all randomized subjects who received at least one dose of study treatment
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results without the prior written consent of the sponsor. The Sponsor has the opportunity to review all proposed abstracts, manuscripts, presentations, or data analyses regarding this trial 45 days prior to submission for publication/presentation. The sponsor has the right to review and comment with regard to proprietary information, accuracy, and compliance with FDA regulations.
- Publication restrictions are in place
Restriction type: OTHER