Trial Outcomes & Findings for A Study to Evaluate and Compare the Efficacy and Pharmacokinetics of MK-0873 for the Treatment of Plaque Psoriasis (MK-0873-022) (NCT NCT01235728)
NCT ID: NCT01235728
Last Updated: 2019-02-08
Results Overview
Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with increasing score reflecting increased lesion severity. The TLS score (range 0 to 12) is calculated as the sum of the 3 components.
COMPLETED
PHASE1
24 participants
Baseline and Day 29
2019-02-08
Participant Flow
Participant milestones
| Measure |
Treatment Sequence 1
Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
|
Treatment Sequence 2
Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
|
Treatment Sequence 3
Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
|
Treatment Sequence 4
Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and calcitriol on upper lesion C and MK-873 on upper lesion D.
|
Treatment Sequence 5
Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
|
Treatment Sequence 6
Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
|
Treatment Sequence 7
Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
|
Treatment Sequence 8
Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and calcitriol on upper lesion C and MK-0873 on upper lesion D.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
2
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence 1
Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
|
Treatment Sequence 2
Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
|
Treatment Sequence 3
Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
|
Treatment Sequence 4
Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and calcitriol on upper lesion C and MK-873 on upper lesion D.
|
Treatment Sequence 5
Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
|
Treatment Sequence 6
Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
|
Treatment Sequence 7
Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
|
Treatment Sequence 8
Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and calcitriol on upper lesion C and MK-0873 on upper lesion D.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate and Compare the Efficacy and Pharmacokinetics of MK-0873 for the Treatment of Plaque Psoriasis (MK-0873-022)
Baseline characteristics by cohort
| Measure |
MK-0873
n=24 Participants
Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
|
|---|---|
|
Age, Continuous
|
43.3 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 29Population: The population consisted of all participants that received treatment, had no major protocol violations, and had TLS scores available at baseline and Day 29.
Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with increasing score reflecting increased lesion severity. The TLS score (range 0 to 12) is calculated as the sum of the 3 components.
Outcome measures
| Measure |
MK-0873
n=23 Lesions
Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving MK-0873 was evaluated.
|
MK-0873 Vehicle
n=23 Lesions
Participants were randomized to receive MK-0873 vehicle on upper or lower lesion A or B and MK-0873 on the opposing lesion B or A. The lesion receiving MK-0873 vehicle was evaluated.
|
|---|---|---|
|
Least Squares Mean Percent Change From Baseline (Predose Day 1) of Target Lesion Severity (TLS) Score for Lesions Treated With MK-0873 and Lesions Treated With MK-0873 Vehicle
|
-47.37 Percent Change
Interval -56.87 to -37.86
|
-42.71 Percent Change
Interval -52.21 to -33.22
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: The population consisted of all participants that received treatment, had no major protocol violations, and had TLS scores available at baseline and Day 29
Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with increasing score reflecting increased lesion severity. The TLS score (range 0 to 12) is calculated as the sum of the 3 components.
Outcome measures
| Measure |
MK-0873
n=23 Lesions
Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving MK-0873 was evaluated.
|
MK-0873 Vehicle
n=23 Lesions
Participants were randomized to receive MK-0873 vehicle on upper or lower lesion A or B and MK-0873 on the opposing lesion B or A. The lesion receiving MK-0873 vehicle was evaluated.
|
|---|---|---|
|
Least Squares Mean Percent Change From Baseline (Predose Day 1) of TLS Score for Lesions Treated With MK-0873 and Lesions Treated With Calcitriol
|
-57.24 Percent Change
Interval -66.82 to -47.67
|
-47.89 Percent Change
Interval -57.39 to -38.4
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29Population: The population consisted of all participants that received treatment, had no major protocol violations, and had MK-0873 plasma trough values available for the Day 8, 15, 22, and 28 treatment.
Plasma samples were collected at 12 hours post-dose on Days 8, 15, 22, and 28 to evaluate the mean maximum plasma concentration at trough of MK-0873.
Outcome measures
| Measure |
MK-0873
n=23 Participants
Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving MK-0873 was evaluated.
|
MK-0873 Vehicle
Participants were randomized to receive MK-0873 vehicle on upper or lower lesion A or B and MK-0873 on the opposing lesion B or A. The lesion receiving MK-0873 vehicle was evaluated.
|
|---|---|---|
|
Mean Maximum Plasma Concentrations at Trough of Day 8, 15, 22, and 29 Following Topical Administration of MK-0873 to Psoriatic Patients
|
3.6 nM
Standard Deviation 3.1
|
—
|
Adverse Events
MK-0873
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-0873
n=24 participants at risk
Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
12.5%
3/24 • Number of events 3
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
12.5%
3/24 • Number of events 3
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER