Trial Outcomes & Findings for A Study to Assess the Clinical Effects of Navarixin in Participants With Psoriasis (MK-7123-009) (NCT NCT00684593)
NCT ID: NCT00684593
Last Updated: 2019-02-05
Results Overview
PASI score is a means to qualify the extent and severity of psoriatic lesions. The total score is calculated as the sum of the extent and severity of lesions on the head, arms, trunk, and legs and the score can range from 0 (no symptoms) to 72 (maximum symptoms).
COMPLETED
PHASE2
31 participants
Baseline and Day 29
2019-02-05
Participant Flow
Participant milestones
| Measure |
Navarixin
Navarixin 30 mg administered orally once daily for 28 days.
|
Placebo
Matching placebo to Navarixin administered orally once daily for 28 days.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
10
|
|
Overall Study
COMPLETED
|
21
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Navarixin
Navarixin 30 mg administered orally once daily for 28 days.
|
Placebo
Matching placebo to Navarixin administered orally once daily for 28 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
A Study to Assess the Clinical Effects of Navarixin in Participants With Psoriasis (MK-7123-009)
Baseline characteristics by cohort
| Measure |
Navarixin
n=21 Participants
Navarixin 30 mg administered orally once daily for 28 days.
|
Placebo
n=10 Participants
Matching placebo to Navarixin administered orally once daily for 28 days.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 Years
STANDARD_DEVIATION 10.5 • n=99 Participants
|
43.9 Years
STANDARD_DEVIATION 13.4 • n=107 Participants
|
47.7 Years
STANDARD_DEVIATION 11.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 29Population: The population consisted of all treated participants with follow-up.
PASI score is a means to qualify the extent and severity of psoriatic lesions. The total score is calculated as the sum of the extent and severity of lesions on the head, arms, trunk, and legs and the score can range from 0 (no symptoms) to 72 (maximum symptoms).
Outcome measures
| Measure |
Navarixin
n=21 Participants
Navarixin 30 mg administered orally once daily for 28 days.
|
Placebo
n=9 Participants
Matching placebo to SCH 527123 administered orally once daily for 28 days.
|
|---|---|---|
|
Mean Percent Change From Baseline in the Psoriasis and Activity Severity Index (PASI) Score at Day 29
|
-3.30 Score on a Scale
Standard Deviation 15.05
|
-2.14 Score on a Scale
Standard Deviation 13.26
|
SECONDARY outcome
Timeframe: Day 29Population: The population consisted of all treated participants with follow-up.
The PGA is a questionnaire that asks the treating physician to rate the participant's signs and symptoms on a scale where 0=worse, 1=unchanged, 2= slight improvement, 3= fair improvement, 4= good improvement, 5= excellent improvement, and 6=cleared, with higher scores indicating better outcomes.
Outcome measures
| Measure |
Navarixin
n=21 Participants
Navarixin 30 mg administered orally once daily for 28 days.
|
Placebo
n=9 Participants
Matching placebo to SCH 527123 administered orally once daily for 28 days.
|
|---|---|---|
|
Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29
Score = 0 (worse)
|
7 Participants
|
2 Participants
|
|
Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29
Score = 1 (unchanged)
|
6 Participants
|
2 Participants
|
|
Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29
Score = 2 (slight improvement)
|
8 Participants
|
4 Participants
|
|
Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29
Score = 3 (fair improvement)
|
0 Participants
|
1 Participants
|
|
Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29
Score = 4 (good improvement)
|
0 Participants
|
0 Participants
|
|
Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29
Score = 5 (excellent improvement)
|
0 Participants
|
0 Participants
|
|
Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29
Score = 6 (cleared)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: The population consisted of all participants for which serum samples were available for the determination of Cmax at Day 28. One participant was excluded due to erroneous blood sample collection relative to Navarixin dosing.
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean Cmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.
Outcome measures
| Measure |
Navarixin
n=20 Participants
Navarixin 30 mg administered orally once daily for 28 days.
|
Placebo
Matching placebo to SCH 527123 administered orally once daily for 28 days.
|
|---|---|---|
|
Mean Maximum Plasma Concentration (Cmax) of Navarixin at Day 28
|
209.85 ng/mL
Standard Deviation 51.50
|
—
|
SECONDARY outcome
Timeframe: Day 28Population: The population consisted of all enrolled participants for which serum samples were evaluable at Day 28 for AUC (0-24). One participant was excluded due to erroneous blood sample collection relative to Navarixin dosing.
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean AUC(0-24) at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.
Outcome measures
| Measure |
Navarixin
n=20 Participants
Navarixin 30 mg administered orally once daily for 28 days.
|
Placebo
Matching placebo to SCH 527123 administered orally once daily for 28 days.
|
|---|---|---|
|
Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC [0-24]) of Navarixin at Day 28
|
420.37 hr*ng/mL
Standard Deviation 67.57
|
—
|
SECONDARY outcome
Timeframe: Day 28Population: The population consisted of all enrolled participants for which serum samples were evaluable for T1/2. One participant was excluded due to erroneous blood sample collection relative to Navarixin dosing. An additional 2 participants were excluded from the population because their T1/2 was incalculable.
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours to determine the mean T1/2 of Navarixin following oral administration at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.
Outcome measures
| Measure |
Navarixin
n=18 Participants
Navarixin 30 mg administered orally once daily for 28 days.
|
Placebo
Matching placebo to SCH 527123 administered orally once daily for 28 days.
|
|---|---|---|
|
Mean Terminal Phase Half-life (T1/2) of Navarixin at Day 28
|
13.02 Hours
Standard Deviation 6.63
|
—
|
SECONDARY outcome
Timeframe: Day 28Population: The population consisted of all participants for which serum samples were available for the determination of Tmax at Day 28.
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the Mean Tmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.
Outcome measures
| Measure |
Navarixin
n=21 Participants
Navarixin 30 mg administered orally once daily for 28 days.
|
Placebo
Matching placebo to SCH 527123 administered orally once daily for 28 days.
|
|---|---|---|
|
Median Time to Maximum Plasma Concentration (Tmax) of Navarixin at Day 28
|
0.50 Hours
Full Range 51.50 • Interval 0.5 to 1.0
|
—
|
Adverse Events
Navarixin
Placebo
Serious adverse events
| Measure |
Navarixin
n=21 participants at risk
Navarixin 30 mg administered orally once daily for 28 days.
|
Placebo
n=10 participants at risk
Matching placebo to Navarixin administered orally once daily for 28 days.
|
|---|---|---|
|
Vascular disorders
Venous Thrombosis Limb
|
0.00%
0/21 • Up to Day 43
|
10.0%
1/10 • Number of events 1 • Up to Day 43
|
Other adverse events
| Measure |
Navarixin
n=21 participants at risk
Navarixin 30 mg administered orally once daily for 28 days.
|
Placebo
n=10 participants at risk
Matching placebo to Navarixin administered orally once daily for 28 days.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • Number of events 1 • Up to Day 43
|
10.0%
1/10 • Number of events 1 • Up to Day 43
|
|
General disorders
Fatigue
|
4.8%
1/21 • Number of events 1 • Up to Day 43
|
10.0%
1/10 • Number of events 1 • Up to Day 43
|
|
Infections and infestations
Nasopharyngitis
|
28.6%
6/21 • Number of events 6 • Up to Day 43
|
0.00%
0/10 • Up to Day 43
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.5%
2/21 • Number of events 2 • Up to Day 43
|
0.00%
0/10 • Up to Day 43
|
|
Nervous system disorders
Headache
|
23.8%
5/21 • Number of events 6 • Up to Day 43
|
20.0%
2/10 • Number of events 5 • Up to Day 43
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/21 • Up to Day 43
|
10.0%
1/10 • Number of events 1 • Up to Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
14.3%
3/21 • Number of events 3 • Up to Day 43
|
0.00%
0/10 • Up to Day 43
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.5%
2/21 • Number of events 2 • Up to Day 43
|
0.00%
0/10 • Up to Day 43
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regard to (1) proprietary information that is protected, (2) the accuracy of the information contained in the publication, and (3) to ensure that the presentation is fairly balanced and in compliance with FDA regulations.
- Publication restrictions are in place
Restriction type: OTHER