Trial Outcomes & Findings for A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis (NCT NCT01700985)
NCT ID: NCT01700985
Last Updated: 2018-10-25
Results Overview
The percentage of subjects with ODS "treatment success" at EOS where EOS is the subject's last completed visit. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
COMPLETED
PHASE2
44 participants
baseline and Day 15 (End of Study - EOS)
2018-10-25
Participant Flow
Recruitment period: May 2012 to September 2012 The location of clinical sites included dermatology clinical research centers.
All subjects who met the entry criteria were randomized and enrolled into the study.
Participant milestones
| Measure |
122-0551
122-0551: Applied twice daily for two weeks
|
Vehicle
Vehicle: Applied twice daily for two weeks
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
|
Overall Study
COMPLETED
|
23
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
122-0551
122-0551: Applied twice daily for two weeks
|
Vehicle
Vehicle: Applied twice daily for two weeks
|
|---|---|---|
|
Overall Study
Incarcerated
|
0
|
1
|
Baseline Characteristics
A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
122-0551
n=23 Participants
122-0551: Applied twice daily for two weeks
|
Vehicle
n=21 Participants
Vehicle: Applied twice daily for two weeks
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
48.6 years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
50.0 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
21 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and Day 15 (End of Study - EOS)Population: Analysis shown is the Intent-to-treat (ITT) population, defined as all participants who were randomized, applied at least one dose, and had at least one follow-up visit after the Baseline visit. One study participant (VEH group) did not return to the clinic (incarcerated) following Visit 1 (baseline visit) and was excluded from the ITT population.
The percentage of subjects with ODS "treatment success" at EOS where EOS is the subject's last completed visit. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
Outcome measures
| Measure |
122-0551
n=23 Participants
122-0551: Applied twice daily for two weeks
|
Vehicle
n=20 Participants
Vehicle: Applied twice daily for two weeks
|
|---|---|---|
|
Change in Overall Disease Severity (ODS) Score
|
52.2 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: baseline, Day 8, and Day 15Population: Analysis shown is the Intent-to-treat (ITT) population.
The percentage of subjects with ODS "treatment success" at Day 8 and Day 15. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
Outcome measures
| Measure |
122-0551
n=23 Participants
122-0551: Applied twice daily for two weeks
|
Vehicle
n=20 Participants
Vehicle: Applied twice daily for two weeks
|
|---|---|---|
|
ODS "Treatment Success" at Day 8 and Day 15
Day 8
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
ODS "Treatment Success" at Day 8 and Day 15
Day 15
|
52.2 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: baseline, Day 8, and Day 15Population: Analysis shown is the Intent-to-treat (ITT) population.
The percentage of subjects rated "improved" with respect to ODS at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in ODS score relative to baseline. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
Outcome measures
| Measure |
122-0551
n=23 Participants
122-0551: Applied twice daily for two weeks
|
Vehicle
n=20 Participants
Vehicle: Applied twice daily for two weeks
|
|---|---|---|
|
ODS "Improved" at Day 8 and Day 15
Day 8
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
ODS "Improved" at Day 8 and Day 15
Day 15
|
52.2 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: baseline, Day 8 and Day 15Population: Analysis shown is the Intent-to-treat (ITT) population.
The percentage of subjects rated "treatment success" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. "Treatment success" is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
Outcome measures
| Measure |
122-0551
n=23 Participants
122-0551: Applied twice daily for two weeks
|
Vehicle
n=20 Participants
Vehicle: Applied twice daily for two weeks
|
|---|---|---|
|
"Treatment Success" for Clinical Signs and Symptoms of Psoriasis
Scaling (Day 8)
|
21.7 percentage of participants
|
0.0 percentage of participants
|
|
"Treatment Success" for Clinical Signs and Symptoms of Psoriasis
Scaling (Day 15)
|
60.9 percentage of participants
|
0.0 percentage of participants
|
|
"Treatment Success" for Clinical Signs and Symptoms of Psoriasis
Erythema (Day 8)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
"Treatment Success" for Clinical Signs and Symptoms of Psoriasis
Erythema (Day 15)
|
21.7 percentage of participants
|
0.0 percentage of participants
|
|
"Treatment Success" for Clinical Signs and Symptoms of Psoriasis
Plaque Elevation (Day 8)
|
8.7 percentage of participants
|
0.0 percentage of participants
|
|
"Treatment Success" for Clinical Signs and Symptoms of Psoriasis
Plaque Elevation (Day 15)
|
56.5 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: baseline, Day 8 and Day 15Population: Analysis shown is the Intent-to-treat (ITT) population.
The percentage of subjects rated "improved" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
Outcome measures
| Measure |
122-0551
n=23 Participants
122-0551: Applied twice daily for two weeks
|
Vehicle
n=20 Participants
Vehicle: Applied twice daily for two weeks
|
|---|---|---|
|
"Improved" for Clinical Signs and Symptoms of Psoriasis
Scaling (Day 8)
|
26.1 percentage of participants
|
0.0 percentage of participants
|
|
"Improved" for Clinical Signs and Symptoms of Psoriasis
Scaling (Day 15)
|
73.9 percentage of participants
|
0.0 percentage of participants
|
|
"Improved" for Clinical Signs and Symptoms of Psoriasis
Erythema (Day 8)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
"Improved" for Clinical Signs and Symptoms of Psoriasis
Erythema (Day 15)
|
34.8 percentage of participants
|
0.0 percentage of participants
|
|
"Improved" for Clinical Signs and Symptoms of Psoriasis
Plaque Elevation (Day 8)
|
4.3 percentage of participants
|
0.0 percentage of participants
|
|
"Improved" for Clinical Signs and Symptoms of Psoriasis
Plaque Elevation (Day 15)
|
56.5 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: baseline, Day 8 and Day 15Population: Analysis shown is the Intent-to-treat (ITT) population. The mean percent BSA at baseline was 4.8 for the active group (122-0551) and 4.6 for the vehicle group.
Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.
Outcome measures
| Measure |
122-0551
n=23 Participants
122-0551: Applied twice daily for two weeks
|
Vehicle
n=20 Participants
Vehicle: Applied twice daily for two weeks
|
|---|---|---|
|
Change in % Body Surface Area (BSA) With Psoriasis
Day 8
|
-0.3 Change in percent BSA
Standard Deviation 0.69
|
0.0 Change in percent BSA
Standard Deviation 0.0
|
|
Change in % Body Surface Area (BSA) With Psoriasis
Day 15
|
-1.3 Change in percent BSA
Standard Deviation 2.07
|
0.0 Change in percent BSA
Standard Deviation 0.32
|
Adverse Events
122-0551
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
122-0551
n=23 participants at risk
122-0551: Applied twice daily for two weeks
|
Vehicle
n=21 participants at risk
Vehicle: Applied twice daily for two weeks
|
|---|---|---|
|
General disorders
Influenza like illness
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed and applied the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
0.00%
0/21 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed and applied the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/23 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed and applied the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
4.8%
1/21 • Number of events 1 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed and applied the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/23 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed and applied the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
9.5%
2/21 • Number of events 2 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed and applied the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 12 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 30 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER