Trial Outcomes & Findings for A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306) (NCT NCT02368210)
NCT ID: NCT02368210
Last Updated: 2018-11-26
Results Overview
The IGA score is a static evaluation of the overall or "average" degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
151 participants
Primary outcome timeframe
Day 15
Results posted on
2018-11-26
Participant Flow
Recruitment period: January 2015 to June 2015 The location of clinical sites included dermatology clinics and clinical research centers.
All subjects who met the entry criteria were randomized and enrolled into the study.
Participant milestones
| Measure |
122-0551 Foam
122-0511 Foam, topically applied twice daily
122-0551 Foam: Topical Foam
|
Vehicle Foam
Vehicle Foam, topically applied twice daily
Vehicle Foam: Topical Foam
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
76
|
|
Overall Study
COMPLETED
|
74
|
75
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
122-0551 Foam
122-0511 Foam, topically applied twice daily
122-0551 Foam: Topical Foam
|
Vehicle Foam
Vehicle Foam, topically applied twice daily
Vehicle Foam: Topical Foam
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)
Baseline characteristics by cohort
| Measure |
122-0551 Foam
n=75 Participants
122-0511 Foam, topically applied twice daily
122-0551 Foam: Topical Foam
|
Vehicle Foam
n=76 Participants
Vehicle Foam, topically applied twice daily
Vehicle Foam: Topical Foam
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 14.22 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 13.86 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 14.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
108 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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
131 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
|
75 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.
The IGA score is a static evaluation of the overall or "average" degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Outcome measures
| Measure |
122-0551 Foam
n=75 Participants
122-0511 Foam, topically applied twice daily
122-0551 Foam: Topical Foam
|
Vehicle Foam
n=76 Participants
Vehicle Foam, topically applied twice daily
Vehicle Foam: Topical Foam
|
|---|---|---|
|
Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
|
25.3 percentage of participants
|
3.9 percentage of participants
|
SECONDARY outcome
Timeframe: Day 15Population: Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.
A static assessment of the overall or "average" degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Outcome measures
| Measure |
122-0551 Foam
n=75 Participants
122-0511 Foam, topically applied twice daily
122-0551 Foam: Topical Foam
|
Vehicle Foam
n=76 Participants
Vehicle Foam, topically applied twice daily
Vehicle Foam: Topical Foam
|
|---|---|---|
|
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Scaling
|
28.0 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Erythema
|
21.3 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Plaque Elevation
|
26.7 percentage of participants
|
3.9 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 8Population: Analysis shown is based on the Intent-to-Treat (ITT) population and observed results.
"Treatment success" and IGA as defined in the primary outcome measure. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Outcome measures
| Measure |
122-0551 Foam
n=75 Participants
122-0511 Foam, topically applied twice daily
122-0551 Foam: Topical Foam
|
Vehicle Foam
n=76 Participants
Vehicle Foam, topically applied twice daily
Vehicle Foam: Topical Foam
|
|---|---|---|
|
Percentage of Subjects With IGA "Treatment Success"
|
8.1 percentage of participants
|
2.6 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 8Population: Analysis shown is based on the Intent-to-Treat (ITT) population and observed results.
"Treatment success" and clinical signs as defined in the secondary outcome measure. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Outcome measures
| Measure |
122-0551 Foam
n=75 Participants
122-0511 Foam, topically applied twice daily
122-0551 Foam: Topical Foam
|
Vehicle Foam
n=76 Participants
Vehicle Foam, topically applied twice daily
Vehicle Foam: Topical Foam
|
|---|---|---|
|
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Scaling
|
12.2 percentage of participants
|
3.9 percentage of participants
|
|
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Erythema
|
10.8 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Plaque Elevation
|
10.8 percentage of participants
|
3.9 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Day 15Population: Analysis shown is based on the Intent-to-Treat (ITT) population and observed results.
Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).
Outcome measures
| Measure |
122-0551 Foam
n=75 Participants
122-0511 Foam, topically applied twice daily
122-0551 Foam: Topical Foam
|
Vehicle Foam
n=76 Participants
Vehicle Foam, topically applied twice daily
Vehicle Foam: Topical Foam
|
|---|---|---|
|
Change From Baseline in Pruritus Score
|
-4.4 units on a scale
Standard Deviation 4.03
|
-2.0 units on a scale
Standard Deviation 3.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Day 15Population: Analysis shown is based on the Intent-to-Treat (ITT) population and observed results.
The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.
Outcome measures
| Measure |
122-0551 Foam
n=75 Participants
122-0511 Foam, topically applied twice daily
122-0551 Foam: Topical Foam
|
Vehicle Foam
n=76 Participants
Vehicle Foam, topically applied twice daily
Vehicle Foam: Topical Foam
|
|---|---|---|
|
Change in Percent Body Surface Area (BSA) With Active Psoriasis
Change in % BSA at Day 15
|
-0.9 Change in percent BSA
Standard Deviation 1.56
|
-0.2 Change in percent BSA
Standard Deviation 0.69
|
|
Change in Percent Body Surface Area (BSA) With Active Psoriasis
Baseline % BSA
|
5.7 Change in percent BSA
Standard Deviation 3.09
|
5.7 Change in percent BSA
Standard Deviation 3.22
|
Adverse Events
122-0551 Foam
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Vehicle Foam
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
122-0551 Foam
n=75 participants at risk
122-0511 Foam, topically applied twice daily
122-0551 Foam: Topical Foam
|
Vehicle Foam
n=76 participants at risk
Vehicle Foam, topically applied twice daily
Vehicle Foam: Topical Foam
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/75 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
0.00%
0/76 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
|
General disorders
Application site pain
|
1.3%
1/75 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
0.00%
0/76 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
|
General disorders
Application site pruritus
|
0.00%
0/75 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
1.3%
1/76 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/75 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
1.3%
1/76 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
|
Infections and infestations
Hordeolum
|
1.3%
1/75 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
0.00%
0/76 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
|
Infections and infestations
Influenza
|
1.3%
1/75 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
0.00%
0/76 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/75 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
0.00%
0/76 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
|
Infections and infestations
Laceration
|
1.3%
1/75 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
0.00%
0/76 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.3%
1/75 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
0.00%
0/76 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/75 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
1.3%
1/76 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or 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; because the first dose of the test article was applied at the study site (Day 1), all participants (N=151) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
|
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 thirty 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