Trial Outcomes & Findings for A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (NCT NCT02367911)

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

144 participants

Primary outcome timeframe

Day 15

Results posted on

2018-11-08

Participant Flow

Recruitment period: January 2015 to August 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

Participant milestones
Measure	Active Arm 122-0551 Foam, topically applied twice daily for two weeks 122-0551 Foam: 122-0551 Foam applied twice daily to treat psoriasis	Vehicle Arm Vehicle Foam, topically applied twice daily for two weeks Vehicle Foam: Vehicle Foam applied twice daily to treat psoriasis
Overall Study STARTED	71	73
Overall Study COMPLETED	66	69
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Arm 122-0551 Foam, topically applied twice daily for two weeks 122-0551 Foam: 122-0551 Foam applied twice daily to treat psoriasis	Vehicle Arm Vehicle Foam, topically applied twice daily for two weeks Vehicle Foam: Vehicle Foam applied twice daily to treat psoriasis
Overall Study Withdrawal by Subject	3	2
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Arm n=71 Participants 122-0551 Foam, topically applied twice daily for two weeks 122-0551 Foam: 122-0551 Foam applied twice daily to treat psoriasis	Vehicle Arm n=73 Participants Vehicle Foam, topically applied twice daily for two weeks Vehicle Foam: Vehicle Foam applied twice daily to treat psoriasis	Total n=144 Participants Total of all reporting groups
Age, Continuous	52.4 years STANDARD_DEVIATION 13.44 • n=5 Participants	52.0 years STANDARD_DEVIATION 13.75 • n=7 Participants	52.2 years STANDARD_DEVIATION 13.55 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	36 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	37 Participants n=7 Participants	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants	69 Participants n=7 Participants	135 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/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	68 Participants n=5 Participants	64 Participants n=7 Participants	132 Participants n=5 Participants
Region of Enrollment United States	71 Participants n=5 Participants	73 Participants n=7 Participants	144 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 15

Population: Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and dispensed 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).

Outcome measures

Outcome measures
Measure	Active Arm n=71 Participants 122-0551 Foam, topically applied twice daily for two weeks 122-0551 Foam: 122-0551 Foam applied twice daily to treat psoriasis	Vehicle Arm n=73 Participants Vehicle Foam, topically applied twice daily for two weeks Vehicle Foam: Vehicle Foam applied twice daily to treat psoriasis
Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)	18.3 percentage of participants	9.6 percentage of participants

SECONDARY outcome

Timeframe: Day 15

Population: Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Missing data was imputed as failure.

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

Outcome measures
Measure	Active Arm n=71 Participants 122-0551 Foam, topically applied twice daily for two weeks 122-0551 Foam: 122-0551 Foam applied twice daily to treat psoriasis	Vehicle Arm n=73 Participants Vehicle Foam, topically applied twice daily for two weeks Vehicle Foam: Vehicle Foam applied twice daily to treat psoriasis
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) Scaling	32.4 percentage of participants	13.7 percentage of participants
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) Erythema	16.9 percentage of participants	8.2 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	26.8 percentage of participants	13.7 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 8

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active Arm n=71 participants at risk 122-0551 Foam, topically applied twice daily for two weeks 122-0551 Foam: 122-0551 Foam applied twice daily to treat psoriasis	Vehicle Arm n=73 participants at risk Vehicle Foam, topically applied twice daily for two weeks Vehicle Foam: Vehicle Foam applied twice daily to treat psoriasis
General disorders Application site dryness	0.00% 0/71 • Treatment emergent 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=144) were included in the safety population.	1.4% 1/73 • Number of events 1 • Treatment emergent 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=144) were included in the safety population.
General disorders Application site pain	0.00% 0/71 • Treatment emergent 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=144) were included in the safety population.	1.4% 1/73 • Number of events 1 • Treatment emergent 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=144) were included in the safety population.
Infections and infestations Gastroenteritis viral	0.00% 0/71 • Treatment emergent 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=144) were included in the safety population.	1.4% 1/73 • Number of events 1 • Treatment emergent 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=144) were included in the safety population.
Infections and infestations Sinusitis	1.4% 1/71 • Number of events 1 • Treatment emergent 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=144) were included in the safety population.	0.00% 0/73 • Treatment emergent 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=144) were included in the safety population.
Skin and subcutaneous tissue disorders Trichorrhexis	1.4% 1/71 • Number of events 1 • Treatment emergent 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=144) were included in the safety population.	0.00% 0/73 • Treatment emergent 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=144) were included in the safety population.

Additional Information

Clinical Research Director

Therapeutics, Inc.

Phone: 858-571-1800

Email: [email protected]

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