Trial Outcomes & Findings for A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -304) (NCT NCT01871402)

Last Updated: 2016-05-13

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

221 participants

Primary outcome timeframe

Day 15

Results posted on

2016-05-13

Participant Flow

Recruitment period: May 2013 to December 2013 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 Topical lotion, applied twice daily 000-0551 Lotion	Vehicle Arm Topical lotion, applied twice daily Vehicle Lotion
Overall Study STARTED	110	111
Overall Study COMPLETED	109	108
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Arm Topical lotion, applied twice daily 000-0551 Lotion	Vehicle Arm Topical lotion, applied twice daily Vehicle Lotion
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	0	2
Overall Study Non-compliance	0	1

Baseline Characteristics

A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -304)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Arm n=110 Participants Topical lotion, applied twice daily 000-0551 Lotion	Vehicle Arm n=111 Participants Topical lotion, applied twice daily Vehicle Lotion	Total n=221 Participants Total of all reporting groups
Age, Continuous	52.9 years STANDARD_DEVIATION 12.28 • n=5 Participants	50.8 years STANDARD_DEVIATION 14.15 • n=7 Participants	51.8 years STANDARD_DEVIATION 13.26 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	46 Participants n=7 Participants	93 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	65 Participants n=7 Participants	128 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	15 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	105 Participants n=5 Participants	96 Participants n=7 Participants	201 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	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	88 Participants n=5 Participants	87 Participants n=7 Participants	175 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	3 Participants n=7 Participants	7 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	110 participants n=5 Participants	111 participants n=7 Participants	221 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 15

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

Outcome measures

Outcome measures
Measure	Active Arm n=110 Participants Topical lotion, applied twice daily 000-0551 Lotion	Vehicle Arm n=111 Participants Topical lotion, applied twice daily Vehicle Lotion
Proportion of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)	44.5 percentage of participants	6.3 percentage of participants

SECONDARY outcome

Timeframe: Day 15

Population: Analysis shown is based on the ITT population.

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=110 Participants Topical lotion, applied twice daily 000-0551 Lotion	Vehicle Arm n=111 Participants Topical lotion, applied twice daily Vehicle Lotion
Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) Scaling	55.5 percentage of participants	10.8 percentage of participants
Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) Erythema	36.4 percentage of participants	7.2 percentage of participants
Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) Plaque Elevation	45.5 percentage of participants	8.1 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 8

Population: Analysis shown is based on the ITT population. Only participants with observed values are reported.

Interim analysis of IGA. "Treatment success" and IGA as defined in the primary outcome measure.

Outcome measures

Outcome measures
Measure	Active Arm n=109 Participants Topical lotion, applied twice daily 000-0551 Lotion	Vehicle Arm n=110 Participants Topical lotion, applied twice daily Vehicle Lotion
Proportion of Subjects With IGA "Treatment Success" at Day 8	16.5 percentage of participants	1.8 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 8

Population: Analysis shown is based on the ITT population. Only participants with observed values are reported.

Interim analysis of clinical signs of psoriasis (scaling, erythema and plaque elevation). "Treatment success" and clinical signs as defined in the secondary outcome measure.

Outcome measures

Outcome measures
Measure	Active Arm n=109 Participants Topical lotion, applied twice daily 000-0551 Lotion	Vehicle Arm n=110 Participants Topical lotion, applied twice daily Vehicle Lotion
Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis at Day 8 Scaling	33.9 percentage of participants	6.4 percentage of participants
Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis at Day 8 Erythema	13.8 percentage of participants	0.9 percentage of participants
Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis at Day 8 Plaque Elevation	21.1 percentage of participants	3.6 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Day 15

Population: Analysis shown is based on the ITT population. Only participants with observed values are reported.

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

Outcome measures
Measure	Active Arm n=109 Participants Topical lotion, applied twice daily 000-0551 Lotion	Vehicle Arm n=107 Participants Topical lotion, applied twice daily Vehicle Lotion
Change From Baseline in Pruritus Score at Day 15	-5.2 units on a scale Standard Deviation 3.46	-3.1 units on a scale Standard Deviation 3.35

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 8 and Day 15

Population: Analysis shown is based on the ITT population at Days 8 and 15 and compared to baseline. Number of Participants Analyzed is at Day 15; at Day 8, N=109 (Active) and N=110 (Vehicle). Only participants with observed values are reported.

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

Outcome measures
Measure	Active Arm n=109 Participants Topical lotion, applied twice daily 000-0551 Lotion	Vehicle Arm n=108 Participants Topical lotion, applied twice daily Vehicle Lotion
Change in % Body Surface Area (BSA) With Active Psoriasis at Days 8 and 15 Day 8	-0.7 Change in %BSA Standard Deviation 1.59	-0.1 Change in %BSA Standard Deviation 0.73
Change in % Body Surface Area (BSA) With Active Psoriasis at Days 8 and 15 Day 15	-1.6 Change in %BSA Standard Deviation 2.22	-0.2 Change in %BSA Standard Deviation 1.07

Adverse Events

Active Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Vehicle Arm

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active Arm n=110 participants at risk Topical lotion, applied twice daily 000-0551 Lotion	Vehicle Arm n=111 participants at risk Topical lotion, applied twice daily Vehicle Lotion
Gastrointestinal disorders Dyspepsia	0.91% 1/110 • 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 subjects enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=221) were included in the safety population. Most AEs were mild in severity.	0.00% 0/111 • 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 subjects enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=221) were included in the safety population. Most AEs were mild in severity.
Gastrointestinal disorders Toothache	0.00% 0/110 • 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 subjects enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=221) were included in the safety population. Most AEs were mild in severity.	0.90% 1/111 • 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 subjects enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=221) were included in the safety population. Most AEs were mild in severity.
General disorders Application site erythema	0.00% 0/110 • 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 subjects enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=221) were included in the safety population. Most AEs were mild in severity.	0.90% 1/111 • 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 subjects enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=221) were included in the safety population. Most AEs were mild in severity.
General disorders Application site pain	0.00% 0/110 • 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 subjects enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=221) were included in the safety population. Most AEs were mild in severity.	3.6% 4/111 • Number of events 5 • 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 subjects enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=221) were included in the safety population. Most AEs were mild in severity.
Musculoskeletal and connective tissue disorders Arthralgia	0.91% 1/110 • 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 subjects enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=221) were included in the safety population. Most AEs were mild in severity.	0.00% 0/111 • 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 subjects enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=221) were included in the safety population. Most AEs were mild in severity.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/110 • 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 subjects enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=221) were included in the safety population. Most AEs were mild in severity.	0.90% 1/111 • 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 subjects enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=221) were included in the safety population. Most AEs were mild in severity.

Additional Information

Clinical Research, Therapeutics, Inc.

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 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