Trial Outcomes & Findings for A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310) (NCT NCT02742441)

Last Updated: 2018-11-14

Results Overview

The IGA score is a static evaluation of the overall or "average" degree of severity taking into account all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee. This evaluation takes into consideration the three individual characteristics of psoriasis (scaling, erythema and plaque elevation) with the IGA score at each visit representing the average of scaling, erythema or plaque elevation that is present amongst all of the lesions eligible for treatment. IGA will be assessed on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

409 participants

Primary outcome timeframe

Day 15

Results posted on

2018-11-14

Participant Flow

Recruitment period: June 2016 to February 2017 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	122-0551 Foam 122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam 122-0551 Foam: Topical Foam containing active drug	Vehicle Foam Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam Vehicle Foam: Topical Foam containing no active drug
Overall Study STARTED	205	204
Overall Study COMPLETED	199	196
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal

Reasons for withdrawal
Measure	122-0551 Foam 122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam 122-0551 Foam: Topical Foam containing active drug	Vehicle Foam Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam Vehicle Foam: Topical Foam containing no active drug
Overall Study Lost to Follow-up	4	4
Overall Study Withdrawal by Subject	2	2
Overall Study Adverse Event	0	2

Baseline Characteristics

A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	122-0551 Foam n=205 Participants 122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam 122-0551 Foam: Topical Foam containing active drug	Vehicle Foam n=204 Participants Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam Vehicle Foam: Topical Foam containing no active drug	Total n=409 Participants Total of all reporting groups
Age, Continuous	50.3 years STANDARD_DEVIATION 13.9 • n=5 Participants	50.1 years STANDARD_DEVIATION 14.0 • n=7 Participants	50.2 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	86 Participants n=7 Participants	178 Participants n=5 Participants
Sex: Female, Male Male	113 Participants n=5 Participants	118 Participants n=7 Participants	231 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	54 Participants n=5 Participants	54 Participants n=7 Participants	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	151 Participants n=5 Participants	150 Participants n=7 Participants	301 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	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 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	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) White	190 Participants n=5 Participants	185 Participants n=7 Participants	375 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	205 participants n=5 Participants	204 participants n=7 Participants	409 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	122-0551 Foam n=205 Participants 122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam 122-0551 Foam: Topical Foam containing active drug	Vehicle Foam n=204 Participants Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam Vehicle Foam: Topical Foam containing no active drug
Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)	30.7 percentage of participants	7.4 percentage of participants

SECONDARY outcome

Timeframe: Day 15

Population: Analysis shown is based on the Intent-to-Treat (ITT) population.

Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee.

Outcome measures

Outcome measures
Measure	122-0551 Foam n=205 Participants 122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam 122-0551 Foam: Topical Foam containing active drug	Vehicle Foam n=204 Participants Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam Vehicle Foam: Topical Foam containing no active drug
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) Plaque Elevation	35.0 percentage of participants	9.9 percentage of participants
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) Scaling	33.7 percentage of participants	9.8 percentage of participants
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) Erythema	28.8 percentage of participants	8.3 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.

Outcome measures

Outcome measures
Measure	122-0551 Foam n=199 Participants 122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam 122-0551 Foam: Topical Foam containing active drug	Vehicle Foam n=196 Participants Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam Vehicle Foam: Topical Foam containing no active drug
Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)	9.5 percentage of participants	3.6 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.

Outcome measures

Outcome measures
Measure	122-0551 Foam n=205 Participants 122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam 122-0551 Foam: Topical Foam containing active drug	Vehicle Foam n=204 Participants Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam Vehicle Foam: Topical Foam containing no active drug
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) Scaling	14.2 percentage of participants	3.6 percentage of participants
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) Erythema	8.0 percentage of participants	3.1 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	13.2 percentage of participants	3.6 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 15

Population: Analysis shown is based on the ITT population. Only participants with observed values are reported. Pruritus scores were based on the patient's assessment of pruritus ranging from a score of 5 (no pruritus) to 25 (most severe pruritus).

At the Baseline Visit, prior to the first application of the test article, the subject's overall experience of pruritus within the previous two (2) weeks will be assessed and scored (range 1-5) using a questionnaire that assesses the degree, duration, direction, disability, and distribution of the subject's pruritus. Possible total scores range from 5 (no pruritus) to 25 (most severe pruritus). At Day 15, the overall experience of pruritus, in the previous two weeks, will be scored using the same questionnaire.

Outcome measures

Outcome measures
Measure	122-0551 Foam n=205 Participants 122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam 122-0551 Foam: Topical Foam containing active drug	Vehicle Foam n=204 Participants Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam Vehicle Foam: Topical Foam containing no active drug
Change From Baseline in Pruritus Score	-4.3 scores on a scale Standard Deviation 3.8	-2.5 scores on a scale Standard Deviation 3.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 15

Population: Analysis shown is based on the ITT population. Only participants with observed values are reported. The mean percent BSA with active psoriasis at Baseline was 5.4% and 5.1% for the active and vehicle groups, respectively.

The percent (%) Body Surface Area (BSA) with active psoriasis in the Treatment Area will be determined at the Baseline Visit and Week 2 (Day 15) and documented. At Baseline, the percent BSA with active psoriasis in the Treatment Area must be 2% to 12%, inclusive.

Outcome measures

Outcome measures
Measure	122-0551 Foam n=199 Participants 122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam 122-0551 Foam: Topical Foam containing active drug	Vehicle Foam n=196 Participants Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam Vehicle Foam: Topical Foam containing no active drug
Changes in Percent BSA With Active Psoriasis in the Treatment Area	-1.5 Change in percent BSA Standard Deviation 2.3	-0.2 Change in percent BSA Standard Deviation 1.5

Adverse Events

122-0551 Foam

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Vehicle Foam

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	122-0551 Foam n=205 participants at risk 122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam 122-0551 Foam: Topical Foam containing active drug	Vehicle Foam n=204 participants at risk Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam Vehicle Foam: Topical Foam containing no active drug
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/205 • 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 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 enrolled subjects (N=409) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.	0.49% 1/204 • 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 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 enrolled subjects (N=409) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.

Other adverse events

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