A Phase 3 interventional study of 122-0551 Foam and Vehicle Foam in Plaque Psoriasis, sponsored by Therapeutics, Inc.. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-08.
Sponsored by Therapeutics, Inc. · Phase 3, Interventional, and Treatment
This Phase 3 study has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 144 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Therapeutics, Inc. is the lead sponsor of 16 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
122-0551 Foam, topically applied twice daily for two weeks
Drug: 122-0551 Foam
Vehicle Foam, topically applied twice daily for two weeks
Drug: Vehicle Foam
122-0551 Foam applied twice daily to treat psoriasis
Vehicle Foam applied twice daily to treat psoriasis
Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
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).
Time frame: Day 15
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
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).
Time frame: Day 15
Proportion of Subjects With IGA "Treatment Success"
"Treatment success" and IGA as defined in the primary outcome measure.
Time frame: Day 8
Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
"Treatment success" and clinical signs as defined in the secondary outcome measure.
Time frame: Day 8
Change From Baseline in Pruritus Score
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).
Time frame: Day 15
Change in % Body Surface Area (BSA) With Active Psoriasis
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.
Time frame: Day 8 and Day 15
Recruitment period: January 2015 to August 2015 The location of clinical sites included dermatology clinics and clinical research centers.
| Milestone | Active Arm | Vehicle Arm |
|---|---|---|
| Started | 71 | 73 |
| Completed | 66 | 69 |
| Not completed | 5 | 4 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Lost to follow-up | 2 | 2 |
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).
| percentage of participants | Active Arm | Vehicle Arm |
|---|---|---|
| Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA) | 18.3 | 9.6 |
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).
| percentage of participants | Active Arm | Vehicle Arm |
|---|---|---|
| Scaling | 32.4 | 13.7 |
| Erythema | 16.9 | 8.2 |
| Plaque Elevation | 26.8 | 13.7 |
"Treatment success" and IGA as defined in the primary outcome measure.
Results for this outcome have not been posted.
"Treatment success" and clinical signs as defined in the secondary outcome measure.
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Arm | 0/71 (0%) | 0/71 (0%) | 2/71 (2.8%) |
| Vehicle Arm | 0/73 (0%) | 0/73 (0%) | 3/73 (4.1%) |
| Event | Active Arm | Vehicle Arm |
|---|---|---|
| SinusitisInfections and infestations | 1/71 | 0/73 |
| TrichorrhexisSkin and subcutaneous tissue disorders | 1/71 | 0/73 |
| Application site drynessGeneral disorders | 0/71 | 1/73 |
| Application site painGeneral disorders | 0/71 | 1/73 |
| Gastroenteritis viralInfections and infestations | 0/71 | 1/73 |
Baseline demographics is based on the Intent-To-Treat (ITT) population, defined as all enrolled subjects in the study who were randomized and dispensed the test article.
| Age, Continuous(years) | Active Arm | Vehicle Arm | Total |
|---|---|---|---|
| Mean | 52.4 ± 13.44 | 52.0 ± 13.75 | 52.2 ± 13.55 |
| Sex: Female, Male(Participants) | Active Arm | Vehicle Arm | Total |
|---|---|---|---|
| Female | 35 | 36 | 71 |
| Male | 36 | 37 | 73 |
| Ethnicity (NIH/OMB)(Participants) | Active Arm | Vehicle Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 4 | 9 |
| Not Hispanic or Latino | 66 | 69 | 135 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Active Arm | Vehicle Arm | Total |
|---|---|---|---|
| Race — Asian | 1 | 2 | 3 |
| Race — Black or African American | 2 | 7 | 9 |
| Race — White | 68 | 64 | 132 |
| Region of Enrollment(Participants) | Active Arm | Vehicle Arm | Total |
|---|---|---|---|
| United States | 71 | 73 | 144 |
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Therapeutics, Inc.