Plaque Psoriasis
Conditions
Brief summary
This Phase 3 study (Study 306) 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.
Interventions
DRUG122-0551 Foam
Topical Foam
DRUGVehicle Foam
Topical Foam
Sponsors
Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% affected body surface area. * Subject has an Investigator's Global Assessment (IGA) score of at least three (moderate) at study start. * If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study.
Exclusion criteria
* Subject has spontaneously improving or rapidly deteriorating plaque psoriasis. * Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis. * Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk by study participation. * Subject has used any phototherapy (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to study start. * Subject has used any systemic methotrexate, retinoids, systemic corticosteroids \[including intralesional, intra-articular, and intramuscular corticosteroids\], cyclosporine or analogous products within 90 days prior to study start. * Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental therapy) within five half-lives of the biologic prior to study start. * Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start or is intending to have such exposure during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA) | Day 15 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Day 15 | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With IGA Treatment Success | Day 8 | 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). |
| Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Day 8 | 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). |
| Change From Baseline in Pruritus Score | Baseline and Day 15 | 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). |
| Change in Percent Body Surface Area (BSA) With Active Psoriasis | Baseline and Day 15 | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment period: January 2015 to June 2015 The location of clinical sites included dermatology clinics and clinical research centers.
Pre-assignment details
All subjects who met the entry criteria were randomized and enrolled into the study.
Participants by arm
| Arm | Count |
|---|---|
| 122-0551 Foam 122-0511 Foam, topically applied twice daily
122-0551 Foam: Topical Foam | 75 |
| Vehicle Foam Vehicle Foam, topically applied twice daily
Vehicle Foam: Topical Foam | 76 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | 122-0551 Foam | Total | Vehicle Foam |
|---|---|---|---|
| Age, Continuous | 54.0 years STANDARD_DEVIATION 14.22 | 54.5 years STANDARD_DEVIATION 14 | 55.1 years STANDARD_DEVIATION 13.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 43 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 108 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 15 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 63 Participants | 131 Participants | 68 Participants |
| Region of Enrollment United States | 75 Participants | 151 Participants | 76 Participants |
| Sex: Female, Male Female | 27 Participants | 49 Participants | 22 Participants |
| Sex: Female, Male Male | 48 Participants | 102 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 76 |
| other Total, other adverse events | 5 / 75 | 3 / 76 |
| serious Total, serious adverse events | 0 / 75 | 0 / 76 |
Outcome results
Primary
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/very severe).
Time frame: Day 15
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 122-0551 Foam | Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA) | 25.3 percentage of participants |
| Vehicle Foam | Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA) | 3.9 percentage of participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 122-0551 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 |
| 122-0551 Foam | 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 |
| 122-0551 Foam | 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 |
| Vehicle Foam | Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Scaling | 5.3 percentage of participants |
| Vehicle Foam | Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Erythema | 2.6 percentage of participants |
| Vehicle Foam | Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Plaque Elevation | 3.9 percentage of participants |
Comparison: Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).p-value: <0.001Cochran-Mantel-Haenszel
Comparison: Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).p-value: <0.001Cochran-Mantel-Haenszel
Comparison: Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).p-value: <0.001Cochran-Mantel-Haenszel
Other Pre-specified
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: Baseline and Day 15
Population: Analysis shown is based on the Intent-to-Treat (ITT) population and observed results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 122-0551 Foam | Change From Baseline in Pruritus Score | -4.4 units on a scale | Standard Deviation 4.03 |
| Vehicle Foam | Change From Baseline in Pruritus Score | -2.0 units on a scale | Standard Deviation 3.19 |
Other Pre-specified
Change in Percent 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: Baseline and Day 15
Population: Analysis shown is based on the Intent-to-Treat (ITT) population and observed results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 122-0551 Foam | Change in Percent Body Surface Area (BSA) With Active Psoriasis | Baseline % BSA | 5.7 Change in percent BSA | Standard Deviation 3.09 |
| 122-0551 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 |
| Vehicle Foam | Change in Percent Body Surface Area (BSA) With Active Psoriasis | Baseline % BSA | 5.7 Change in percent BSA | Standard Deviation 3.22 |
| Vehicle Foam | Change in Percent Body Surface Area (BSA) With Active Psoriasis | Change in % BSA at Day 15 | -0.2 Change in percent BSA | Standard Deviation 0.69 |
Other Pre-specified
Percentage 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. 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 8
Population: Analysis shown is based on the Intent-to-Treat (ITT) population and observed results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 122-0551 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 |
| 122-0551 Foam | 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 |
| 122-0551 Foam | 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 |
| Vehicle Foam | Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Scaling | 3.9 percentage of participants |
| Vehicle Foam | Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Erythema | 1.3 percentage of participants |
| Vehicle Foam | Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Plaque Elevation | 3.9 percentage of participants |
Other Pre-specified
Percentage of Subjects With IGA Treatment Success
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).
Time frame: Day 8
Population: Analysis shown is based on the Intent-to-Treat (ITT) population and observed results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 122-0551 Foam | Percentage of Subjects With IGA Treatment Success | 8.1 percentage of participants |
| Vehicle Foam | Percentage of Subjects With IGA Treatment Success | 2.6 percentage of participants |