Plaque Psoriasis
Conditions
Keywords
psoriasis, lotion, investigator's global assessment
Brief summary
This Phase 3 study has been designed to determine and compare the efficacy and safety of 000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque psoriasis.
Interventions
DRUG000-0551 Lotion
DRUGVehicle Lotion
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 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. * Subject has used topical body (excluding the scalp) psoriasis therapy (including coal tar, anthralin, steroids, retinoids, vitamin D analogs) within 14 days prior to study start. * Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at study start. * Subject is currently using lithium or Plaquenil (hydroxychloroquine). * Subject is currently using a beta-blocking medication (e.g., propanolol) or angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized. * Subject is pregnant, lactating, or is planning to become pregnant during the study. * Subject is currently enrolled in an investigational drug or device study. * Subject has used an investigational drug or investigational device treatment within 30 days prior to study start. * Subject has been previously enrolled in this study and treated with a test article.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion 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 |
|---|---|---|
| Proportion 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 |
|---|---|---|
| Proportion of Subjects With IGA Treatment Success at Day 8 | Day 8 | Interim analysis of IGA. Treatment success and IGA as defined in the primary outcome measure. |
| Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis at Day 8 | Day 8 | Interim analysis of clinical signs of psoriasis (scaling, erythema and plaque elevation). Treatment success and clinical signs as defined in the secondary outcome measure. |
| Change From Baseline in Pruritus Score at Day 15 | 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 % Body Surface Area (BSA) With Active Psoriasis at Days 8 and 15 | Baseline, Day 8 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: May 2013 to December 2013 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 |
|---|---|
| Active Arm Topical lotion, applied twice daily
000-0551 Lotion | 110 |
| Vehicle Arm Topical lotion, applied twice daily
Vehicle Lotion | 111 |
| Total | 221 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Non-compliance | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Active Arm | Total | Vehicle Arm |
|---|---|---|---|
| Age, Continuous | 52.9 years STANDARD_DEVIATION 12.28 | 51.8 years STANDARD_DEVIATION 13.26 | 50.8 years STANDARD_DEVIATION 14.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 20 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 105 Participants | 201 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 21 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 88 Participants | 175 Participants | 87 Participants |
| Region of Enrollment United States | 110 participants | 221 participants | 111 participants |
| Sex: Female, Male Female | 47 Participants | 93 Participants | 46 Participants |
| Sex: Female, Male Male | 63 Participants | 128 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 110 | 7 / 111 |
| serious Total, serious adverse events | 0 / 110 | 0 / 111 |
Outcome results
Primary
Proportion 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 Intent-to-Treat population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Arm | Proportion of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA) | 44.5 percentage of participants |
| Vehicle Arm | Proportion of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA) | 6.3 percentage of participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Proportion 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Arm | 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 |
| Active Arm | 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 |
| Active Arm | 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 |
| Vehicle Arm | Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Scaling | 10.8 percentage of participants |
| Vehicle Arm | Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Erythema | 7.2 percentage of participants |
| Vehicle Arm | Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Plaque Elevation | 8.1 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
Other Pre-specified
Change From Baseline in Pruritus Score at 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).
Time frame: Baseline and Day 15
Population: Analysis shown is based on the ITT population. Only participants with observed values are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Arm | Change From Baseline in Pruritus Score at Day 15 | -5.2 units on a scale | Standard Deviation 3.46 |
| Vehicle Arm | Change From Baseline in Pruritus Score at Day 15 | -3.1 units on a scale | Standard Deviation 3.35 |
Other Pre-specified
Change in % Body Surface Area (BSA) With Active Psoriasis at Days 8 and 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Arm | 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 |
| Active Arm | 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 |
| Vehicle Arm | Change in % Body Surface Area (BSA) With Active Psoriasis at Days 8 and 15 | Day 8 | -0.1 Change in %BSA | Standard Deviation 0.73 |
| Vehicle Arm | Change in % Body Surface Area (BSA) With Active Psoriasis at Days 8 and 15 | Day 15 | -0.2 Change in %BSA | Standard Deviation 1.07 |
Other Pre-specified
Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis at Day 8
Interim analysis of 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
Population: Analysis shown is based on the ITT population. Only participants with observed values are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Arm | Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis at Day 8 | Scaling | 33.9 percentage of participants |
| Active Arm | Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis at Day 8 | Erythema | 13.8 percentage of participants |
| Active Arm | 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 |
| Vehicle Arm | Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis at Day 8 | Scaling | 6.4 percentage of participants |
| Vehicle Arm | Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis at Day 8 | Erythema | 0.9 percentage of participants |
| Vehicle Arm | Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis at Day 8 | Plaque Elevation | 3.6 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
Other Pre-specified
Proportion of Subjects With IGA Treatment Success at Day 8
Interim analysis of IGA. Treatment success and IGA as defined in the primary outcome measure.
Time frame: Day 8
Population: Analysis shown is based on the ITT population. Only participants with observed values are reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Arm | Proportion of Subjects With IGA Treatment Success at Day 8 | 16.5 percentage of participants |
| Vehicle Arm | Proportion of Subjects With IGA Treatment Success at Day 8 | 1.8 percentage of participants |
p-value: <0.001Cochran-Mantel-Haenszel