Plaque Psoriasis
Conditions
Brief summary
This Phase 3 study (Study 310) 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 containing active drug
DRUGVehicle Foam
Topical Foam containing no active drug
Sponsors
Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is male or non-pregnant female and is at least 18 years of age at the time of the Screening Visit. 2. Subject has provided written informed consent. 3. Subject is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study. 4. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% body surface area (BSA) (excluding the face, scalp, groin, axillae and other intertriginous areas). 5. Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit. 6. Females must be post-menopausal , surgically sterile or use an effective method of birth control , with a negative urine pregnancy test (UPT) at the Baseline Visit.
Exclusion criteria
1. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis. 2. Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis. 3. 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. 4. 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 the Baseline Visit. 5. 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 the Baseline Visit. 6. Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental therapy) within five (5) half-lives of the biologic prior to the Baseline Visit. Published or documented half-life of the product provided by the commercial supplier or Sponsor should be used to establish this value. 7. Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the Baseline Visit or is intending to have such exposure during the study which in the opinion of the investigator is thought to modify the subject's disease. 8. Subject has used topical body (excluding the scalp) psoriasis therapy (including coal tar, anthralin, steroids, retinoids and vitamin D analogs) within 14 days prior to the Baseline Visit. 9. Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at the Baseline Visit. 10. Subject is currently using lithium or Plaquenil (hydroxychloroquine). 11. Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized, in the opinion of the investigator. 12. Subject has a history of sensitivity to any of the ingredients in the test articles. 13. Subject is pregnant, lactating, or is planning to become pregnant during the study. 14. Subject is currently enrolled in an investigational drug or device study. 15. Subject has used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit. 16. Subject has been previously enrolled in this study and treated with a test article. 17. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
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 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. |
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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA) | Day 8 | — |
| Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Day 8 | — |
| Change From Baseline in Pruritus Score | Day 15 | 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. |
| Changes in Percent BSA With Active Psoriasis in the Treatment Area | Day 15 | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment period: June 2016 to February 2017 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
Intervention: Drug: 122-0551 Foam
122-0551 Foam: Topical Foam containing active drug | 205 |
| Vehicle Foam Vehicle Foam, topically applied twice daily
Intervention: Drug: Vehicle Foam
Vehicle Foam: Topical Foam containing no active drug | 204 |
| Total | 409 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | 122-0551 Foam | Total | Vehicle Foam |
|---|---|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 13.9 | 50.2 years STANDARD_DEVIATION 13.9 | 50.1 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants | 108 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 151 Participants | 301 Participants | 150 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 26 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 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 | 190 Participants | 375 Participants | 185 Participants |
| Region of Enrollment United States | 205 participants | 409 participants | 204 participants |
| Sex: Female, Male Female | 92 Participants | 178 Participants | 86 Participants |
| Sex: Female, Male Male | 113 Participants | 231 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 205 | 0 / 204 |
| other Total, other adverse events | 12 / 205 | 14 / 204 |
| serious Total, serious adverse events | 0 / 205 | 1 / 204 |
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 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.
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) |
|---|---|---|
| 122-0551 Foam | Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA) | 30.7 percentage of participants |
| Vehicle Foam | Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA) | 7.4 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)
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.
Time frame: Day 15
Population: Analysis shown is based on the Intent-to-Treat (ITT) population.
| 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) | Plaque Elevation | 35.0 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) | Scaling | 33.7 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 | 28.8 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) | Plaque Elevation | 9.9 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) | Scaling | 9.8 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) | Erythema | 8.3 percentage of participants |
Comparison: Treatment groups were compared with respect to each of the clinical signs of psoriasis (plaque elevation, scaling, and erythema).p-value: <0.001Cochran-Mantel-Haenszel
Other Pre-specified
Change From Baseline in Pruritus Score
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 122-0551 Foam | Change From Baseline in Pruritus Score | -4.3 scores on a scale | Standard Deviation 3.8 |
| Vehicle Foam | Change From Baseline in Pruritus Score | -2.5 scores on a scale | Standard Deviation 3.3 |
Other Pre-specified
Changes in Percent BSA With Active Psoriasis in the Treatment Area
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 122-0551 Foam | Changes in Percent BSA With Active Psoriasis in the Treatment Area | -1.5 Change in percent BSA | Standard Deviation 2.3 |
| Vehicle Foam | Changes in Percent BSA With Active Psoriasis in the Treatment Area | -0.2 Change in percent BSA | Standard Deviation 1.5 |
Other Pre-specified
Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA)
Time frame: Day 8
Population: Analysis shown is based on the ITT population. Only participants with observed values are reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 122-0551 Foam | Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA) | 9.5 percentage of participants |
| Vehicle Foam | Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA) | 3.6 percentage of participants |
p-value: 0.012Cochran-Mantel-Haenszel
Other Pre-specified
Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
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) |
|---|---|---|---|
| 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 | 13.2 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) | Scaling | 14.2 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 | 8.0 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 | 3.6 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) | Scaling | 3.6 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) | Erythema | 3.1 percentage of participants |