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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Arm | Experimental | 122-0551 Foam, topically applied twice daily for two weeks |
|
| Vehicle Arm | Placebo Comparator | Vehicle Foam, topically applied twice daily for two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 122-0551 Foam | Drug | 122-0551 Foam applied twice daily to treat psoriasis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With IGA "Treatment Success" | "Treatment success" and IGA as defined in the primary outcome measure. | Day 8 |
| Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Andrasfay | Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama | 35205 | United States | ||
| UCSD Dermatology |
All subjects who met the entry criteria were randomized and enrolled into the study.
Recruitment period: January 2015 to August 2015
The location of clinical sites included dermatology clinics and clinical research centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Arm | 122-0551 Foam, topically applied twice daily for two weeks 122-0551 Foam: 122-0551 Foam applied twice daily to treat psoriasis |
| FG001 | Vehicle Arm | Vehicle Foam, topically applied twice daily for two weeks Vehicle Foam: Vehicle Foam applied twice daily to treat psoriasis |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Arm | 122-0551 Foam, topically applied twice daily for two weeks 122-0551 Foam: 122-0551 Foam applied twice daily to treat psoriasis |
| BG001 | Vehicle Arm | Vehicle Foam, topically applied twice daily for two weeks Vehicle Foam: Vehicle Foam applied twice daily to treat psoriasis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and dispensed the test article. | Posted | Number | percentage of participants | Day 15 |
|
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.
The safety population included all participants 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 participants (N=144) were included in the safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Arm | 122-0551 Foam, topically applied twice daily for two weeks 122-0551 Foam: 122-0551 Foam applied twice daily to treat psoriasis |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site dryness | General disorders | MedDRA (17.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Director | Therapeutics, Inc. | 858-571-1800 | projectmanager@therapeuticsinc.com |
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| Vehicle Foam |
| Drug |
Vehicle Foam applied twice daily to treat psoriasis |
|
| Day 15 |
"Treatment success" and clinical signs as defined in the secondary outcome measure. |
| 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). | 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. | Day 8 and Day 15 |
| San Diego |
| California |
| 92122 |
| United States |
| Leavitt Medical Associates of Florida d/b/a Ameriderm Research | Ormond Beach | Florida | 32174 | United States |
| Shideler Clinical Research Center | Carmel | Indiana | 46032 | United States |
| The Indiana Clinical Trials Center, PC | Plainfield | Indiana | 46168 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| Arlington Research Center, Inc. | Arlington | Texas | 76011 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Vehicle Arm | Vehicle Foam, topically applied twice daily for two weeks Vehicle Foam: Vehicle Foam applied twice daily to treat psoriasis |
|
|
| 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). | Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Missing data was imputed as failure. | Posted | Number | percentage of participants | Day 15 |
|
|
|
| Other Pre-specified | Proportion of Subjects With IGA "Treatment Success" | "Treatment success" and IGA as defined in the primary outcome measure. | Not Posted | Day 8 | Participants |
| Other Pre-specified | 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. | Not Posted | Day 8 | Participants |
| 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). | Not Posted | Day 15 | Participants |
| Other Pre-specified | 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. | Not Posted | Day 8 and Day 15 | Participants |
| 0 |
| 71 |
| 0 |
| 71 |
| 2 |
| 71 |
| EG001 | Vehicle Arm | Vehicle Foam, topically applied twice daily for two weeks Vehicle Foam: Vehicle Foam applied twice daily to treat psoriasis | 0 | 73 | 0 | 73 | 3 | 73 |
| Application site pain | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Trichorrhexis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
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 thirty days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
| Plaque Elevation |
|