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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Arm | Experimental | Topical lotion, applied twice daily |
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| Vehicle Arm | Placebo Comparator | Topical lotion, applied twice daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 000-0551 Lotion | Drug |
| ||
| Vehicle Lotion |
| Measure | Description | Time Frame |
|---|---|---|
| The 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). | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| The 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 |
|---|---|---|
| Percentage of Subjects With IGA "Treatment Success" at Day 8 | Interim analysis of IGA. "Treatment success" and IGA as defined in the primary outcome measure. | Day 8 |
| Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) at Day 8 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Syd Dromgoole, Ph.D. | Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama | United States | |||
| MOORE Clinical Research, Inc. |
All subjects who met the entry criteria were randomized and enrolled into the study.
Recruitment period: June 2013 to February 2014
The location of clinical sites included dermatology clinics and clinical research centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Arm | Topical lotion, applied twice daily 000-0551 Lotion |
| FG001 | Vehicle Arm | Topical lotion, applied twice daily Vehicle Lotion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Day 15 |
Interim analysis of clinical signs of psoriasis. "Treatment success" for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) at Day 8 as defined in the secondary outcome measure. |
| Day 8 |
| 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). | Baseline and Day 15 |
| Change in Percent Body Surface Area (% BSA) With Active Psoriasis at 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. | Day 15 |
| Brandon |
| Florida |
| United States |
| Florida Academic Dermatology Center | Miami | Florida | United States |
| Park Avenue Dermatology, PA | Orange Park | Florida | United States |
| The Indiana Clinical Trials Center, PC | Plainfield | Indiana | United States |
| Hamzavi Dermatology | Fort Gratiot | Michigan | United States |
| The Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | United States |
| Arlington Research Center, Inc. | Arlington | Texas | United States |
| DermResearch, Inc. | Austin | Texas | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Arm | Topical lotion, applied twice daily 000-0551 Lotion |
| BG001 | Vehicle Arm | Topical lotion, applied twice daily Vehicle Lotion |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | The 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). | All subjects were classified into the following datasets: intent-to-treat (ITT), per protocol (PP), and safety populations. 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. | Posted | Number | percentage of participants | Day 15 |
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| Secondary | The 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. | Posted | Number | percentage of participants | Day 15 |
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| Other Pre-specified | Percentage of Subjects With IGA "Treatment Success" at Day 8 | Interim analysis of IGA. "Treatment success" and IGA as defined in the primary outcome measure. | 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. Only participants with observed values are reported. | Posted | Number | percentage of participants | Day 8 |
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| Other Pre-specified | Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) at Day 8 | Interim analysis of clinical signs of psoriasis. "Treatment success" for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) at Day 8 as defined in the secondary outcome measure. | 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. Only participants with observed values are reported. | Posted | Number | percentage of participants | Day 8 |
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| 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). | 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. Only participants with observed values are reported. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 15 |
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| Other Pre-specified | Change in Percent Body Surface Area (% BSA) With Active Psoriasis at 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. | Analysis shown is based on the Intent-to-Treat (ITT) population at Day 15 and compared to baseline. ITT was defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported. | Posted | Mean | Standard Deviation | Change in %BSA | Day 15 |
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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 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=222) were included in the safety population. Most AEs were mild in severity.
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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 | Topical lotion, applied twice daily 000-0551 Lotion | 1 | 110 | 10 | 110 | ||
| EG001 | Vehicle Arm | Topical lotion, applied twice daily Vehicle Lotion | 0 | 112 | 5 | 112 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Obstructive Pulmonary Disease with Acute Exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Non-systematic Assessment | The event was determined to be unrelated to the test article. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bowel movement irregularity | Gastrointestinal disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Application site atrophy | General disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Application site pain | General disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Application site telangiectasia | General disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Otitis media acute | Infections and infestations | MedDRA, version 16.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA, version 16.0 | Non-systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA, version 16.0 | Non-systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA, version 16.0 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Nail bed disorder | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research, Therapeutics Inc. | Therapeutics, Inc. | 585-571-1800 | clinicalreseach@therapeuticsinc.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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