Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, multi-center study to evaluate the efficacy and safety of VTAMA (tapinarof) cream, 1% in adults with intertriginous psoriasis
This is an open-label study in which participants will be assigned to receive VTAMA (tapinarof) cream, 1% once daily for 12 weeks. Study participants will have a follow-up period of 1 week. The study duration will be up to 17 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VTAMA® (tapinarof) Cream 1% | Experimental | VTAMA® (tapinarof) Cream 1% applied topically once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VTAMA® (tapinarof) Cream 1% | Drug | VTAMA® (tapinarof) Cream 1% applied topically once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve an Intertriginous PGA (iPGA) Score of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement | Intertriginous Physician Global Assessment (iPGA) is a clinical tool for assessing the current state/severity of a subject's psoriasis in the intertriginous areas at a given timepoint. It is a static 5-point assessment of plaque qualities on the clinical characteristics of erythema, scaling, and plaque thickness/elevation within the intertriginous areas. The iPGA ranges from 0 to 4, and is calculated as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher iPGA scores represent more severe disease. | from Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Achieve an iPGA Score of 0 or 1 With a ≥ 2 Grade Improvement | Intertriginous Physician Global Assessment (iPGA) is a clinical tool for assessing the current state/severity of a subject's psoriasis in the intertriginous areas at a given timepoint. It is a static 5-point assessment of plaque qualities on the clinical characteristics of erythema, scaling, and plaque thickness/elevation within the intertriginous areas. The iPGA ranges from 0 to 4, and is calculated as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher iPGA scores represent more severe disease. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermavant Investigative Site | Fort Smith | Arkansas | 72916 | United States | ||
| Dermavant Investigative Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | VTAMA® (Tapinarof) Cream 1% | VTAMA® (tapinarof) Cream 1% applied topically once daily VTAMA® (tapinarof) Cream 1%: VTAMA® (tapinarof) Cream 1% applied topically once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 14, 2022 | Jun 25, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| from Baseline to Week 12 |
| Los Angeles |
| California |
| 90045 |
| United States |
| Dermavant Investigative Site | Boca Raton | Florida | 33431 | United States |
| Dermavant Investigative Site | Margate | Florida | 33063 | United States |
| Dermavant Investigative Site | Plainfield | Indiana | 46168 | United States |
| Dermavant Investigative Site | Houston | Texas | 77004 | United States |
| Dermavant Investigative Site | Webster | Texas | 77598 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | VTAMA® (Tapinarof) Cream 1% | VTAMA® (tapinarof) Cream 1% applied topically once daily VTAMA® (tapinarof) Cream 1%: VTAMA® (tapinarof) Cream 1% applied topically once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Intertriginous PGA | Intertriginous Physician Global Assessment (iPGA) is a clinical tool for assessing the current state/severity of a subject's psoriasis in the intertriginous areas at a given timepoint. It is a static 5-point assessment of plaque qualities on the clinical characteristics of erythema, scaling, and plaque thickness/elevation within the intertriginous areas. The iPGA ranges from 0 to 4, and is calculated as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher iPGA scores represent more severe disease. | Count of Participants | Participants |
|
| 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 Participants Who Achieve an Intertriginous PGA (iPGA) Score of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement | Intertriginous Physician Global Assessment (iPGA) is a clinical tool for assessing the current state/severity of a subject's psoriasis in the intertriginous areas at a given timepoint. It is a static 5-point assessment of plaque qualities on the clinical characteristics of erythema, scaling, and plaque thickness/elevation within the intertriginous areas. The iPGA ranges from 0 to 4, and is calculated as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher iPGA scores represent more severe disease. | Observed cases | Posted | Count of Participants | Participants | from Baseline to Week 12 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Time to Achieve an iPGA Score of 0 or 1 With a ≥ 2 Grade Improvement | Intertriginous Physician Global Assessment (iPGA) is a clinical tool for assessing the current state/severity of a subject's psoriasis in the intertriginous areas at a given timepoint. It is a static 5-point assessment of plaque qualities on the clinical characteristics of erythema, scaling, and plaque thickness/elevation within the intertriginous areas. The iPGA ranges from 0 to 4, and is calculated as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher iPGA scores represent more severe disease. | Observed cases | Posted | Median | 95% Confidence Interval | days | from Baseline to Week 12 |
|
|
13 Weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VTAMA® (Tapinarof) Cream 1% | VTAMA® (tapinarof) Cream 1% applied topically once daily VTAMA® (tapinarof) Cream 1%: VTAMA® (tapinarof) Cream 1% applied topically once daily | 0 | 34 | 2 | 34 | 13 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Folliculitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Lead, Late-Stage Clinical Development | Organon and Co | 551-430-6000 | pdrl@organon.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2023 | Apr 29, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571829 | tapinarof |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 2 - Mild |
|
| 3 - Moderate |
|
| 4 - Severe |
|
|