Psoriasis
Conditions
Keywords
Tapinarof, Plaque psoriasis, Adult, Phase 4, Topical, Open-label, Efficacy, Safety, Psoriasis, Intertriginous Psoriasis, Inverse Psoriasis
Brief summary
This is an open-label, multi-center study to evaluate the efficacy and safety of VTAMA (tapinarof) cream, 1% in adults with intertriginous psoriasis
Detailed description
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.
Interventions
DRUGVTAMA® (tapinarof) Cream 1%
VTAMA® (tapinarof) Cream 1% applied topically once daily
Sponsors
Organon and Co
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older, at the time of signing the informed consent * Participants with clinical diagnosis of plaque psoriasis, including lesion(s) in intertriginous area(s) and stable disease in intertriginous areas for at least 3 months prior to the study * An iPGA score of 2 (mild), 3 (moderate), or 4 (severe) at screening and baseline * Female subjects of child bearing potential who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study * Negative pregnancy test at Baseline (Day 1) * Capable of giving written informed consent
Exclusion criteria
* Diagnosis of a type of psoriasis other than plaque psoriasis * Any sign of infection of any of the psoriatic lesions * Concurrent significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study * History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with participation in the study and ability to understand and give informed consent * History of sensitivity to the study product, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study * Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001); previous or current use of VTAMA® (Tapinarof) Cream 1% * Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer) * UV light therapy or prolonged exposure to natural or artificial sources of UV radiation (e.g., phototherapy, tanning beds/booths, or therapeutic sunbathing) within 4 weeks prior to the Baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve an Intertriginous PGA (iPGA) Score of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement | from Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Achieve an iPGA Score of 0 or 1 With a ≥ 2 Grade Improvement | from Baseline to Week 12 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VTAMA® (Tapinarof) Cream 1% VTAMA® (tapinarof) Cream 1% applied topically once daily
VTAMA® (tapinarof) Cream 1%: VTAMA® (tapinarof) Cream 1% applied topically once daily | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | VTAMA® (Tapinarof) Cream 1% |
|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 15.88 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Intertriginous PGA 0 - Clear | 0 Participants |
| Intertriginous PGA 1 - Almost Clear | 0 Participants |
| Intertriginous PGA 2 - Mild | 10 Participants |
| Intertriginous PGA 3 - Moderate | 22 Participants |
| Intertriginous PGA 4 - Severe | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 13 / 34 |
| serious Total, serious adverse events | 2 / 34 |
Outcome results
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.
Time frame: from Baseline to Week 12
Population: Observed cases
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VTAMA® (Tapinarof) Cream 1% | Percentage of Participants Who Achieve an Intertriginous PGA (iPGA) Score of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement | 24 Participants |
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.
Time frame: from Baseline to Week 12
Population: Observed cases
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| VTAMA® (Tapinarof) Cream 1% | Time to Achieve an iPGA Score of 0 or 1 With a ≥ 2 Grade Improvement | 45.0 days |